Gap analysis report - Coe

Gap analysis report Needs Assessment – Falsified Medical Products

(NA-FAMED) of the MEDICRIME Convention

Gap analysis report Needs Assessment – Falsified Medical Products

(NA-FAMED) of the MEDICRIME Convention

MEDICRIME SecretariatDirectorate General I- Human Rights and Rule of Law

Council of Europe

All requests concerning the reproductionor translation of all or part of this

document should be addressed to theDirectorate of Communication (F-67075

Strasbourg Cedex or [email protected]).Comments on this report are welcome and can be sent to:

Council of EuropeMEDICRIME Secretariat

Avenue de l’EuropeF-67075 Strasbourg Cedex, France

E-mail: [email protected]

Cover photo: Shutterstock

Cover and layout: Calligramme

© Council of Europe, November 2021Printed at the Council of Europe

The content of this publication does not necessarily reflect the views or policies of the Council of Europe, the MEDICRIME Committee or any official position of the governments of the countries participating in this report, and nor does it imply any endorsement.The terms employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the Council of Europe concerning the legal status of any country or of its authorities.Information on links to Internet sites contained in the present publication are provided for the convenience of the reader. The Council of Europe takes no responsibility for the continued accuracy of that information or for the content of any external website.The named authors alone are responsible for the views expressed in this publication.

Mr. Hugo BONARProf. Dr. iur. Dr. med. Carlos ROMEO-CASABONAProf. Dr. iur. Dr. med. Asier Urruela MOR

mailto:[email protected]

Table of Contents Page 3

TABLE OF CONTENTS

ABBREVIATIONS 5

EXECUTIVE SUMMARY 7

I. INTRODUCTION 9

1.1 Context 9

1.2 Objective 9

1.3 Methodology 9

1.4 Countries participating 10

1.5 Limitations 11

II. GENERAL REPORT 13

2.1. Applicable Law 13

2.2. Issues Analysed 13

2.3. Conclusions 15

2.4. Recommendations 16

III. COUNTRY REPORTS 17

3.1 Andorra 17

3.2 Armenia 19

3.3 Austria 21

3.4 Azerbaijan 23

3.5 Bulgaria 25

3. 6 Canada 28

3.7 Cyprus 29

3.8 Czech Republic 31

3.9 Denmark 33

3.10 Ecuador 35

3.11 Estonia 37

3.12 Finland 40

3.13 Germany 41

3.14 Georgia 44

3.15 Greece 47

3.16 Guinea 49

3.17 Iceland 51

3.18 Ireland 53

3.19 Italy 55

3.20 Japan 57

3.21 Latvia 60

3.22 Lithuania 62

3.23 Mexico 64

3.24 Montenegro 66

3.25 Morocco 69

3.26 North Macedonia 71

3.27 Norway 73

3.28 Poland 75

3.29 Romania 78

3.30 Serbia 80

3.31 Slovak Republic 83

3.32 Slovenia 85

3.33 Sweden 87

3.34 Tunisia 90

3.35 United Kingdom 92

3.36 United States of America 94

IV. APPENDICES 97

Appendix 1- NA-FAMED -0- Gap Analysis Survey 97

Appendix 2 - NA-FAMED - A1 -Document A 100

Appendix 3 - NA-FAMED - A2 - Appendix 1 107

Appendix 4 - NA-FAMED Document B - Case Law (Law-enforcement or jurisprudential) analysis 108

Appendix 5 - Links to country laws by National Consultants 175

Appendix 6 – List of National Consultants 181

ABBREVIATIONS Page 5

ABBREVIATIONS

AMG Medicinal Product Act, 2005, as amended (Germany)

AMWHV Medicines and Drug Manufacturing Ordinance (Germany)

CC Criminal Code

CoE Council of Europe

EU European Union

GHL General Health Law -Ley General de Salud (México)

IVDR In Vitro Diagnostic Medical Device Regulation (2017/746)

LMPMD Law on Medicinal Products and Medical Devices (North Macedonia)

MDR European Union Medical Device Regulation (2017/745)

MPG Law on Medical Devices (Germany)

MPDG Medical Device Implementation Law (Germany)

NA-FAMED Needs Assessment-Falsified Medical Products

OWiG Law on Administrative Contraventions (Ordnungswidrigkeitengesetz) (Germany)

PC Penal Code

StGB Criminal Code (Austria and Germany)

EXECUTIVE SUMMARY Page 7

EXECUTIVE SUMMARY

1. Guinea

L aunched by the Council of Europe (hereinafter, CoE), the multiregional project entitled “Needs Assessment - Falsified Medical Products” (NA-FAMED) is aimed at providing technical assistance and supporting CoE member States and other countries to fight against the falsification of medical products and other similar

crimes. Against this background, a questionnaire to establish a baseline assessment on the state of readiness of CoE member States and other countries to fight against this growing crime was drafted and sent to 40 countries around the world. The summary report of the responses received to this questionnaire illustrates that some countries have already begun the implementation of national laws that facilitate a preparedness to sign and ratify the MEDICRIME Convention.As the countries reported on in this report have not yet signed or rati-fied the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (hereinafter, the “MEDICRIME Convention” or “the Convention”), with one exception1. This report is not a monitoring exercise. It provides support to those countries in indicating areas where cor-respondence may exist between national laws and the MEDICRIME Convention, or where further work may be needed to facilitate implementation on reaching ratification

The substantive Criminal Law provisions of the Convention (Articles 5-13) are underpinned by the Definitions (Article 4). Unless these definitions are adequately implemented into internal laws the substantive provisions will be deficient and thus weaken the application of the MEDICRIME Convention and the ability of the countries to combat counterfeiting of medical products and similar crimes involving threats to public health. If the base offences of the Convention (Articles 5-8) are deficient, the applicability of other provisions (Articles 9 -13) will not be possible.

It should be noted that the MEDICRIME Convention has been designed to comprehensively deal through the criminal law with crises that threaten public health, as the COVID-19 pandemic, that involve criminal acts, endanger the rights and welfare of victims, and challenge national and international cooperation to combat medical product counterfeiting, as defined in Articles 1 and 4.j.

The study outlines in IV. General Report the general horizontal issues that are reported in a number of countries in responses to the questionnaire. There follows the study recommendations and conclusions.

The individual country reports proceed in V. Country Reports through the format of the questionnaire in identifying areas where the CoE could provide support towards ratification and full implementation of the MEDICRIME Convention.

Page 9

I. INTRODUCTION

2. See definition of the term ‘counterfeit’ in Article 4.j), MEDICRIME Convention3. See definition of the term ‘medical product’ in Article 4.a), MEDICRIME Convention4. General Overview Questionnaire on the Implementation of the MEDICRIME Convention. Available at: https://rm.coe.

int/t-medicrime-2020-cp-e-country-profile-questionnaire/1680a0ba04

1.1 Context

The CoE is conducting this Gap Analysis Survey to assess the level to which current domestic criminal and other legislation support the prohibition and enforcement against counterfeit2/falsified medical products as criminal offences for the purpose of protecting public health. This is the first part of a two-part survey. The focus of this first part is on the definitions and the substantive criminal law. It also begins to ascertain the extent of criminal actions related to medical product counterfeiting and similar crimes prosecuted by countries. In addition, the MEDICRIME Secretariat, as part of the NA-FAMED survey, is recording details of the different agencies/organisations in countries on the distribution of responsibilities for enforcing against the counterfeiting of medical products and similar crimes. Part 2 of the NA-FAMED survey will be circulated at a future date and will focus on the non-substantive criminal law aspects of the MEDICRIME Convention.

1.2 Objective

The purpose of the NA- FAMED survey is to identify for the CoE how best it can support its member States and other countries build a criminal law and supporting framework under the MEDICRIME Convention to combat counterfeit/falsified medical products3 and similar crimes involving threats to public health. This is the criminal law approach, which aims at criminalising behaviour that balances and complements the public health approach to protect the medical product. The gap analysis aims to improve and strengthen legal, regulatory and policy frameworks in different countries. NA-FAMED will identify the main beneficiaries and the legal and procedural issues leading to criminalisation of the production and trade in falsified medical products.

1.3 Methodology

The NA-FAMED survey was distributed to one national consultant in the relevant national legislation for each of the 40 countries involved in the survey. These countries excluded, mostly, Parties to the MEDICRIME Convention that were previously surveyed in the General Overview Questionnaire4 on the implementation of the MEDICRIME Convention in 2020. The national consultant was free to contact their national Ministries/agencies that are normally involved in combating counterfeit/falsified medical products (Justice, Health, Police Service, Customs Service, health product regulatory authority, etc). This approach is to achieve an objective review of legislation in place in the selected countries in the survey in relation to the Criminal Law provisions that address the counterfeiting, as defined in the MEDICRIME Convention, of medical products. It also provides data on some case law in the selected countries in the survey. The data obtained from this survey enables an assessment to be made on the legislative needs by country in order to correspond with the provision of the MEDICRIME Convention should the country wish to ratify the Convention and complete implementation. Wherever a non-response was provided, it was taken that no relevant provision in the internal law could be found by the national consultant to correspond with the MEDICRIME Convention.

https://rm.coe.int/t-medicrime-2020-cp-e-country-profile-questionnaire/1680a0ba04

https://rm.coe.int/t-medicrime-2020-cp-e-country-profile-questionnaire/1680a0ba04

Page 10 Gap analysis report

It is noted that the countries included in the survey have not ratified the Convention and have no obligations at this stage to come into correspondence with it. The NA-FAMED report implies a prospective analysis related to the level of needs for implementation of certain provisions of the MEDICRIME Convention of countries included in the study in view of their potential accession to the Convention. This has been done to facilitate an early assessment of laws of those countries to enable them to achieve correspondence with the MEDICRIME Convention at an early stage. No obligation has been assumed up to now by those countries related to the MEDICRIME Convention, and consequently the present study must be considered in those prospective terms. The intention by the Council of Europe is to facilitate the identification of areas where the implementation of the MEDICRIME Convention would require legislative activity by the country.

The submissions by the national consultants were requested to be in either the English or French language, or both. Only one consolidated response to the Survey was submitted by each national consultant. The survey assessors, in drafting this report, were not in a position to translate and interpret appropriately from different languages other than from the English and French languages.

The NA-FAMED questionnaire was grouped under two main sections. The choice of these sections did not seek to prioritise the various provisions of the Convention: equal importance was attached to all rights and principles therein. This report was conducted based on the information provided by national consultants under the headings of: Preliminary (matters) and Substantive Criminal Law. The General Report on horizontal review, those issues looking in a horizontal way and not on a country-by-country way, comments only on the issues of greatest importance to the MEDICRIME Convention implementation. Many other issues are listed in the chapter “Country Reports – an assessment by the Report drafters on responses received from national consultants” and are reflected in the state of implementation chart of the MEDICRIME Convention.

National consultants were also requested to provide information on case law from their respective countries relevant to matters contained in the MEDICRIME Convention. This was requested under the heading of Case-law (law enforcement or jurisprudential) analysis.

As regards the CoE member States and the other countries considered in the NA-FAMED survey that have not signed or ratified the MEDICRIME Convention to date, this report seeks to assess existing legislation of those countries against the selected articles of the MEDICRIME Convention. This permits countries identify legislative gaps and consequential legislative needs that may assist them prepare to reach full ratification and subsequent implementation. It is meant to indicate, as at a minimum, what is absent and if included, would be sufficient in law in circumstances where the country sought to ratify the MEDICRIME Convention.

The reporting in this report is based on the following considerations:

f Where correspondence between internal laws and the specific article of the Convention is absent a com-ment in each article is made.

f Where there is a sufficiency of correspondence with the specific article in the MEDICRIME Convention, but different wording is used in internal laws, it is recommended, for the avoidance of any doubts on the intent of the Convention provision, and national language permitting and being respected, the language and wording of the Convention be adopted.

f Where the internal law provision is different, though sufficient in intent and content, this will be stated.

f Where the internal law provision is incomplete, further action will be needed and this will be stated.

f Where correspondence with the specific article of the Convention is found, no further action is recommended.

1.4 Countries participating

A total of 40 countries were circulated with the NA-FAMED survey from which 36 countries responded. One country withdrew and no response was received at the time of drafting of this report from the national consultant in relation to Israel, Luxembourg and the Netherlands. A total of 22 responses were received to the survey on case-law. The report was concluded based on the information received.

The participating CoE member States are the following: Andorra, Armenia, Austria, Azerbaijan, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Georgia, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Montenegro, North Macedonia, Norway, Poland, Romania, Serbia, Slovak Republic, Slovenia, Sweden and United Kingdom.

The participating non-CoE member States are the following: Canada, Ecuador, Guinea, Japan, Mexico, Morocco, Tunisia and United States of America.

I. Introduction Page 11

1.5 Limitations

This report is based on submissions made by national consultants on the relevant national laws. They do not necessarily reflect the respective national government’s opinion. Web links are provided by the national consultant in support of the submissions made. These links may not be exhaustive and have not been independently verified. They are provided for information only in this report.

Laws contemplated by countries but not enacted at the time of drafting of this report are not taken into consideration, even where the national consultant included this information. The reason for this is that no assessment can be made on laws in draft form only. Laws enacted but not yet entered into force at the completion date of this report have been included only for information and not to assess correspondence with the MEDICRIME Convention.

Medical Device Regulation 2017/745/EU (MDR)

The EU made new regulations in 2017 on medical devices, namely Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The implementation date for Regulation 2017/745 is 26 May 2021. This Regulation provides a definition of a falsified medical device. EU member States are required to implement the regulation from that date and include any national enforcement measures. Where a member State of the EU has, prior to the drafting of this report, implemented legislative provisions necessary to give effect to certain provisions that correspond with the MEDICRIME Convention this has been taken into consideration in this report. It is recognised that from 26 May 2021 the remaining EU Member States included in this report will also have taken into account the effect of those regulations. Their correspondence with certain articles of the MEDICRIME Convention should then have altered. However, such EU member States may require that further actions still be needed to come into full correspondence with all articles of the MEDICRIME Convention, in particular any criminal law enforcement requirements.

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II. GENERAL REPORT

This horizontal study is intended to

f identify issues in common to the member States and other countries considered in this report, for noting where the implementation process may be facilitated and enhanced and

f to identify for the CoE how best it can support member States build a criminal law and supporting framework under the MEDICRIME Convention to combat counterfeit/falsified medical products and similar crimes involving threats to public health.

2.1. Applicable Law

It is noted that the internal laws that may be used in the countries in this report to address the falsification of medical products and similar crimes involving threats to public health are:

i. a mixture of the criminal and regulatory laws;

ii. in some countries, it is mainly the penal laws that are used to contain criminal law provisions on the falsi-fication of medical products;

iii. in other countries it is mainly the regulatory law provision;

iv. in some, there is no applicable law.

In most countries, the two types of laws are not coordinated towards and not intended for the challenges now raised by the issues contemplated by the MEDICRIME Convention. These include the use of definitions where they may not be an applicable offence. Offences may not apply where there is no applicable base offence. This may arise, for example, in relation to aiding or abetting and attempt.

In no case could there be found a single law dealing with the counterfeiting of medical products and similar crimes involving threats to public health.

2.2. Issues Analysed

General comment

The MEDICRIME Convention was drafted with the intent that it be a holistic instrument with an interlinking fabric of support between provisions. It has been observed that countries included in this report, in the absence of specific criminal laws relating to the counterfeiting of medical products and similar crimes involving threats to public health, may rely on disparate provisions in both regulatory and the general criminal laws which were intended for different purposes. This approach would make ratification of the Convention challenging. In most of the national laws of countries included in this study in relation to specific articles, it is noted that it is the regulatory provisions that exist and that in some cases, the breach of these provisions can have a sanction that is criminal in nature. This position tends to obscure that the regulatory provisions are intended to regulate the manufacture, supply and marketing of medical products with a view to providing safe, efficacious and quality medical products, and act as a preventive measure for potential breaches. Such laws, in most case, did not contemplate that they would be used in the manner of the criminal law to investigate and prosecute intentional


offending with the intention that there be a penal sanction, but this is generally the only avenue open in the absence of any, not alone specific criminal law provisions. Examples of this relate to such areas as are contemplated by the substantive articles of the Convention, in particular Article 5-9 and 11. This applies also to Article 10 and 12, MEDICRIME Convention which were not considered in the NA-FAMED study. Where there is a reliance on the criminal law, and not on regulatory laws, it is often on laws that are inappropriate or inapplicable. An example of this is a reliance on the Criminal Code and similar laws to provide for the offences of aiding and abetting and attempt. In some such cases the application of the Criminal Code may not apply outside the specified offences and sanctions provided for in the Code. These generally do not apply to medical products. It is recognised that in a limited number of cases that it is the Criminal Code that is used to address counterfeiting and other intentional offending relating to medicinal products and or medical devices. In most such cases, the provision is very general and requires more specificity to come into full correspondence with the MEDICRIME Convention.

It is important to emphasise at this point that according to Article 1 (Object and Scope) the MEDICRIME Convention is a criminal law instrument to prevent and combat threats to public health through the criminalisation of certain acts; protecting the rights of victims of the offences established under this Convention; and promoting national and international co-operation.

The NA-FAMED report limits its analysis to the sphere of definitions (Article 4, MEDICRIME Convention), to the offences established based on Articles 5 – 8, to the aiding and abetting and attempt (Article 9), to corporate liability (Article 11), and to the aggravating circumstances (Article 13). Due the methodological approach chosen in this report, other provisions have not been considered at this time. These include Article 10 (Jurisdiction), Article 12 (Sanctions and measures), and Article 14 (Previous convictions) as well as Investigation, prosecution and procedural law aspects implied by the MEDICRIME Convention (Chapter III), Co-operation of authorities an information exchange (Chapter IV), Measures for prevention (Chapter V), Measures for protection (Chapter VI) and International Cooperation (Chapter VII). As these latter mentioned provisions of the MEDICRIME Convention also imply important obligations for Parties, further analysis related to these topics will have to be developed in the future.

Analysis of the different articles considered

Article 4 – definitions

No country included in this report has national laws which include full implementation of all the definitions included in Article 4 of the MEDICRIME Convention. The importance of the implementation of such definitions must be highlighted as they are the basis for the correct application of the criminal offences established in Chapter II of the MEDICRIME Convention. Different terms with similar meanings to the terms in Article 4 have been observed. In order to ensure homogeneity, it is recommended that the terms used in Article 4 be used when drafting legislation towards ratification of the Convention.

Articles 5 - 8

In most of the countries included in the report, the legislation is mostly regulatory or general and does not provide for offences in the criminal law that would correspond with the offences contemplated by Article 5–8, MEDICRIME Convention. In some countries, specific criminal law provisions are used. It is important to refer to the Explanatory Report to the Convention when it states, “in the case of an individual committing an offence established under Articles 5 and 6, Parties must provide for prison sentences that can give rise to extradition”.

Other Substantive Criminal Law Provisions: Article 9 (aiding or abetting and attempt), Article 11 (Corporate liability) and Article 13 (aggravating circumstances) are directly connected with the way in which each country establishes the offences of Articles 5-8 MEDICRIME Convention. The implementation at the internal level of Articles 9-13 MEDICRIME Convention only achieves full significance based on an adequate criminalisation of Articles 5-8 MEDICRIME Convention by each country.

As the Convention ensures the harmonisation at the international level (at least for the countries that have signed and ratified the Convention) for these offences, the absence of such for a great number of countries results in a weak and uncoordinated response to the counterfeiting of medical products and similar crimes. This facilitates intentional offending, in particular, by organised criminal groups, and the consequential threat to public health. Countries need to think on the international cooperation level to address the threat at the local level.

II. General report Page 15

Case law review

The national consultants, in 22 countries, submitted examples of case law relating to prosecutions involving medical products (see Appendix 4). It was not intended that the submissions be analysed for correspondence to the MEDICRIME Convention as none of the countries, not having ratified the Convention, have obligations under it.

In relation to the MEDICRIME Convention, the following can be extrapolated from the submissions made.

The type of offending behaviours contemplated by the MEDICRIME Convention in Articles 5-8, 9 and 11, appear to have existed for many years in the past and will continue to do so and be prosecuted, utilising varying provision in the 22 countries included in the Case law review survey. There is no evidence, regionally or globally, to suggest that this type of offending behaviour relating to counterfeit (falsified) medical products and similar crimes involving threats to public health will not continue. It is, therefore, reasonable to assume that these 22 countries will continue to be confronted with such crimes. For the remainder of the 16 countries in the NA-FAMED report for whom no submissions were made on case law by the national consultants, it is reasonable to assume that they are in no different a position than the 22 countries just mentioned. The national consultants were not instructed on the number of prosecutions to report on. Of the 22 countries, some national consultants submitted a single example of a recent relevant prosecution, while in other countries cases going back many years were submitted.

Aggravating circumstances, as contemplated by Article 13 a-e, MEDICRIME Convention, appeared to have played a part in several the case law submissions made. It is unclear the extend of all such circumstances that played a part in the offending behaviours prosecuted, even where there was no law existed to provide for the aggravating circumstances to be considered by the Court in determining sanctions.

The reports on prosecution in the 22 countries appeared to have based these on the criminal law, administrative law and general (e.g., Trademark law). It cannot be reported that there was a consistent approach on which choice of law would be used when looking horizontally across countries. This suggests the absence of a harmonised approach across countries in prosecutable offences relating to counterfeit/falsified medical products and similar crimes.

It is unclear whether the offences involved in some prosecutions attracted a custodial sentence sufficient enough to enable extradition under the Convention, if any custodial sentence was possible. It is noted that Article 12 MEDICRIME Convention provides that for the offences contemplated by Articles 5 and 6, when committed by natural persons, penalties should involve the deprivation of liberty that may give rise to extradition.

The case law review reported by national consultants suggests that had the countries involved in the NA-FAMED survey ratified the MEDICRIME Convention, they would have had at their disposal a dedicated criminal law framework to address the offending behaviours in a consistent and harmonised manner for the purpose of comprehensively and effectively prosecuting counterfeiting (falsification) of medical products and similar crimes involving threats to public health.

This report, in the following section of the Country Report, assesses specific provisions of the country laws for correspondence with the relevant article of the Convention. While an overall assessment of correspondence with the Convention should be reflected by this approach, this has not always been possible due to the absence of a definition and or the base criminal law offence.

2.3. Conclusions

1. The responses to the questionnaire by national consultants having surveyed the national laws indicate that countries are attempting to address the counterfeiting of medical products and other similar crimes involving threats to public health through whatever existing laws are available notwithstanding that such laws were not sufficiently comprehensive or intended for this purpose.

2. The countries recognise the threat existing to public health from falsified medical products and similar crimes. They have, in many cases put in place laws that partially, though not wholly or comprehensively, support an early ratification and implementation of the MEDICRIME Convention.

3. The NA-FAMED survey report identifies for the CoE member States and other countries included in this survey, legal and procedural gaps that need to be closed for the criminalisation of the products and trade of falsified medical products.

4. The CoE can now establish how best it can support member States and other countries build a criminal law and supporting framework under the MEDICRIME Convention to combat counterfeit/falsified medical products and similar crimes involving threats to public health.


2.4. Recommendations

It is recommended that:1. In the drafting of internal laws to prepare for ratification and implementation of the MEDICRIME Convention,

a single holistic law encompassing all elements provided for in the Convention be enacted. 2. A hybrid approach to drafting the implementing law be used whereby the criminal law and the regulatory

law reference points co-exist. This avoids a disjointed approach of trying to relate medical product technical details, such as definitions, to disconnected criminal law offences. It would facilitate simpler and friendlier use for investigation and prosecution of intentional offending and ensure better outcomes for protecting public health.

3. The general criminal law may adequately implement the corresponding provision in the Convention, for example in Articles 9 and 11, to the extent that the domestic law adequately implements the offences defined in the Convention. This is reliant on such offences being implemented in the internal law, then criminalisation of the commission of such offence arises automatically.

4. Isolated reliance on provisions in other laws should not be used as correspondence with specific articles in the Convention as this will defeat the intent and spirit of the Convention. It would weaken the impact on combating counterfeit medical products and other similar crimes involving threats to public health.

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III. COUNTRY REPORTS

T he Country Report assessment is made for specific articles and not in a holistic way to provide a guide at this time on the possible extent of correspondence with those specific articles of the Convention by national legislation. The General Report, above, should be read regarding the full implementation of the

MEDICRIME Convention.

3.1 Andorra

Article 4 - Definitions

a. Article 4.a MEDICRIME Convention – Medical ProductNo provision could be found in internal laws corresponding with Article 4.a, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductNo provision could be found in internal laws corresponding with Article 4.b, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceNo provision could be found in internal laws corresponding with Article 4.c, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientNo provision could be found in internal laws corresponding with Article 4d, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceNo provision could be found in internal laws corresponding with Article 4e, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryNo provision could be found in internal laws corresponding with Article 4f, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision could be found in internal laws corresponding with Article 4.g, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision could be found in internal laws corresponding with Article 4h, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision could be found in internal laws corresponding with Article 4.i, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitNo provision could be found in internal laws corresponding with Article 4.j, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision could be found in internal laws corresponding with Article 4.k, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.k, MEDICRIME Convention.


CHAPTER II – SUBSTANTIVE CRIMINAL LAW

Article 5 – Manufacturing of counterfeits

Article 276.1 and 2 Criminal Code (CC) of Andorra (LLei 9/2005, qualificada del Codi Penal). Pharmaceutical crimes, as regards medicinal products, provides for endangerment resulting from a failure to meet technical standards. This offence describes a substandard medicinal product which may not necessarily also be counterfeit. A counterfeit medicinal product may and usually be made substandard in its production and an offence under this provision may assist the prosecution. It will not, however substitute for an offence of the manufacture or adulteration of a counterfeit medical product. It does not correspond with Article 5, MEDICRIME Convention. No provisions in internal law, as regards active substances, excipients, medical devices, parts, material, and accessories, can be found corresponding with Article 5, MEDICRIME Convention.

Further action is needed to correspond with Article 5, MEDICRIME Convention.

Article 6 – Supplying, offering to supply, and trafficking in counterfeits

Art. 276.3 CC describes partly the ingredients of a counterfeit medicinal product, as regards placing it on the market. This provision does not adequately encompass all the requirements of Article 6, MEDICRIME Convention and does not include active substances, excipients, medical devices, parts, material, and accessories.

Further action is required to fully correspond with Article 6, MEDICRIME Convention.

Article 7 – Falsification of documents

Art. 435 CC corresponds with Article 7, MEDICRIME Convention.

Article 8 – Similar crimes involving threats to public health

8.a.i: Article 276.1 and 2 CC partially correspond with Article 8.a.i, MEDICRIME Convention.

8.a.ii: No provision could be found in internal laws corresponding with Article 8.a.ii, MEDICRIME Convention.

8.b. No provision could be found in internal laws corresponding with Article 8.b, MEDICRIME Convention.

Further action is required to correspond fully with Article 8 MEDICRIME Convention.

Article 9 – Aiding or abetting and attempt

9.1: Article 23 CC, as regards aiding and abetting, corresponds with Article 9.1, MEDICRIME Convention.

9.2: Article 276.6 CC, as regards attempt, corresponds with Article 9.1, MEDICRIME Convention.

Article 11 – Corporate liability

11.1. a, b, c: No provision could be found in internal laws corresponding with Article 11.1, MEDICRIME Convention.

11.2: No provision could be found in internal laws corresponding with Article 11.1, MEDICRIME Convention.

11.3: According to Article 71, Criminal Code, and jurisprudence of Andorran courts the liability of a legal person may be civil or administrative.

11.4: Such liability shall be without prejudice to the criminal liability of the natural persons who have committed the offence according to Andorran Domestic Criminal Law and jurisprudence of Andorran courts. This corresponds with Article 11.4, MEDICRIME Convention.

Further action is needed to correspond with Article 11.1 and 11.2, MEDICRIME Convention.

Article 13 – Aggravating circumstances

13.a: Article 276 in connection with art. 102 and 113 and following ones of the Criminal Code

13.b and c: Article 30.3 CC, as regards an abuse of trust but not specifying the circumstance of acting in the course of a professional duty or as a duty of a manufacturer or in trade, partially corresponds with Article 13.b and c, MEDICRIME Convention. Art. 276.5 Criminal Code is also applicable.

III. Country reports Page 19

13.d: No provision could be found in internal laws corresponding with Article 13. d, MEDICRIME Convention.

13.e: Article 30.7 CC partially corresponds with Article 13.e, MEDICRIME Convention.

13.f: Article 30.7 CC corresponds with Article 13.f, MEDICRIME Convention.

Further action is needed to fully correspond with Article 13, MEDICRIME Convention.

3.2 Armenia


a. Article 4.a, MEDICRIME Convention – Medical ProductNo provision in internal law, as regards the term ‘medical product’ could be found corresponding to Article 4.a, MEDICRIME Convention. The term should be defined to correspond with Art 4.a, MEDICRIME Convention.

b. Article 4.b, MEDICRIME Convention – Medicinal ProductArticle 3, Law on Medicines, as regards medicinal products, corresponds with Article 4.b, MEDICRIME Convention. Article 3, p.1.11, Law on Medicines, as regards investigational medicinal products, corresponds with Article 4.b, MEDICRIME Convention.

c. Article 4.c, MEDICRIME Convention -Active substanceArticle 3, p.1.8, Law on Medicines, defines the term ‘substance’ rather than active substance. This is similar to, but does not fully correspond with Article 4.c, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.c, MEDICRIME Convention.

d. Article 4.d, MEDICRIME Convention – ExcipientLaw on Medicines, Art. 3, p.1.10, Law of Medicines, defines the term ‘excipient’ similar to the term ‘substance’ and does not fully correspond with Article 4.d, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e, MEDICRIME Convention – Medical DeviceNo provision in internal law, as regards the term ‘medical device’ could be found corresponding to Article 4.e, MEDICRIME Convention.Action is needed to correspond with Article 4.e, MEDICRIME Convention.

f. Article 4.f, MEDICRIME Convention – AccessoryNo provision in internal law, as regards the term ‘accessory’ could be found corresponding to Article 4.f, MEDICRIME Convention.Action is needed to correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g, MEDICRIME Convention – Parts and materialsNo provision in internal law, as regards the terms ‘parts’, and ‘materials’, could be found corresponding to Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h, MEDICRIME Convention – DocumentNo provision in internal law, as regards the term ‘document’, could be found corresponding to Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i, MEDICRIME Convention – ManufacturingArticle 3, p.1.18 Law on Medicines, as regards the term ‘Manufacturing’ only refers to the term ‘Manufacture’, which in turn, only refers to medicinal products. No provision in internal law, as regards active substances, excipients, medical devices, parts and materials, and accessories, could be found to correspond with Article 4.1, MEDICRIME Convention.Further action is needed to correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 3, p.1.15, Law on Medicines, as regards medicinal products, corresponds with Article 4.j, MEDICRIME Convention. There is no corresponding provision, as regards medical devices corresponding to Article 4.j, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – Victim Article 58, Code of Criminal Procedure, corresponds to Article 4.k, MEDICRIME Convention.




Article 280.2, Criminal Code provides a general law offence for the manufacture of a false drug. There is no similar provision as regards medical devices and accessories, parts or materials. There is insufficient correspondence with Article 5, MEDICRIME Convention.



Article. 280.2 Criminal Code provides a general criminal law offence for the supply of a false drug.

There is no similar provision as regards medical devices and accessories, parts, or materials. There is insufficient correspondence with Article 6, MEDICRIME Convention.



Article 325, CC provides criminal liability for forgery of an official document, which could also be a document related to medical products. This provision is general criminal law. It corresponds with Article 7, MEDICRIME Convention.


8.a.i: Article 280.2, paragraph 1, CC refers to a pharmaceutical practice without a licence, the breach of which is a criminal offence. However, it is unclear what the scope of the pharmaceutical practice means. A condition for this offence requires that this negligently causes damage to human health, which is not a condition in Article 8.a.1, MEDICRIME Convention.

8.a.ii: No provision in internal law corresponds with Article 8.aii, MEDICRIME Convention.

8.b: No provision in internal law corresponds with Article 8.b, MEDICRIME Convention.



9.1: Article 38, part. 1, CC; Article 39, part. 2, C; Article. 39, part 5, CC corresponds with Article 9.i, MEDICRIME Convention.

9.2: Article 33, parts 1and 2, CC criminalises the attempt of all criminal offences regulated in the CC. The penalties applicable to a completed criminal act shall also apply to attempt. The aider or abettor is punished in general as well and the penalties applicable to offenders of a criminal offence shall also apply to the aider or abettor and the helper. Article 33, CC corresponds with Article 9.2, MEDICRIME Convention.


No provision in internal law corresponds with Article 11, MEDICRIME Convention.

Action is needed to correspond with Article 11, MEDICRIME Convention.


13.a: Articles 280 and Article 280.2 and 4, CC are constituent elements of the offence.

13.b: No provision in internal law corresponds with Article 13.b, MEDICRIME Convention.

13.c: No provision in internal law corresponds with Article 13.c, MEDICRIME Convention.

13.d: Article 63, paragraph 12, CC provides as aggravating circumstance the committal of crime in a way that is dangerous for society. This is considered to be too general to fully correspond with Article 13 d, MEDICRIME Convention.


13.e: Article 63 paragraph 3 CC corresponds with Article 13.e, MEDICRIME Convention.

13.f: Article 63 paragraph 1, CC corresponds with Article 13.e, MEDICRIME Convention.

Further action is needed to fully correspond with Article 13 MEDICRIME Convention.

3.3 Austria


a. Article 4.a MEDICRIME Convention – Medical Product No provision in internal law, as regards the term ‘medical product’, corresponds with Article 4.a, MEDICRIME

Convention. Further action is needed to fully correspond with Article 4.a MEDICRIME Convention.b. Article 4.b MEDICRIME Convention – Medicinal Product § 1 Abs.1 no. 1 and 2 Medicinal Product Act 2005 (AMG) and §2a Abs. 14 AMG, as regards investigational

medicinal products correspond with Article 4.b MEDICRIME Convention. It is noted that the wording of § 1 Abs.1 no. 1 does not use the term ’presentation’ but the term used in its place, ‘intent’, is interpreted in Austrian medicines jurisprudence as being the same as ‘presentation.

c. Article 4.c MEDICRIME Convention – Active substance § 1 Abs. 4a AMG defines the term ‘active ingredients’ to correspond with Article 4.c MEDICRIME Convention.

The term ‘active ingredients’ is separately defined in § 2 Abs. 24a Austrian Ordinance on Good Manufacturing Practices - AMBO 2009 and has the same meaning as in § 1 Abs. 4a AMG.

d. Article 4.d MEDICRIME Convention – Excipient § 1 Abs. 4b AMG defines the term ‘excipient to correspond with Article 4.d MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical Device § 1 Abs. 2 Medical Devices Act corresponds with Article 4.e MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – Accessory § 2 Abs. 2 Medical Device Act (MPG) corresponds to Article 4.f MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materials There is no legal definition of the term ‘parts’ and ‘materials’. Action is needed to correspond with Article 4.g MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – Document There is no legal definition of the term ‘document. Action is needed to correspond with Article 4.h MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – Manufacturing § 2 Abs.10 AMG, as regards medicinal products and active substances, corresponds with Article 4.i MEDICRIME

Convention. Excipients are not specifically defined and use the European Guidelines based on Article 47 of Directive 2001/83/EC.

§2 Abs.7 and 8 MPG, as regards medical devices and accessories, correspond with Article 4.i MEDICRIME, Convention.

j. Article 4.j MEDICRIME Convention – Counterfeit § 1 Abs. 25 and 26 AMG, implement Directive 2011/62/EU, amending Directive 2001/83, EC, as regards

medicinal products and active substances, respectively, and correspond with Article 4.j MEDICRIME Convention. There is no definition of the term ‘counterfeit’ as regards medical devices.

Further action is needed to fully correspond with Article 4.j MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – Victim § 65. 1. C, Criminal Procedure Code 1975, is general law and is not specific to medical products. § 65. 1.C

defines the term ‘victim’ as “any other person who has suffered damage as a result of a criminal act or who could otherwise have been impaired in their legally protected legal interests. This corresponds the intent of Article 4.k MEDICRIME Convention.




§ 82b Abs. 1, AMG provides an offence corresponding to Article 5.1, MEDICRIME Convention as regards medicinal products, active substances, or excipients. Adulteration is considered to be encompassed in manufacturing of a counterfeit medicinal product and no separate offence exists. There is no offence as regards medical devices, accessories, parts, and materials.



§ 82b. 2 AMG corresponds with Article 6, MEDICRIME Convention, as regards medicinal products, active substances, and excipients. There is no offence as regards medical devices, accessories, parts, and materials.



§ 82b Abs. 7 AMG corresponds with Article 7, MEDICRIME Convention. No provision in internal law can be found as regards the falsification of documents related to medical devices, parts, materials, and accessories.



8.a.i: §§ 84 Abs. 1. No.s 5, 6, 7, 7a, 9, 17, and 25 AMG correspond with Article 8. a. (i), MEDICRIME Convention.

8.a.ii: §§111 Abs. 1 no.1 to 6 and 39 Medical Devices Act (MPG) correspond with Article

8.a (ii) MEDICRIME Convention.

8.b: §§ 108 and 146, Criminal Code (StGB) are general law provisions regarding deception and fraud and not specific to medical products. They adequately correspond with Article 8.b, MEDICRIME Convention.


§§ 12 and 15, StGB correspond with Article 9, MEDICRIME Convention.


11.1: Section 2.1, The Association Responsibility Act corresponds with Article 11.1, MEDICRIME Convention.

11.2: Sections 3.1 and 3.2, The Association Responsibility Act., corresponds with Article.

11.2, MEDICRIME Convention.

11.3: Domestic law, as regards criminal, administrative and civil liability, corresponds with Article 11.3, MEDICRIME Convention.

11.4: Section 3.4, The Association Responsibility Act corresponds with Art. 11.4, MEDICRIME Convention.


13.a: § 82b Abs. 6 AMG provides for aggravating circumstances in relation to medicinal products where the conduct results in the death of a person or serious bodily injury (Section 84 (1) StGB) of a larger number of people. This, as regards medicinal products, corresponds with Article 13.a, MEDICRIME Convention.There are no aggravating circumstances provided in the MPG for medical devices.Further action is needed to correspond fully with Article 13.a, MEDICRIME Convention.

13.b: § 82b Abs. 3 and 5 AMG provides for aggravating circumstances for specified healthcare professionals - doctor, dentist, veterinarian, pharmacist, dentist, or midwife. This is a restricted list of professionals. Article 13.b, MEDICRIME Convention is not restricted to healthcare professionals.There are no aggravating circumstances provided in the MPG for medical devices.Further action is needed to correspond fully with Article 13.b, MEDICRIME Convention.


13.c: AMG and MPG do not provide for aggravating circumstances that correspond with Article 13.c, MEDICRIME Convention. § 32.(1), (2), and (3) StGB provide for sentencing guidance for the Criminal Law. These include the negative or indifferent attitude of the perpetrator to legally protected values and the level of premeditation. § 32. StGB encompasses, to an extent, the intent of Article 13, c, MEDICRIME Convention as regards medicinal products and medical devices.Further action is required to fully correspond with Article 13.c, MEDICRIME Convention.

13.d: AMG and MPG do not provide for aggravating circumstances that correspond with Article 13.d, MEDICRIME Convention. § 32.(1), (2), and (3) StGB provide for sentencing guidance for the Criminal Law. These include the negative or indifferent attitude of the perpetrator to legally protected values and the level of premeditation. § 32. StGB encompasses, to an extent, the intent of Article 13, d, MEDICRIME Convention as regards medicinal products and medical devices.Further action is required to fully correspond with Article 13.d, MEDICRIME Convention.

13.e: AMG and MPG do not provide for aggravating circumstances that correspond with Article 13.e, MEDICRIME Convention. § 278a, StGB provides for aggravating circumstances for involvement in organised crimes and this is not specifically focused on crimes that relate to medical products. However, the provision does not exclude conduct involving medical product related crime and it specifies circumstance that aims at the recurring and planned commission of serious criminal acts that threaten life and physical integrity, among others. This sufficiently encompasses the intent of Article 13, e, MEDICRIME Convention as regards medicinal products and medical devices.

13.f: AMG and MPG do not provide for aggravating circumstances that correspond with Article 13.f, MEDICRIME Convention. § 33 Abs. 1 No. 1 and 2 StGB corresponds with Article 13.f, MEDICRIME Convention.

3.4 Azerbaijan


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law could be found corresponding with Article 4.a, MEDICRIME Convention. Action is necessary to correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 1.0.1, Law of the Republic of Azerbaijan on Medicinal products, as regards medicinal products, correspond substantially with Article 4.b, MEDICRIME Convention. There is no term found in the law of medicinal products defined relating to investigational medicinal products, but Article 6.5.4, in relation to authorisations exemptions, approximate to the term ‘investigational medicinal products. Article 1.0.5 Law of the Azerbaijan Republic about veterinary Science, 2005, amended 2020, as regards veterinary medicines, substantially correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceArticle 1.0.3, Law of the Republic of Azerbaijan on Medicinal products provides a definition of the term ‘active substance’, which is not as broad as, but partially corresponds with Article 4, MEDICRIME Convention. When combined with Article 1.0.2, which uses the term ‘drugs’ when used in the manufacture of medicinal products, both correspond substantially with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientNo provision in internal law can be found corresponding with Article 4.d, MEDICRIME Convention. The term ‘excipient’ is defined by the decision of the Collegium of the Ministry of Health, which is a normative-legal act according to the Constitution of the Republic of Azerbaijan (Article 148. I. 6). Further action is needed to correspond fully with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 1.0.1, Law of the Republic of Azerbaijan on Medicinal products, as regards medical devices, provides a definition of the term that is not as comprehensive as, but partially corresponds with Article 4.3, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryNo provision in internal law can be found corresponding with Article 4.f, MEDICRIME Convention.Action is needed to correspond with Article 4.f, MEDICRIME Convention.


g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law can be found corresponding with Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law can be found corresponding with Article 4.h, MEDICRIME Convention.Action is required to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingArticles 2.1 and 3.6, Law of the Republic of Azerbaijan on Medicinal products, describe the process of the manufacture of medicinal products, but does not cover the manufacture of active substances or excipients. It does not include the manufacture of medical devices, materials of such devices, including designing devices, the parts, or materials, or of bringing medical devices, the parts or materials to their final state, as well as accessories. Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitNo provision in internal law can be found corresponding with Article 4.j, MEDICRIME Convention.Action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 87, Criminal Procedure Code substantially corresponds with Article 4.k, MEDICRIME Convention.



Article 68-4.1 Code of Administrative Offences, provides an offence for the production of Falsified Medications. It is unclear whether this provision includes medical devices as the term ‘medication’ rather than ‘medicinal product’ is used (see the inclusion of medical devices under the term ‘medicinal product’ in 4. b, above). This partially corresponds with Article 5, MEDICRIME Convention.Further action is needed to fully correspond with Article 5 MEDICRIME Convention.


Article 68-4.1 Code of Administrative Offences provides an offence for the storage for sale, sale and importation of falsified medications. It is unclear whether this provision includes medical devices as the term ‘medication’ rather than ‘medicinal product’ is used (see the inclusion of medical devices under the term ‘medicinal product’ in 4. b, above). This partially corresponds with Article 6, MEDICRIME Convention.



Article 313, Criminal Code, which provides for the preparation of false documents and the act of tampering with documents, corresponds with Article 7, MEDICRIME Convention.


8.a.i: Article 200.1.1, Criminal Code, as regards unauthorised medicinal products Partially corresponds with Article 8, MEDICRIME Convention. Article 5.1.1, 5.1.2, and 5.1.1, Law of the Republic of Azerbaijan on Medicinal products, as regards manufacturing, wholesale, and retail sales, require State Authorisations. There are no offences for breaches of these requirements in this law. Article 68.4.1, Code of Administrative Offences, as regards the manufacture, storage for sale, retail sale and placing on the market of medications, provide for equivalent offences. This corresponds with Article 8.a.i, MEDICRIME Convention.

8.a.ii: It is unclear whether the provisions mentioned immediately above include medical devices as the term ‘medication’ rather than ‘medicinal product’ is used (see the inclusion of medical devices under the term ‘medicinal product’ in 4. b, above).

Further action is required to fully correspond with Article 8.a, MEDICRIME Convention.

8.b: No provision in internal law could be found corresponding to Article 8.b, MEDICRIME Convention.


Action is required to fully correspond with Article 8.b, MEDICRIME Convention.


9.1: Articles 31, 32, 33, Criminal Code, as regards aiding and abetting, correspond with Article 9.1, MEDICRIME Convention.

9.2: Article 29, Criminal Code, as regards attempt, corresponds with Article 9.2, MEDICRIME Convention.


11.1: Article 99-4, Criminal Code correspond to Article 11.1, MEDICRIME Convention.

11.2: Article 99-4.1, Criminal Code corresponds with Article 11.2, MEDICRIME Convention.

11.3: Article 18, Law of the Republic of Azerbaijan on Medicinal products corresponds with Article 11.3, MEDICRIME Convention.

11.4: Article 99-4.2; Article 99-4.3; and Article 99-4.4, Criminal Code corresponds with Article 11.4, MEDICRIME Convention.


13.a: Article 200-1.4, Criminal Code, as regards the act involves the death of a person by negligence or other grave consequences, corresponds with Article 13.a, MEDICRIME Convention.

13.b: No provision in internal law could be found corresponding with Article 13.b, MEDICRIME Convention.

Action is needed to correspond with Article 13.b, MEDICRIME Convention.

13.c: No provision in internal law could be found corresponding with Article 13.c, MEDICRIME Convention.

Action is needed to correspond with Article 13.c, MEDICRIME Convention.

13.d: No provision in internal law could be found corresponding with Article 13.d, MEDICRIME Convention.

Action is needed to correspond with Article 13.d, MEDICRIME Convention.

13.e: Article 200-1.2.2 Criminal Code corresponds with Article 13.e, MEDCRIME Convention.13.f: Article 200-1.2.1, Criminal Code corresponds with Article 13.f, MEDICRIME Convention.

3.5 Bulgaria


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law, as regards the term ‘medical product’, could be found corresponding with Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions of medicinal product and medical device.Further action is needed to fully correspond with Art 4.a MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 3, ‘Law on Medicinal Products in human medicine’, as regards medicinal products for human use, and §1, pt. 9, Law on Veterinary Medicines corresponds, as regards medicinal products for veterinary use, corresponds to Article 4.b, MEDICRIME Convention.No provision in internal law, as regards the term ‘investigational medicinal products’ could be found corresponding to Article 4.b MEDICRIME Convention. Further action is needed to fully correspond with Art 4.b MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substancePt. 1 of §1, ‘Law on Medicinal Products in human medicine’ corresponds with Article 4c, MEDICRIME Convention, except that it does not include medicinal products for veterinary use.Action is needed to correspond with Art 4.c MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – Excipient


Pt. 46 of §1, ‘Law on Medicinal Products in human medicine’ refers to the term ‘auxiliary substance’ and corresponds with Article 4c, MEDICRIME Convention. The Law on Veterinary Medicines does not correspond with Article 4.d, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DevicePt. 29, §1, Law on Medical Devices, 2007 corresponds with Article 4e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryPt. 29, §1, Law on Medical Devices, 2007, corresponds with Article 4e, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law, as regards the terms ‘parts’ and ‘materials’ could be found to correspond with Article 4.g, MEDICRIME Convention.

Action is needed to correspond with Art 4.g MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentArticle 93, pts 5 and 6 of the Criminal Code provide for the definitions of a document and a falsified document, respectively, in general. Pt. 5 of §1, Law on Medicinal Products in human medicine defines the term “valid documentation” as documentation in compliance with requirements of the law in regards of content and completeness. Pt 9 of §1, Law on Medical Devices uses the term “Identification data of the device” to describe documents. Apart from the provisions of the Criminal Code, the other definitions are insufficient on their own, but in combination with the Criminal Code they are sufficient to correspond with Article 4h MEDICRIME Convention. It is recommended that one definition be provided by law to encompass the intent of Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingPt. 52 of §1. The Law of Medicinal Products in human medicine corresponds with Article 4.i MEDICRIME convention. §1, pt. 90, Law on Veterinary Medicines corresponds with Article 4.i, MEDICRIME Convention. There is no definition in the Law of Medical Devices for the term ‘manufacturing’ as regards medical devices and accessories. Further action is needed to fully correspond with Art 4.i MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitPt. 81a. § 1. The Law of Medicinal Products in human medicine defines the term ‘falsified’ and it corresponds with Article 4.j MEDICRIME Convention. There is no equivalent definition for medical devices or for medicinal products for veterinary use.Further action is needed to fully correspond with Art 4.j MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 74, Code of Criminal Procedure, 2006, defines the term ‘victim’ generally and with a scope that encompasses any victim of a property or non-property crime. Further action is needed to fully correspond with Art 4.k MEDICRIME Convention.



Art. 284a of Law on Medicinal Products in human medicine creates an administrative violation for manufacturing, exporting, and importing of falsified medicinal products not requiring intentional conduct in relation to medicinal products for human use. Due to the absence of the requirement for intentional conduct, this does not correspond with Article 5.1. MEDICRIME Convention. There is no corresponding offence in relation to medicinal products for veterinary use or for medical devices, accessories, parts, and materials.

Clarification is required on the status of adulteration to ensure that it corresponds with Article 5.2 MEDICRIME Convention.

Art. 350a of Criminal Code provides a criminal offence for producing veterinary medical products that puts the life or health of another at risk. Notwithstanding that this provision may address aspects of the intent required, it does not correspond with Article 5, MEDICRIME Convention.

Action is needed to correspond with Art 5.1 MEDICRIME Convention.



Art. 284a of Law on Medicinal Products in human medicine provides as an administrative violation the exporting, importing, keeping in stock, trading, or rendering with falsified medicinal products. This administrative offence does not require intentional conduct in relation to medicinal products for human. Due to the absence of the requirement for intentional conduct, this does not correspond with Article 6.1 MEDICRIME Convention. There is no corresponding offence in relation to medicinal products for veterinary use or for medical devices, accessories, parts and materials. Art. 350a of Criminal Code provides a criminal offence for placing on the market veterinary medical products that puts the life or health of another at risk. Notwithstanding that this provision may address aspects of the intent required of the Convention, it does not correspond with Article 6, MEDICRIME Convention.

Action is needed to correspond with Art 6, MEDICRIME Convention.


Articles 308 and 319, Criminal Code (CC) provide for criminal offences relating to documents generally and not specifically to medical products. The offences incorporate the spirit and intent of Article 7 MEDICRIME Convention.



8.a.i. ii. Apart from the requirement for intentional conduct, as required by Article 8 MEDICRIME Convention, Article 281 of Law on Medicinal Products in human medicine and Article 119 of Law on Medical Devices provide for administrative offences for breaches relating to behaviours corresponding to the behaviours mentioned in Article 8 MEDICRIME Convention. No provision in internal law can be found in relation to medicinal products for veterinary use that corresponds with Articles 8.a. i.

Action is needed as regards the criminalisation of intentional behaviours and the inclusion of medicinal products for veterinary use to correspond with Article 8.a, MEDICRIME Convention.

8.b. There is no provision for criminalisation in relation to the commercial use of original documents outside their intended use within the legal medical product supply chain.

Action is needed to correspond with Art 8.b, MEDICRIME Convention.


Articles 20 and 21, CC correspond with Article 9.1 MEDICRIME Convention.

Articles 17 and 18, CC correspond with Article 9.2 MEDICRIME Convention.


Article 83a of the Administrative Violations and Punishments Law, 1969, as amended, is a general law provision that does not specifically address medical products. Apart from not having any provision for criminal law liability, Article 83a correspond with Article11.1. a, b and c, 11.2, 11.3. and 11.4 MEDICRIME Convention.


Aggravating circumstances are not enumerated for in the substantive laws and there is no correspondence with Article 13 MEDICRIME Convention. Articles 54, § 2 and 56, CC provide that the Court in its punishment may consider such circumstances where they are not a substantive element of the crime.



3. 6 Canada


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law, as regards the term ’medical product’ could be found corresponding with Article 4.a, MEDICRIME Convention.Action is needed to correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 2, Food and Drugs Act R.S.C., 1985, as regards the term ‘medicinal product’, provides a similar definition under the term ‘drug’. This substantially corresponds with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceC.01A.001 (1), Division 1A, Food and Drug Regulations, C.R.C., as regards the term ‘active substance’, is similar but not fully corresponding with Article 4.c, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientNo provision in internal law, as regards the term ‘excipient’ could be found corresponding with Article 4.d, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 2, Food and Drugs Act R.S.C., 1985, as regards the term ‘medical device’’, provides a similar definition under the term ‘device’. This substantially corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryNo provision in internal law, as regards the term ‘accessory’, could be found corresponding with Article 4.f, MEDICRIME Convention.Action is needed to correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law, as regards the terms ‘parts’ and ‘materials’, could be found corresponding with Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law, as regards the term ‘’document’, could be found corresponding with Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision in internal law, as regards the term ‘manufacturing’, could be found corresponding with Article 4.i, MEDICRIME Convention.Action is needed to correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitPart 4.0, Policy on Counterfeit Health Products (POL-0048), as regards the term ‘counterfeit’, provides a definition of counterfeit health product that is similar in intent, but not in wording, and when taken together with the following explanations provided in Part 4.0, they approximate to the meaning in Article 4.j, MEDICRIME Convention. However, as a policy document that does not constitute part of the Food and Drugs Act or its associated regulations this does not apply as a definition intended in the manner used in Articles 5-8, 9 and 11, MEDICRIME Convention. There is no correspondence with Article 4.j, MEDICRIME Convention.Action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 2, Criminal Code, as regards the term ‘victim’, is similar in meaning and intent and corresponds with Article 4.k, MEDICRIME Convention.




No provision in internal law could be found corresponding with Article 5, MEDICRIME Convention.Action is needed to correspond with Article 5, MEDICRIME Convention.


No provision in internal law could be found corresponding with Article 6, MEDICRIME Convention.Action is needed to correspond with Article 6, MEDICRIME Convention.


Article 366 (1) and (2), Criminal Code, correspond with Article 7, MEDICRIME Convention.


No provision in internal law could be found corresponding with Article 8.a and b, MEDICRIME Convention.Action is needed to correspond with Article 8, MEDICRIME Convention.


9.1: Article 21(1) and (2), Criminal Code, as regards aiding and abetting, corresponds with Article 9.1, MEDICRIME Convention.9.2: Article 24(1), Criminal Code, as regards attempt, corresponds with Article 9.2, MEDICRIME Convention.


11.1.a, b, c: Article 22.2, Criminal Code corresponds with Article 11.1.a, b and c, MEDICRIME Convention.11.2: Article 22.1, Criminal Code corresponds with Article 11.2, MEDICRIME Convention.11.3: Criminal, civil, and administrative sanctions are applicable to legal persons and correspond with Article 11.3, MEDICRIME Convention.11.4: Article 22.2, Criminal Code corresponds with Article 11.4, MEDICRIME Convention.


13.a: Article 380.1(1) (c.1), Criminal Code, partially corresponds with Article 13.a, MEDICRIME Convention.

13.b-f: No provision in internal law, as regards aggravating circumstances, could be found to correspond with Article 13.b-f, MEDICRIME Convention.Further action is required to correspond with Article 13, MEDICRIME Convention.

3.7 Cyprus



b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 2, The Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law of 2001 to 2020 and Article 2, The Veterinary Medicinal Products (Control of Quality, Registration, Circulation, Manufacturing, Providing and Use) Law of 2006 to 2011, together correspond to Article 4.b, MEDICRIME Convention. No legal definition for the term ‘investigational medicinal products’ is provided. Further action is needed to fully correspond with Art 4.b MEDICRIME Convention.


c. Article 4.c MEDICRIME Convention -Active substanceArticle 2, The Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law of 2001 to 2020 corresponds to Art 4.c MEDICRIME Convention. There is no legal definition of the term ‘active substance’’ in relation to veterinary medicinal products. Further action is needed to fully correspond with Art 4.c MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 2, The Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law of 2001 to 2020 corresponds to Article 4.d. No definition for the term excipient for veterinary medicinal products is provided. Further action is needed to fully correspond with Art 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceRegulation 2, The Basic Requirements (Medical Devices) Regulations of 2003 as amended, corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention - AccessoryRegulation 2, The Basic Requirements (Medical Devices) Regulations of 2003, as amended, corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision could be found in internal laws corresponding with Article 4.g, MEDICRIME Convention. Further action is needed to fully correspond with Art 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision could be found in internal laws corresponding with Article 4.h. MEDICRIME Convention. Further action is needed to fully correspond with Art 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision could be found in internal laws corresponding with Article 4.i, MEDICRIME Convention. Further action is needed to fully correspond with Art 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 2, The Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law of 2001 to 2020 corresponds with Article 4.j as regards medicinal products for human use. The law does not cover medicinal products for veterinary use, medical devices, active substances, excipients, parts, materials, and accessories as well as documents. Further action is needed to fully correspond with Art 4.j MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision could be found in internal laws corresponding with Article 4.k, MEDICRIME Convention. Further action is needed to fully correspond with Art 4.k, MEDICRIME Convention.



5.1: Article 99(1)(d), The Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law of 2001 to 2020 creates an offence not requiring intentional conduct in relation to medicinal products for human use corresponding to Article 5.1. There is no corresponding offence in relation to medicinal products for veterinary use or for medical devices, accessories, parts, and materials. Further action is needed to correspond with Art 5.1 MEDICRIME Convention.5.2. Clarification is required on the status of adulteration to ensure that it corresponds with Article 5.2 MEDICRIME Convention.


6.1. Article 100, The Customs Code Law creates a criminal offence for the breach of any prohibited act in Customs Laws or other laws. Apart from the requirement for intentional conduct, as required by Article 6.1 MEDICRIME Convention Article 99(1)(d), The Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law of 2001 to 2020 corresponds to Article 6 MEDICRIME Convention. There is no provision in relation to medicinal products for veterinary use and for medical devices.Action is needed to correspond with Art 6.1 MEDICRIME Convention.



No provision could be found in internal laws corresponding with Article 7, MEDICRIME Convention.

Action is needed to correspond with Art 7 MEDICRIME Convention.


8.a.i: Apart from the requirement for intentional conduct, as required by Article 8 MEDICRIME Convention, the wording of Article 99(1)(a), (b) and (c), Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law of 2001 to 2020 and Article 100(1)(a), (b) and (c), Veterinary Medicinal Products (Control of Quality, Registration, Circulation, Manufacturing, Providing and Use) Law of 2006 to 2011 correspond with Article 8 MEDICRIME Convention for authorisations, in so far as such an activity is not covered by Articles 5, 6 and 7, in relation to the manufacturing, the keeping in stock for supply, importing, exporting, supplying, offering to supply or placing on the market of medicinal products.

Further action is required as regards the criminalisation of intentional behaviours to correspond fully with Article 8.a.i, MEDICRIME Convention.

8.a.ii: Apart from the requirement for intentional conduct, as required by Article 8 MEDICRIME Convention, the wording of Article 52, The Basic Requirements for Specific Products Categories Law of 2002 to 2013 correspond to the requirement of Article 8 MEDICRIME Convention, in so far as such an activity is not covered by Articles 5, 6 and 7, in relation to not being in compliance with the conformity requirements as regards manufacturing, the keeping in stock for supply, importing, exporting, supplying, offering to supply or placing on the market of medical devices.

Further action is needed as regards the criminalisation of intentional behaviours in order to correspond fully with Article 8.a.ii, MEDICRIME Convention.

8.b: No provision could be found in internal laws corresponding with Article 8.b, MEDICRIME Convention.



No provision could be found in internal laws corresponding with Article 9, MEDICRIME Convention. Action is needed to correspond with Art 9 MEDICRIME Convention.


11.1. a, b, and c, 11.2, 11.3, and 11.4: Article 100, Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law of 2001 to 2020 and Article 101, The Veterinary Medicinal Products (Control of Quality, Registration, Circulation, Manufacturing, Providing and Use) Law of 2006 to 2011 correspond with the requirements of Article 11 MEDICRIME Convention. No provision could be found in internal laws in relation to Article 11 requirements as regards medical devices.

Further action is required to fully correspond with Art 11, MEDICRIME Convention.


No provision could be found in internal laws corresponding with Article 13, MEDICRIME Convention. Action is needed to correspond with Art 13 MEDICRIME Convention.

3.8 Czech Republic


a. Article 4.a MEDICRIME Convention – Medical ProductSection 1, Medicines Act defines the term ‘medical product’ that includes medicinal products and medicinal substances. These relate only to human use and not veterinary use. There is no inclusion for medical devices in this definition.Further action is needed to correspond with Art 4.a MEDICRIME Convention.


b. Article 4.b MEDICRIME Convention – Medicinal ProductSection 2, Medicines Act corresponds with Article 4.b MEDICRIME Convention. There is no specific definition for investigational medicinal products.Further action is needed to fully correspond with Art 4.b MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceSection 2, Medicines Act corresponds with Article 4.c MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientSection 2, Medicines Act corresponds with Article 4.d MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceSection 2, Medical Device Act, 2004 corresponds with Article 4.e MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessorySection 3(5), Medical Device Act, 2004 corresponds with Article 4.f MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision could be found in internal laws corresponding with Article 4.g, MEDICRIME Convention. Action is needed to correspond with Art 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision could be found in internal laws corresponding with Article 4.h, MEDICRIME Convention. Action is needed to correspond with Art 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingSection 5.c. of the Medical Devices Act, as regards medical devices, corresponds with Article 4.i MEDICRIME Convention. There is no correspondence as regards the manufacture of accessories. No provision could be found in internal laws, as regards the manufacture of medicinal products, corresponding with Article 4.i, MEDICRIME Convention.Further action is needed to correspond with Art 4.i MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitSection 5 (14), Medicines Act, as regards medical products for human use, corresponds to Article 4.j MEDICRIME Convention. There is no correspondence with Article 4.j as regards medical products for veterinary use and medical devices

k. Article 4.k MEDICRIME Convention – VictimSection 2 (2-4), Act on Victims of Crime Act provides a general law definition. It does not include psychological injury.Further action is needed to fully correspond with Art 4.k MEDICRIME Convention.



Section 146, Criminal Code (CC) is general criminal law creating an intentional offence of causing bodily harm. While this could be used in conjunction with an offence of the manufacture of a falsified medical product, there is no correspondence with Article 5 MEDICRIME Convention notwithstanding that there is a definition that there is a definition of a falsified medicinal product.



Section 251 CC is general criminal law creating an intentional offence for ‘Unauthorized Business Activities’. While this could be used in conjunction with an offence specified in Article 6 MEDICRIME Convention, there is no correspondence with Article 6 MEDICRIME Convention.

Action is needed to correspond with Art 6 MEDICRIME Convention.


Section 348 CC is general criminal creating an intentional offence for forgery and alteration of ‘Public Documents’. While this could substantially correspond with the requirements of Article 7 MEDICRIME Convention it appears restricted to ‘public documents generally and may not capture all documents intended by Article 7.

Further action is needed to fully correspond with Art 7, MEDICRIME Convention.



8.a.i. ii: Sections 103, 104, 105 and 108 of the Medicines Act requires authorisations Which create administrative offences for the non-compliance with authorisation requirements of medicinal products for human use. Medicinal Products for veterinary use also need to be considered.

Title XIV, Medical Device Act 2014, as regards medical devices, provides offences relating to the non-compliance and non-conformity requirements laid out in Title VI of the Act. These administrative offences do not require intentional behaviour and do not correspond with Article 8.a, MEDICRIME Convention.

Action is required to correspond with Art 8.a, MEDICRIME Convention.




Sections 21, 23 and 24 CC, as regards, attempts, accomplices, and participants, relate to intentional behaviours, respectively. As no intentional behaviours are provided for relating to Article 5-8, MEDICRIME Convention there is no correspondence with Article 9, MEDICRIME Convention.



Sections 8 and 9, Act on Liability of Legal Entities 2012 contains the elements of corporate Liability provided for in Article 11.1, 11.2, and 11.4, MEDICRIME Convention. According to the Act on Liability of Legal Entities, the legal persons in the Czech Republic may be criminally liable for all the criminal offences specified in the MEDICRIME Convention.


Section 42, Criminal Code provides for aggravating circumstances which may be supplemented by The Court according to the circumstance of the case. There is sufficient correspondence, though not direct, between Section 42 and Article 13. a-e, but not relating to Article 13. f MEDICRIME Convention.

3.9 Denmark


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law, as regards the term ‘medical product’, could be found corresponding with Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions of medicinal product and medical device.Further action is needed to fully correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal Product§ 2(1) Danish Medicines Act corresponds with Article 4.b, MEDICRIME Convention, except for investigational medicinal products which are not defined.Further action is needed to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substance§ 2(3) The Medicines Act corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – Excipient§ 2(4) The Medicines Act corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical Device§ 1(2)(1), Executive Order on Medical Devices 2008 corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – Accessory§ 1(2)(2), Executive Order on Medical Devices 2008 corresponds with Article 4.f, MEDICRIME Convention.


g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision could be found in internal laws, as regards the terms ‘parts’ and ‘materials’, corresponding with Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – Document§171, (2) and (3), the Criminal Code (CC) provides a legal definition for the term ‘document’. This does not include the term ‘tampering’.Further action is needed to fully correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – Manufacturing§3 (6), ‘Order on the manufacture and importation of medicinal products and intermediate products’‎, as regards medicinal products, and §3 (3), ‘Order on the manufacture, importation, and distribution of active substances for the manufacture of medicinal products’, as regards active substances, approximately corresponds with Article 4.i, MEDICRIME Convention.There is no legal definition of the term ‘manufacturing’ as regards medical devices. ‎§1.‎‎ (6), Medical Device Order, 2006, defines the term ‘manufacturer’ and this, as regards medical devices, partly corresponds with Article 4.i, MEDICRIME Convention.Further action is needed in order fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitNo provision could be found in internal laws, as regards the term ‘counterfeit’, corresponding with Article 4.j, MEDICRIME Convention. Action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – Victim No provision could be found in internal laws, as regards the terms ‘victim, corresponding with Article 4.k, MEDICRIME Convention. Action is needed to correspond with Article 4.k, MEDICRIME Convention.



§ 38. a, Order of the Law on Medicinal Products, 2018, as regards medicinal products, but not active substances or excipients, corresponds with Article 5, MEDICRIME Convention.

No provision could be found in internal laws, as regards medical devices, accessories, parts and materials, corresponding with Article 5, MEDICRIME Convention.Further action is needed to correspond with Article 5, MEDICRIME Convention.


§ 38. a, Order of the Law on Medicinal Products, 2018, as regards medicinal products, but not active substances or excipients, corresponds with Article 6, MEDICRIME Convention.

No provision could be found in internal laws, as regards medical devices, accessories, parts and materials, corresponding with Article 6, MEDICRIME Convention.



§ 171 (1) CC 2005 is a general criminal law provision and is not specific to medical products. § 171 (1) CC does not include the act of ‘tampering’. It otherwise corresponds with Article 7, MEDICRIME Convention.



8.a.i: § 39, Order of the Law on Medicinal Products, 2018, as regards medicinal products but not active substances or excipients corresponds with Article 8.a. i, MEDICRIME Convention.


8.a.ii: § 4, (1), (2) and (3), § 21(1)(1), Medical Devices Order, 2008, as regards medical devices, but not accessories, parts, and materials, correspond with Article 8.a.ii, MEDICRIME Convention.


Further action is needed to fully correspond with Article 8. a and b, MEDICRIME Convention.


§ 21 (1) and § 23 (1), CC correspond with Article 9.2 and 9.1, MEDICRIME Convention, respectively.


11.1. a, b, c: § 27. (1) CC is general in scope and only requires that the natural person at fault be one who is connected to the legal person, not that it requires the natural person be a person with the power of representation has authority to take decisions or be in control. Depending on the circumstances of the natural person at fault, § 27. (1), CC could correspond with Article 11.1.a, b, and c, MEDICRIME Convention. 11.2. § 27. (1) CC general in scope and only requires that the natural person at fault be one who is connected to the legal person, not that it requires the liability to arise where the lack of supervision or control of a natural person facilitated the commission of the offence. Depending on the circumstances of the natural person at fault, § 27. (1), CC could correspond to a limited extent with Article 11.2, MEDICRIME Convention.

11.3. There is administrative and civil liability and 26. (1) CC provides for criminal liability of the legal person and correspond with Article 11.3, MEDICRIME Convention.

11.4: there is correspondence with Article 11.4, MEDICRIME Convention.


§ 81. (1) and (8), Penal Code corresponds with Article 13. b, c and f, MEDICRIME Convention.

§ 80. (2) could be interpreted to correspond with Article 13.a, MEDICRIME Convention.

Further action is needed to correspond with Article 13. d, and e, MEDICRIME Convention.

3.10 Ecuador


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law could be found to correspond with Article 4.a, MEDICRIME Convention. There are separate definitions of the terms’ medicine’ and ‘medical device’, both components of the term medical product.Action is needed to correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 259, Health Organic Law, as regards authorised medicinal products for human use only, substantially corresponds with Article 4.b, MEDICRIME Convention. There is no provision corresponding to Article 4.b as regards unauthorised medicinal products, or for investigational medicinal products.Further action is needed to correspond with Art 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention - Active substanceArticle 3. Health Regulations Bioequivalence in Medicine for Human Consumption corresponds substantially with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 2, Requirement for Industrial Registration of Drug Producers, and Article 52, Regulation for Obtaining Sanitary Registration of Biological Medicines, substantially correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceThe Health Organic Law, except for software designated by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, substantially corresponds with Article 4.e, MEDICRIME Convention.Further action is needed to fully correspond with Art 4.e, MEDICRIME Convention.


f. Article 4.f MEDICRIME Convention – AccessoryArticle 3, Health Regulations for the Control of Medical Devices, Human Use, correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsArticle 3, Health Regulations for the Control of Medical Devices, Human Use, correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law could be found to correspond with Article 4.h, MEDICRIME Convention. Action is needed to correspond with Art 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingArticle 3, Health Regulations for Obtaining the Health Registration, is similar in intent, but more general than Article 4.i, MEDICRIME Convention.Further action is needed to fully correspond with Art 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 3, Technical Health Standards for the Control of Products for Human Consumption Regulations, corresponds with Article 4.j, MEDICRIME Convention. Clarification is required on the application of this definition to medicinal products for veterinary use and medical devices, accessories, parts, and materials.Further action is needed to fully correspond with Art 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 441 (1) and (2), Integral Criminal Organic Code, is general Criminal Law and is not specific to medical products. Other than including legal person as victims, it corresponds with Article 4.k, MEDICRIME Convention.



Article 217.1, Integral Criminal Organic Code, except for medicinal products for veterinary use, substantially corresponds with Article 5, MEDICRIME Convention.



Article 217.1, Integral Criminal Organic Code, except for medicinal products for veterinary use, substantially corresponds with Article 6, MEDICRIME Convention.



Article 217.1, Integral Criminal Organic Code criminalises the person who possesses a counterfeit or adulterated container or packaging. This does not include the act of falsification, including other documents nor in relation to medicinal products for veterinary use. This is insufficient to correspond with Article 7, MEDICRIME Convention.



8.a. i: Article 140, Health Organic Law, as regards medicinal products for human use only, prohibits the importation, marketing, and sale without registration. This does not criminalise this behaviour and appears to be an administrative prohibition only. This law does not provide for a similar prohibition for medicinal products for veterinary use.

8.a. ii: It is unclear whether there is a requirement for medical devices to be in compliance with conformity requirements to be placed on the market. Where such a requirement exists in regulatory laws, there is no criminalisation in law for a breach of such requirement.

8.b: No provision in internal law could be found to correspond with Article 8, b, MEDICRIME Convention.


Action is required to correspond with Art 8. a and b, MEDICRIME Convention.


Article 43 and 39, Integral Criminal Organic Code, as regards accomplices and attempts, respectively, correspond with Article 9, MEDICRIME Convention.


11.1. a, b, c: Article 49, Integral Criminal Organic Code, corresponds with Article 11.1, a, b, and c, MEDICRIME Convention.

11.2: Clarification is required on whether Article 49, Integral Criminal Organic Code, as regards the lack of supervision or control by the natural person, corresponds with Article 11.2, MEDICRIME Convention.

11.3: Article 564, Integral Criminal Organic Code, corresponds with Article 11.3, MEDICRIME Convention.

11.4. Article 49, Integral Criminal Organic Code, corresponds with Article 11.4, MEDICRIME Convention.

Further action is needed to fully correspond with Article 11.2, MEDICRIME Convention.


13.a: Article 217.1, Integral Criminal Organic Code corresponds with Article 13.a, MEDICRIME Convention.

13.b: Article 217.1, Integral Criminal Organic Code corresponds with Article 13.b, MEDICRIME Convention.

13.c: There is no correspondence in internal law with Article 13. c, MEDICRIME Convention.

13.d: There is no correspondence in internal law with Article 13. d, MEDICRIME Convention.

13.e: There is no correspondence in internal law with Article 13. e, MEDICRIME Convention.

13. f: Article 57, Integral Criminal Organic Code corresponds with Article 13.f, MEDICRIME Convention.

Further action is needed to correspond with Article 13.c, d and e, MEDICRIME Convention.

3.11 Estonia


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision, as regards the term ‘medical product’, could be found in internal law corresponding with Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions for the terms ‘medicinal products’ and ‘medical device’.Action is needed to correspond with Article 4. a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal Product§ 2 Medicinal Products Act 2004 (MPA), as amended, corresponds with Article 4.b, MEDICRIME Convention. § 2 MPA does not use the term ‘presentation’ within the meaning of ‘medicinal product’, but the sense is the same as in Article 4.b, MEDICRIME Convention. The term ‘investigational medicinal products’ is not defined in § 2 and is encompassed in the meaning of ‘medicinal product’.

c. Article 4.c MEDICRIME Convention -Active substance§ 5(1) MPA corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – Excipient§ 5(3) MPA, while more general in wording, corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical Device§ 3(1) Medical Devices Act, 2004 (MDA), as amended, corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – Accessory§ 4 MDA corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g, MEDICRIME Convention – Parts and materials


No provision, as regards the terms ‘parts’, and ‘materials’’, could be found in internal law corresponding with Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision, as regards the term ‘document’, could be found in internal law corresponding with Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – Manufacturing§ 16. (2,) MPA, does not specifically provide this definition, but effectively does so in relation to the requirement for a Manufacturing Authorisation. This provision, in conjunction with § 16(7), and § 2(1) and 8(1) of the Rules for Manufacturing Medicinal Products 2014, correspond, as regards medicinal products, active substances and excipients with Article 4.1, MEDICRIME Convention.No provision in the MDA can be found to specifically provide the definition as regards medical devices. § 15(1) MDA refers, as regards the liability of manufacturers, to some of the requirements of the term ‘Manufacturing’ in Article 4.i, MEDICRIME Convention.No provision in the MDA can be found to specifically provide the definition of the term ‘manufacturing’, as regards the term ‘accessories.Action is needed to correspond with Article 4. i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – Counterfeit§ 10.1 MPA, as regards medicinal products, corresponds with Article 4.j, MEDICRIME Convention. No provision in the MDA can be found to specifically provide the definition of the term ‘counterfeit’ (or ‘falsified’). There is no correspondence with Article 4.j, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – Victim§ 37(1) Code of Criminal Procedure does not correspond directly or sufficiently with Article 4.k, MEDICRIME Convention. § 37(1) requires that the illegal act be directed at the victim and this does not appear to encompass any indirect suffering by the victim and does not include resultant psychological effects on the victim. However, the status of victim is applied to a person who suffers due to the death of a person close to the victim and caused by the illegal act. This is general criminal law and may otherwise be applied to counterfeit medicinal products. As breaches of the MDA are misdemeanours, they do not attract the status of ‘victim’ within their scope.Action is needed to correspond with Article 4.k, MEDICRIME Convention.



§ 104, MPA provides for the penalty for violation of the requirements for handling medicinal products. While §3. (1), MPA includes the act of manufacturing in the definition of the term ‘handling’ it is noted that §3 (3) confines the act of handling to public authorities, unless otherwise stated.

Public authorities, in this context, include governmental authorities, state agencies administered by Governmental authorities, and local authorities. § 104, MPA does not appear to extend beyond this.

Without further clarification, it is considered that § 104 MPA does not correspond with Article 5, MEDICRIME Convention.

Article 5.1, MEDICRIME Convention.

MDA does not provide an offence for the manufacturing (or any term corresponding to manufacturing) of a counterfeit (falsified) medical device. MDA does not correspond with Article 5.1, MEDICRIME Convention.

§ 194, Penal Code, 2001, as amended, criminalises the trafficking of medicinal products for the purpose of acts that include manufacturing. It is unclear whether § 194, Penal Code could correspond with Article 5.1, MEDICRIME Convention.



Article 6 – Supplying, offering to supply, and trafficking in counterfeits.

§ 3 MPA, as regards medicinal products and active substance, and with the caveat regarding the scope of the MDA to public authorities (as referred to above in Article 5), may not enable §104 MPA to correspond with Article 6, MEDICRIME Convention.

MDA, as regards medical devices, does not provide an offence for the behaviours listed in Article 6.1, MEDICRIME Convention and does not correspond with Article 6.1, MEDICRIME Convention.

§ 194, Penal Code, 2001, as amended, criminalises the trafficking of medicinal products

for the purpose of acts that include behaviours covered by Article 6, MEDICRIME Convention. It is unclear whether § 194, Penal Code could correspond with Article .1, MEDICRIME Convention.



§§ 344, 345, and 346, Penal Code are general Criminal Law provisions and not specific to medical products. These provision concern counterfeit documents and damage to official documents and could potentially correspond with the intent of Article 7, MEDICRIME Convention.


Article 8 – Similar crimes involving threats to public health.

8.a. i: §§ 104 and 106, MPA, as regards medicinal products, correspond with Article 8.a.i, MEDICRIME Convention.

8.a. ii: § 39 MDA, as regards medical devices and accessories, corresponds with Article 8.a.ii, MEDICRIME Convention.

8.b: There is no correspondence in law with Article 8.b, MEDICRIME Convention.



9.1. § 22, Penal Code, as regards ‘aiding and abetting, apart from consideration of the caveat contained in § 23, corresponds with Article 9.1, MEDICRIME Convention. § 23 Penal Code does not penalise aiding or abetting as regards misdemeanours. § 112 MPA permits extrajudicial proceedings in relation to § 104 and § 106 as misdemeanours only. § 104 and § 106 relate to the violation of requirements for handling of medicinal products and marketing authorisations, respectively. There is no provision in the MDA regarding violation of requirements for handling of medical devices and none for counterfeit medical devices, accessories, parts, and materials. There is no correspondence in internal law with Article 9.1, MEDICRIME Convention.


9.2: § 25 and § 25.1 Penal Code corresponds with Article 9.2, MEDICRIME Convention.


11.1. a, b, and c: § 14. (1), Penal Code, corresponds with Article 11.1, a, b, and c, MEDICRIME Convention.

11.2: § 13 Penal Code provides for liability for omissions where the legal person was required to act. When taken in conjunction with § 16(4) Penal Code, which provides for indirect intent where foreseeability of the consequences of a failure to act occurs, correspond with Article 13.2, MEDICRIME Convention.

11.3: § 14. Penal Code, as regards criminal liability, §§ 104 and 106 MPA and §39 MDA, with the exception of manufacturing, as regards administrative liability, and civil liability, together correspond with Article 11.3. MEDICRIME Convention.


11.4: § 14(2) Penal Code, as regards the liability of the legal person without prejudice to the criminal liability of the natural persons who committed the act, correspond with Article 11.4, MEDICRIME Convention.



§ 58 Penal Code provides for aggravating circumstance. This does not correspond with Article 13, a -f, MEDICRIME Convention. The Courts may interpret the Penal Code to correspond with Article 13, MEDICRIME Convention. This potentially arises in § 58 (7), which provides an aggravating circumstance for the commission of the offence in a manner which is dangerous to the public such as to correspond with Article 13.a, MEDICRIME Convention, or §255 Penal Code, which provides for offences against Public Security as regards criminal organisations, to correspond with Article 13.e, MEDICRIME Convention.


3.12 Finland

Article 4 – Definitions

a. Article 4.a MEDICRIME Convention – Medical ProductNo provision could be found in internal laws corresponding with Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions of the terms ’medicinal products’ and ‘medical devices’.Further action is needed to fully correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductSection 3, Medicines Act 1987, as amended, except of investigational medicinal products, corresponds with Article 4.b MEDICRIME Convention.Further action is needed to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceSection 5, Medicines Act 1987, as amended, corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 5. (c) Medicines Act 1987, as amended, corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceSection 1, Medical Device Act 2010, substantially corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessorySection 5. (6), Medical Devices Act 2010, corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision could be found in internal laws corresponding with Article 4.g, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision could be found in internal laws corresponding with Article 4.h, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision, as regards the manufacturing of medicinal products, medical devices or accessories, could be found in internal laws corresponding with Article 4.i, MEDICRIME Convention. Section 5. (13), Medical Device Act 2010, contains the definition of ‘manufacturer’ which specifies the different processes required for the definition of ‘manufacturing’ of medical devices and accessories.Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitSection 3.a, Medicines Act 1987, as amended, corresponds with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision, as regards the term ‘victim’, could be found in internal laws corresponding with Article 4.k, MEDICRIME Convention.Action is needed to fully correspond with Article 4.k, MEDICRIME Convention.




No provision, as regards the manufacturing of counterfeits, could be found in internal laws corresponding with Article 5, MEDICRIME Convention.



No provision, as regards the supplying, offering to supply, and trafficking in counterfeit medical products could be found in internal laws corresponding with Article 6, MEDICRIME Convention.Action is needed to correspond with Article 6, MEDICRIME Convention.


Section 1, Chapter 33, Criminal Code (CC) provides the offence of ‘forgery’. This corresponds with Article 7, MEDICRIME Convention.


8.a.ii: Sections 8, 17, 17.a, 19, 20. a, and 32, Medicines Act 1987, as amended, corresponds with Article 8.a.i, MEDICRIME Convention.8.a.ii: Sections 6, 8, and 9, Medical Device Act, 2010, corresponds with Article 8.a.ii, MEDICRIME Convention.8.b: There is no correspondence with Article 8.b, MEDICRIME Convention.Further action is needed to fully correspond with Article 8.b, MEDICRIME Convention.


Section 6, Chapter 5, CC 1989, as amended, provides an offence for abetting and requires intentional conduct. As there is no provision for the criminalisation of offences in internal law corresponding to those contained in Articles 5-8, MEDICRIME Convention, there is no correspondence with Article 9, MEDICRIME Convention.



Section 2, Chapter 9, CC 1989, as amended, which regulates the liability of legal persons in Finland, does not cover offences under the Medicines Act. There is no corresponds with Article 11, MEDICRIME Convention.

Action is needed to correspond with Article11, MEDICRIME Convention.


Section 4, CC 1989, provides for the regulation of general principles (515/2003) by which sentence are determined in just proportion to the harmfulness and dangerousness of the offending, the motives for the acts and other culpability of the offender manifest in the offence. This potentially applies to Article 13. a-d, MEDICRIME Convention. Section 5, Chapter 6, CC 1989, as amended, correspond with Article 13. e and f, MEDICRIME Convention.


3.13 Germany


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision, as regards the term ‘medical product’, could be found in internal law corresponding with Article 4.a, MEDICRIME Convention. It is noted that the terms ‘medicinal product’ and ‘medical device’ are separately defined.Action is needed to correspond with Article 4. a, MEDICRIME Convention.


b. Article 4.b MEDICRIME Convention – Medicinal Product§ 2 para 1, Medicinal Product Act, 2005, as amended (AMG) does not use the term ‘presentation’ within the meaning of ‘medicinal product’, but the sense of the wording is considered by the AMG to be the same as that in Article 4.b, MEDICRIME Convention. The term ‘investigational medicinal product’ is not defined in the AMG and is considered to be encompassed in the meaning of ‘medicinal product’. The AMG provides reference to ‘investigational medicinal products’ within its text. § 2 para 1 AMG is considered to correspond with Article 4.b, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substance§ 4 para 19 AMG corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – Excipient§ 2 para 2, Medicines and Drug Manufacturing Ordinance (AMWHV) corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical Device§ 3 Nr. 1, Law on Medical Devices (MPG) corresponds with Article 4.e, MEDICRIME Convention. It is noted that the Medical Device Implementation Law (MPDG) (implementing Regulation (EU) 2017/745) has been adopted in Germany in 2020 and due to be implemented from May 2021. § 3.1 corresponds with Article 4.e MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention -Accessory§ 3 Nr. 9 MPG corresponds with Article 4.f, MEDICRIME Convention. It is noted that the Medical Device Implementation Law (MPDG) (implementing Regulation (EU) 2017/745) has been adopted in Germany in 2020 and due to be implemented from May 2021. § 2 para 1 sentence 2MPDG corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision, as regards the terms ‘parts’, and ‘materials’’, could be found in internal law corresponding with Article 4.g, MEDICRIME Convention. While § 13 para 2 MPDG refers to counterfeit parts and materials, it does not define either parts or materials.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision, as regards the term ‘document’, could be found in internal law corresponding with Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – Manufacturing§ 4 para. 14 AMG, as regards medicinal products, corresponds with Article 4.i, MEDICRIME Convention. § 20a AMG, as regards active substances, does not define the term ‘manufacturing’, but references its part relating to the manufacture of medicinal products. It is considered to correspond with Article 4.i, MEDICRIME Convention.§ 3 Nr. 15 MPG and § 2 para 1 sentence 2 MPDG do not define the term ‘manufacturing’ as regards medical devices. Both laws define the term ‘manufacturer’ which encapsulates some of the components of the definition of the term ‘manufacturing’, but excluding parts and materials, and accessories. Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention as regards medical devices, parts and materials, and accessories.

j. Article 4.j MEDICRIME Convention – Counterfeit§ 4 para. 40 AMG and § 4 para 41 AMG, as regards medicinal products and active substances, respectively correspond with Article 4.j, MEDICRIME Convention.MPG does not contain a legal definition of the term ‘counterfeit’ (or falsified). § 2 para 1 sentence 2 MPDG corresponds with Article 4.j, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision, as regards the term ‘victim, could be found in internal law corresponding with Article 4.k, MEDICRIME Convention.Action is needed to correspond with Article 4.k MEDICRIME Convention.




§ 8 para 2 AMG, as regards medicinal products and active substances, corresponds with Article 5, MEDICRIME Convention. MPG, as regards medical devices, does not provide an intentional conduct offence corresponding with Article 5.1, MEDICRIME Convention. § 13 para 1 MPDG, as regards medical devices, parts, and material, but not accessories, correspond with Article 5.1, MEDICRIME Convention.



§ 8 para 2 AMG, as regards medicinal products and active ingredients, and except for import and export, correspond with Article. 6, MEDICRIME Convention. There is no offence in MPG that corresponds with Article 6, MEDICRIME Convention. While § 4 para 2 MPG prohibits the putting into circulation of medical devices, if they are provided with a misguiding identification, description, or presentation. It is unclear that this refers to counterfeit devices or to regulatory behaviours not intended to be associated with counterfeiting. § 13 para 1 MPDG corresponds with Article 6, MEDICRIME Convention.

Further action is needed to correspond fully with Article 6 MEDICRIME Convention.


§ 267 para 1 Criminal Code (StGB), as interpreted from German jurisprudence, does not apply to the falsification of documentation envisaged by Article 7, MEDICRIME Convention.

Action is needed to correspond with Article 7 MEDICRIME Convention.


8.a.i: § 13 (1), para 1 and 3, as regards manufacturing authorisations, § 52a (1), as regards wholesaling authorisations, and § 21 (1), as regards marketing authorisations, AMG, as regards medicinal products and active substances correspond with Article 8, a, i, MEDICRIME Convention.

8.a.ii: § 6 para 1 sentence 1 and 2, MPG corresponds with Article 8, a. ii, MEDICRIME Convention. §11, §12 and §13, MPDG, the penalties for contravention are provided by §92 and §93 MPDG, correspond with Article 8.a.ii, MEDICRIME Convention.

8.b: No provision could be found in internal law corresponding with Article 8.b, MEDICRIME Convention.Action is needed to correspond with Article 8.b, MEDICRIME Convention.


9.1: § 26, and § 27, StGB, as regards abetting and aiding, respectively, correspond with Article 9.1, MEDICRIME Convention.

9.2: § 23 (1) StGB provides for the criminalisation of attempts for serious offences and only when expressly stated for less serious offences. No indication is provided in law as to the level of seriousness attaching to offences in Articles 5-8, MEDICRIME Convention. § 95 para 2 AMG provides for the criminalisation of attempts as regards medicinal products but does not include all the relevant offences in relation to Articles 5 - 8, MEDICRIME Convention. Relevant offences are contained in § 96 which does not contain any provision for the criminalisation of attempts. § 92 MPDG, as regards intentional offences mentioned in this section, correspond with Article 9.2 MEDICRIME Convention.

Further action is needed to fully correspond with Article 9.2 MEDICRIME Convention.


11.1: § 30 para 1, 2 and 3, Law on Administrative Contraventions (OWiG) corresponds with Article 11.1.a, b and c, MEDICRIME Convention.


11.2: No provision in OWiG could be found that correspond with Article 11.2, MEDICRIME Convention.

Action is needed to fully correspond with Article 11.2 MEDICRIME Convention.

11.3: § 30 OWiG provides for administrative liability. Liability may also be civil, but not criminal. This corresponds with Article 11.3, MEDICRIME Convention. It is noted that, while the wording of § 30 provides for the commission of a criminal offence or an administrative offence, the Constitutional jurisprudence has ruled out the application of criminal liability for legal persons.

11.4: No provision in OWiG could be found that corresponds with Article 11.4, MEDICRIME Convention. However, it is a basic principle of German criminal law that corporate liability will not exclude the criminal liability of any natural person.


§ 46 para 1 and 2 StGB provides the general principles, with an indicative list of aggravating circumstances in paragraph 2 to support the decision on fixing a penalty by the Courts. This is general Criminal Law that does not specifically consider criminal offending as regards medical product and also does not exclude it.

13.a: § 95 para 3 AMG corresponds, as regards medicinal products and active substances, with Article 13.a, MEDICRIME Convention. There is no correspondence in the MPG with Article 13.a, MEDICRIME Convention. § 92 para 5 MPDG corresponds with Article 13.a, MEDICRIME Convention.

13.b: There is no correspondence, as regards AMG, MPG and MPDG, with Article 13. b, MEDICRIME Convention. It is noted that § 46 para 2, StGB contains a circumstance with regard to the degree of breach of the offender’s duties, it is not considered to fully correspond with Article 13.b, MEDICRIME Convention.

13.c: There is no correspondence, as regards AMG, MPG and MPDG, with Article 13. c, MEDICRIME Convention. It is noted that § 46 para 2, StGB contains a circumstance with regard to the degree of breach of the offender’s duties, it is not considered to fully correspond with Article 13.c, MEDICRIME Convention.

13.d: There is no correspondence, as regards AMG, MPG and MPDG, with Article 13. d, MEDICRIME Convention..

13.e: § 95 para (3).2, AMG, as regards medicinal products and active substances, corresponds with Article 13. e, MEDICRIME Convention. § 92 para 5 MPDG corresponds with Article 13. e, MEDICRIME Convention.

13.f: There is no correspondence, as regards AMG, MPG and MPDG, with Article 13. f, MEDICRIME Convention. It is noted that § 46 para 2, StGB contains a circumstance regarding the offender’s prior history, it is not considered to fully correspond with Article 13.f, MEDICRIME Convention.

Further action is needed to fully correspond with Article 13. a, b, c, d and f, MEDICRIME Convention.

3.14 Georgia


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision, as regards the term ‘medical product’, could be found in internal law corresponding with Article 4.a, MEDICRIME Convention. Action is needed to correspond with Article 4. a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 1. (13) Law of Georgia on Medicines and Pharmaceutical Activities, on the term ‘Pharmaceuticals’ as regards the term ‘medicinal products’, does not correspond with Article 4.b, MEDICRIME Convention. This is because the terms “medicinal product” and ‘investigational medicinal products’ are not defined. In addition, the term ‘pharmaceuticals’ in internal law is general and, unlike the provision of the Convention, does not include specific information as to the purpose and circumstances of their use.Action is needed to correspond with Article 4. b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substance


Article. 1. (42), Law of Georgia on Medicines and Pharmaceutical Activities refers to the ‘pharmaceuticals substance’. The term ‘substance is general and refers to any substance used in the manufacture of a medicinal product, does not fully correspond with Article 4.c, MEDICRIME Convention.Further action is needed to fully correspond with Article 4. c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientNo provision, as regards the term ‘excipient’, could be found in internal law corresponding with Article 4.d, MEDICRIME Convention. Action is needed to correspond with Article 4. d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 1. (12), Law of Georgia on Medicines and Pharmaceutical Activities uses the term ‘medical goods’ which is a general term encompassing products within the notion of medical devices, as contained in Article 4.e, MEDICRIME Convention. However, due to the generally of Article 1. (12) it does not sufficiently correspond with Article 4.e, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryNo provision, as regards the term ‘accessory’, could be found in internal law corresponding with Article 4.f, MEDICRIME Convention. Action is needed to correspond with Article 4. f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision, as regards the term ‘parts’ and ‘materials’, could be found in internal law corresponding with Article 4.e, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision, as regards the term ‘document’, could be found in internal law correspondence with Article 4.h, MEDICRIME Convention. Article 1. (4), 1. (7), 1. (51), and 1 (52), Law of Georgia on Medicines and Pharmaceutical Activities refers to various documents, but not all relevant documents that may be intended by Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingArticle1. (47), Law of Georgia on Medicines and Pharmaceutical Activities, as regards the Manufacturing of a pharmaceutical product, does not include the manufacturing of a medical device or accessory, or parts and materials. This general law provision does not adequately correspond with Article 4.i, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 1. (33), Law of Georgia on Medicines and Pharmaceutical Activities, as regards counterfeit pharmaceutical products, is general in nature. It does not adequately correspond with Article 4.j, MEDICRIME Convention. Action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 3. (22), Criminal Procedure Code of Georgia, provides that a person is considered a victim if it is established that they have suffered a damage because of a crime (notwithstanding of what the crime was). While this is general in nature, it sufficiently corresponds with Article 4.k, MEDICRIME Convention.



Article 197, Criminal Code (CC) of Georgia provides for the general offence of falsification. The generality of this provision is such that it is considered not to sufficiently correspond with Article 5, MEDICRIME Convention.




Article 197, CC provides for the general offence of falsification. The generality of this provision is such that it does not specify the targeted offending as envisaged by the Convention, such as offering to supply, keeping in stock, importing, and exporting of counterfeit medical products. It does not sufficiently correspond with Article 5, MEDICRIME Convention.Further action is needed to fully correspond with Article 6, MEDICRIME Convention.


Article 362 CC provides for the general offence of making, purchase, storage for sale or use, sale or use of forged identity cards or other official documents. This provision is considered too general to sufficiently correspond with the intent of Article 7, MEDICRIME Convention.



8.a.i, ii: Article 246 CC provides for a criminal offence for an Illegal medical or pharmaceutical practice that results in health damage. While this offence addresses the actual resulting impact of illegal medical and pharmaceutical products, it does not encompass the intent of Article 8.a, MEDICRIME Convention.Action is needed to correspond with Article 8.a.i and ii, MEDICRIME Convention.

8.b: No provision could be found to correspond with Article 8.b, MEDCRIME Convention.



9.1: Article 24 (1, 2, 3) and 25 (3) CC, as regards aiding and abetting, does not envisage the criminalising intended by and is does not sufficiently correspond with Article 9.1, MEDICRIME Convention.

9.2: Article 19 (1, 2) CC, as regards attempt, does not envisage the criminalising intended by and is does not sufficiently correspond with Article 9.2, MEDICRIME Convention.

Action is needed to correspond with Article 9.1 and 9.2, MEDICRIME Convention.


11.1. a, b, c: Article 107(2) and (3) CC provides for the criminal liability for legal entities only if the relevant article of the CC determines the liability of a legal entity. The application of these provisions only applies to the forging of documents, but not otherwise. There is insufficient correspondence with Article 11.1. a, b, and c, MEDICRIME Convention.

Further action is needed to fully correspond with Article 11.1. a, b, and c, MEDICRIME Convention.

11.2: Article 107(4) CC provides for the criminal liability for legal entities only if the relevant article of the CC determines the liability of a legal entity. The application of these provisions only applies to the forging of documents, but not otherwise. There is insufficient correspondence with Article 11.2, MEDICRIME Convention.


11.3: The general laws correspond with Article 11.3, MEDICRIME Convention.

11.4: The general laws correspond with Article 11.4, MEDICRIME Convention.


Article 17, 197(3) and (4), and Article 246(2), CC are not completely in compliance with the corresponding provision of the MEDICRIME Convention, as it does not cover all aggravating circumstances envisaged by the Convention, which should entail a more severe liability for committing the crime under specific circumstances. In particular:


b) the offence was committed by persons abusing the confidence placed in them in their capacity as professionals.

c) the offence was committed by persons abusing the confidence placed in them as manufacturers as well as suppliers.

d) the offences of supplying and offering to supply were committed having resort to means of large-scale distribution, such as information systems, including the Internet.

e) the offence was committed in the framework of a criminal organization.

The circumstances outlined above are the aggravating circumstances for other crimes envisaged by the Criminal Code and not the ones that would be relevant for achieving the objective of the Convention.

3.15 Greece


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision, as regards the term ‘medical product’, could be found in internal law corresponding with Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions for the terms ‘medicinal products’ and ‘medical device’.Action is needed to correspond with Article 4. a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductMinisterial Decision 32221/2013 - published in ΦΕΚ Β ‘/ 2485 / 3-10-2013, Article 2. 1, as regards medicinal products for human use, corresponds with Article 4.b, MEDICRIME Convention. No provision for a definition, as regards medicinal products for veterinary use or for investigational medicinal products, could found in internal law corresponding with Article 4.b, MEDICRIME Convention.Further action is needed to correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceMinisterial Decision 32221/2013 - published in ΦΕΚ Β ‘/ 2485 / 3-10-2013, Article 2. 2, as regards the term ‘active substance’ corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientMinisterial Decision 32221/2013 - published in ΦΕΚ Β ‘/ 2485 / 3-10-2013, Article 2.4, as regards the term ‘excipient’, substantially corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceMinisterial Decision 130648/2009 published in ΦΕΚ 2198/B/2-10-2009), Article 2.1, as regards the term ‘medical device’, corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryMinisterial Decision 130648/2009 published in ΦΕΚ 2198/B/2-10-2009), Article 2.1, as regards the term ‘accessory’, corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law could be found to correspond with Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law could be found to correspond with Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision in internal law, as regards the term ‘manufacturing’ could be found corresponding to Article 4.i, MEDICRIME Convention. It is noted that the term ‘manufacturer’ in relation to medical devices can be found defined in Ministerial Decision 130648/2009 published in ΦΕΚ 2198/B/2-10-2009), Article 2.1, and while this describes some of the functions intended by Article 4.1, MEDICRIME Convention, it does not correspond with it.


Action is needed to correspond with Article 4.i MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitMinisterial Decision 32221/2013 - published in ΦΕΚ Β ‘/ 2485 / 3-10-2013, Part 1, Article 36, as regards the term ‘counterfeit’, as regards medicinal products for human use, corresponds, with Article 4.j, MEDICRIME Convention. Law 721/1977 on the approval of the circulation and control of veterinary medicinal products partially corresponds with Article 4.j, MEDICRIME Convention. No provision in internal law, as regards medical devices, could be found corresponding with Article 4.j, MEDICRIME Convention.Further action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 55.i, Law 4478/2017, published in ΦΕΚ 91/Α/23-6-2017, as regards the term ‘victim’ is provided in relation to the implementation of the Council of Europe Convention on Laundering, Search, Seizure and Confiscation of the Proceeds from Crime and on the Financing of Terrorism (Warsaw Convention, CETS 198, 2005). It is unclear whether, in internal law, this provision is applicable outside of Law 4487/2017. No specific provision in internal law can be found to correspond with Article 4.k, MEDICRIME Convention.Action is needed to correspond with Article 4.k, MEDICRIME Convention.



5.1: Ministerial Decision 32221/2013, published in ΦΕΚ Β ‘/ 2485 / 3-10-2013, Art. 175. 3, provides for administrative fines to produce counterfeit medicines. This does not correspond with Article 5.1, MEDICRIME Convention.

5.2: Article 19.9, Legislative Decree 96/1973 relates to pharmaceutical products that are adulterated, but not the act of adulterating the product. As this provision is related to the finding on inspection of adulterated pharmaceutical products and those not in compliance with approved composition, it is unclear whether the provision is intended as a licensing provision, an administrative law matter, or as a criminal offence.

Action is required to correspond with Article 5.1 and 5.2, MEDICRIME Convention.


Article 19, §9, Legislative Decree 96/1973, as regards pharmaceutical products, prohibits the distribution or holding such products with the intention of selling them. Ministerial Decision 32221/2013, published in ΦΕΚ Β ‘/ 2485 / 3-10-2013, Art. 175. 3, provides for administrative fines to distribute, broker, import and export of counterfeit medicines.

Clarification is required on the status of this offence as regards the intentional conduct required by the MEDICRIME Convention.

No provision in internal law applicable to medical devices can be found to correspond with Article 6, MEDICRIME Convention.



Article 216.1, Penal Code is a general criminal law offence that is not specific to the type of documents contemplated by Article 7, MEDICRIME Convention. It is sufficient to correspond with Article 7.


8.a.i: Ministerial Decision 32221/2013, published in ΦΕΚ Β ‘/ 2485 / 3-10-2013, Article 175.3, provides for administrative fines for non-compliances set out in the Ministerial Decision on the production, distribution, import and export active substances and excipients. No provision can be found in internal law, as regards medicinal products for human use or medicinal products for veterinary use, to correspond with Article 8.a.ii, MEDICRIME Convention.


8.a. ii: No provision in internal law, as regards medical devices, could be found corresponding with Article 8.a.ii, MEDICRIME Convention.

8.b: No provision in internal law, as regards medical devices, could be found corresponding with Article 8.b, MEDICRIME Convention.


Articles 45 and 46, Penal Code, as regards aiding and abetting, correspond with Article 9, MEDICRIME Convention.


No provision in internal law could be found corresponding with Article 11, MEDICRIME Convention. In Greece, the legal person acts only through their representatives and cannot be on their own be subject to the criminal law.



Law 5607/1932, and Article 19.9, Legislative Decree 97/1973, both regarding recidivist offending behaviours involving pharmaceutical offences but other medical products, may partially correspond with Article 13.f, MEDICRIME Convention.

Internal law does not correspond with article 13, MEDICRIME Convention.


3.16 Guinea


a. Article 4.a MEDICRIME Convention – Medical ProductArticle 1.a, Loi L/2018/024/AN, 2018, on medicines, health products and the practice of the profession of pharmacy, provides for the meaning of the term “produit de santé” (health product) and it is insufficient to fully correspond with Article 4.a, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 1. b, Law L/2018/024/AN,2018, as regards the term ‘medicinal product’, but excluding investigational medical products, substantially corresponds with Article 4.b, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceArticle 1. t, Law L/2018/024/AN 2018, as regards the term ‘active substance’, corresponds with Article 4.c MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 1.u, Law L/2018/024/AN 2018, as regards the term ‘excipient’ corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 1. p, Law L/2018/024/AN 2018, as regards the term ‘medical device’, corresponds with Article 4.e MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryArticle 1. v, Law L/2018/024/AN 2018, as regards the term ‘accessory’, corresponds with Article 4.f MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsArticle 1. w, Law L/2018/024/AN 2018, as regards the terms ‘parts’ and ‘materials’, corresponds with Article 4.g MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – Document


Article 1. y, Law L/2018/024/AN 2018, as regards the term ‘document’, corresponds with 4.h MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingArticle 1. x, Law L/2018/024/AN 2018, as regards the term ‘manufacturing,’ corresponds with 4.i MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 35 Law L/2018/024/AN 2018, as regards the term ‘counterfeit’, corresponds with 4.j MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision in internal law, as regards the term ‘victim’, corresponds with Article 4.k, MEDICRIME Convention. Action is needed to correspond with Article 4.k, MEDICRIME Convention.



Article 35 in conjunction with Article 169, Law L/2018/024/AN 2018, and Article 880 Criminal Code (L/2016/59/AN), do not sufficiently correspond with Article 5, MEDICRIME Convention.



Article 170 Law L/2018/024/AN 2018, and Article 880 Criminal Code do not sufficiently correspond with Article 6, MEDICRIME Convention.



Art. 585 Criminal Code corresponds with Article 7 MEDICRIME Convention.


8.a.i. ii: Article 177, Law L/2018/024/AN 2018, in conjunction with Article 75 and following ones, do not sufficiently correspond with Article 8.a.i and ii, MEDICRIME Convention.

Further action is needed to fully correspond with Article 8.a. MEDICRIME Convention.

8.b: No provision in internal law can be found to correspond with Article 8.b, MEDICRIME Convention.

Further action is needed to correspond fully with Article 8.a and b, MEDICRIME Convention.


9.1: Article 173, Law L/2018/024/AN 2018, and Articles 19 and 20, Criminal Code, correspond with Article 9.1 MEDICRIME Convention.

9.2: Article 172, Law L/2018/024/AN 2018, and Article 18 Criminal Code, correspond with Article 9.2 MEDICRIME Convention (see also art. 18 Criminal Code).


11.1. a, b, c: Article 16, Criminal Code corresponds with Article 11.1. a, b, c, MEDICRIME Convention

11.2: No provision in internal law could be found to correspond with Article 11.2, MEDICRIME Convention.

Action is needed to correspond with Article 11.2, MEDICRIME Convention.

11.3: Article 16, Criminal Code corresponds with Article 11.3, MEDICRIME Convention.

11.4: Article 16, Criminal Code corresponds with article 11.4, MEDICRIME Convention.



13.e: Article 161, Criminal Code, corresponds with Article 13.e, MEDICRIME Convention.

13.f: Article 99, Criminal Code, corresponds with Article 13.f, MEDICRIME Convention.

No provision in internal law could be found corresponding with Articles 13, a, b, c and d MEDICRIME Convention.

Further action is needed to correspond with Articles 13, a, b, c and d MEDICRIME Convention.

3.17 Iceland


a Article 4.a MEDICRIME Convention – Medical ProductNo provision, as regards the term ‘medical product’, could be found in internal law corresponding with Article 4.a, MEDICRIME Convention. It is noted that the terms ‘medicinal product’ and ‘medical device’ are separately defined.Action is needed to correspond with Article 4.a MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 3(3), Medicinal Products Act, 2020, corresponds with Article 4.b, MEDICRIME Convention. The term ‘investigational medicinal products’ is not defined and is considered to be encompassed in the meaning of ‘medicinal product’.

c. Article 4.c MEDICRIME Convention -Active substanceArticle 3(22) Medicinal Products Act, 2020, corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 3(5), Medicinal Products Act, 2020, corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 3(1), Act on Medical Devices, 2001, as amended, corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryArticle 2(2), Regulation on Medical Devices, 2010, corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision, as regards the terms ‘parts’ ‘materials’’, could be found in internal law corresponding with Article 4.g, MEDICRIME Convention. Action is needed to correspond with Article 4.g MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision, as regards the term ‘document’, could be found in internal law corresponding with Article 4.h, MEDICRIME Convention. Action is needed to correspond with Article 4.h MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingArticle 3(2), Medicinal Products Act, 2020, as regards medicinal products, but not active substances and excipients, corresponds with Article 4.i, MEDICRIME Convention.There is no legal definition of the term ‘manufacturing’ as regards medical devices. The term ‘manufacturer’ is defined in §3.2, Act on Medical Devices Act, 2001, and this incorporates, as regards medical devices, part of the definition in Article 4.i, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 3. (3), Medicinal Products Act, 2020, corresponds with Article 4, j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision, as regards the term ‘victim’, could be found in internal law corresponding with Article 4.k, MEDICRIME Convention. Action is needed to correspond with Article 4.k MEDICRIME Convention.




No provision could be found in internal law that corresponds with Article 5, MEDICRIME Convention.



No provision could be found in internal law that corresponds with Article 6, MEDICRIME Convention. It is noted that Article 173, Criminal Code (CC) 1940, as amended, penalises anyone who offers for sale or involved in the distribution of medicinal products knowing that those products do not possess the required properties and that their use could endanger human life and health. While this provision could potentially address some of the behaviours intended by Article 6, MEDICRIME Convention, it does not address, either directly or indirectly all of them.



Articles 155-159, Criminal Code, 1940, as amended, correspond with Article 7, MEDICRIME Convention.


8.a.i: Article 100. a, d, e, g, and Article 103. c, h and f, Medicinal Products Act, correspond with Article 8.a.i, MEDICRIME Convention.

8.a.ii: The Act on Medical Devices does not correspond with Article 8, a, ii, MEDICRIME Convention.

8.b: Section 157, CC, 1940, as amended, prohibits the use of a document for a different purpose than intended. This is a general criminal law provision which does not specifically focus on documentation intended for medical purposes but does not exclude its applicability. Section 157 corresponds with Article 8. MEDICRIME Convention. No provision in the Medicinal Product Act or the Act on Medical Devices can be found corresponding with Article 8.b, MEDICRIME Convention.

Action is needed to fully correspond with Article 8, a. ii, and 8.b, MEDICRIME Convention.


Article, 104, Medicinal Product Act, as regards attempts and acting as an accessory, corresponds with Article 9.1 and 9.2, MEDICRIME Convention. Articles 20 and 22, CC, 1940, as amended, as regards attempts and aiding and abetting, respectively, correspond with Article 9, MEDICRIME Convention.


11.1. a, b, c: Articles 19.c, CC, as amended, while not being specific on the conditions in 11.1, a, b, and c, corresponds with Article 11.1, MEDICRIME Convention.

11.2: Article 19, CC corresponds with Article 11.2, MEDICRIME Convention.

11.3: Article 92 and 93, Medicinal Products Act, as regards administrative and civil liability, respectively, and Article 19. d, CC, as regards criminal liability, correspond with Article 11.3, MEDICRIME Convention.

11.4: Article 103, Medicinal Products Act, as regards medicinal products, and Article 19. c, and d, correspond with Article 11.4, MEDICRIME Convention.



13. a-d: No provision in the Criminal Code, the Medicinal Products Act and the Act on Medical Devices could be found to correspond with Article 13, a, b, c, and d, MEDICRIME Convention.

13.e: Article 175.a, CC corresponds with Article 13.e, MEDICRIME Convention.

13.f: Article 71, CC corresponds with Article 13.f, MEDICRIME Convention.

Further action is needed to fully correspond with Article 13 a – d, MEDICRIME Convention.

3.18 Ireland


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision, as regards the term ‘medical product’ could be found in internal law corresponding to Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions of the terms ‘medicinal product’ and ‘medical device’.Action is needed to correspond with Article 4.a MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductSection 1(1) of the Irish Medicines Board Act 1995, as amended by section 10(c) of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 refers to Directive 2001/83/EU, as amended, on the definition of medicinal products, and Article 3 of the Medicinal Products (Control of Manufacture) Regulations 2007, together and separately correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceArticle 3 (1) of the Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. 539 of 2007) corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientMedicinal Products (Control of Manufacture) Regulations, 2007, S.I. 539 of 2007 corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceSection 1(1) of the Irish Medicines Board Act 1995, as amended by section 10(c) of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 refers to the EU Directives on the definition of medical devices - Directive 2007/47/EU (amending directive 93/42/EU regarding medical devices). The definition has been implemented in Irish legislation in Regulation 5 (ii), European Communities (Medical Devices) (Amendment) Regulations 2009 (S.I. No. 110/2009) and corresponds with Article 4.e, MEDICRIME Convention.Article 4.f MEDICRIME Convention – Accessory

f. European Communities (Medical Devices) Regulations, 1994 (S.I. No. 252/1994) corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision, as regards the terms ‘parts’ and ‘materials’ could be found in internal law corresponding to Article 4.a, MEDICRIME Convention.Further action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4. MEDICRIME Convention – DocumentSections 2 and 24, Criminal Justice (Theft and Fraud Offences) Act 2001, and Section 32A, Irish Medicines Board Acts 1995 and 2006, both correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingRegulation 3, Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. 539 of 2009), as regards medicinal products for human use, Section 1, Animal Remedies Act 1993, as regards medicinal products for veterinary use, and Regulation 2, European Communities (Medical Devices) Regulations, 1994 (S.I. No. 252/1994), as regards medical devices, but not accessories, correspond with Article 4.i, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – Counterfeit


Regulation 3, Medicinal Products (Control of Manufacture) Regulations, 2007, as amended by Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013 (S.I. 163 of 2013), excluding medical devices, corresponds with Article 4.j, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimSection 2. (1), Criminal Justice (Victims of Crime) Act 2017 corresponds with Article 4.k, MEDICRIME Convention.



Regulation 14B. (1) and 14.C, Medicinal Products (Control of Manufacture) Regulations, 2007, (S.I. 539 of 2007), as amended by Medicinal Products Control of Manufacture) (Amendment) Regulations 2013 (S.I. 163 of 3013), as regards medicinal products and active substances, respectively, correspond with Article 5, MEDICRIME Convention. There is no existing provision in law for falsified/counterfeit medical devices, accessories, and parts and material. A new law, yet to be enacted, is scheduled for implementation from May 2021 to include the falsification of medical devices, accessories and parts and materials.


Article 6 – Supplying, offering to supply, and trafficking in counterfeits.

Regulation 14.B. Medicinal Products (Control of Wholesale Distribution) Regulations, 2007 (S.I. 538 of 2007), as amended by Regulation 6, Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013 (S.I.164 of 2013), as regards medicinal products, corresponds with Article 6, MEDICRIME Convention. There is no existing provision in law for falsified/counterfeit medical devices, accessories, and parts and material. A new law, yet to be enacted, is scheduled for implementation from May 2021 to include the falsification of medical devices, accessories and parts and materials.



Articles 25, 26, 27, 28, 29 and 30, Criminal Justice (Theft and Fraud Offences) Act 2001 correspond with Article 7, MEDICRIME Convention.


8.a.i. ii, iii: Regulation 4, Medicinal Products (Control of Manufacture) Regulations, 2007 (S.I. 539 of 2007), Regulation 5, Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. 538 of 2007), Regulation 6, Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. 540 of 2007), as regards medicinal products for human use, European Communities (Animal Remedies) (No. 2) Regulations 2007 ( S.I. No. 786/2007), as regards medicinal products for veterinary use, and European Communities (Medical Devices) Regulations, 1994 (S.I. No. 252/1994), as regards medical devices, corresponds with Article 8.a.i, and ii, MEDICRIME Convention.

8.b: No provision in internal law can be found corresponding to Article 8.b.

Further action is needed to correspond with Article 8.b, MEDICRIME Convention.

Article 9 – Aiding or abetting and attempt.

9.1: Section 22 of the Petty Sessions Ireland Act 1851 and Section 7 of the Criminal Law Act 1997, as regards aiding and abetting, corresponds with Article 9.1, MEDICRIME Convention.

9.2: Save where provided by a particular statute, any attempt to commit an indictable (serious) offence is capable of being prosecuted as being contrary to the Irish common law and corresponds with Article 9.2, MEDICRIME Convention.



Section 33, Irish Medicines Board Acts 1995 and 2006, correspond with Articles 11.1, 11.2, 11.3 and 11.4 MEDICRIME Conventions.


Aggravating and mitigating factors are not part of the substantive criminal law and remain within judicial discretion which is guided by sentencing rules, principles and policies that must be applied.


3.19 Italy


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision, as regards the term ‘medical product’ could be found in internal law corresponding to Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions of the terms ‘medicinal product’ and ‘medical device’.Action is needed to correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 1.1.a, Legislative Decree No. 219 of 24 April 2006 on the implementation of Directive 2001/83/EC (Medicine Code), as regards medicinal products for human use, corresponds with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceArticle 1. 1. b-bis), Legislative Decree 219/2006, and Article 1. x) Legislative Decree 193/2006 correspond with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention - ExcipientArticle 1.1.b, b-ter) Legislative Decree 219/2006 substantially corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 1. 2. a), Legislative Decree 1997 corresponds with Article 4.e, MEDICRIME Convention. This provision will be repealed by Regulation 2017/745/EU with effect from 26 May 2021 when the new definition of medical device will be implemented.

f. Article 4.f MEDICRIME Convention – AccessoryArticle 1. 2. b), Legislative Decree 1997, corresponds with Article 4.f, MEDICRIME Convention. This provision will be repealed by Regulation 2017/745/EU with effect from 26 May 2021 when the new definition of medical device will be implemented.

g. Article 4.g MEDICRIME Convention – Parts and materialsThe terms “parts” and “materials” as defined by the internal legislation correspond substantially to the definition established in the MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentThe term “document” as defined by the internal legislation corresponds substantially to the definition established in the MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingThe term “manufacturing” as defined by the internal legislation corresponds substantially to the definition established in the MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 1.1.nn-bis), Legislative Decree 1997The term “counterfeit” as defined by the internal legislation corresponds substantially to the definition established in the MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimThe term “victim” as defined by the internal legislation corresponds substantially to the definition established in the MEDICRIME Convention.




Article 441 Penal Code provides for the offence of adulteration and counterfeiting of products that are detrimental to public health. While not specified, this encompasses these acts in relation to medical products. An offence under this provision includes the required element of proving the detrimental effect on public health and falsification. Article 147,7-bis, Legislative Decree 219/2006 punishes the manufacturing of a falsified medicine. This offence does not require an element of endangerment, suffice that it is intentionally falsified. Article 5, MEDICRIME Convention requires that the act of manufacturing a falsified medical product constitutes the offence. While endangerment is not a required element of the offence, Article 13.a provides an aggravating circumstance for such.

While Article 441 Penal Code could be useful in prosecuting the counterfeiting of medical products, it cannot be used where endangerment cannot be proven. The Legislative Decree relates to medicinal products and not medical devices.

Further action is required to fully correspond with Article 5, MEDICRIME Convention.


Article 442, Penal Code provides for, in relation to adulterated and counterfeited products, the keeping for trade, places on the market for supply, or distributes. This offence requires the elements of endangerment of public health and falsification of the product, which is not specific to medical products. Article 147, 7-bis, Legislative Decree 219/2006 provides for the offence of distributing, importing, exporting, brokering, trading and selling by distance sales to the public, of falsified medicinal products. There is no similar provision in relation to medical devices. The element of endangerment to public health is not required in this offence.

Article 6, MEDICRIME Convention requires, in relation to a falsified medical product, a range of acts which Article 147,7-bis to constitutes the offence. While endangerment is not a required element of the offence, Article 13.a provides an aggravating circumstance for such.

While Article 442 Penal Code could be useful in prosecuting the counterfeiting of medical products, it cannot be used where endangerment cannot be proven. The Legislative Decree relates to medicinal products and not medical devices.



No provision in internal law corresponds with Article 7, MEDICRIME Convention.Action is needed to correspond with Article 7, MEDICRIME Convention.


8.a.i: Articles 147 and 148 Legislative Decree 219/2006, as regards medicinal products for human use, and Art. 108 Legislative Decree nº 193/2006, as regards medicinal products for animal use, correspond with Article 8.a.i, MEDICRIME Convention.

8.a.ii: Articles 4 and 5, Legislative Decree, 46/1997, as regards medical devices, correspond with Article 8.a.ii, MEDICRIME Convention.




9.1: Article 110, Penal Code, as regards aiding and abetting, corresponds with Article 9.1 MEDICRIME Convention.

9.2: Article 56, Penal Code, as regards attempt, corresponds with Article 9 MEDICRIME Convention.


For the offences referred to in Articles 440 and 442 the configurability of the attempt is controversial, having committed a crime of danger, and therefore there would be an excessive anticipation of the threshold of punishment.


11.1. a, b, c: Legislative Decree No 231/2001, as general corporate liability offences, corresponds with Article 11, a, b and c, MEDICRIME Convention. These offences are not specific to those contained in the MEDICRIME Convention established measures to ensure that legal persons can be held liable for certain crimes, when they are committed to their advantage by any natural person, acting individually or as a part of an organ of the legal person, who has a leading position within it based on: (a) representation of the legal entity; (b) the authority to take decisions on behalf of the legal entity; (c) the authority to exercise control within the legal entity. The outline of the procedure provided for in the MEDICRIME Convention is that governed by Legislative Decree 231/2001; however, currently, the conduct contained in the Convention is not provided for by general law. New provisions should therefore be introduced when the MEDICRIME Convention is ratified, providing for the criminal and/or administrative liability of legal persons, including for offences of infringement of medicinal products introduced by the Convention.

11.2: Article 5 paragraph.1 b) and article 7 Legislative Decree 231/2001 corresponds with Article 11.2, MEDICRIME Convention

11.3: Subject to the legal principles of the domestic criminal code and of the Legislative decree 231/01, the liability of a legal person may be civil or administrative and correspond with Article 11.3, MEDICRIME Convention.

11.4. Article 40, Penal Code corresponds with Article 11.4, MEDICRIME Convention.


13.a: No provision in internal law could be found to correspond with Article 13.a, MEDICRIME Convention.

13.b: Article 61.11), Penal Code corresponds with Article 13.b, MEDICRIME Convention.

13.c: Article 61. 11), Penal Code corresponds with article 13.c, MEDICRIME Convention.

13.d: Article 112-quarter, 1 and 2, Legislative Decree 219/2006 provide for an offence encompassing elements of supplying having resort to means of remote sales of medicinal products, the penalty for which is prescribed by Article 112-ter Legislative decree 219/2006. Notwithstanding that this could be used in prosecution relating to this type of offence, it does not include all medical products. No aggravating circumstances could be found in internal law corresponding to Article 13.d, MEDICRIME Convention.

13.e: Article 416, Penal Code refers to criminal associations but not fully corresponds to Article 13.e, MEDICRIME Convention

13.f: Article 99, Penal Code corresponds with Article 13.f, MEDICRIME Convention.

Further action is needed to correspond with Article 13.a and f, MEDICRIME Convention.

3.20 Japan


a. Article 4.a MEDICRIME Convention – Medical ProductThe Law for Ensuring Quality, Efficacy, and Safety of Drugs and Medical Devices (commonly-called the Pharmaceutical and Medical Device Act) (SQESPM) does not correspond with Article 4.a, MEDICRIME Convention.Action is needed for the internal law to fully correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 2(2), SQESPM, corresponds partially with Article 4.b, MEDICRIME Convention, except for the presentation criterion at Article 4.b.i, and as regards investigational medicinal products at Article 4.b.iii, MEDICRIME Convention.Further action is needed to correspond with Article 4.b, MEDICRIME Convention.


c. Article 4.c MEDICRIME Convention -Active substanceArticle 3.1. (2) and (3), SQESPM, partially corresponds with the intent of Article 4.c, MEDICRIME Convention and is not separately or individually defined.Further action is needed to correspond with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientNo provision in internal law could be found to correspond with Article 4.d, MEDICRIME Convention.Action is needed to correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 2. (4), SQESPM is similar in intent, though not in word, and corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryNo provision in internal law could be found to correspond with Article 4.f, MEDICRIME Convention.Action is needed to correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law could be found to correspond with Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentArticles 50, 51, and 52 SQESPM specify information on labelling requirements. However, this is insufficient and does not correspond with the intent or wording in Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision in internal law could be found to correspond with Article 4.i, MEDICRIME Convention.Action is needed to correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitNo provision in internal law could be found to correspond with Article 4.j, MEDICRIME Convention.Action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 2 (1) and (2), Basic Act on Crime Victims 2004, is a general law provision and not specific to medical products. It sufficiently corresponds with Article 4.k, MEDICRIME Convention.



Articles 55(2) and 64, SQESPM, except for active substances, excipients, accessories, parts and materials, correspond with Article 5, MEDICRIME Convention. It is noted that adulteration is considered as part of the manufacturing process.

Further action is needed to fully correspond with Article ,5 MEDICRIME Convention.


Articles 55(2) and 64, SQESPM, except for the acts of offering and export, and all activities in relation to active substances, excipients, accessories, parts, and materials, correspond with Article 6, MEDICRIME Convention.



Article 159, Penal Code 1907, is a general Criminal Law provision and not specific to medical products. This corresponds with the intent of Article 7, MEDICRIME Convention.



8.a.i. ii: Article 12(1), 13(1) and 14(1) SQESPM, as regards pharmaceutical medicinal products, and Articles 23-2 (1), 23-2(1), 23-2-3 (1), 23-2-4(1), and 23-2-5 (1) SQESPM, as regards medical devices, for which the penalties are prescribed by Articles 84 and 86 SQESPM, correspond with Article 8.a.i and ii, MEDICRIME Convention.

8.b: No provision in internal law could be found to correspond with Article 8.b, MEDICRIME Convention.


Article 9 – Aiding or abetting and attempt.

9.1: Articles 61 and 62 Penal Code corresponds with Article 9.1, MEDICRIME Convention.

9.2: Article 44, Penal Code, criminalises attempt, but limited to when punishable in a prohibition, and which includes fraudulent acts where a person obtains, or causes another to obtain an illegal profit by the means described. This may also include computer crimes.

The provisions of the Penal Code, the Customs Code 1954, Act on Punishment of Organized Crimes and Control of Proceeds of Crimes 1999, and SQESPM, individually and in combination, are insufficient to fully correspond with Article 9.2, MEDICRIME Convention.



11.1. a, b, c: Articles 75 and 90, SQESPM, correspond with Article 11.1, a, b, and c, MEDICRIME Convention.

11.2: Article 715 (1) and (2), Civil Code, as regards the lack of supervision or control by The natural person referred to in 11.1, has made possible the commission of an offence established under and corresponds with Article 11.2, MEDICRIME Convention.

11.3: Article 90, SQESPM, and Article 715, Civil Code, as regards criminal and Administrative liability, correspond with Article 11.3, MEDICRIME Convention.

11.4: Article 90, SQESPM, corresponds with Article 11.4, MEDICRIME Convention.


13.a: Articles 204, 205, 209, and 210, Penal Code, in combination, is sufficient to correspond with the intent of Article 13.a, MEDICRIME Convention.13.b: Laws relating to healthcare practitioners provide for aggravating factors in relation to professional sanctions where they have committed a crime or wrongful act related to pharmaceutical affairs or medicine. These potentially may also relate to criminal acts as described under the MEDICRIME Convention. No other professionals are included in aggravating circumstance. Neither SQESPM nor the Penal Code have any provisions that fall within Article 13.b, MEDICRIME Convention. There is insufficient correspondence with Article 13b, MEDICRIME Convention.Further action is needed to fully correspond with Article 13.b, MEDICRIME Convention.13.c: Article 75. (1) SQESPM provides for the rescinding of authorisations where there have been abuses of authorisations, including by manufacturers and suppliers. This does not include the offences relating to counterfeiting of medical products and is insufficient to correspond with Article 13.c, MEDICRIME Convention.Further action is needed to fully correspond with Article 13.a, MEDICRIME Convention. 13.d: While Article 6, Act on Regulation of Transmission of Specified Electronic Mail, prohibits sending advertisement by email where the sender’s details are falsified, this potentially could be used in prosecutions regarding offences in Articles 5, 6, 7 and 8 MEDICRIME Convention, However, this provision, while it could support a prosecution of offences contemplated by the Convention, is not intended for such offences, but for the regulation of advertisements by email. It is not an aggravating circumstance intended by Article 13, d, MEDICRIME Convention.Articles 12 and 15, Act on Specified Commercial Transactions, 1976, could potentially be used in prosecutions in relation to medical products involved in offending described in Article 5, 6, 7 and 8, MEDICRIME Convention. However, they are more correctly intended To regulate commercial activity, not as aggravating circumstances intended by Article 13.d, MEDICRIME Convention.

Further action is needed to fully correspond with Article 13.d, MEDICRIME Convention.


13.e: The SQESPM, Penal Code or the Act on Punishment of Organized Crimes and Control of Proceeds of Crime, as regards aggravating circumstances where the offence was committed in the framework of a criminal organisation, in so far as they do not already form part of the constituent elements of the offence, do not correspond with Article 13.e, MEDICRIME Convention.

Further action is required to fully correspond with Article 13e, MEDICRIME Convention.

13.f: Articles 57 and 59, Penal Code correspond with Article 13.f, MEDICRIME Convention.

3.21 Latvia


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision, as regards the term ‘medical product’, could be found in internal law which corresponds with Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions of the terms ‘medicinal product’ and ‘medical device’.Action is needed to correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductSection 1.17, Pharmaceutical Law, except for investigational medicinal products, corresponds with Article 4. b, MEDICRIME Convention.Further action is required to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceSection 1.16, Pharmaceutical Law, corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientSection 122 Pharmaceutical Law, substantially corresponds with Article 4.d, MEDCIRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 21, Medical Treatment Law, substantially corresponds with Article 2.e, MEDICRIME Convention.Further action is needed to fully align with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryParagraph 2.13, Procedures for registration, conformity assessment, distribution, operation, and technical supervision of medical devices, (Regulation 689), corresponds with Article 4.f, Medical Devices

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law, as regards the terms ‘parts’ and ‘materials’, could be found which corresponds with Article 4.g, MEDICRIME Convention.Action is required to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law, as regards the terms ‘documents’, could be found which corresponds with Article 4.h, MEDICRIME Convention.Action is required to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingSection 1.21, Pharmaceutical Law, as regards the manufacturing of medicinal products, mentions some of the activities in the manufacturing process, and does not sufficiently correspond with Article 4.i, MEDICRIME Convention. Paragraph 34, Procedures for registration, conformity assessment, distribution, operation, and technical supervision of medical devices, (Regulation 689), as regards the manufacturing of medical devices, does not adequately correspond with Article 4.i, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitSection 1. 161 Pharmaceutical Law, as regards medicinal products, except for medical devices, corresponds with Article 4.j, MEDICRIME Convention.Further action is needed to fully correspond, as regards medical devices, with Article 4. J, MEDICRIME Convention.


k. Article 4.k MEDICRIME Convention – VictimNo offence in internal law, as regards the term ‘victim’ can be found which corresponds with Article 4.k, MEDICRIME Convention. While the definition of the term ‘victim’ can be found in Section 43, Law on Administrative Liability, this is not a definition applicable in the criminal law.Action is needed to correspond with Article 4.k, MEDICRIME Convention.



No provision in internal law, as regards the intentional manufacturing of a counterfeit medical products, active substances, excipients, parts, materials, and accessories, can be found which corresponds with Article 5, MEDICRIME Convention. Section 92 and 97(2), Pharmaceutical Law provides for fines in cases of the manufacturing or preparation of falsified medical products and active substance for human use and veterinary use, Respectively. Paragraph 68.10, Procedures for the Licensing of Pharmaceutical Activity (Regulation 800 of 2011), provides for the revocation of licences from manufacturers, and importers of falsified medicinal products for human and veterinary use, falsified investigational medicinal products and falsified active substances. None of these administrative provisions correspond with Article 5 MEDICRIME Convention.

Action is required to fully correspond with Article 5, MEDICRIME Convention.


No provision in internal law, as regards the intentional supplying or the offering to supply, including brokering, the trafficking, including keeping in stock, importing, and exporting of a counterfeit medical products, active substances, excipients, parts, materials, and accessories, can be found which correspond with Article 6, MEDICRIME Convention. Section 91, Pharmaceutical Law provides for fines in cases of the import, export, or distribution of falsified medical products and active substance for human use and Section 97(1), Pharmaceutical Law, in cases of the distribution of medicinal products for veterinary use, and falsified active substances. Paragraph 68.10, Procedures for the Licensing of Pharmaceutical Activity (Regulation 800 of 2011), provides for the revocation of licences from distributors and importers of falsified medicinal products for human and veterinary use, falsified investigational medicinal products and falsified active substances. None of these administrative provisions correspond with Article 6 MEDICRIME Convention.

Action is required to correspond with Article 6, MEDICRIME Convention.


No provision in internal law can be found which corresponds with Article 7, MEDICRIME Convention. It is noted that Section 190, The Criminal Law, provides the intentional offence, relating to smuggling, for the use of false documents and it is qualified by the requirement to be committed on a significant scale. This does not correspond with the intent of Article 7, MEDICRIME Convention.



8.a.i. ii: No provision in internal law can be found which corresponds with Article 8.a.i and ii, MEDICRIME Convention.

8.b: No provision in internal law can be found which corresponds with Article 8.b, MEDICRIME Convention.

Action is required to correspond with Article 8.a and b, MEDICRIME Convention.


No provision in internal law can be found which corresponds with Article 9, MEDICRIME Convention. It is noted that as no intentional offence, as contemplated by Article 5-8, MEDICRIME Convention, exist in internal law, there can be no applicable offence corresponding with Article 9, MEDICRIME Convention.

Action is required to correspond with Article 9.1 and 9.2, MEDICRIME Convention.



11.1 – 11.4: No provision in internal law can be found which corresponds with Article 11.1– 11.4, MEDICRIME Convention. It is noted that no intentional offence, as contemplated by Article 5-8, MEDICRIME Convention, exist in internal law, there can be no applicable offence corresponding with Article 11, MEDICRIME Convention.



No provision in internal law can be found which corresponds with Article 13, MEDICRIME Convention.


3.22 Lithuania


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision, as regards the term ‘medical product’, could be found in internal law corresponding to Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions of the terms ‘medicinal product’ and ‘medical device’.Action is needed to correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 2. 47, 2. 50 and 2. 79, the Law on Pharmacy of the Republic of Lithuania corresponds with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceArticle 2. 72.1, Law on Pharmacy of the Republic of Lithuania corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 3. 30.2, Law on Pharmacy of the Republic of Lithuania, while broadly formulated, substantially corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 2.7, Law on the Health System of the Republic of Lithuania corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryRegulation 7.5, Technical Regulation on the Safety of Medical Devices, 2009, corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision, as regards the terms ‘parts’ and ‘materials’’, could be found in internal law corresponding to Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision, as regards the term ‘document’’, could be found in internal law corresponding to Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingArticle 2. 48 and 2.55, Law on Pharmacy of the Republic of Lithuania, as regards medicinal products, define ‘Manufacturing of an investigational medicinal product’ and ‘Manufacture of a medicinal product’, respectively. These definitions, together or separately, do not adequately correspond with Article 4.i, MEDICRIME Convention. No provision, as regards the term ‘manufacturing’ of active substances and excipients can be found in internal law corresponding with Article 4.i, MEDICRIME Convention. Regulation 2.8, Law on the Health System of the Republic of Lithuania, as regards medical devices, defines the term ‘Manufacturer’ and includes in this many of the elements contained in the term ‘Manufacturing’, but do not sufficiently


correspond with Article 4.i, MEDICRIME Convention. No provision, as regards the term ‘manufacturing’ of accessories can be found in internal law corresponding with Article 4.i, MEDICRIME Convention.Action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 2.8.1, Law on Pharmacy of the Republic of Lithuania, corresponds with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision, as regards the term ‘victim’’, could be found in internal law corresponding to Article 4.h, MEDICRIME Convention.Action is required to correspond with Article 4.k, MEDICRIME Convention.



Article 275, Criminal Code (CC) provides an offence for endangerment arising from unauthorised manufacture of medicines and medicinal substances. While this may support a prosecution in relation to activities contemplated by Article 5, MEDICRIME Convention, the CC provision is insufficient to correspond with the Convention. No provision in internal law can be found regarding the intentional manufacturing of a counterfeit active substances, excipient, medical device, parts, materials, and accessories.


It should be also noted that the legal liability concerning the mere fact of manufacturing the falsified medicinal products etc. is foreseen in the Code of the Administrative Offences. Article 63 of this Code foresees the administrative liability for manufacturing the falsified medicinal products, import from the third countries, export, wholesale distribution, sale and brokering of falsified medicinal products.

The provisions mentioned above refer to medicines or medicinal substances but not to medical devices and other elements.


No provision in internal law could be found to correspond with Article 6, MEDICRIME Convention. It is noted that while Article 2.8.1, Law on Pharmacy of the Republic of Lithuania provide a definition for counterfeit medicinal product (see Art 4.j above), no provision for offence in internal law could be found to be associated with this.

Article 44.7, Code of Administrative Offences provides penalties in relation to the import and export from and to third countries, wholesale distribution, brokering, retail sales and remote selling of a falsified medicinal preparation. This provision also includes aggravating circumstances in relation to these activities. Clarification is required on whether Article 44.7 is intended as the offence to be associated with Article 2.8.1, above, or merely as penalties.



Article 300.1 CC foresees criminal liability for any type of falsification of a document, regardless of the sphere (medical, legal, economic etc.) to which it is related. Article 300.1 CC corresponds with Article 7, MEDICRIME Convention.


8.a.i, ii: Article 202 CC provides offences for dealing in economic, commercial, financial, and professional activities without authorisation and is not specific to products intended by the MEDICRIME Convention. This provision could be used in the prosecution of offences contemplated by Article 8.a.i and ii, MEDICRIME Convention. Article 275 CC is specific to unauthorised pharmaceutical products and is more general than what is contemplated by Article 8.a.i. This provision does not apply to medical devices. No provision in internal law can be found to correspond with Article 8.a.ii, MEDICRIME Convention. It is noted that Article 199 concerning the smuggling and deception of Customs, respectively, may also support Article 8.a requirements.


Further action is required to fully correspond with Article 8 MEDICRIME Convention.



9.1: Article 24 CC, as regards aiding and abetting, correspond with Article 9.1, MEDICRIME Convention.

9.2: Article 22 CC, as regards attempt, corresponds with Article 9.2, MEDICRIME Convention.


11.1: Article 20.2 CC corresponds with Article 11.1 MEDICRIME Convention.

11.2: Article 20.2 and 20.3 CC correspond with Article 11.2, MEDICRIME Convention.

11.3: General provisions of the Criminal Code, the Civil Code of the Republic of Lithuania and the Law on Pharmacy of the Republic of Lithuania show that depending on the certain action or omission in the field the liability of a legal person may be criminal, civil or administrative. This corresponds with Article 11.3, MEDICRIME Convention.

11.4: Article 20.5 CC corresponds with Article 11.4, MEDICRIME Convention.


13.a and e: Article 60, Criminal Code corresponds with Article 13, MEDICRIME Convention.

Article 60, Criminal Code does not directly include (or include partially) the following aggravating circumstances foreseen in Article 13 of the MEDICRIME Convention:

13.b: the offence was committed by persons abusing the confidence placed in them in their capacity as professionals.

13.c: the offence was committed by persons abusing the confidence placed in them as manufacturers as well as suppliers.

13.d: the offences of supplying and offering to supply were committed having resort to means of large-scale distribution, such as information systems, including the Internet.

It should also be noted that sometimes some aggravating circumstances mentioned in the MEDICRIME Convention according to the national legislation could constitute a separate offence.

Further action is needed to fully correspond with Article 13. b, c, and d, MEDICRIME Convention.

3.23 Mexico


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law could be found to correspond with Article 4.a, MEDICRIME Convention.Further action is needed to fully correspond with Art 4.a MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 221-I and II, General Health Law -Ley General de Salud (GHL) is broader, but substantially corresponds with Article 4.b, MEDICRIME Convention, with the exception that it does not include investigational medicinal products.Further action is needed to correspond with Article 4.b, MEDICRIME Convention .

c. Article 4.c MEDICRIME Convention -Active substanceArticle 221-III GHL as regards the term ‘active substance’, uses the term ‘raw material’ which has the same intent, but more restrictive in meaning and does not sufficiently correspond with Article 4.c, MEDICRIME Convention.Further action is required to fully correspond with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 221-IV GHL, as regards the term ‘excipient’, uses the term ‘’additive’ which has the same intent and sufficiently correspond with Article 4.d, MEDICRIME Convention 4.d, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical Device


Article 262 GHL, as regards the term ‘medical device’, uses not one but several terms to describe what the Convention understands to be covered under the term ‘medical device’. The terms used are 1) medical equipment; 2) prostheses, orthotics, and functional aids; 3) diagnostic agents; 4) dental use inputs; 5) surgical and healing materials; and 6) hygienic products. Their intended use is included in each case. While this is not the same as a definition in the Convention, the intent and content are similar and with some modification would sufficiently correspond with Article 4.e, MEDICRIME Convention.Further action is needed to correspond fully with Article 4e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryArticle 262-I GHL uses the term ‘accessory’ as part of what is included in the term ‘medical equipment’ and does not have any definition of what it is intended to mean and does not correspond with Article 4.f, MEDICRIME Convention.Further action is required to correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsGHL contains numerous references to the word ‘material’ and does not use it in the manner intended in and not in correspondence with Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g. MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentArticle 221 –V GHL, as regards medicines, the term ‘materials’ to mean inputs for the packaging and packaging of the medicinal products. This does not encompass the meaning intended by and does not correspond with Article 4.h, MEDICRIME Convention.Further action is needed to correspond fully with Article 4h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision in internal law could be found to correspond with Article 4i, MEDICRIME Convention. It is noted that Article 197, while not being a definition of the term ‘manufacturing’ includes many of its intended components regarding generally all processes intended by GHL.Action is needed to correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticles 208 and 208 Bis GHL establishes a concept of falsification of a medicinal product in a more limited manner than established by and does not correspond with Article 4.j, MEDICRIME Convention.Action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision in internal law could be found to correspond with Article 4.k, MEDICRIME Convention.Action is needed to correspond with Article 4.k, MEDICRIME Convention.



Article 464 Ter- I and -II, GHL, as regards medicinal products, active substances, and excipients, corresponds with Article 5.1 and 5.2, MEDICRIME Convention. No provision in internal law could be found to correspond with Article 5, MEDICRIME Convention, as regards medical devices, medical equipment, prostheses, orthotics and functional aids, diagnostic agents, dental use inputs, surgical and healing materials, and hygienic products in general.

Further action is needed for the internal law to fully correspond with Article 5, MEDICRIME Convention.


Article 464 Ter-III, GHL, as regards medicinal products, active substances, and excipients, partially corresponds with Article 6, MEDICRIME Convention. It is noted that the activity of brokering is not specifically included in this provision but may be considered to be part of the activity of trading. This requires to be clarified for full correspondence with Article 6, MEDICRIME Convention. No provision in internal law could be found to correspond with Article 6, MEDICRIME Convention, as regards medical devices, medical equipment, prostheses, orthotics and functional aids, diagnostic agents, dental use inputs, surgical and healing materials, and hygienic products in general.




No provision in internal law could be found to correspond with Article 7, MEDICRIME Convention.

Action is needed for the internal law to correspond with Article 7, MEDICRIME Convention.


8.a.i: Article 464 Ter – I, GHL, as regards medicinal products, corresponds to a limited extent with Article 8.a.i, MEDICRIME Convention. No provision in internal law, as regards the import and export of medicinal products, could be found corresponding with Article 8.a.i, MEDICRIME Convention.

Further action is needed for the internal law to fully correspond with Article 8.a.i, MEDICRIME Convention.

8.a. ii: No provision in internal law, as regards medical device, could be found to correspond with Article 8.a. ii, MEDICRIME Convention.

Further action is needed for the internal law to fully correspond with Article 8.a.ii, MEDICRIME Convention.


Action is needed for the internal law to fully correspond with Article 8.b, MEDICRIME Convention.


9.1: Article 13-VI, Federal Criminal Code (FCC), describes a perpetrator or participant in any type of offence to the person who helps or assists another in the commission of a crime. This is a general criminal law provision and applies equally to offences in the GHL. While the terms ‘aiding’ and ‘abetting’ are not used, the provision of Article 13-VI are sufficient to correspond with Article 9.1, MEDICRIME Convention.

9.2: Article 12, FCC, as regards attempt, is a general criminal law provision that equally applies to offences in the GHL and corresponds with Article 9.2, MEDICRIME Convention.


11.1. a, b, c: No provision in internal law could be found that regulate the corporate liability in criminal proceedings in the case of offences established in MEDICRIME Convention, despite Article 11 Bis FCC which determines the criminal liability of a legal person. That occurs because the crimes established in Article 464 Ter of the GHL are not included in the list of offences indicated in Article 11 Bis, FCC that could enable a criminal prosecution of crimes committed by corporations. There is no correspondence with Article 11.a, b, c, MEDICRIME Convention.

11.2: No provision in internal law could be found to correspond with Article 11.2, MEDICRIME Convention.

11.3: Article 416, GHL provide for Administrative penalties. This corresponds with Article 11.3, MEDICRIME Convention. It is noted that there is no specific provision in internal law that regulates the corporate liability of the offences established in MEDICRIME Convention in a particular form.

11.4: No provision in internal law could be found to correspond with Article 8.b, MEDICRIME Convention.

Further action is needed for the internal law to fully correspond with Article 11.1, 11.2 and 11.4, MEDICRIME Convention.




3.24 Montenegro


a. Article 4.a MEDICRIME Convention – Medical Product


No provision could be found in internal laws corresponding with Article 4.a, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticles 28 and 6 para 1 item 38 Law on Medicinal Products (Official Gazette of Montenegro No. 80/2020) correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceLaw on Medicinal Products corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientLaw on Medicinal Products defines the term excipient in a way which is not fully corresponding with Article 4.d, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceLaw on Medical Devices (Official Gazette of Montenegro No.24/2019) corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryLaw on Medical Devices corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materials Article 9 para 1 item 69 Law on Medical Devices defines the concept of spare part of a medical device. This definition does not correspond with Article 4.g, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentArticle 142 (29) Criminal Code of Montenegro covers the wide range of modalities of document including that which corresponds with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingLaw on Medical Devices refers to the manufacturing of a medical device in a manner that does not fully corresponds to Article 4.i, MEDICRIME Convention. No direct reference to the manufacturing of medicinal products is included in the internal legislation except for the mention that manufacture of medicinal products in Montenegro can only be performed by legal persons that have manufacturing authorization in accordance with the Law. There is no correspondence with Article 4.i, MEDICRIME Convention.Action is needed to correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitLaw on Medicinal Products (Official Gazette of Montenegro No. 80/2020) and Law on Medical Devices, together corresponds with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 142 (11), Criminal Code of Montenegro defines the term victim in a manner that does not correspond with Article 4.k, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.k, MEDICRIME Convention.



Criminal Code of Montenegro does not correspond directly with Article 5 MEDICRIME Convention as it does not prescribe the manufacturing of counterfeited medical products as criminal offence. Article 3, Law on Medicinal Products corresponds with Article 5 MEDICRIME Convention as it prohibits the manufacture of falsified medicinal products. No intentional offence could be found, as regards for the intentional manufacture of falsified active substances, medical devices, excipients, accessories, parts, and materials, corresponding with Article 5, MEDICRIME Convention.



Article 284 of Criminal Code of Montenegro (Unlawful Trade) does not completely implement the corresponding provision of the MEDICRIME Convention, but it prescribes an offence in the case of an unauthorized sale, purchase or exchange of goods or objects whose trade is prohibited or restricted. This offence is general in nature and


very wide. Whether the movement of any goods is restricted or prohibited depends on the relevant regulations. Article 3, Law on Medicinal Products and Article 7, Law of Medical Devices prohibit trade of falsified medicinal product and falsified medicinal devices. No offence could be found, as regards falsified active substances, medical devices, excipients, accessories, parts, and materials, which corresponds with Article 6, MEDICRIME Convention.



Articles 412-415, Criminal Code of Montenegro corresponds with the intent of Article 7, MEDICRIME Convention.


8.a.i: Article 3, Law on Medicinal Products corresponds with Article 8.a.i, MEDICRIME Convention.

8.a.ii: Article 3, Law on Medicinal Products corresponds, with Article 8.a.i, MEDICRIME Convention.

8.b: No offence could be found which corresponds with Article 8.b, MEDICRIME Convention.



Arts. 24 (Instigation), 25 (Aiding), 26, 27 and 20 (Attempt), Criminal Code corresponds with the intent of Article 9 MEDICRIME Convention, but are inapplicable as regards Articles 5, 6 and 8, MEDICRIME Convention as these offences are not established as criminal offences under the Criminal Code of Montenegro. There is, therefore, no correspondence with Article 9, MEDICRIME Convention.



11.1 and 11.2: Articles 4 and 5, Law on Criminal Liability of Legal entities (Published in the “Official Gazette of the Republic of Montenegro”, Nos. 2/2007, 13/2007, 30/12 and 39/16) corresponds with 11 para 1 and 2 MEDICRIME Convention, but are inapplicable as regards Articles 5, 6 and 8, MEDICRIME Convention as these offences are not established as criminal offences under the Criminal Code of Montenegro. There is, therefore, no correspondence with Article 11.1 and 11.2, MEDICRIME Convention.

11.3: As Article 5,6, and 8, MEDICRIME Convention are not established as criminal offences under the Criminal Code of Montenegro, criminal liability of legal entities is not established related to those offences.

11.4: Article 6, Law on Criminal Liability of Legal Entities (Limits of liability of legal entity for criminal offences) prescribes that under the established legal conditions the legal entity shall be held liable for a criminal offence even if the responsible person who committed such criminal offence has not been convicted of such criminal offence. Furthermore, liability of a legal entity shall not exclude criminal liability of a responsible person for the criminal offence committed. Nevertheless, as Articles 5, 6 and 8 are not established as criminal offences under the Criminal Code of Montenegro, criminal liability of legal entities is not established related to those offences.



13.a: The Criminal Code provides aggravating circumstances under the heading of Serious Offences against Human Health which means that if a criminal offence under Articles 287, 290, 291, 293, 296, 297 and 299 result in a serious body injury or severe damage to health of a person or grave damage to health of a person, or death of a person, the perpetrator shall be punished with a more severe prison sentence. Nevertheless, as Articles 5, 6 and 8, MEDICRIME Convention are not established as criminal offences under the Criminal Code of Montenegro, there is no correspondence with Article 13.a, MEDICRIME Convention.

13.b: No provision could be found in internal law corresponding with Article 13.b, MEDICRIME Convention.

13.c: No provision could be found in internal law corresponding with Article 13.c, MEDICRIME Convention.

13.d: No provision could be found in internal law corresponding with Article 13.d, MEDICRIME Convention.


13.e: Article 401.a, Criminal Code of Montenegro prescribes as a criminal offence the creation of a criminal organization. Nevertheless, as Articles 5, 6 and 8, MEDICRIME Convention are not established as criminal offences under the Criminal Code of Montenegro, there is no correspondence with Article 13.e, MEDICRIME Convention.

13.f: Article 43 and 44, Criminal Code of Montenegro provides for aggravating circumstances for recidivism and multiple recidivism, respectively. Nevertheless, as Article 5, 6 and 8, MEDICRIME Convention are not established as criminal offences under the Criminal Code of Montenegro, there is no correspondence with Article 13.f, MEDICRIME Convention.

Action is needed to correspond with Article 13.a-f, MEDICRIME Convention.

3.25 Morocco


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law could be found to correspond with Article 4.a, MEDICRIME Convention. There are separate definitions of the terms’ medicine’ and ‘medical device’, both components of the term medical product.Action is needed to correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 1, Law nº 17-04, Medicines and Pharmaceutical Code, as regards the term ‘medicinal product’, does not include investigational medicinal products and otherwise corresponds with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention - Active substanceArticle 3, Law nº 17-04, as regards the term ‘active substance’ partially corresponds with the intent of Article 4.c, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 1. 7, DECREE 2-14-841 of August 5, 2015 related to the marketing authorization of drugs for human use, as regards the term ‘excipient’, substantially corresponds with the intent of Article 4.d, MEDICRIME Convention relating to medicinal products for human use only. It does not include excipients intended for use in medicinal products for veterinary use.Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 1 and 3, Law No. 84-12 on medical devices, as regards the term ‘medical device’ substantially corresponds with Article 4.e, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryArticle 1.3), Law No. 84-12 on medical devices, as regards the term ‘accessory’, corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law could be found to correspond with Article 4.g, MEDICRIME Convention. Action is needed to correspond with Article 4.f, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law could be found to correspond with Article 4.h, MEDICRIME Convention. Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingArticle 18, Law nº 17-04, on Medicines and Pharmaceutical Code, as regards medicinal products, and Article 1.7), Law No. 84-12 on medical devices, individually and together partially correspond with Article 4.i, MEDICRIME Convention. No provision in internal law could be found, as regards the manufacturing of accessories, corresponding to Article 4.i, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitNo provision in internal law could be found to correspond with Article 4.j, MEDICRIME Convention. It is noted that Article 4, Law No. 13-83 is a general criminal law offence on the enforcement against fraud and


applies generally, to all goods, but not specifically, to medical products. Article 4 encompasses, generally, some of the components of the requirements of Article 4.j, MEDICRIME Convention.For the avoidance of doubt on the interpretation of this section being applicable to the MEDICRIME Convention, a separate provision is needed to fully correspond with Article 4.j, MEDICRIME Convention.Action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – Victim Article 7, Criminal Procedure Act (Law No. 22-01), as regards the term ‘victim’, partially corresponds with Article 4.k, MEDICRIME Convention. It is noted that the provision does not include psychological effects.Further action is needed to fully correspond with Article 4.k, MEDICRIME Convention.



Article 5. (1), Law No. 13-83 on the enforcement against fraud involving goods in general, specifies an offence that includes the falsification of medicinal products. As there is no definition of the term ‘falsification’ or ‘counterfeit’ in accordance with Article 4.j, MEDICRIME Convention, it is unclear on the extent to which Article 5 (1), Law No. 13-83 corresponds with article 5, MEDICRIME Convention.









8.a. i: Articles 150-156, Medicines and Pharmaceutical Code, Law 17-04, provide offences relating to the marketing of medicinal products that relates specifically to their risk. As these medicinal products may or may not have marketing authorisations, it is unclear whether they may correspond with Article 8.a.i, MEDICRIME Convention. As the law provides for offences for non-compliance with good manufacturing practice, it does not clarify whether this relates to substandard practices of intentional offences or whether it includes the failure to hold a manufacturer’s authorisation where one is required. Clarification is required in the internal law to fully correspond with Article 8,a.i, MEDICRIME Convention.

8.a. ii: No provision in internal law could be found to correspond with Article 8.a.ii, MEDICRIME Convention.


Action is needed to correspond with Article 8.a and b, MEDICRIME Convention.


9.1: The combination of Articles 129 and 130 of the Criminal Code allows the following conclusions to be drawn: the existence of complicity requires the meeting of three elements: legal, material, and moral; The act of complicity is punishable only insofar as the main act itself falls within the scope of criminal law; The modalities of material expression of forms of complicity enacted by article 129 of the Criminal Code. are to be interpreted restrictively. Thus, only the modalities provided for in this article can serve as a basis to prosecution. Apart from these forms, there is no act of complicity.

9.2: Article 114, Criminal Code indicates the two conditions of the punishable attempt: a positive condition and a negative condition (absence of voluntary withdrawal). It should be noted that the penal legislator required the existence of a special provision to punish attempted crime. (Articles. 114, 115, 116 and 117, Criminal Code).





Action is needed to correspond with Article 11, MEDICRIME Convention


No provision in internal law, as regards aggravating circumstances, could be found to correspond with Article 13 a-e, MEDICRIME Convention.

Articles 154, Criminal Code, as regards recidivism, corresponds with Article 13.f, MEDICRIME Convention.

Further action is needed to correspond with Article 13.a-e, MEDICRIME Convention.

3.26 North Macedonia



b. Article 4.b MEDICRIME Convention – Medicinal ProductThe Macedonian definition of medicinal product does not cover the veterinary use (only the human one is mentioned, and the veterinary issues are subject to another law)) and the point iii. of the respective Convention provision (an investigational medicinal product) is also not part of the Macedonian definition (LMPMD, art. 2, para 1). Therefore, the general law does not fully implement the MEDICRIME Convention in respect of article 4.b. Article 2.1, Law on Medicinal Products and Medical Devices (LMPMD), as regards medicinal products for human, correspond to Article 4.b, MEDICRIME Convention. This provision, as regards medicinal products for veterinary use, and as regards investigational medicinal products, does not correspond with Article 4.b, MEDICRIME Convention. Further action is needed to correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceArticle 2.3, LMPMD partially corresponds but requires considerable amendment in order to fully correspond with Article 4.c, MEDICRIME Convention.Further action is required to correspond with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 2, 4, LMPMD defines the term ‘excipient’ such that it does not require it to be essential for the integrity of the finished product and does not fully correspond with Article 4.d, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 2.49, LMPMD substantially corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention - AccessoryNo provision in internal law, as regards the term ‘accessory’’, could be found. The wording of Article 2.49.1, LMPMD, as regards medical devices, includes the use of materials intended by their manufacturers to be used together with a medical device to enable its use. This could be interpreted to correspond, though not fully, with the intent of the term ‘accessory’, rather than the term ‘material’ in this context. The use of Article 2.49.1 wording becomes problematic as the intent of the law could relate to either the term ‘accessory’ or the terms ‘parts’ and ‘materials’, or all these terms, or even none of them. Further action is needed to fully correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materials


No provision in internal law, as regards the terms ’parts’, and ‘materials’, could be found. The Wording of Article 2.49.1, LMPMD, as regards medical devices, includes the use of materials intended by their manufacturers to be used together with a medical device to enable its use. This corresponds, though not fully, with the intent of the terms ’parts’ and ‘materials. The use of Article 2.49.1 wording becomes problematic as the intent of the law could relate to either the term ‘accessory’ or the terms ‘parts’ and ‘materials’, or all these terms, or even none of them. Further action is needed to fully correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law, as regards the term ‘document’, could be found corresponding with Article 4.h, MEDICRIME Convention. Article 2, LMPMD lists several documents, but is insufficient to correspond with Article 4.h. MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision in internal law, as regards the term ‘manufacturing’, could be found corresponding with Article 4.h, MEDICRIME Convention. Action is needed to correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitNo provision in internal law, as regards the term ‘counterfeit’, could be found corresponding with Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 122.22, North Macedonian Criminal Code (MCC) is the general criminal law and is not specific to medical product related crimes. It corresponds with the intent of Article 4.k, MEDICRIME Convention.



5.1. Art. 212 MCC criminalises the production of medicines or other treatments that are harmful to health. While counterfeit medical products create a risk of harm, the provision does not correspond with Article 5, MEDICRIME Convention.



Art. 212 MCC criminalises the trade in medicines or other treatments that are harmful to health. While counterfeit medical products create a risk of harm, the provision does not correspond with Article 6, MEDICRIME Convention.



Article 361, 378 and 379 MCC, as regards the making of a false document or tampering with a document, correspond with Article 7, MEDICRIME Convention.


Art. 212 MCC criminalises generally the production and trade in medicines or other treatments that are harmful to health. This does not sufficiently correspond with Article 8a.i and ii, MEDICRIME Convention. Article 212 does not criminalise intentional actions intended by Article 8.a regarding medicinal products and medical devices that require authorisation and compliance with conformity requirements where such requirements exist, and not already covered by Article 5, 6 and 7.

Further action is required to fully correspond with the intent of Article 8.a and b, MEDICRIME Convention.



9.1: Articles 23 and 24 MCC, as regards abetting and aiding, respectively, correspond with Article 9.1 MEDICRIME Convention.

9.2: Article 19 MCC, as regards crimes that are punishable by a maxim of at least five years, correspond with Article 9.2, MEDICRIME Convention. In all the other crimes the attempts are punishable only if it is specifically stipulated in a separate provision.



11.1: Article 28-a (1), MCC, as regards the legal person attracting liability when based on a power of representation of the legal person does not correspond fully with Article 11.1.a, MEDICRIME Convention as Article 28-a (2) restricts the liability in such cases to where there is a significant property benefit acquired or significant damaged has been caused to another.

Further action is required to correspond fully with Article 11, a, MEDICRIME Convention.

Article 28-a (1), as regards the legal person attracting liability when based on the authority to take decisions on behalf of and to exercise control within the legal person, corresponds with Article 11, b and c, MEDICRIME Convention.

11.2: Article 28-a (1), MCC, as regards the lack of supervision or control has made possible the commission of an offence, does not fully correspond with Article 11.2, MEDICRIME Convention as Article 28-a (2) restricts the liability in such cases to where there is a significant property benefit acquired or significant damaged has been caused to another.

Further action is required to fully correspond with Article 11.2 MEDICRIME Convention.

11.3: The criminal liability of the legal persons as well as the civil and administrative liability are stipulated in several laws that are part of the primary legislation.

11.4: Article 28-b (1) and (2) MCC corresponds with Article 11.4, MEDICRIME Convention.


Article 39 MCC, apart from 39(4), is general in application and requires the Court to consider aggravating and alleviating circumstances. This does not correspond fully with Article 13, a, b, c, d and e, MEDICRIME Convention.

Article 39 (4) MCC, as regards recidivism, corresponds with Article 13.f, MEDICRIME Convention.


3.27 Norway


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law, as regards the term ‘medical product’, could be found corresponding with Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions for the terms ‘medicinal product’ and ‘medical device’.Further action is needed to fully correspond with Art 4.a MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal Product§ 1 Legemiddelloven 1992 (The Medicines Act) , as amended, and § 1.3, Regulations on Medicinal Products, 2009, as amended, correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substance§ 1.2. (b), Regulations on the Manufacture and Import of Medicines, 2004, as amended, corresponds with Article 4.c, MEDICRIME Convention.



§ 1.2. (c), Regulations on the Manufacture and Import of Medicines, 2004, as amended, corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical Device§ 3, Medical Equipment Act, 2005, as amended, corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – Accessory§ 3, Medical Equipment Act, 2005, as amended, includes the term ‘accessory’ in the definition of the term ‘medical device’ and does not separately define the term ‘accessory’. § 1.5, Regulations on Medical Equipment, 2005, as amended, corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materials§ 3, Medical Equipment Act, 2005, as amended, includes the term ‘material’ in the definition of the term ‘medical equipment’ (medical device), but does not separately define the term ‘material’ or the term ‘parts’. § 3, Medical Equipment Act, 2005 does not correspond with Article 4.g, MEDICRIME Convention.Action is needed to correspond with Art 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentSection 361, Penal Code, 2005, as amended, provides a ‘meaning’ of the term ‘document’ A ‘document’ in this chapter means an information carrier relating to a legal matter of which is suitable as evidence for a legal matter’. This corresponds generally with the intent of Article 4.h, MEDICRIME Convention. §§ 2.17 and 18, Regulations on the Manufacture and Import of Medicines, while not a definition, incorporates what is intended in documentation as regards medicinal products being manufactured and imported.Further action is needed to fully correspond with Art 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – Manufacturing§ 1.2. (f), Regulations on the Manufacture and Import of Medicines refers to the definition of the term ’manufacture’ which encompasses the intent, though not the identical definition of Article 4.i, MEDICRIME Convention. § 1.5. (f), Regulations on Medical Equipment refers to the definition of the term ’manufacturer’ which encompasses some, but not all aspects of the definition of ‘manufacturing in Article 4.i, MEDICRIME Convention.Further action, as regards medical products, is needed to fully correspond with Art 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – Counterfeit§ 1.2 (f), Regulations on the Manufacture and Import of Medicines, as regards medicinal products, active substances and excipients in manufacturing and importation, corresponds with the Article 4.j, MEDICRIME Convention. The definition of counterfeit is not found in other medical product legislation.Further needed is required to fully correspond with Art 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision in internal law could be found to correspond with Article 4.k, MEDICRIME Convention. Action is needed to correspond with Art 4.k, MEDICRIME Convention.



No provision in internal law could be found corresponding with Article 5, MEDICRIME Convention.



No provision in internal law could be found corresponding with Article 6, MEDICRIME Convention.



Section 361, Penal Code, while not being specific to documents related to medical products, corresponds with the intent of Article 7, MEDICRIME Convention.



8.a.i: § 31. Act on Medicines, as regards medicinal products, active substances, and excipients, corresponds with the intent of Article 8.a.i, MEDICRIME Convention.

8.a.ii: § 13. Medical Equipment Act, as regards medical devices, accessories, parts and materials, corresponds with Article 8.a.ii, MEDICRIME Convention.8.b: No provision in internal law could be found corresponding with Article 8.b, MEDICRIME Convention.Action is required to correspond with Article 8.b, MEDICRIME Convention.


9.1: Section 15, Penal Code, as regards aiding and abetting, criminalises any person who contributes to the violation of a law. While the terms ‘aiding’ and ‘abetting’ are not used, the section is sufficient to correspond with the intent of Article 9.1, MEDICRIME Convention.

9.2: Section 16, Penal Code, as regards attempts, corresponds with Article 9.2, MEDICRIME Convention.


11.1. a, b, c: Section 27, Penal Code is general in wording and application. It includes the circumstances of a violation by a person, without specifying their level of power of representation, authority to take decisions or ability to control, who has acted on behalf of an enterprise. This broadly corresponds with Article 11.1, MEDICRIME Convention.

11.2: Section 28, (c), Penal Code, corresponds with Article 11.2, MEDICRIME Convention.

11.3: Sections 29 and 30, Penal Code, and as regards medicinal products, active substances and excipients, § 5.12; Regulations on Medicinal Products, as regards the revocation of marketing authorisations: § 2.7, Regulations on the Manufacture and Import of Medicines; § 2.b, Regulations on Wholesale Business with Medicines, and§ 32, Act on Medicines, all combine to provide for criminal, civil, and administrative liability for legal persons. As regards Medical Devices, accessories, and parts and material, no corresponding provisions could be found to correspond with Article 11.3, MEDICRIME Convention.

11.4: Section 27, Penal Code corresponds with Article 11.4, MEDICRIME Convention.

Further action is required to fully correspond with Article 11.1 and 11.3, MEDICRIME Convention.


13.a: Section 77. b, Penal Code corresponds with Article 13.a, MEDICRIME Convention.13.b, c: Section 77. j, Penal Code corresponds with Article 13.b and c, MEDICRIME Convention.13.d: No provision in internal law could be found corresponding with Article 13.d, MEDICRIME Convention.13.e: Section 77. e, Penal Code corresponds with Article 13.e, MEDICRIME Convention.13.f: Section 77. k, Penal Code corresponds with Article 13.f, MEDICRIME Convention.Action is required to correspond with Article 13.d, MEDICRIME Convention.

3.28 Poland


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law, as regards the term ‘medical products’, can be found to correspond with Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions of the terms ‘medicinal products’ and ‘medical devices’.Further action is needed to fully correspond with Article 4.a, MEDICRIME Convention.


b. Article 4.b MEDICRIME Convention – Medicinal Product.Article 2. 32), Pharmaceutical Law, provides the definitions as regards the term ‘medicinal product’ but excluding ‘investigational medicinal products’. Investigational medicinal products are separately defined in Article 2.2c, Pharmaceutical Law. Together, they correspond with Article 4.b, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceArticle 2.38c), Pharmaceutical Law, as regards the term ‘active substance’, is more expansive and corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 2.38d), Pharmaceutical Law, as regards the term ‘excipient’, substantially corresponds with Article 4.d, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 3, Act on Medical Devices, as regards the term ‘medical device’, corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryArticle 2.33), Pharmaceutical Law, as regards the term ‘accessory’, corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law, as regards the terms ‘parts’ and ‘materials’, can be found to correspond with Article 4.g, MEDICRIME Convention. Further action is needed to fully correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentArticle 14, Penal Code, as regards the term ’document’, is general Criminal law and is not specific to the subject matter contained in the MEDICRIME Convention. It is broad in its interpretation and partially corresponds with the intent of Article 4.h, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingArticle 2.42), Pharmaceutical Law, as regards the term ‘manufacturing’, provides the definition under the term ‘manufacture of medical products. While it is broader in its definition and does not include excipients, it substantially corresponds with Article 4.i, MEDICRIME Convention. No provision in internal law, as regards the manufacturing of medical devices, accessories and parts and materials, could be found corresponding with Article 4.i, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 2.38a), Pharmaceutical Law, as regards the term ‘counterfeit’ as it refers to medicinal products and active substances only, corresponds with Article 4.j, MEDICRIME Convention. No provision in internal law, as regards excipients, medical devices, accessories, parts and materials could be found to correspond with Article 4.j, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision in internal law, as regards the term ‘victim’, could be found to correspond with Article 4.k, MEDICRIME Convention.Action is needed to correspond with Article 4.k, MEDICRIME Convention.



Article 124b, Pharmaceutical Law, as regards medicinal products and active substances only, corresponds with Article 5, MEDICRIME Convention. No provision in internal law, as regards excipients, medical devices, accessories, parts and materials could be found to correspond with Article 5, MEDICRIME Convention.




Article 124b, Pharmaceutical Law, provides the offence of intentionally supply a falsified medicinal product or active substance. While all the activities included in Article 6.1, MEDICRIME Convention are not contained in Article 124b, Polish criminal law doctrine interprets its provision such that it would correspond, as regards medicinal products and active substances only, with Article 6.1, MEDICRIME Convention. No provision in the internal law, as regards excipients, medical devices, accessories, parts, and materials could be found to correspond with Article 6, MEDICRIME Convention.



Article 270, Penal Code corresponds with Article 7, MEDICRIME Convention.


8.a.i: Articles124, 124.a, 125, 125.a, and 127.a, Pharmaceutical Law, together, as regards medicinal products for human and veterinary use, correspond with Article 8.a.i MEDICRIME Convention.

8.a.ii: Articles 93, 94, 95 and 96, Pharmaceutical Law, together, as regards medical devices, correspond with Article 8.a.ii, MEDICRIME Convention.

8.b: No provision in internal law, as regards the commercial use of original documents outside their intended use within the legal medical product supply chain, can be found to correspond with Article 8.b, MEDICRIME Convention.

Action is needed to correspond with Article 8. b, MEDICRIME Convention.


9.1: Article 19.3, Penal Code, as regards aiding and abetting, corresponds with Article 9.1 MEDICRIME Convention.

9.2: Article 13, Penal Code, as regards attempt, corresponds with Article 9.2, MEDICRIME Convention.


11.1. a, b, c: Article 16, Liability of Collective Subjects for Acts Prohibited under Punishment Act, corresponds with Article 11.1, a, b and c, MEDICRIME Convention.

11.2: Article 16, Liability of Collective Subjects for Acts Prohibited under Punishment Act, corresponds with Article 11.2, MEDICRIME Convention.

11.3: Criminal, administrative, and civil liability of the legal person is applicable and corresponds with Article 11.3, MEDICRIME Convention.

11.4: Article 6, Liability of Collective Subjects for Acts Prohibited under Punishment Act, corresponds with Article 11.4, MEDICRIME Convention.


13.a: No provision in internal law could be found corresponding with Article 13.a, MEDICRIME Convention.

13.b and c: Article 53.2, Penal Code provides the general approach towards both aggravating and mitigating circumstances and includes a consideration of “…the type and degree of transgression against obligations imposed on the perpetrator…”. While this potentially could partially include the abuse of confidence placed in the capacity of professionals or manufacturers as well as suppliers, this does not directly or adequately correspond with Article 13.b and c, MEDICRIME Convention.

13.d: Article 53.2, Penal Code provides the general approach towards both aggravating and mitigating circumstances. This does not directly or adequately correspond with Article 13.b and c, MEDICRIME Convention.

13.e: Article 258, Penal Code corresponds with Article 13.e, MEDICRIME Convention.


13.f: Article 64, Penal Code, provides for recidivism as an aggravating circumstance. This corresponds with Article 13, f, MEDICRIME Convention.

Further action is needed to fully correspond with Article 13.a, b, c, and d, MEDICRIME Convention.

3.29 Romania


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law could be found corresponding to Article 4. a, MEDICRIME Convention. It is noted that separate definitions exist for the terms ‘medicinal product’ and ‘medical device’.Further action is required to fully correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 699, item 1, Law no. 95/2006 on the healthcare does not correspond with Article 4.b, MEDICRIME Convention. Article 699, item 1, Law no. 95/2006 on the healthcare reform addresses only the medicinal products for human use and it does not include references to investigational medicinal products or to medicinal products for veterinary use.Further action is needed to correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention - Active substanceArticle 699, item 3 of Law no. 95/2006 on the healthcare reform may be construed as corresponding with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 699, item 4 of Law no. 95/2006 on the healthcare reform, does not completely correspond with article 4.d, MEDICRIME Convention.Further action is required to correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 2, para. 1, items 1 and 3 of Government Decision no. 54/2009 regarding the requirements for placing medical devices on the market and Article 2, items 1 and 2 of Government Decision no. 798/2003 on establishing the conditions for the placing on the market and use of medical devices for in vitro diagnosis. These provisions, together and separately, correspond with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryArticle 2 para. 1 item 2 of Government Decision no. 54/2009 regarding the requirement for placing medical devices on the market, and Article 2, item 3, Government Decision no.798/2003 on establishing the conditions for the placing on the market and use of medical devices for in vitro diagnosis. These provisions, together and separately, correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law could be found to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law could be found to correspond with Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision in internal law could be found to correspond with Article 4.i, MEDICRIME Convention. It is noted that the term ‘manufacturer’ is provided by Article 699 item 41 of Law no. 95/2006 on the healthcare reform as regards medicinal products for human use, by Article 2 paragraph 1 item 14 of Government Decision no. 54/2009 regarding the requirements for placing medical devices on the market as regards medical devices, and Article 2 items 6 of Government Decision no. 798/2003 on establishing the conditions for the placing on the market and use of medical devices for in vitro diagnosis, as regards medical devices for in-vitro diagnostics. These provisions do not sufficiently correspond with Article 4.i, MEDICRIME Convention.Further action is needed to correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 699, item 40 of Law no. 95/2006, corresponds with Article 4.j, MEDICRIME Convention.Article 4.k MEDICRIME Convention – Victim


Article 79, Criminal Code (CC) refers to the term ‘injured person’. While the term ‘victim’ is not specifically defined, Article 79 CC sufficiently corresponds with Article 4.k, MEDICRIME Convention.



Article 357. 2, Criminal Code (CC) provides for an offence for the preparation of a counterfeit or substituted medicine. This provision is limited to circumstances where the medicinal product is harmful to health. Article 357.2 does not contain provisions as regards active substances, excipients, medical devices, parts, materials, or accessories. This does not sufficiently correspond with Article 5, MEDICRIME Convention.



Article 357. 2, CC, provides for an offence for the offering or display for sale of counterfeit or substituted medicines that are harmful to health. Article 358.3, CC, provides for an offence for the sale of medicines knowing that they are counterfeit, altered or with their validity period expired if they are harmful to health. Article 358.3, CC, is limited to circumstances where the medicinal product is harmful to health. Neither Article 357.2 nor Article 358.3, CC, contain provisions as regards active substances, excipients, medical devices, parts, materials, or accessories.

This does not sufficiently correspond with Article 6, MEDICRIME Convention.



The internal criminal law does not correspond directly with Article 7.1, MEDICRIME Convention as it does not provide a specific offence of the falsification of documents Related to medicinal products, active substances, excipients, parts, materials, or accessories. It is noted that Article 320, CC, as regards the making of a false official document and the adulteration of an official document, and Article 323, CC, as regards the use of an official document, are criminalised. These provisions may be sufficient to partially correspond with Article 7, MEDICRIME Convention.

Further action is necessary to fully correspond with Article 7, MEDICRIME Convention.


8.a: No provision in internal law could be found to correspond with Article 8.a, i, or ii, MEDICRIME Convention. It is noted that the non-compliance with authorisations and compliance with the conformity requirements, as mentioned in Article 8.a, are considered as misdemeanours in the administrative law and are not criminalised. This does not correspond with Article 8.a, MEDICRIME Convention.

8.b: No offence in internal law could be found to correspond with Article 8.b, MEDICRIME Convention.

Action is required to correspond with Article 8.a and 8.b, MEDICRIME Convention.


9.1: Article 49, CC, as regards aiding and abetting, corresponds with Article 9.1 MEDICRIME Convention.

9.2: Article 32.1, CC, provides that attempt to commit an offence is criminalised. However, it is limited in the CC to provisions specifically permitting sanctioning for attempts. Neither article 357.2 and 358.3 are specifically provided for sanctions as regards attempt. This does not correspond with Article 9.2, MEDICRIME Convention.

Action is needed to correspond with Article 9.2, MEDICRIME Convention.



11.1. a, b, c: Article 135. 1, CC, creates legal criminal liability of legal persons where acts are committed by them and in their interest. This is the general criminal law and is it does address the requirements that legal personal can be held liable specifically for the offences contemplated in the Convention and does not correspond with Article 11.1, MEDICRIME Convention.

11.2: No provision in internal law can be found to correspond with Article 11.2, MEDICRIME Convention.

11.3: liability of legal persons can be civil or administrative, depending on the nature of the provision that stipulates the sanction imposed to the legal person.

11.4: The general law does not correspond with Article 11.4, MEDICRIME Convention as it does not provide a specific distinction in respect of the liability of legal or natural persons in relation to offences of counterfeiting of medical products.



13.a: The domestic law does not correspond directly with Article 13.a, of the MEDICRIME Convention as it does not provide a specific aggravating circumstance in determining the sanctions in relation to the offences established in accordance with this Convention. In Romania, if an offence caused the death of, or damage to the physical or mental health of the victim, the person found guilty may also be prosecuted and convicted for the offence of manslaughter (Article 192, CC) or any other offence against life or physical integrity stipulated in the CC.


13.c: No provision in internal law could be found to correspond with Article 13.c, MEDICRIME Convention.

13.d: No provision in internal law could be found to correspond with Article 13.d, MEDICRIME Convention.

13.e: The domestic criminal law does not correspond directly with Article 13.e, MEDICRIME Convention as it does not provide a specific aggravating circumstance if the offences established in accordance with this Convention are committed in the framework of a criminal organisation. The general law is used here to address the corresponding article of the Convention because it creates a general (ordinary) offence for an intentional act similar to the article of the convention and attracts a criminal conviction (article 367 CC).

13.f: The domestic criminal law does not correspond directly with Article 13.f, MEDICRIME Convention as it does not provide a specific aggravating circumstance if the perpetrator has previously been convicted of offences of the same nature as the offences established in accordance with this Convention. The general criminal provisions in Romania stipulate an additional sanction for the person who commits a repeated offence. These provisions regarding the punishment regime for repeated offences apply to any other offence provided by the Romanian criminal laws (Article 41, CC).


3.30 Serbia


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law could be found to correspond with Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions for the terms ‘medicinal product’ and ‘medical device’.Further action is needed to fully correspond with Art 4.a MEDICRIME Convention.

b. Article 4.b, MEDICRIME Convention – Medicinal ProductArticle 14, Law on Medicinal Products and Medical Devices, as regards the term ‘medicinal products’, substantially corresponds with Article 4.b, MEDICRIME Convention with the exception that it does not include the term ‘investigational medicinal products’.Further action is needed to correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substance


Article 2. Paragraph 1 Point 27), Law on Medicinal Products and Medical Devices, as regards the term ‘active substance’, corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 2. Paragraph 1 Point 28) Law on Medicinal Products and Medical Devices, asregards the term ‘excipient’, corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArt. 2 Para 1 Law on Medical Devices, as regards the term ‘medical device’, corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryArt. 2. Paragraph 1 Point 2) Law on Medicinal Products and Medical Devices, as regards the term ‘accessory’, corresponds with Article 4.f, MEDICRIME Convention. The definition of the term “accessory” corresponds to that set out in Article 4 (f ).

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law could be found to correspond with Article 4.g, MEDICRIME Convention.Further action is needed to fully correspond with Art 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law could be found to correspond with Article 4.h, MEDICRIME Convention. While Article 2. Paragraph 1 Points 27), 34), 35), 36), 39), 56), 93) and Art. 93 Para 4 Law on Medical Devices describes different documents, this does not correspond with Article 4.h.Further action is needed to fully correspond with Art 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingArticle 95, Law on Medicinal Products and Medical Devices, as regards the manufacturing of medicinal products, substantially corresponds with Article 4.i, MEDICRIME Convention, except that it does not specifically include excipients. Article 2. Paragraph 1 Point 79 Law on Medical Devices, as regards the manufacturing of medical devices, substantially corresponds with Article 4.i, MEDICRIME Convention, except that it does not specifically include parts and materials and the designing of the device.Further action is needed regarding both the manufacturing of medicinal products and medical devices definitions to fully correspond with Article 4.h, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 2. Paragraph 1 Point 94) Law on Medical Devices, and Article. 2. Paragraph 1 Point 36) Law on Medicinal Products and Medical Devices, individually and in combination substantially correspond with Article 4.j, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 2. Paragraph 1 Point 11), Criminal Code uses the term ‘injured party’ as regards injury to personal or property rights. This corresponds with the intent of but not as specific as Article 4.k, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.k, MEDICRIME Convention.



Article 109. 5), Law on Medicinal Products and Medical Devices, as regards medicinal products, corresponds with Article 5, MEDICRIME Convention Article 67.5), Law on Medical Devices and Article 188.5) individually and together, as regards falsified medical devices, corresponds with Article 5, MEDICRIME Convention.

Art. 256.1 Criminal Code prohibits the production of harmful products. While this may support prosecutions for the manufacturing of a counterfeit medicinal product or a harmful medical device, it does not correspond with Article 5, MEDICRIME Convention.


Article 134. Paragraph 1 Points 5), 6), 7) and Paragraph 2 Law on Medicinal Products and Medical Devices as regards the sale of falsified medicinal products, partially corresponds with Article 6, MEDICRIME Convention. Article


82.9), Law on Medical Devices, as regards the placing on the market of a falsified medical devices, corresponds partially, with Article 6, MEDICRIME Convention.

Art. 256.1 Criminal Code prohibits the production and putting into circulation of harmful products. While this may support prosecutions for the manufacturing of a counterfeit medicinal product or a harmful medical device, it does not correspond with Article 6, MEDICRIME Convention.

Further action is required to correspond fully with Article 6, MEDICRIME Convention.


The Articles 355 and 356 Criminal Code, correspond with Article 7.1, MEDICRIME Convention.


8. a. i: Articles 109, 119, 134, and 217, Law on Medicinal Products and Medical Devices, as regards medicinal products, correspond with Article 8.a.i, MEDICRIME Convention.

8.a.ii: Article 126, Law on Medical Devices, and Article 188 and 217, Law on Medicinal Products and Medical Devices, prohibit the manufacture of a medical device that is not in conformance with its essential requirements, and the unauthorised manufacture of a medical device, respectively, correspond with Article 8.a.ii, MEDICRIME Convention. Art. 256.1 Criminal Code prohibits the production of harmful products. While this may support prosecutions for the manufacturing and marketing of a harmful medicinal product or a harmful medical device, it does not correspond with Article 8. a, MEDICRIME Convention.

8.b: No provision in internal law could be found to correspond with article 8.b, MEDICRIME Convention.

Further action is required to correspond fully with Article 8.a.ii, and 8.b, MEDICRIME Convention.


9.1: Article 34 and 35 Criminal Code, as regards aiding and abetting, correspond with Article 9.1, MEDICRIME Convention.

9.2: Article 30 and 355, Criminal Code, as regards attempt, corresponds with Article 9.2, MEDICRIME Convention.


11.1: Article 6, Law on The Liability of Legal Entities for Criminal Offences, generally correspond with Article 11.1, MEDICRIME Convention.

11.2: Article 6, Law on The Liability of Legal Entities for Criminal Offences, corresponds with Article 11.2, MEDICRIME Convention.

11.3: Legal entities are subject to Criminal Law, Administrative Law and Civil Law Requirements and correspond with Article 11.3, MEDICRIME Convention.

11.4: Article 7, Law on The Liability of Legal Entities for Criminal Offences, corresponds with Article 11.4, MEDICRIME Convention.


Article 54, Criminal Code, provides for aggravating circumstances to be taken into consideration in the determining of sentence.

13.a: Article 259, Criminal Code, as regards death, grievous bodily harm, or serious health impairment, qualifies the correspondence with Article 13.a, MEDICRIME Convention.

13.b-e: No specific provision in internal law could be found to correspond with Article 13, b-e, MEDICRIME Convention.

13. f: Article 55, Criminal Code, as regards recidivism, corresponds with Article 13.f, MEDICRIME Convention.

Further action is needed to fully correspond with Article 13. b-e, MEDICRIME Convention.


3.31 Slovak Republic


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal laws could be found corresponding with Article 4.a, MEDICRIME Convention.Action is needed to correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductThe definition of a “medicinal product” in the Act No. 362/2011 Coll. of Laws is not identical with Article 4.b, MEDICRIME Convention and diverts from the definition in the Directive 2001/83/EC of the European Parliament and the Council. On the other hand, Section 2, paragraph 7 read in conjunction with Section 2, paragraph 5, and other related provisions cover most elements contained in Article 4(b) of the MEDICRIME Convention. The lack of explicit definition of the Investigational Medical Product makes it difficult to determine whether the definition of the medicinal product under Section 2, paragraph 7 also includes investigational medicinal product within the meaning of Article 4(b)(iii), MEDICRIME Convention. Further action is needed to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceThe term “effectives substance” in Section 2, paragraph 33 of the Act No. 362/2011 Coll. of Laws does not fully correspond with the term “active substance” under Article 4(c), MEDICRIME Convention. Further action is needed to fully correspond with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientSection 2, paragraph 6 of the Act No. 362/2011 Coll. of Laws, as regards the term “excipient”, under does not fully correspond with Article 4(d) of the MEDICRIME Convention.Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceA new Section 143k, paragraph 1, Law on Medicinal Products and Medical Devices (Act No. 362/2011 Coll. of Laws) corresponds with Article 4(e) of the MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessorySection 2. (19(d), Law on Medicinal Products and Medical Devices, includes the concept of accessories in the context of in vitro diagnostic medical devices and corresponds, to this limited extent with Article 4.f, MEDICRIME Convention. It is noted that Section 143k includes the basic concept of medical devices applying by 25 May 2021. This does not provide that accessories are considered as part of the medical device and does not provide a separate term of ‘accessory. This does not fully correspond with Article 4.f, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal laws could be found corresponding with Article 4(g), MEDICRIME Convention. Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal laws, as regards the term ‘document’, could be found corresponding with Article 4(h), MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision in internal laws, as regards the term ‘manufacturing’, could be found corresponding with Article 4(i), MEDICRIME Convention. Further action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitThe phrase “counterfeit medicinal product for human use” is defined in positive terms (what is a counterfeit medicinal product) in Section 2, paragraph 35 as well as in negative way (what is not a counterfeit medicinal product) in Section 2, paragraph 36 of the Act No. 362/2011 Coll. of Laws. Further action is needed to fully correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision in internal laws, as regards the term ‘victim’, could be found corresponding with Article 4(k), MEDICRIME Convention. The definition of a “victim” under the Act No. 274/2017 Coll. of Laws is to be used


solely in the context of the application of the said Act. The Act No. 301/2005 Coll. of Laws operates with the term “injured party” whose definition to some extent overlaps with the above definition of a “victim.” Action is needed to correspond with Article 4.k, MEDICRIME Convention.



Section 170b, Criminal Code, as regards medicinal products and medical devices, but not active substances, excipients, part, materials, and accessories, partially corresponds with Article 5, MEDICRIME Convention. It is noted that the extend of the falsification of manufacturing appears not to include the actual manufacturing of a falsified medicinal product and medical device. The provision includes activities of falsification of the identity and source of the medicinal product, and the identity, source, conformity assessment and conformity mark of the medical device.



Section 170b, Criminal Code, as regards medicinal products and medical devices, but not active substances, excipients, part, materials, and accessories, corresponds with Article 6, MEDICRIME Convention.


Section 170b. (2), Criminal Code, criminalises the falsification of certain documentation related to the finished medicinal product and medical device. This is a specific provision for the mentioned documentation and not documents in general as contemplated by Article 7, MEDICRIME Convention. Section 170b (2) partially corresponds with Article 7, MEDICRIME Convention.



8.a.i, ii: Section 170a (1), Criminal Code, corresponds with Article 8.a.i and ii, MEDICRIME Convention.

8.b: No provision in internal laws could be found corresponding with Article 8.b MEDICRIME Convention.



9.1: Sections 13, 20 and 21, Criminal Code, together correspond with Article 9.1, MEDICRIME Convention.

9.2: Article 14, Criminal Code, corresponds with Article 9.2, MEDICRIME Convention.


11.1. a, b, c: Law on the Criminal Liability of legal persons (The Act No. 91/2016 Coll. of Laws) established criminal liability of legal/juridical persons, types of sanctions and the specifics of the Criminal proceedings against juridical persons. However, this Act only applies to specific categories of criminal offences as enumerated in Section 3. The Act does not apply to criminal offences under Sections 170, 170a, or 170b of the Criminal Code which provides for the criminalisation relating to medical products.


11.2: Section 4, Law on the Criminal Liability of legal persons (Act No. 91/2016 Coll. Of Laws) sets basic principles for establishing criminal liability of legal persons and is consistent with the requirements of Article 11. 2, MEDICRIME Convention. However, the

Act does not apply to criminal offences under Sections 170, 170a, or 170b of the Criminal Code which provides for the criminalisation relating to medical products.



11.3: The Criminal Code and the medicinal products and medical devices, create criminal and administrative liability. However, the Act does not apply to criminal offences under Sections 170, 170a, or 170b of the Criminal Code which provides for the criminalisation relating to medical products. Civil and administrative liability attaches to legal person and this corresponds with Article 11.3, MEDICRIME Convention.

11.4 No criminal liability for legal persons is established under the internal legislation in connection with the offences established in arts. 5-8 MEDICRIME Convention. There is no correspondence with Article 11.4, MEDICRIME Convention.

Further action is needed to fully correspond with Article 11.1, 11.2 and 11.4, MEDICRIME Convention.


13.a: Sections 170a(3) and 170b(4(a)) and (5)(a), Criminal Code, as regards the causing of bodily harm or death, corresponds with Article 13 MEDICRIME Convention. However, these are qualified to the extent of the offending.

13.b: Section 170, (2) (a), Criminal Code, is limited to anyone in the provision of healthcare and while this could include professionals, it does not sufficiently correspond with Article 13.b, MEDICRIME Convention.

13.c: No provision in internal law, apart from Section 170 (2)(a), could be found to correspond with Article 13.c, MEDICRIME Convention.

13.d: Section 170a, (2) (d) and Section 170, b (3) (d) in connection with Section 122. (2), Criminal Code, as regards the commission of the offence publicly where it involves printed matter or the dissemination on radio, television or use of a computer network, could be interpreted as sufficiently corresponding with Article 13.d, MEDICRIME Convention.

13.e: Section 170.a and 170.b, Criminal Code, refer to the concept of ‘dangerous grouping’ and which is separate in the ‘criminal group’. The term ‘dangerous grouping’ could be interpreted to correspond with the intent of Article 13.e, MEDICRIME Convention.

13.f: Section 170a, (2)(a) and Section 170b, (3) (a), Criminal Code correspond with Article 13.f, MEDICRIME Convention.

3.32 Slovenia



b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 5, Medicinal Products Act 2014, as amended (MPA), apart from the term ‘investigational medicinal product’, corresponds with Article 4.b, MEDICRIME Convention. Clarification is required on whether the term ‘investigational medicinal products’ is considered as part of the term as part of the definition ‘medicinal product’.Action is needed to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substanceArticle 6.96, MPA corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientArticle 6.63, MPA corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceArticle 3. (1), Medical Device Act 2009 (MDA), corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryArticle 3. (2), MDA, corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materials


No provision in internal law, as regards the terms ‘parts’ and ‘materials’ could be found to correspond with Article 4.g, MEDICRIME Convention. Action is needed to correspond with Art 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law, as regards the term ‘document’ could be found to correspond with Article 4.h, MEDICRIME Convention Action is needed to correspond with Art 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingNo provision in internal law, as regards the term ‘manufacturing’ could be found to correspond with Article 4.i, MEDICRIME Convention.Action is needed to correspond with Art 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitArticle 6.62, as regards medicinal products, active substances, and excipients, corresponds with Article 4.j, MEDICRIME Convention. There is no legal definition of the term ‘counterfeit’ as regards medical devices, accessories and parts and materials.Further action is needed to fully correspond with Art 4.i, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimArticle 144, Criminal Procedures Act, 1994, as amended (CPC), refers to ‘injured party’ when describing victims and includes one whom any of his personal or property rights have been violated or endangered by a criminal offense. Article 144 CPC, in a broad manner, corresponds with Article 4.k, MEDICRIME Convention.Further action is needed to fully correspond with Art 4.k, MEDICRIME Convention.



No provision in internal law, as regards the counterfeiting (or falsification) of medical products, could be found to correspond with Article 5, MEDICRIME Convention. Article 183.(1), Criminal Code criminalises the manufacture of medicines or other medical remedies dangerous to health but does specifically not criminalises acts corresponding to Article 5, MEDICRIME Convention.



No provision in internal law could be found to correspond with Article 6, MEDICRIME Convention Article 183. (1), Criminal Code criminalises the sale or otherwise supply of medicines or other medical remedies dangerous to health, but does not specifically criminalise acts corresponding to Article 6, MEDICRIME Convention.



Article 251. (1) and (3), Criminal Code, as regards the falsification of documents, corresponds with Article 7, MEDICRIME Convention.


8.a.i: Article 20, as regards marketing authorisations, Article 90. (1), as regards manufacturing authorisations, and Article 97, as regards wholesaling authorisations of medicinal products, create mandatory provision in the MPA. The breach of such provisions results in offending conduct that is not punishable in the Criminal Law but is by administrative sanctions. Articles 20, 90. (1), and 97 MPA do not correspond with Article 8.a.i, MEDICRIME Convention.

Action is needed to correspond with Art 8.a.i, MEDICRIME Convention.


8.a. ii: Article 67. (1), as regards the compliance of requirements of the MDA, Article 67. (5) and (6), as regards the placing of the CE mark on medical devices, criminalises the acts of the legal person which are misdemeanours punishable by fines. This does not include all the requirements of Article 8.a.ii, MEDICRIME Convention.

Action is needed to correspond with Art 8.a.ii, MEDICRIME Convention.

8.b: No provision in internal law could be found to correspond with Article 8.b, MEDICRIME Convention Action is needed to correspond with Art 8.b, MEDICRIME Convention.


9.1: Article 20. (2), and Article 38, Criminal Code, as regards accomplices, aiding and abetting, corresponds with Article 9.1, MEDICRIME Convention.

9.2: Article 34, Criminal Code, as regards attempts, corresponds with Article 9.2, MEDICRIME Convention.


11.1. a, b, c: Article 4 and 5, Law on Liability of Legal Entities for Criminal Offenses 1999, as amended, corresponds with Article 11.1.a, b, and c, MEDICRIME Convention.

11.2: Article 4.4, and 5.3, Law on Liability of Legal Entities for Criminal Offenses corresponds with Article 11.2, MEDICRIME Convention.

11.3: Law on Liability of Legal Entities for Criminal Offenses and the MPA provide for Criminal Civil and Administrative liability for legal persons. This corresponds with Article 11.3, MEDICRIME Convention.

11.4: Article 5.4, Law on Liability of Legal Entities for Criminal Offenses, and Article 42,

Criminal Code corresponds with Article 11.4, MEDICRIME Convention.


Article 49, Criminal Code provides the general rules for sentencing and correspond in some respects with Article 13, MEDICRIME Convention.

13.a: Article 183 (4) and (5), Criminal Code, which refer to the ‘Production and marketing of harmful treatment agents’ and their consequence in serious bodily injury or results in the death, respectively, correspond to Article 13.a, MEDICRIME Convention.

13.b: There is no correspondence with Article 13.b, MEDICRIME Convention.

13.c: There is no correspondence with Article 13.c, MEDICRIME Convention.

13.d: There is no correspondence with Article 13.d, MEDICRIME Convention.

13.e: Article 42, Criminal Code, as regards offending in the framework of a criminal organisation, corresponds with Article 13.e, MEDICRIME Convention.

13.f: Article 49. (3), Criminal Code, as regards previous history of the same type, corresponds with Article 13.f, MEDICRIME Convention.

Further action is needed to fully correspond with Article 13.b, c and d, MEDICRIME Convention.

3.33 Sweden



b. Article 4.b MEDICRIME Convention – Medicinal Product


Chapter 2, Section 1, Medicinal Products Act, as regards the term ‘medicinal product’, corresponds with Article 4.b, MEDICRIME Convention. No provision in internal law, as regards the term investigational product, other than a reference to Regulation (EU) No 536/2014 (human clinical trials), could be found to correspond with Article 4.b, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention -Active substance Chapter 2, Section 1, Medicinal Products Act, as regards active substances, corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientChapter 2, Section 1, Medicinal Products Act, as regards the term ‘excipient’ substantially corresponds with Article 4.d, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceSection 2, Medical Devices Act, as regards the term ‘medical device’ corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryNo provision in internal law, as regards the term ‘accessory’, could be found to correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law, as regards the term ‘accessory’ could be found to correspond with Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentChapter 14, Section 1, Swedish Criminal Code uses the term ‘instrument’. It is generally described and does not fully correspond with Article 4.h, MEDICRIME Convention.Further action is needed to fully correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – Manufacturing Chapter 2, Section 1, Medicinal Products Act, as regards the term ‘manufacturing’ is inadequately described and does not correspond sufficiently with Article 4.i, MEDICRIME Convention.Action is needed to correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – Counterfeit Chapter 2, § 1, Medicinal Products Act, as regards medicinal products, corresponds with Article 4.j, MEDICRIME Convention. No provision in internal law, as regards medical devices, could be found to correspond with Article 4.j, MEDICRIME Convention. Further action, as regards medical devices, is needed to correspond with Article 4.j, MEDICRIME Convention.

k Article 4.k MEDICRIME Convention – Victim No provision in internal law, as regards the term ‘victim’ could be found to correspond with Article 4.k, MEDICRIME Convention.Action is required to correspond with Article 4.k, MEDICRIME Convention.










Chapter 14, Sections 1 and 2; Swedish Criminal Code correspond with Article 7, MEDICRIME Convention.


8.a. i: Chapter 16, Section 1.4, Medicinal Product Act, on criminalisation, as regards prohibition on manufacturing and importation without authorisation, Article 14.1, as regards prohibition on marketing without authorisation, and Chapter 9, Section 1, Medicinal Products Trading Act, as regards the wholesaling of medicinal products without authorisation, correspond with Article 8.a.i, MEDICRIME Convention.

8.a. ii: Article 17, Medical Device Act, as regards the intentional or negligent placing a medical device on the market without conforming to the essential requirements, corresponds to Article 8.a.ii, MEDICRIME Convention. However,

8.b): No provision in internal law could be found corresponding to Article 8.b, MEDICRIME Convention.

Further action is needed to correspond with article 8.b, MEDICRIME Convention.


9.1: Chapter 23, Section 4, Swedish Criminal Code, as regards aiding and abetting, provides that the provision applies in respect of any statute where offences arise. As the Medicinal Product Act, Medicinal Products Trading Act, and the Medical Device Act do not provide for the criminalisation of offences referred to in Article 5 and 6 MEDICRIME Convention, the provision in the Criminal code, as regards aiding and abetting, does not correspond with Article 9.1, MEDICRIME Convention.

9.2: Chapter 23, Section 1, Swedish Criminal Code, as regards attempt, provides that the provision applies in respect of any statute where offences arise. As the Medicinal Product Act, Medicinal Products Trading Act, and the Medical Device Act do not provide for the criminalisation of offences referred to in Article 5 and 6 MEDICRIME Convention, the provision in the Criminal code, as regards attempt, does not correspond with Article 9.2, MEDICRIME Convention.



11.1 and 11.2: Chapter 36, Section 7, Criminal Code, corresponds with Article 11.1 and 11.2 MEDICRIME Convention.

11.3: Swedish law provides for Criminal Law, Civil Law and Administrative liability corresponding to Article 11.3, MEDICRIME Convention.

11.4: It is unclear whether the Criminal Code corresponds with Article 11.4, MEDICRIME Convention.

It is noted that as Medicinal Product Act, Medicinal Products Trading Act, and the Medical Device Act do not provide for the criminalisation of offences referred to in Article 5 and 6 MEDICRIME Convention, the provision in the Criminal code, as regards corporate liability, may not correspond with Article 11.1, 11.2 and 11.4, MEDICRIME Convention.

The concept of corporate liability is recognised in several international legal agreements. It has previously been established that the provisions of a corporate fine as provided by Chapter 36, Section 7, Criminal Code meet the requirements of corporate liability. Based on these considerations, the provisions of Article 11 in the Convention are adequately implemented by Swedish legislation.


Aggravating circumstances may be taken in consideration by the Courts in determining the sentence.

13.a: Chapter 29, Section 1, Criminal Code includes consideration on whether the act involved a serious attack on someone’s life or health or personal security. This is more restrictive than the Convention as it introduces the gravity to seriousness. It substantially corresponds with Article 13.a, MEDICRIME Convention.

Further action is needed to fully correspond with Article 13.a, MEDICRIME Convention.


13.b and c: Chapter 29, Section 2, point 4, Criminal Code provides for the abuse of trust as an aggravating circumstance without specifying a profession or trade. This substantially corresponds with Article 13, b and c.

Further action is needed to correspond fully with Article 13.b and c, MEDICRIME Convention.

13.d: No provision in internal law could be found to correspond with Article 13.d, MEDICRIME Convention.

13.e: Chapter 29, Section 2, point 6, as regards commission in the framework of a criminal organisation, corresponds with Article 13.d, MEDICRIME Convention

13.f: Chapter 29, Section 4, Criminal Code as regards recidivism, corresponds with Article 13.f, MEDICRIME Convention.

Further action is needed to correspond with Article 13.d, MEDICRIME Convention.

3.34 Tunisia


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law, as regards the term ‘medical product’, could be found to correspond with Article 4.a, MEDICRIME Convention.Action is needed to correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal ProductArticle 21, Law nº 73-55, 1973, as regards the term medicinal product, substantially, but not fully, corresponds with Article 4.b, MEDICRIME Convention. No provision in Article 21 includes investigational medicinal products. Action is needed to fully correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention - Active substanceNo provision in internal law, as regards the term ‘active substance’, could be found to correspond with Article 4.c, MEDICRIME Convention.Action is needed to correspond with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientNo provision in internal law, as regards the term ‘excipient’, could be found to correspond with Article 4.d, MEDICRIME Convention.Action is needed to correspond with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceNo provision in internal law, as regards the term ‘medical device’, could be found to correspond with Article 4.e, MEDICRIME Convention.Action is needed to correspond with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryNo provision in internal law, as regards the term ‘accessory’, could be found to correspond with Article 4.f, MEDICRIME Convention.Action is needed to correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law, as regards the terms ‘parts’ and ‘materials’, could be found to correspond with Article 4.g, MEDICRIME Convention.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentArticle 1, Annex to the Decree nº90-1400, 1990, contains reference to specific documents and does not define the term ‘document’. No provision in internal law, as regards the term ‘document’, could be found to correspond with Article 4.h, MEDICRIME Convention.Action is needed to correspond with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingArticle 1, Annex to the Decree nº90-1400, 1990, as regards the term ‘manufacturing’ of medicinal products, partially, but not fully, corresponds with Article 4.i, MEDICRIME Convention. No provision in internal law,


as regards the term ‘manufacturing’ of medical devices, could be found to correspond with Article 4.i, MEDICRIME Convention.Action is needed to correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitNo provision in internal law, as regards the term ‘counterfeit’, could be found to correspond with Article 4.j, MEDICRIME Convention.Action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision in internal law, as regards the term ‘victim’, could be found to correspond with Article 4.k, MEDICRIME Convention.Action is needed to correspond with Article 4.k, MEDICRIME Convention.



No provision in internal law, as regards the offence of the intentional manufacturing of a counterfeit medical product, active substances, excipients, parts, materials, and accessories, could be found to correspond with Article 5, MEDICRIME Convention.



No provision in internal law, as regards the offence of the intentional supply, or the offering to supply, including brokering, the trafficking, including keeping in stock, importing, and exporting of counterfeit medical product, active substances, excipients, parts, materials, and accessories, could be found to correspond with Article 6, MEDICRIME Convention.



Article 172, Criminal Code corresponds with Article 7, MEDICRIME Convention.


8.a.i and ii: Law 85-91, 1985, as amended, requires authorisation for the manufacture and registration of medicines for human use, but it is unclear whether there is a criminal offence established for their intentional breach. No provision in internal law, as regards the intentional breach of authorisations relating to the keeping in stock for supply, importing, exporting, supplying, offering to supply or other requirements for authorisation, could be found to correspond with Article 8. a. i, and ii, MEDICRIME Convention.


Action is needed to correspond with Article 8. a and b, MEDICRIME Convention.


9.1: Article 32 Criminal Code, as regards ‘aiding’ or ‘abetting’, is a general criminal law offence that corresponds with the intent of Article 9.1, MEDICRIME Convention.

9.2: Article 59 Criminal Code, provides that ’attempt’ is only punishable where the penalty is associated with a criminal offence with a minimum penalty of 5 years of imprisonment. This does not sufficiently correspond with Article 9.2 MEDICRIME Convention.

Further action is needed to correspond with Article 9.2 MEDICRIME Convention.






The Criminal Code provides as offences all the circumstances in Article 13. a -c and e and do not require them as aggravating circumstances.

13.a: Article 225, Criminal Code.

13.b: Article 297, Criminal Code.

13.c: Article 298, Criminal Code

13.d: Act on the competition and Prices.

13.e: Articles131 and 132, Criminal Code

13.f: Article 47, Criminal Code

3.35 United Kingdom



b. Article 4.b MEDICRIME Convention – Medicinal ProductRegulation 2(1), The Human Medicine Regulations 2012, as regards medicinal products, 2(1), The Medicines for Human Use (Clinical Trials) Regulations 2004, as regards investigational medicinal products, and Regulation 2(1), The Veterinary Medicine Regulations 2013, as regards medicinal products for veterinary use, correspond with Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention - Active substanceRegulation 8(1), Human Medicines Regulations 2012, as regards active substances for medicinal products for human use, corresponds with Article 4.c, MEDICRIME Convention. Part 3, Chapter 1, Section 14(1), Medicines and Medical Device Act 2021, as regards active substances for medicinal products for veterinary use, corresponds with Article 4.c, MEDICRIME Convention.

d. Article 4.d MEDICRIME Convention – ExcipientRegulation 8(1), Human Medicines Regulations 2012, as regards medicinal products for human use, broadly corresponds with Article 4.d, MEDICRIME Convention. While the Veterinary Medicines Regulations 2013 makes numerous references to excipients in its text it does not define the term.Further action is needed to correspond fully with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical DeviceRegulation 2(1), Medical Devices Regulations 2002, corresponds with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryRegulation 5(1), Medical Devices Regulations 2002, corresponds with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsNo provision in internal law could be found to correspond with Article 4.g, MEDICRIME Convention.Further action is needed to fully correspond with Art 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – DocumentNo provision in internal law could be found to correspond with Article 4.h, MEDICRIME Convention.Further action is needed to fully correspond with Art 4.h, MEDICRIME Convention.


i. Article 4.i MEDICRIME Convention – ManufacturingRegulation 8(1), Human Medicines Regulations 2012, as regards medicinal products for human use includes the term ‘manufacture’ which encompasses much of what is included in the term ‘manufacturing’ but does not define the term ‘manufacturing. Regulation A17, Human Medicines Regulations 2012, as regards active substances; Regulation 5(3), Veterinary Medicines Regulations 2013, as regards medicinal products for veterinary use; and Regulation 2, Medical Devices Regulations 2002, as regards medical devices and accessories, correspond with Article 4.i, MEDICRIME Convention. Further action is needed to fully correspond with article 4.i MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – CounterfeitRegulation 8(1), Human Medicines Regulations 2012, as regards medicinal products for human use, corresponds with Article 4.j, MEDICRIME Convention. No provision in internal law, as regards medicinal products for veterinary use or for medical devices, could be found to correspond with Article 4.j, MEDICRIME Convention. Further action is needed to correspond fully with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – VictimNo provision in internal law could be found to correspond with Article 4.k, MEDICRIME Convention. Action is needed to correspond fully with Article 4.k, MEDICRIME Convention.



5.1: Section 2, Fraud Act 2006, as regards the jurisdictions of England, Wales, and Northern Ireland, and Section 49, Criminal Justice and Licensing (Scotland) Act 2010 are general Criminal Law fraud offences. This involves the dishonestly making of representation. While this may support a prosecution in relation to counterfeit medical products, it does not correspond with Article 5, MEDICRIME Convention.



Section 2, Fraud Act 2006, as regards the jurisdictions of England, Wales, and Northern Ireland and Section 49, Criminal Justice and Licensing (Scotland) Act 2010 are general Criminal Law fraud offences. This involves the dishonestly making of representation. While this may support a prosecution in relation to counterfeit medical products, it does not correspond with Article 6, MEDICRIME Convention.



There is no correspondence with Article 7, MEDICRIME Convention.

Action is needed to correspond fully with Article 7, MEDICRIME Convention.


8.a.i: Regulation 34(1), Human Medicines Regulations 2012, as regards manufacturing licences, Regulation 18(1), as regards wholesale dealing licences, and Regulation 47(1), as regards marketing authorisations, correspond with Article 8.a.ii, MEDICRIME Convention. Regulation 43(q), (r), (s), and 47(1) Veterinary Medicines Regulations 2013, as regards supply, correspond with Article 8.a.i, MEDICRIME Convention.

8.a.ii: Regulation 8, Medical Devices Regulations 2002, as regards placing on the market or putting into service in compliance with the essential requirements, corresponds with Article 8.a.i, MEDICRIME Convention. It is noted that Regulation 60A (1), Medicines and Medical Devices Act 2021, as regards supply and placing on the market, substantially corresponds with Article 8.a.(ii), MEDICRIME Convention.

8.b: No provision could be found in internal law to correspond with Article 8.b, MEDICRIME Convention.

Further action is needed to fully correspond with Article 8.b, MEDICRIME Convention.



9.1. Ss. 44, 45, 46, Serious Crime Act 2007, as regards England, Wales, and Northern Ireland, and Section 293. (2), Criminal Procedures (Scotland) Act, 1995, as regards Scotland, correspond with Article 9.1: MEDICRIME Convention. However, in the absence of an offence under Articles 5 and 6, MEDICRIME Convention, the internal laws have no effect in this regard.

9.2: Section. 1, Criminal Attempts Act 1981, as regards England and Wales, Section 294, Criminal Procedure (Scotland) Act 1995, as regards Scotland, and Section 3, The Criminal Attempts and Conspiracy (Northern Ireland) Order 1983, individually and together correspond with Article 9.2 MEDICRIME Convention. However, in the absence of an offence under Articles 5 and 6, MEDICRIME Convention, the internal laws have no effect in this regard.



11.1: Section12, Fraud Act 2006, as regards England, Wales, and Northern Ireland, and Common Law (Purcell Meats (Scotland) Ltd. v. McLeod 1986 SCCR 672) as regards Scotland, and as regards medical product regulations for the UK, Regulation 338, Human Medicines Regulations 2012, Regulation 44(2), Veterinary Medicines Regulations 2013, and the provision of Regulation 60C, Medical Devices Regulations 2002 (inserted by Schedule 3, Medicines and Medical Device Act 2021), correspond with Article 11.1, MEDICRIME Convention.

11.2: Regulation 338, Human Medicines Regulations 2012, Regulation 44(2), Veterinary Medicines Regulations 2013, (and the provisions of Regulation 60C Medical Devices Regulations 2021correspond with Article 11.2, MEDICRIME Convention.

11.3: The liability can be criminal or civil.

11.4: S.12(2), Fraud Act 2006, as regards England, Wales and Northern Ireland, the Common Law, as regards Scotland, and as regards the U.K., S993, Companies Act 2006, and Regulation 338, Human Medicines Regulations 2012, Regulation 44(2), Veterinary Medicines Regulations 2013, correspond with Article 11.4, MEDICRIME Convention.


Aggravating circumstances for the UK arise from a hybrid of statue, sentencing guidelines issued by a Sentencing Council established by statute, by court specific guidelines and sentencing guidelines made by superior courts. It is a matter for the courts to consider the guidelines in determining sentences.

Some of the specific guidance for aggravating circumstances provided by statute arise, such as in relation to Art. 13.e MEDICRIME Convention, for offences committed in the framework of a criminal organisation - S. 29 of the Criminal Justice and Licensing (Scotland) Act 2010, and in relation to Article 13.f, MEDICRIME Convention, for offences of the same nature previously committed – S. 65, Sentencing Act 2020, as regards England and Wales.

Further Action is required to correspond fully with Article 13, MEDICRIME Convention.

3.36 United States of America


a. Article 4.a MEDICRIME Convention – Medical ProductNo provision in internal law, as regards the term ‘medical product’ could be found corresponding with Article 4.a, MEDICRIME Convention. It is noted that there are separate definitions of the terms ‘medicinal product’ and ‘medical device’.Action is needed to fully correspond with Article 4.a, MEDICRIME Convention.

b. Article 4.b MEDICRIME Convention – Medicinal Product21 U.S.C. §321 (g)(1), corresponds with the meaning of Article 4.b, MEDICRIME Convention.

c. Article 4.c MEDICRIME Convention - Active substance21 CFR 310.3 (g), and 21CFR §314.3 correspond to Article 4.c, MEDICRIME Convention.



21 CFR §201.117 includes a description of excipients under the heading of ‘inactive ingredients’ and does not separately define it. The term ‘inactive ingredients’ corresponds with Article 4.d, MEDICRIME Convention.

e. Article 4.e MEDICRIME Convention – Medical Device21 U.S.C. §321 (h), as regards medical devices and which includes accessories, components, and material, approximates to the meaning of Article 4.e, MEDICRIME Convention. 21 U.S.C. 360 j(o) excludes software intended to be used in conjunction with the device.Further action is needed to fully correspond with Article 4.e, MEDICRIME Convention.

f. Article 4.f MEDICRIME Convention – AccessoryThe term ‘accessory’ is not defined. It is defined in a guidance document by the U.S. Food and Drug Administration (US FDA), and it corresponds with Article 4.f, MEDICRIME Convention.Further action needed to fully correspond with Article 4.f, MEDICRIME Convention.

g. Article 4.g MEDICRIME Convention – Parts and materialsThe term ‘materials’ is used throughout 21 U.S.C, Chapter 9, but is not defined, nor is the term ‘parts’.Action is needed to correspond with Article 4.g, MEDICRIME Convention.

h. Article 4.h MEDICRIME Convention – Document18 U.S.C. § 2318, (b)(5), concerning the trafficking in counterfeit labels, illicit labels, or counterfeit documentation or packaging, corresponds with Article 4.h, MEDICRIME Convention.

i. Article 4.i MEDICRIME Convention – ManufacturingThe term ‘manufacturing’ is defined in a limited manner in some State laws, and in relation to blood products for human use, but not by federal law or in all States in relation to medical products. There is no correspondence with Article 4.i, MEDICRIME Convention.Action is needed to fully correspond with Article 4.i, MEDICRIME Convention.

j. Article 4.j MEDICRIME Convention – Counterfeit21 U.S. Code § 321(g)(1) defines the term ‘counterfeit’ in a manner that includes aspects of misrepresentation of identity of the medical product, but is insufficient to capture misrepresentation of source, including the history of the product. It is noted that U.S. Congressional reports include submissions that mention the term ‘falsified’ as regards medical products and define it in a manner consistent with Article 4.j, MEDICRIME Convention. However, the legal definition remains as that in 21 U.S. Code § 321(g)(1). This does not correspond with Article 4.j, MEDICRIME Convention.Further action is needed to correspond with Article 4.j, MEDICRIME Convention.

k. Article 4.k MEDICRIME Convention – Victim18 U.S.C. § 3771, (e), (2), (A) and (B), is a broad general criminal law definition that encompasses broadly the intent of Article 4.k, MEDICRIME Convention.



5.1: 21 U.S.C. § 331, (g), as regards medical products, and 21 U.S.C. § 331 (i), (3), as Regards causing any medical product to be counterfeit medicinal product, correspond with Article 5.1, MEDICRIME Convention.

5.2: 21 U.S.C. § 331 (2), as regards adulteration of medicinal products in interstate trade, corresponds with Article 5.,2, MEDICRIME Convention. However, this may not apply outside interstate trade.



18 U.S.C. § 2320 (a), (1), (2), and (4), as regards the trafficking in counterfeit goods or services, corresponds with Article 6, MEDICRIME Convention. 21 U.S.C. § 331, (a), and (c).


21 U.S.C. § 331, as regards regulatory law, and 18 U.S.C. §495, as regards general forgery offences, respectively, sufficiently correspond with Article 7, MEDICRIME Convention.



8.a.i., ii: 21 U.S.C. § 355 and §360 correspond with Article 8.a. i and ii, MEDICRIME Convention.

8.b: There is no correspondence, as regards the commercial use of original documents outside their intended use within the legal medical product supply chain, with Article 8.b, MEDICRIME Convention.



9.1: 18 U.S.C. §2, as regards aiding and abetting, corresponds with Article 9.1.MEDICRIME Convention.

9.2: 18 U.S.C. § 371 is a general conspiracy criminal law provision that does not directly address attempt. 18 U.S.C. § 2320 includes attempts in the trafficking in counterfeit goods or services and Partially corresponds with Article 9.2, MEDICRIME Convention.

Further action is needed to correspond fully with Article 9.2, MEDICRIME Convention.


11.1. a, b, c: Case law precedent in the Common Law Legal System has ensured that corporate liability arises through the acts of its agents (New York Central & Hudson River Railroad Co. v. United States, 212 U.S. 481, 494-95 (1909)). This is not specified in statutory law and does not completely correspond with Article 11.1, MEDICRIME Convention.

11.2: U.S. case law has developed the doctrine of “responsible corporate official” which provides for corporate liability where offending results from a failure to supervise (United States v. Park, 421 U.S. 658 (1975)). This corresponds with the intent of Article 11.2, MEDICRIME Convention.

11.3: Criminal, civil, and administrative sanctions are applicable to legal persons and Correspond with Article 11.3, MEDICRIME Convention.

11.4: U.S. case law precedent has ensured that legal entities are held liable for the acts of and distinct from that of their servants and agents (New York Central & Hudson River Railroad Co. v. United States, 212 U.S. 481, 494-95 (1909)). This corresponds with Article 11.4, MEDICRIME Convention.

Further action is needed to correspond with Article 11.1, MEDICRIME Convention.


13.a: 18 U.S.C. § 3571, USSG § 2N2.1, as regards the creation of a substantial risk of bodily injury or death, or bodily injury, death, or extreme psychological injury, corresponds to Article 13.a MEDICRIME Convention.

13.b, c, d, e, and f: There is no direct correspondence with Article 13. b – f. MEDICRIME Convention. Circumstance already forming part of the constituent elements of the offence obviate the requirement for aggravating circumstances in some instances. Sentencing guidelines are used to guide the Courts on aggravating circumstances and by 18 U.S. Code § 3553 - Imposition of a sentence.

Further action is needed to correspond with Article 13. b – f, MEDICRIME Convention.

Page 97

IV. A

PPEN

DIC

ES

App

endi

x 1-

NA

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ap A

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sim

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rim

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volv

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thre

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MED

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per

son

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e-m

ail

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acc

ount

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trod

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In th

e fr

amew

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of th

e Pr

ojec

t ent

itled

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ds A

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smen

t - F

alsi

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the

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ass

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the

leve

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omes

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ther

law

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port

the

proh

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gain

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ount

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for

the

purp

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This

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e fir

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o-pa

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cus

of th

is fi

rst p

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s on

the

defin

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s an

d th

e su

bsta

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w. P

art 2

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t a fu

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d w

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focu

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non-

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asp

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of t

he M

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y its

Art

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1.1

, whi

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Surv

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Artic

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– O

bjec

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pur

pose

1

T

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urpo

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is to

pre

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and

com

bat t

hrea

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pub

lic h

ealth

by:

a.

prov

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g fo

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crim

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isat

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p

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offe

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est

ablis

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unde

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c.

p

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otin

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inte

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oper

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II. P

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Gap

Ana

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rvey

The

purp

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of th

is G

ap A

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Surv

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to id

entif

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Cou

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of E

urop

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w b

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sup

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its

Mem

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build

a c

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w a

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amew

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unde

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cr

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whi

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at c

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viou

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ppro

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whi

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ims

at p

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Item

s th

at y

ou w

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Doc

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egis

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ap A

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fill-

in1. A

ppen

dix

to D

ocum

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xpla

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prov

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ase-

law

ana

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a co

llect

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of re

leva

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fals

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glis

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d/or

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volv

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com

batin

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lsifi

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tice,

Hea

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olic

e se

rvic

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usto

ms,

Hea

lth P

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egul

ator

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ency

, etc

).

IV. I

nstr

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ons

to c

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the

Legi

slat

ive

Gap

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The

Legi

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ive

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s req

uire

s res

pons

es to

be

prov

ided

in th

e Co

lum

n 2

and

in C

olum

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In y

our r

espo

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in C

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and

3, p

leas

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ate

only

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refe

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th

e do

mes

tic

law

pro

visi

on w

ith a

web

link

/hyp

er li

nk to

you

r law

s if

poss

ible

.

(e.g

., Col

3: R

egul

atio

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B (1

), M

edic

inal

Pro

duct

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ntro

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anuf

actu

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egul

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013.

(htt

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w.ir

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2013

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. Add

the

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or sp

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aws

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lace

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d w

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prov

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(e

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for E

U M

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the

tran

spos

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of D

irect

ive

2011

/62/

EU –

Fal

sifie

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at h

as th

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ject

of p

rote

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blic

hea

lth th

roug

h pr

otec

ting

the

med

icin

al p

rodu

ct)

http://www.irishstatutebook.ie/eli/2013/si/163/made/en/print

IV. Appendices Page 99

4.

Plea

se p

rovi

de in

nar

rati

ve fo

rm in

an

App

endi

x, in

Eng

lish

and/

or F

renc

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ngua

ges

a.

The

text

of t

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gisl

ativ

e pr

ovis

ion

that

you

refe

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in C

olum

ns 2

and

/or 3

(e

.g. “

14B.

(1) A

per

son

shal

l not

man

ufac

ture

, im

port

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xpor

t a m

edic

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she

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a fa

lsifi

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med

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st

ate

clea

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hy th

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nera

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s (C

olum

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quat

ely

impl

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cor

resp

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of t

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EDIC

RIM

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nven

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(Col

umn

1).

(e.g

. Thi

s pr

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law

and

was

impl

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to tr

ansp

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the

Dire

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11/6

2/EU

(fal

sifie

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edic

ines

dire

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he p

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ties

for w

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, on

sum

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are

a fi

ne n

ot e

xcee

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€4,

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of i

mpr

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men

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exc

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year

, or b

oth;

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conv

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indi

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to a

fine

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€120

,000

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a te

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10

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idin

g an

offe

nce

requ

iring

the

inte

ntio

nal c

ondu

ct a

nd a

ttra

cts

a cr

imin

al

conv

ictio

n). (

http

://w

ww

.iris

hsta

tute

book

.ie/e

li/20

06/a

ct/3

/sec

tion/

16/e

nact

ed/e

n/ht

ml#

sec1

6 )

c.

stat

e cl

early

if th

e ge

nera

l law

s (C

olum

n 3)

do

not a

dequ

atel

y or

at a

ll im

plem

ent t

he c

orre

spon

ding

pro

visi

on in

the

MED

ICRI

ME

Conv

entio

n (C

olum

n 1)

.(e

.g. T

he g

ener

al la

w d

oes n

ot co

mpl

etel

y/ a

dequ

atel

y (ex

clud

e as a

pplic

able

) im

plem

ent t

he co

rres

pond

ing

prov

isio

n of

the M

EDIC

RIM

E Co

nven

tion

as it

doe

s not

incl

ude

med

ical

dev

ices

. The

pur

pose

of t

he g

ener

al la

w p

rovi

sion

is to

pro

tect

the

publ

ic h

ealth

by

prot

ectin

g th

e m

edic

inal

pro

duct

whe

reas

the

purp

ose

of th

e M

EDIC

RIM

E Co

nven

tion

in th

is re

spec

t is t

o pr

otec

t the

pub

lic b

y cr

imin

alis

ing

the

offen

ding

beh

avio

urs)

.

(e.g

. The

dom

estic

law

doe

s not

cor

resp

ond

dire

ctly

to A

rtic

le (N

o.) o

f the

MED

ICRI

ME

Conv

entio

n as

it d

oes n

ot p

rovi

de a

spec

ific

offen

ce re

latin

g to

med

ical

pro

duct

s. Th

e ge

nera

l law

is u

sed

to a

ddre

ss th

e co

rres

pond

ing

artic

le o

f the

Con

vent

ion

beca

use

it cr

eate

s a

gene

ral o

ffenc

e fo

r an

inte

ntio

nal a

ct s

imila

r to

Artic

le (N

o.) o

f the

co

nven

tion

and

attr

acts

a c

rimin

al co

nvic

tion…

V. A

ddit

iona

l doc

umen

ts

This

exe

rcis

e w

ill b

e co

mpl

eted

with

add

ition

al re

spon

ses t

o be

pro

vide

d to

add

ition

al d

ocum

ents

, in

part

icul

ar a

case

-law

info

rmat

ion

docu

men

t and

an

over

view

doc

umen

t.

fTh

e ca

se-la

w a

naly

sis r

efer

s to

any

conc

rete

cas

e oc

curr

ed in

you

r cou

ntry

on

the

topi

c of

fals

ified

med

ical

pro

duct

s and

sim

ilar c

rimes

. Onl

y re

leva

nt ca

ses a

re re

quire

d.

The

reas

on is

to fi

nd o

ut w

heth

er th

ere

have

bee

n (o

r not

) in

your

cou

ntry

any

cas

e or

ope

ratio

ns im

plem

ente

d by

law

-enf

orce

men

t aut

horit

ies

that

hav

e ta

ckle

d th

is

topi

c. T

he id

ea is

not

to p

rovi

de u

s w

ith p

lent

y of

cas

es, j

ust w

ith th

ose

rele

vant

.

fO

verv

iew

doc

umen

t: so

me

addi

tiona

l inf

orm

atio

n fr

om y

our c

ount

ry a

bout

this

topi

c is

alw

ays

wel

com

e.

The

fulfi

lmen

t of t

hese

bot

h do

cum

ents

is s

elf-

expl

anat

ory.

VI.

Cont

act

In c

ase

of d

oubt

or q

uest

ion,

ple

ase

do n

ot h

esita

te to

con

tact

the

MED

ICRI

ME

Secr

etar

iat a

t: m

edic

rim

e@co

e.in

t

mailto:[email protected]


App

endi

x 2

- NA

-FA

MED

- A

1 -D

ocum

ent A

LEG

ISLA

TIV

E G

AP

AN

ALY

SIS:

ple

ase

spec

ify y

our c

ount

ry

MED

ICRI

ME

Conv

enti

on p

rovi

sion

Dom

esti

c Cr

imin

al L

aw e

nact

ed

spec

ifica

lly to

impl

emen

t the

M

EDIC

RIM

E Co

nven

tion

Gen

eral

dom

esti

c la

ws

(Cri

min

al o

r Reg

ulat

ory

– sp

ecify

whi

ch in

eac

h ca

se)

that

cor

resp

ond

to th

e pr

ovis

ion

in C

olum

n 1

Colu

mn

1Co

lum

n 2

Colu

mn

3

Art

icle

4 –

Defi

niti

ons

4.a.

The

term

“med

ical

pro

duct

” sha

ll m

ean

med

icin

al p

rodu

cts

and

med

ical

dev

ices

4.b.

The

term

“med

icin

al p

rodu

ct” s

hall

mea

n m

edic

ines

for h

uman

and

vet

erin

ary

use,

whi

ch

may

be:

i. a

ny s

ubst

ance

or c

ombi

natio

n of

sub

stan

ces

pres

ente

d as

hav

ing

prop

ertie

s fo

r tre

atin

g or

pr

even

ting

dise

ase

in h

uman

s or

ani

mal

s.

ii a

ny s

ubst

ance

or c

ombi

natio

n of

sub

stan

ces

whi

ch m

ay b

e us

ed in

or a

dmin

iste

red

to

hum

an b

eing

s or

ani

mal

s ei

ther

with

a

view

to re

stor

ing,

cor

rect

ing

or m

odify

ing

phys

iolo

gica

l fun

ctio

ns b

y ex

ertin

g a

phar

mac

olog

ical

, im

mun

olog

ical

or m

etab

olic

ac

tion,

or t

o m

akin

g a

med

ical

dia

gnos

is;

iii.

an

inve

stig

atio

nal m

edic

inal

pro

duct

4.c.

the

term

“act

ive

subs

tanc

e” s

hall

mea

n an

y su

bsta

nce

or m

ixtu

re o

f sub

stan

ces

that

is

desi

gnat

ed to

be

used

in th

e m

anuf

actu

re o

f a

med

icin

al p

rodu

ct, a

nd th

at, w

hen

used

in th

e pr

oduc

tion

of a

med

icin

al p

rodu

ct, b

ecom

es

an a

ctiv

e in

gred

ient

of t

he m

edic

inal

pro

duct


4.d.

the

term

“exc

ipie

nt” s

hall

mea

n an

y su

bsta

nce

that

is n

ot a

n ac

tive

subs

tanc

e or

a

finis

hed

med

icin

al p

rodu

ct, b

ut is

par

t of t

he

com

posi

tion

of a

med

icin

al p

rodu

ct fo

r hum

an

or v

eter

inar

y us

e an

d es

sent

ial f

or th

e in

tegr

ity

of th

e fin

ishe

d pr

oduc

t

4.e.

the

term

“med

ical

dev

ice”

sha

ll m

ean

any

inst

rum

ent,

appa

ratu

s, ap

plia

nce,

sof

twar

e,

mat

eria

l or o

ther

art

icle

, whe

ther

use

d al

one

or in

com

bina

tion,

incl

udin

g th

e so

ftw

are,

de

sign

ated

by

its m

anuf

actu

rer t

o be

use

d sp

ecifi

cally

for d

iagn

ostic

and

/or t

hera

peut

ic

purp

oses

and

nec

essa

ry fo

r its

pro

per

appl

icat

ion,

des

igna

ted

by th

e m

anuf

actu

rer t

o be

use

d fo

r hum

an b

eing

s fo

r the

pur

pose

of:

i. d

iagn

osis

, pre

vent

ion,

mon

itorin

g,

trea

tmen

t, or

alle

viat

ion

of d

isea

se;

ii. d

iagn

osis

, mon

itorin

g, tr

eatm

ent,

alle

viat

ion

of o

r com

pens

atio

n fo

r an

inju

ry o

r han

dica

p;

iii.

inve

stig

atio

n, re

plac

emen

t, or

mod

ifica

tion

of th

e an

atom

y or

of a

phy

siol

ogic

al p

roce

ss;

iv.

cont

rol o

f con

cept

ion.

and

whi

ch d

oes

not a

chie

ve it

s pr

inci

pal

inte

nded

act

ion

in o

r on

the

hum

an b

ody

by

phar

mac

olog

ical

, im

mun

olog

ical

, or m

etab

olic

m

eans

, but

whi

ch m

ay b

e as

sist

ed in

its

func

tion

by s

uch

mea

ns;

4.f.

the

term

“acc

esso

ry” s

hall

mea

n an

art

icle

w

hich

whi

lst n

ot b

eing

a m

edic

al d

evic

e is

de

sign

ated

spe

cific

ally

by

its m

anuf

actu

rer

to b

e us

ed to

geth

er w

ith a

med

ical

dev

ice

to

enab

le it

to b

e us

ed in

acc

orda

nce

with

the

use

of th

e m

edic

al d

evic

e in

tend

ed b

y th

e m

anuf

actu

rer o

f the

med

ical

dev

ice


4.g.

the

term

s “pa

rts”

and

“mat

eria

ls” s

hall

mea

n al

l par

ts a

nd m

ater

ials

con

stru

cted

and

de

sign

ated

to b

e us

ed fo

r med

ical

dev

ices

and

th

at a

re e

ssen

tial f

or th

e in

tegr

ity th

ereo

f

4.h.

the

term

“doc

umen

t” s

hall

mea

n an

y do

cum

ent r

elat

ed to

a m

edic

al p

rodu

ct,

an a

ctiv

e su

bsta

nce,

an

exci

pien

t, a

part

, a

mat

eria

l or a

n ac

cess

ory,

incl

udin

g th

e pa

ckag

ing,

labe

ling,

inst

ruct

ions

for u

se,

cert

ifica

te o

f orig

in o

r any

oth

er c

ertifi

cate

ac

com

pany

ing

it, o

r oth

erw

ise

dire

ctly

as

soci

ated

with

the

man

ufac

turin

g an

d/or

di

strib

utio

n th

ereo

f

4.i

the

term

“man

ufac

turin

g” s

hall

mea

n:

i. as

rega

rds

a m

edic

inal

pro

duct

, any

par

t of

the

proc

ess

of p

rodu

cing

the

med

icin

al

prod

uct,

or a

n ac

tive

subs

tanc

e or

an

exci

pien

t of

suc

h a

prod

uct,

or o

f brin

ging

the

med

icin

al

prod

uct,

activ

e su

bsta

nce,

or e

xcip

ient

to it

s fin

al s

tate

;

ii

a

s re

gard

s a

med

ical

dev

ice,

any

par

t of

the

proc

ess

of p

rodu

cing

the

med

ical

dev

ice,

as

wel

l as

part

s or

mat

eria

ls o

f suc

h a

devi

ce,

incl

udin

g de

sign

ing

the

devi

ce, t

he p

arts

or

mat

eria

ls, o

r of b

ringi

ng th

e m

edic

al d

evic

e,

the

part

s or

mat

eria

ls to

thei

r fina

l sta

te;

i

ii

as

rega

rds

an a

cces

sory

, any

par

t of t

he

proc

ess

of p

rodu

cing

the

acce

ssor

y, in

clud

ing

desi

gnin

g th

e ac

cess

ory,

or o

f brin

ging

the

acce

ssor

y to

its

final

sta

te

4.j.

the

term

“cou

nter

feit”

sha

ll m

ean

a fa

lse

repr

esen

tatio

n as

rega

rds

iden

tity

and/

or

sour

ce


4.k.

the

term

“vic

tim” s

hall

mea

n an

y na

tura

l per

son

suffe

ring

adve

rse

phys

ical

or

psyc

holo

gica

l effe

cts

as a

resu

lt of

hav

ing

used

a

coun

terf

eit m

edic

al p

rodu

ct o

r a m

edic

al

prod

uct m

anuf

actu

red,

sup

plie

d or

pla

ced

on

the

mar

ket w

ithou

t aut

horis

atio

n or

with

out

bein

g in

com

plia

nce

with

the

conf

orm

ity

requ

irem

ents

as

desc

ribed

in A

rtic

le 8

CHA

PTER

II –

SU

BSTA

NTI

VE

CRIM

INA

L LA

W

Art

icle

5 –

Man

ufac

turi

ng o

f cou

nter

feit

s

5.1.

Eac

h Pa

rty

shal

l tak

e th

e ne

cess

ary

legi

slat

ive

and

othe

r mea

sure

s to

est

ablis

h as

off

ence

s un

der i

ts d

omes

tic la

w, t

he in

tent

iona

l m

anuf

actu

ring

of c

ount

erfe

it m

edic

al

prod

ucts

, act

ive

subs

tanc

es, e

xcip

ient

s, pa

rts,

mat

eria

ls a

nd a

cces

sorie

s

5.2.

As

rega

rds

med

icin

al p

rodu

cts

and,

as

appr

opria

te, m

edic

al d

evic

es, a

ctiv

e su

bsta

nces

an

d ex

cipi

ents

, par

agra

ph 1

sha

ll al

so a

pply

to

any

adul

tera

tion

ther

eof

Art

icle

6 –

Sup

plyi

ng, o

ffer

ing

to s

uppl

y, a

nd tr

affick

ing

in c

ount

erfe

its

6.1.

Eac

h Pa

rty

shal

l tak

e th

e ne

cess

ary

legi

slat

ive

and

othe

r mea

sure

s to

est

ablis

h as

offe

nces

und

er it

s do

mes

tic la

w, w

hen

com

mitt

ed in

tent

iona

lly, t

he s

uppl

ying

or

the

offer

ing

to s

uppl

y, in

clud

ing

brok

erin

g,

the

traffi

ckin

g, in

clud

ing

keep

ing

in s

tock

, im

port

ing

and

expo

rtin

g of

cou

nter

feit

med

ical

pro

duct

s, ac

tive

subs

tanc

es,

exci

pien

ts, p

arts

, mat

eria

ls a

nd a

cces

sorie

s


Art

icle

7 –

Fal

sific

atio

n of

doc

umen

ts

7.1.

Eac

h Pa

rty

shal

l tak

e th

e ne

cess

ary

legi

slat

ive

and

othe

r mea

sure

s to

est

ablis

h as

off

ence

s un

der i

ts d

omes

tic la

w th

e m

akin

g of

fa

lse

docu

men

ts o

r the

act

of t

ampe

ring

with

do

cum

ents

, whe

n co

mm

itted

inte

ntio

nally

Art

icle

8 –

Sim

ilar c

rim

es in

volv

ing

thre

ats

to p

ublic

hea

lth

Each

Par

ty s

hall

take

the

nece

ssar

y le

gisl

ativ

e an

d ot

her m

easu

res

to e

stab

lish

as o

ffenc

es

unde

r its

dom

estic

law

, whe

n co

mm

itted

in

tent

iona

lly, i

n so

far a

s su

ch a

n ac

tivity

is n

ot

cove

red

by A

rtic

les

5, 6

and

7:

a th

e m

anuf

actu

ring,

the

keep

ing

in s

tock

for

supp

ly, i

mpo

rtin

g, e

xpor

ting,

sup

plyi

ng,

offer

ing

to s

uppl

y or

pla

cing

on

the

mar

ket

of:

i m

edic

inal

pro

duct

s w

ithou

t aut

horis

atio

n w

here

suc

h au

thor

isat

ion

is re

quire

d un

der

the

dom

estic

law

of t

he P

arty

; or

ii m

edic

al d

evic

es w

ithou

t bei

ng in

co

mpl

ianc

e w

ith th

e co

nfor

mity

re

quire

men

ts, w

here

suc

h co

nfor

mity

is

requ

ired

unde

r the

dom

estic

law

of t

he

Part

y;

b th

e co

mm

erci

al u

se o

f orig

inal

doc

umen

ts

outs

ide

thei

r int

ende

d us

e w

ithin

the

lega

l m

edic

al p

rodu

ct s

uppl

y ch

ain,

as

spec

ified

by

the

dom

estic

law

of t

he P

arty


Art

icle

9 –

Aid

ing

or a

bett

ing

and

atte

mpt

Each

Par

ty s

hall

take

the

nece

ssar

y le

gisl

ativ

e an

d ot

her m

easu

res

to e

stab

lish

as o

ffenc

es

whe

n co

mm

itted

inte

ntio

nally

, aid

ing

or

abet

ting

the

com

mis

sion

of a

ny o

f the

off

ence

s es

tabl

ishe

d in

acc

orda

nce

with

this

Co

nven

tion.

Each

Par

ty s

hall

take

the

nece

ssar

y le

gisl

ativ

e an

d ot

her m

easu

res

to e

stab

lish

as a

n off

ence

th

e in

tent

iona

l att

empt

to c

omm

it an

y of

the

offen

ces

esta

blis

hed

in a

ccor

danc

e w

ith th

is

Conv

entio

n.

Art

icle

11

– Co

rpor

ate

liabi

lity

Each

Par

ty sh

all t

ake

the

nece

ssar

y le

gisl

ativ

e an

d ot

her m

easu

res t

o en

sure

that

lega

l per

sons

ca

n be

hel

d lia

ble

for o

ffenc

es e

stab

lishe

d in

acc

orda

nce

with

this

Con

vent

ion,

whe

n co

mm

itted

for t

heir

bene

fit b

y an

y na

tura

l pe

rson

, act

ing

eith

er in

divi

dual

ly o

r as p

art o

f an

org

an o

f the

lega

l per

son,

who

has

a le

adin

g po

sitio

n w

ithin

it b

ased

on:

a a

pow

er o

f rep

rese

ntat

ion

of th

e le

gal

pers

on;

b an

aut

horit

y to

take

dec

isio

ns o

n be

half

of

the

lega

l per

son;

c an

aut

horit

y to

exe

rcis

e co

ntro

l with

in th

e le

gal p

erso

n.

Apa

rt fr

om th

e ca

ses

prov

ided

for i

n pa

ragr

aph

1, e

ach

Part

y sh

all t

ake

the

nece

ssar

y le

gisl

ativ

e an

d ot

her m

easu

res

to e

nsur

e th

at a

le

gal p

erso

n ca

n be

hel

d lia

ble

whe

re th

e la

ck

of s

uper

visi

on o

r con

trol

by

a na

tura

l per

son

refe

rred

to in

par

agra

ph 1

has

mad

e po

ssib

le

the

com

mis

sion

of a

n off

ence

est

ablis

hed

in a

ccor

danc

e w

ith th

is C

onve

ntio

n fo

r the

be

nefit

of t

hat l

egal

per

son

by a

nat

ural

per

son

actin

g un

der i

ts a

utho

rity.


Subj

ect t

o th

e le

gal p

rinci

ples

of t

he P

arty

, the

lia

bilit

y of

a le

gal p

erso

n m

ay b

e cr

imin

al, c

ivil

or a

dmin

istr

ativ

e

Such

liab

ility

sha

ll be

with

out p

reju

dice

to th

e cr

imin

al li

abili

ty o

f the

nat

ural

per

sons

who

ha

ve c

omm

itted

the

offen

ce

Art

icle

13

– Ag

grav

atin

g ci

rcum

stan

ces

Each

Par

ty s

hall

take

the

nece

ssar

y le

gisl

ativ

e an

d ot

her m

easu

res

to e

nsur

e th

at th

e fo

llow

ing

circ

umst

ance

s, in

so

far a

s th

ey

do n

ot a

lread

y fo

rm p

art o

f the

con

stitu

ent

elem

ents

of t

he o

ffenc

e, m

ay, i

n co

nfor

mity

w

ith th

e re

leva

nt p

rovi

sion

s of

dom

estic

law

, be

take

n in

to c

onsi

dera

tion

as a

ggra

vatin

g ci

rcum

stan

ces

in d

eter

min

ing

the

sanc

tions

in

rela

tion

to th

e off

ence

s es

tabl

ishe

d in

ac

cord

ance

with

this

Con

vent

ion:

a

the

offen

ce c

ause

d th

e de

ath

of, o

r da

mag

e to

the

phys

ical

or m

enta

l hea

lth o

f, th

e vi

ctim

;

b

the

offen

ce w

as c

omm

itted

by

pers

ons

abus

ing

the

confi

denc

e pl

aced

in

them

in th

eir c

apac

ity a

s pr

ofes

sion

als;

c

the

offen

ce w

as c

omm

itted

by

pers

ons

abus

ing

the

confi

denc

e pl

aced

in

them

as

man

ufac

ture

rs a

s w

ell a

s su

pplie

rs;

d

the

offen

ces

of s

uppl

ying

and

off

erin

g to

sup

ply

wer

e co

mm

itted

hav

ing

reso

rt to

mea

ns o

f lar

ge s

cale

dis

trib

utio

n, s

uch

as in

form

atio

n sy

stem

s, in

clud

ing

the

Inte

rnet

;

e

the

offen

ce w

as c

omm

itted

in th

e fr

amew

ork

of a

crim

inal

org

anis

atio

n;

f

the

perp

etra

tor h

as p

revi

ousl

y be

en

conv

icte

d of

offe

nces

of t

he s

ame

natu

re


App

endi

x 3

- NA

-FA

MED

- A

2 - A

ppen

dix

1

APP

END

IX 1

- D

ESCR

IPTI

ON

OF

LAW

S BY

TH

E EX

PERT

MED

ICRI

ME

Prov

isio

nTh

e te

xt o

f the

nat

iona

l leg

isla

tive

pr

ovis

ion

(col

umn

2 an

d/or

3)

Why

the

gene

ral l

aws

(col

umn

2) a

dequ

atel

y im

plem

ents

the

corr

espo

ndin

g pr

ovis

ion

Doe

s th

e ge

nera

l law

(Col

umn

3)

adeq

uate

ly o

r at a

ll im

plem

ents

th

e co

rres

pond

ing

prov

isio

n


App

endi

x 4

- NA

-FA

MED

Doc

umen

t B -

Case

Law

(Law

-enf

orce

men

t or j

uris

prud

enti

al) a

naly

sis

AN

DO

RRA

No

subm

issi

on h

as b

een

rece

ived

on

case

law

from

the

natio

nal c

onsu

ltant

ARM

ENIA

(pre

pare

d by

the

natio

nal c

onsu

ltant

Ms

Alv

ina

GYU

LUM

YAN

)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

30 N

ovem

ber,

2016

Case

‎‎‎

/012

5/01

/16

Citiz

en o

f Arm

enia

M.A

. B. i

n th

e fa

ll of

201

5, w

ithou

t hav

ing

a sp

ecia

l ph

arm

aceu

tical

lice

nse,

had

pre

pare

d an

d so

ld 6

via

ls o

f eye

dro

ps a

nd 3

vi

als

of e

ar d

rops

non

-ste

rile

coun

terf

eit d

rugs

that

wer

e no

t reg

iste

red

in th

e RA

and

did

n’t n

ot m

eet t

he s

tand

ard

requ

irem

ents

as

wel

l as

adop

ted

qual

itativ

e an

d qu

antit

ativ

e ch

arac

teris

tics.

Ass

essi

ng th

e na

ture

of t

he c

rime

com

mitt

ed b

y th

e de

fend

ant M

.А.

B., t

he d

egre

e of

dan

ger t

o so

ciet

y, a

s w

ell a

s th

e sp

ecifi

c ac

tions

he

com

mitt

ed, t

he d

egre

e of

impl

emen

tatio

n of

the

crim

inal

inte

nt

and

the

dam

age

caus

ed a

s a

resu

lt, a

s w

ell a

s th

e so

cial

sig

nific

ance

of

the

viol

ated

pub

lic re

latio

ns, t

he d

irect

ion

of th

e st

ate’

s cr

imin

al

polic

y in

this

are

a, th

e be

havi

our o

f the

def

enda

nt a

fter

com

mitt

ing

the

crim

e, a

s w

ell a

s co

mbi

ning

them

with

circ

umst

ance

s m

itiga

ting

the

resp

onsi

bilit

y an

d pu

nish

men

t of t

he d

efen

dant

, with

a p

ositi

ve

char

acte

ristic

of h

is p

erso

nalit

y an

d th

e ab

senc

e of

agg

rava

ting

circ

umst

ance

s, th

e co

urt r

uled

that

M.A

.B. s

houl

d be

con

vict

ed in

ac

cord

ance

with

par

t 2 o

f Art

icle

280

of t

he R

A C

rimin

al C

ode,

nam

ely,

th

e pu

nish

men

t of i

mpr

ison

men

t for

up

to 1

(one

) yea

r.

The

cour

t dec

ided

to a

pply

the

sent

ence

of 1

(one

) yea

r of

impr

ison

men

t con

ditio

nally

, to

set a

pro

batio

n pe

riod

of 1

(o

ne) y

ear,

plac

ing

cont

rol o

ver d

efen

dant

’s be

havi

our o

n th

e re

leva

nt te

rrito

rial s

ubdi

visi

on o

f the

Sta

te P

roba

tion

Serv

ice

of th

e M

inis

try

of Ju

stic

e.

AU

STRI

A N

o su

bmis

sion

has

bee

n re

ceiv

ed o

n ca

se la

w fr

om th

e na

tiona

l con

sulta

nt


AZE

RBA

IJA

N (p

repa

red

by th

e na

tiona

l con

sulta

nt M

s Ru

hiyy

a IS

AYEV

A)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

1st c

ase

№ 1

(101

)-XXX

/202

1

Dec

isio

n of

the

Baku

Co

urt o

n G

rave

Crim

es o

f 05

Feb

ruar

y 20

21

A p

hysi

cal p

erso

n is

cha

rged

with

Art

icle

s 20

0-1.

2.2,

206

.3.2

and

240

.3.2

of

the

Crim

inal

Cod

e of

the

Repu

blic

of A

zerb

aija

n fo

r ille

gal a

cqui

sitio

n,

inte

ntio

nal s

torin

g, tr

ansp

orta

tion

and

smug

glin

g fo

r the

pur

pose

of

gre

ed a

nd s

ale

in la

rge

amou

nt5 s

tron

g su

bsta

nces

not

rela

ted

to

narc

otic

dru

gs o

r psy

chot

ropi

c su

bsta

nces

(i.e

. sm

uggl

ing

acro

ss th

e cu

stom

s bo

rder

of t

he A

zerb

aija

n Re

publ

ic),

as w

ell a

s w

ith s

torin

g in

la

rge

amou

nt u

nreg

iste

red6 a

nd n

on-t

rans

fera

ble

med

icin

al p

rodu

cts.

Mr.X

is fo

und

guilt

y of

com

mitt

ing

a cr

imin

al o

ffenc

e pr

ovid

ed

for i

n A

rtic

les

200-

1.2.

2, 2

06.3

.2 a

nd 2

40.3

.2 o

f the

Crim

inal

Co

de o

f the

Rep

ublic

of A

zerb

aija

n be

ing

sent

ence

d un

der

Art

icle

200

-1.2

.2 to

impr

ison

men

t for

a te

rm o

f 2 (t

wo)

ye

ars

with

dep

rivat

ion

for 2

(tw

o) y

ears

of t

he ri

ght t

o ho

ld

man

ager

ial a

nd fi

nanc

ially

resp

onsi

ble

posi

tions

in s

tate

and

lo

cal s

elf-

gove

rnm

ent b

odie

s, as

wel

l as

the

right

to e

ngag

e in

non

-sta

te (p

rivat

e) m

edic

al a

ctiv

ities

, un

der A

rtic

le 2

06.3

.2

to im

pris

onm

ent f

or a

term

of 6

(six

) yea

rs, a

nd u

nder

Art

icle

24

0.3.

2 to

impr

ison

men

t for

a te

rm o

f 5 (fi

ve) y

ears

.

Purs

uant

to A

rtic

les

66.3

and

66.

4 of

the

Crim

inal

Cod

e of

the

Repu

blic

of A

zerb

aija

n, th

e m

ain

and

addi

tiona

l pun

ishm

ents

ar

e pa

rtia

lly c

olle

cted

and

Mr.X

is s

ente

nced

to im

pris

onm

ent

for a

term

of 7

(sev

en) y

ears

with

dep

rivat

ion

for 2

(tw

o) y

ears

of

the

right

to h

old

man

ager

ial a

nd fi

nanc

ially

resp

onsi

ble

posi

tions

in s

tate

and

loca

l sel

f-go

vern

men

t bod

ies,

as w

ell a

s th

e rig

ht to

eng

age

in n

on-s

tate

(priv

ate)

med

ical

act

iviti

es.

5.

Und

er A

rtic

le 2

00-1

of t

he C

rimin

al C

ode

of th

e Re

publ

ic o

f Aze

rbai

jan

the

«sig

nific

ant a

mou

nt»

men

tione

d in

Art

icle

200

-1.1

mea

ns th

e am

ount

from

1 0

00 (o

ne th

ousa

nd) t

o 2

000

(tw

o th

ousa

nd) m

anat

s (i.

e. A

ZN),

and

«lar

ge a

mou

nt»

men

tione

d in

Art

icle

200

-1.2

.3 m

eans

the

amou

nt e

xcee

ding

2 0

00 (t

wo

thou

sand

) AZN

.6.

H

ere

“unr

egis

tere

d” m

eans

with

out a

utho

risat

ion

whe

re s

uch

auth

oris

atio

n is

requ

ired

unde

r the

legi

slat

ion

of th

e Re

publ

ic o

f Aze

rbai

jan.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

2nd

case

№ 1

(101

)-XXX

/202

0

Dec

isio

n of

the

Baku

Co

urt o

n G

rave

Crim

es o

f 01

Dec

embe

r 202

0

Thre

e ph

ysic

al p

erso

ns a

re c

harg

ed w

ith A

rtic

les

200-

1.2.

2, 2

00-1

.2.3

and

20

6.3.

2 of

the

Crim

inal

Cod

e of

the

Repu

blic

of A

zerb

aija

n fo

r int

entio

nal

impo

rtin

g an

d st

orin

g, fo

r the

pur

pose

of g

reed

and

sal

e, u

nreg

iste

red

(i.e.

with

out a

utho

risat

ion

whe

re s

uch

auth

oris

atio

n is

requ

ired

unde

r th

e do

mes

tic la

w) m

edic

inal

pro

duct

s in

larg

e am

ount

7, a

s w

ell a

s fo

r sm

uggl

ing

med

icin

al p

rodu

cts

in s

igni

fican

t am

ount

(i.e

. im

port

of

whi

ch is

not

allo

wed

to th

e Re

publ

ic o

f Aze

rbai

jan

in a

ccor

danc

e w

ith

the

Law

of t

he R

epub

lic o

f Aze

rbai

jan

“On

Med

icin

al P

rodu

cts”

(№20

8-III

Q, d

ated

22

Dec

embe

r 200

6).

Tota

l am

ount

: 149

894

.90

AZN

(app

rox.

73

040

Euro

)

Mr.X

1, M

r.X2

and

Mr X

3 ar

e fo

und

guilt

y of

com

mitt

ing

a cr

imin

al o

ffenc

e pr

ovid

ed fo

r in

Art

icle

s 20

0-1.

2.2,

200

-1.2

.3

and

206.

3.2

of th

e Cr

imin

al C

ode

of th

e Re

publ

ic o

f Aze

rbai

jan

bein

g se

nten

ced

unde

r Art

icle

s 20

0-1.

2.2

and

200-

1.2.

3 to

im

pris

onm

ent f

or a

term

of 2

(tw

o) y

ears

with

dep

rivat

ion

for

1 (o

ne) y

ear o

f the

righ

t to

hold

man

ager

ial a

nd fi

nanc

ially

re

spon

sibl

e po

sitio

ns in

sta

te a

nd lo

cal s

elf-

gove

rnm

ent

bodi

es fo

r 1 (o

ne) y

ear,

and

unde

r Art

icle

206

.3.2

to

impr

ison

men

t for

a te

rm o

f 5 (fi

ve) y

ears

.

Purs

uant

to A

rtic

le 6

6.3

of th

e Cr

imin

al C

ode

of th

e Re

publ

ic

of A

zerb

aija

n, th

e m

ain

puni

shm

ents

are

par

tially

col

lect

ed

and

Mr.X

1, M

r.X2

and

Mr.X

3 ar

e se

nten

ced

to im

pris

onm

ent

for a

term

of 5

(five

) yea

rs a

nd 6

(six

) mon

ths

with

dep

rivat

ion

of th

e rig

ht to

hol

d m

anag

eria

l and

mat

eria

lly re

spon

sibl

e po

sitio

ns in

sta

te a

nd lo

cal s

elf-

gove

rnm

ent b

odie

s fo

r 1 (o

ne)

year

.

With

rega

rd to

the

appl

icat

ion

of A

rtic

le 7

0 of

the

Crim

inal

Co

de o

f the

Rep

ublic

of A

zerb

aija

n to

Mr.X

1, M

r.X2

and

Mr.X

3,

the

sent

ence

of i

mpr

ison

men

t im

pose

d on

them

is c

onsi

dere

d co

nditi

onal

with

a p

roba

tion

perio

d of

1 (o

ne) y

ear.

Mr.X

1, M

r.X2

and

Mr.X

3 ar

e ob

liged

not

to c

hang

e th

eir

perm

anen

t pla

ce o

f res

iden

ce w

ithou

t inf

orm

ing

the

bodi

es

supe

rvis

ing

thei

r beh

avio

ur.

7.

Und

er A

rtic

le 2

00-1

of t

he C

rimin

al C

ode

of th

e Re

publ

ic o

f Aze

rbai

jan

the

«sig

nific

ant a

mou

nt»

men

tione

d in

the

Art

icle

200

-1.1

mea

ns th

e am

ount

from

1 0

00 (o

ne th

ousa

nd) t

o 2

000

(tw

o th

ousa

nd) m

anat

s (i.

e. A

ZN),

and

«lar

ge a

mou

nt»

men

tione

d in

the

Art

icle

200

-1.2

.3 m

eans

the

amou

nt e

xcee

ding

2 0

00 (t

wo

thou

sand

) AZN

.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

3rd

case

№ 1

(101

)-XXX

/202

0

Dec

isio

n of

the

Baku

Co

urt o

n G

rave

Crim

es o

f 21

Sep

tem

ber 2

020

A p

hysi

cal p

erso

n is

cha

rged

with

Art

icle

s 20

0–1.

2.2,

200

–1.2

.3 a

nd

206.

3.2

of th

e Cr

imin

al C

ode

of th

e Re

publ

ic o

f Aze

rbai

jan

for i

nten

tiona

l im

port

ing

and

stor

ing,

for t

he p

urpo

se o

f gre

ed a

nd s

ale,

unr

egis

tere

d m

edic

inal

pro

duct

s in

larg

e am

ount

, as

wel

l as

for s

mug

glin

g m

edic

inal

pr

oduc

ts in

sig

nific

ant a

mou

nt.

Tota

l am

ount

: 876

30,6

AZN

(app

rox.

42

700

Euro

)

Mr.X

is fo

und

guilt

y of

com

mitt

ing

a cr

imin

al o

ffenc

e pr

ovid

ed

for i

n Ar

ticle

s 200

–1.2

.2, 2

00–1

.2.3

and

206

.3.2

of t

he C

rimin

al

Code

of t

he R

epub

lic o

f Aze

rbai

jan

bein

g se

nten

ced

unde

r Ar

ticle

206

.3.2

to im

pris

onm

ent f

or a

term

of 5

(five

) yea

rs a

nd

6 (s

ix) m

onth

s and

und

er A

rtic

les 2

00-1

.2.2

and

200

-1.2

.3 to

im

pris

onm

ent f

or a

term

of 3

(thr

ee) y

ears

.

Purs

uant

to A

rtic

le 6

6.3

of th

e Cr

imin

al C

ode

of th

e Re

publ

ic o

f A

zerb

aija

n, th

e pu

nish

men

ts a

re p

artia

lly c

olle

cted

and

Mr.X

1 is

se

nten

ced

to im

pris

onm

ent f

or a

term

of 6

(six

) yea

rs.

Mr.X

will

pas

s hi

s se

nten

ce in

a g

ener

al re

gim

e pe

nite

ntia

ry

inst

itutio

n.

4th

case

№ 1

(101

)-XXX

/201

9

Dec

isio

n of

the

Baku

Co

urt o

n G

rave

Crim

es o

f 29

May

201

9

Nin

e ph

ysic

al p

erso

ns a

re c

harg

ed w

ith A

rtic

les

200–

1.2.

1, 2

00-1

.2.2

, 20

0–1.

2.3,

206

.3.1

, 206

.3.2

, 206

.3.3

and

308

.2 o

f the

Crim

inal

Cod

e of

the

Repu

blic

of A

zerb

aija

n fo

r int

entio

nal m

isus

e of

thei

r offi

cial

po

wer

s in

ord

er to

gai

n an

ille

gal a

dvan

tage

for t

hem

selv

es a

nd th

ird

part

ies

in c

onne

ctio

n w

ith th

e pe

rfor

man

ce o

f the

ir offi

cial

dut

ies

as a

n offi

cial

, cau

sing

sig

nific

ant d

amag

e to

the

lega

lly p

rote

cted

inte

rest

s of

so

ciet

y an

d th

e st

ate;

for i

nten

tiona

l im

port

ing

and

stor

ing

in a

larg

e am

ount

the

unre

gist

ered

med

icin

al p

rodu

cts

for t

he p

urpo

se o

f sal

e,

and

for e

nsur

ing

thei

r sal

e; fo

r eng

agin

g in

illic

it tr

affick

ing

in m

edic

inal

pr

oduc

ts, r

epea

tedl

y, b

eing

a g

roup

of p

erso

ns w

ho h

ave

prev

ious

ly

cons

pire

d an

d us

ing

thei

r offi

cial

pos

ition

to m

ove

secr

etly

and

out

side

th

e cu

stom

s bo

rder

of t

he A

zerb

aija

n Re

publ

ic, u

sing

frau

dule

ntly

do

cum

ents

and

mea

ns o

f cus

tom

s id

entifi

catio

n, n

ot d

ecla

ring

and

mis

repr

esen

ting

larg

e am

ount

s of

sm

uggl

ed u

nreg

iste

red

med

icin

al

prod

ucts

of l

ow-q

ualit

y, n

ot m

eetin

g th

e re

quire

men

ts o

f nor

mat

ive-

tech

nica

l doc

umen

ts.

Mr.X

1, M

r.X2,

Mr X

3, M

r.X4,

Mr.X

5, M

r.X6,

Mr.X

7, M

r.X8

and

Mr.X

9 ar

e fo

und

guilt

y of

com

mitt

ing

a cr

imin

al o

ffenc

e pr

ovid

ed fo

r in

Art

icle

s 20

0–1.

2.1,

200

-1.2

.2, 2

00–1

.2.3

, 20

6.3.

1, 2

06.3

.2, 2

06.3

.3 a

nd 3

08.2

of t

he C

rimin

al C

ode

of

the

Repu

blic

of A

zerb

aija

n be

ing

sent

ence

d un

der A

rtic

les

200-

1.2.

1, 2

00-1

.2.2

and

200

-1.2

.3 to

impr

ison

men

t for

a te

rm

of 2

(tw

o) y

ears

with

dep

rivat

ion

for 1

(one

) yea

r of t

he ri

ght t

o ho

ld m

anag

eria

l and

fina

ncia

lly re

spon

sibl

e po

sitio

ns in

sta

te

and

loca

l sel

f-go

vern

men

t bod

ies,

unde

r Art

icle

s 20

6.3.

2 an

d 20

6.3.

3 to

impr

ison

men

t for

a te

rm o

f 5 (fi

ve) y

ears

and

und

er

Art

icle

308

.2 to

impr

ison

men

t for

a te

rm o

f 3 (t

hree

) yea

rs w

ith

depr

ivat

ion

for 1

(one

) yea

r of t

he ri

ght t

o ho

ld m

anag

eria

l an

d fin

anci

ally

resp

onsi

ble

posi

tions

in s

tate

and

loca

l sel

f-go

vern

men

t bod

ies.

Purs

uant

to A

rtic

le 6

6.3

and

66.4

of t

he C

rimin

al C

ode

of

the

Repu

blic

of A

zerb

aija

n, th

e pu

nish

men

ts a

re p

artia

lly

colle

cted

and

Mr.X

1, M

r.X2,

Mr X

3, M

r.X4,

Mr.X

5, M

r.X6,

Mr.X

7,

Mr.X

8 an

d M

r.X9

are

sent

ence

d to

impr

ison

men

t for

a te

rm

of 6

(six

) yea

rs w

ith d

epriv

atio

n fo

r 1 (o

ne) y

ear o

f the

righ

t to

hold

man

ager

ial a

nd fi

nanc

ially

resp

onsi

ble

posi

tions

in s

tate

an

d lo

cal s

elf-

gove

rnm

ent b

odie

s.

In a

ccor

danc

e w

ith A

rtic

le 7

0 of

the

Crim

inal

Cod

e of

the

Repu

blic

of

Aze

rbai

jan

the

sent

ence

on

impr

isonm

ent s

hall b

e co

nditi

onal

ly

appl

ied

with

a p

roba

tiona

ry p

erio

d of

2 (t

wo)

yea

rs.


BULG

ARI

A (p

repa

red

by th

e na

tiona

l con

sulta

nt M

s M

omia

na G

ENEV

A)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

As

conc

erns

hum

an m

edic

ine,

the

Crim

inal

Cod

e of

Bul

garia

(htt

ps://

ww

w.le

x.bg

/bg/

law

s/ld

oc/1

5896

5452

9) p

rovi

des

no re

spon

sibi

lity

for c

ondu

ct id

entic

al o

r sim

ilar t

o th

at d

escr

ibed

in M

EDIC

RIM

E. O

n th

at re

ason

, the

re a

re n

ot re

leva

nt c

ases

. An

inve

stig

atio

n fo

r rel

evan

t ca

ses,

whe

re th

e pr

oduc

ing,

trad

ing

with

, exp

ortin

g an

d im

port

ing

of

coun

terf

eit m

edic

al p

rodu

cts

was

pun

ishe

d as

frau

d or

uni

nten

tiona

l ca

usin

g of

dea

th o

r inj

ury

in m

ayor

cou

rts

and

atto

rney

offi

ces

in

Bulg

aria

, sho

wed

that

ther

e ar

e no

suc

h ca

ses

– ne

ither

arc

hive

d, n

or

even

pen

ding

.

The

Crim

inal

Cod

e of

Bul

garia

pro

vide

s re

spon

sibi

lity

for p

rodu

cing

or

putt

ing

on th

e m

arke

t of f

oods

tuffs

, ani

mal

feed

, or v

eter

inar

y m

edic

al

prod

ucts

, or d

rinks

(Art

. 350

a). T

he p

rovi

sion

is in

forc

e si

nce

2004

. The

de

taile

d en

quiry

of j

uris

prud

ence

sho

ws

that

ther

e ar

e no

suc

h ca

ses

– ne

ither

arc

hive

d, n

or p

endi

ng.

CAN

AD

A (p

repa

red

by th

e na

tiona

l con

sulta

nt M

r Dav

id L

IPKU

S)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Nov

embe

r 5, 2

020:

Pr

ojec

t Pu

rify

(Law

Enf

orce

men

t: Ro

yal C

anad

ian

Mou

nted

Po

lice)

Proj

ect P

urify

is a

mul

ti-de

part

men

tal p

artn

ersh

ip b

etw

een

the

CBSA

, Hea

lth C

anad

a an

d th

e RC

MP,

whi

ch w

as e

stab

lishe

d to

enh

ance

the

iden

tifica

tion,

inte

rcep

tion

and

trac

king

of u

naut

horiz

ed o

r cou

nter

feit

COVI

D-1

9 he

alth

-rel

ated

pro

duct

s in

Brit

ish

Colu

mbi

a be

twee

n M

arch

20t

h an

d Ju

ne 3

0th,

202

0.

Dur

ing

this

per

iod,

ove

r 380

shi

pmen

ts o

f un

auth

oriz

ed c

onte

nt o

r cou

nter

feit

COVI

D-

19- r

elat

ed g

oods

wer

e de

tain

ed a

t the

bo

rder

, inc

ludi

ng: 4

8,00

0 CO

VID

-19

test

kit

s;

4.5

mill

ion

unit

s of

per

sona

l pro

tect

ive

equi

pmen

t; 3

3,00

0 pr

escr

ipti

on ta

blet

s an

d pi

lls; a

nd o

ver 1

,500

oth

er in

terc

epts

of

frau

dule

nt a

nd p

oten

tial

ly d

ange

rous

pr

oduc

ts

https://www.lex.bg/bg/laws/ldoc/1589654529



PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

R v

Forr

este

r, 20

16 O

NSC

82

09 (S

epte

mbe

r 29,

20

16) R

. v. F

orre

ster

, 201

9 O

NCA

255

(Apr

il 3,

201

9)

Nor

th B

ay P

olic

e Se

rvic

es o

btai

ned

sear

ch w

arra

nts

for i

ndiv

idua

ls in

Nor

th B

ay.

Thos

e in

divi

dual

s (o

pera

tors

of t

his

sche

me

wer

e na

med

to b

e Ra

ymon

d G

odre

au

and

Gre

nvill

e Si

ncla

ir an

d Ju

lie B

aks)

wer

e fo

und

to h

ave

in th

eir p

osse

ssio

n pr

escr

iptio

ns fo

r Fen

tany

l, is

sued

by

Dr.

Ala

n Sa

ckse

n in

Bar

rie. T

he m

atte

r was

re

ferr

ed to

Bar

rie P

olic

e Se

rvic

es, w

ho c

ondu

cted

thei

r ow

n in

vest

igat

ion.

The

y at

tend

ed a

t the

doc

tor’s

offi

ce a

nd th

e do

ctor

’s ow

n au

dit o

f his

reco

rds

indi

cate

d th

at a

ppro

xim

atel

y 19

fals

e pr

escr

iptio

ns w

ere

issu

ed fr

om h

is o

ffice

. Non

e of

thos

e in

divi

dual

s to

who

m p

resc

riptio

ns w

ere

issu

ed w

ere

actu

al p

atie

nts

of D

r. Sa

ckse

n.

One

of t

he In

divi

dual

s is

sued

a p

resc

riptio

n to

“Sea

n Fo

rres

ter”

and

gav

e it

to M

r. Si

ncla

ir. S

ean

Forr

este

r was

nev

er a

pat

ient

of D

r. Sa

ckse

n. M

s. Sa

ks h

ad n

ever

met

Se

an F

orre

ster

, but

sim

ply

acte

d on

the

info

rmat

ion

prov

ided

to h

er b

y M

r. Si

ncla

ir.

Mr.

Sinc

lair

and

Ms.

Baks

wer

e in

volv

ed in

a re

latio

nshi

p at

the

time

of th

e sc

hem

e.

Mr.

Sinc

lair’

s ro

le w

as to

obt

ain

heal

th c

ard

and

othe

r per

tinen

t per

sona

l inf

orm

atio

n fr

om h

is a

ssoc

iate

, Mr.

God

reau

. Gen

eral

ly, M

r. G

odre

au w

ould

obt

ain

heal

th c

ard

num

bers

, dat

es o

f birt

h, a

ddre

sses

, pos

tal c

odes

and

pho

ne n

umbe

rs fr

om a

ssoc

iate

s or

acq

uain

tanc

es, a

nd p

rovi

de th

is in

form

atio

n on

a p

iece

of p

aper

to M

r. Si

ncla

ir.

On

Augu

st 3

0th,

201

3, s

he is

sued

a p

resc

riptio

n to

one

“Sea

n Fo

rres

ter”

and

gav

e it

to

Mr.

Sinc

lair.

Sea

n Fo

rres

ter w

as n

ever

a p

atie

nt o

f Dr.

Sack

sen.

Ms.

Baks

had

nev

er m

et

Sean

For

rest

er, b

ut s

impl

y ac

ted

on th

e in

form

atio

n pr

ovid

ed to

her

by

Mr.

Sinc

lair.

The

focu

s at

Mr.

Forr

este

r’s tr

ial w

as w

heth

er o

r not

Mr.

Forr

este

r att

ende

d at

Sh

oppe

r’s D

rug

Mar

t on

Youn

g St

reet

in B

arrie

on

the

date

s in

que

stio

n to

fill

thes

e pr

escr

iptio

ns. M

r. Fo

rres

ter d

enie

d hi

s in

volv

emen

t.

R v

Forr

este

r, 20

16 O

NSC

820

9

Mr.

Forr

este

r was

cha

rged

as

it re

late

d to

the

poss

essi

on o

f a s

ubst

ance

for

the

purp

ose

of tr

affick

ing,

con

trar

y to

sec

tion

5(2)

of t

he C

ontr

olle

d D

rug

and

Subs

tanc

es A

ct, S

.C. 1

996,

c.1

9 [C

DSA

] and

thre

e co

unts

rela

ted

to p

osse

ssin

g a

forg

ed d

ocum

ent,

in th

is c

ase,

a m

edic

al p

resc

riptio

n, c

ontr

ary

to s

ectio

n 36

8(1)

(d) o

f th

e Cr

imin

al C

ode,

R.S

.C.,

1985

, c. C

-46

[Crim

inal

Cod

e].

In 2

016,

Sea

n Fo

rres

ter w

as fo

und

guilt

y on

all

six

coun

ts b

efor

e th

e co

urt.

The

Cour

t con

clud

ed

that

the

Crow

n pr

oved

bey

ond

a re

ason

able

do

ubt t

hat M

r. Fo

rres

ter w

as in

pos

sess

ion

of

the

med

ical

pre

scrip

tion.

It w

as g

iven

to h

im b

y M

r. Si

ncla

ir on

Aug

ust 3

0th,

201

3. It

was

giv

en

to M

r. Si

ncla

ir by

Ms.

Baks

, usi

ng a

fake

pat

ient

pr

ofile

cre

ated

whe

n sh

e w

as w

orki

ng a

t Dr.

Sack

sen’

s offi

ce. T

he m

edic

al p

resc

riptio

n w

as

forg

ed. M

r. Fo

rres

ter w

as n

ot a

legi

timat

e pa

tient

of

Dr.

Sack

sen.

The

forg

ery

by M

s. Ba

ks h

ad b

een

adm

itted

and

she

has

bee

n fo

und

guilt

y w

ith

resp

ect t

o th

is fo

rger

y. F

urth

er, M

r. Fo

rres

ter k

new

he

was

not

a p

atie

nt o

f Dr.

Sack

sen,

yet

he

took

th

e pr

escr

iptio

n in

to S

hopp

er’s

for fi

lling

kno

win

g th

at th

e pr

escr

iptio

n w

as fo

rged

.

The

Cour

t was

sat

isfie

d th

at M

r. Fo

rres

ter

know

ingl

y us

ed th

is fo

rged

doc

umen

t con

trar

y to

Sect

ion

368(

1)(a

) of t

he C

rimin

al C

ode

whi

ch

prov

ides

that

: “Ev

eryo

ne c

omm

its a

n off

ence

w

ho k

now

ingl

y or

bel

ievi

ng th

at a

doc

umen

t is

forg

ed...

uses

, dea

ls w

ith o

r act

s on

it a

s if

it w

ere

genu

ine.”

On

App

eal (

2019

) the

Cou

rt a

ccep

ted

the

subm

issi

on th

at th

ere

was

no

evid

ence

to

supp

ort t

he a

ppel

lant

’s co

nvic

tion

for t

raffi

ckin

g on

Oct

ober

30,

201

3 gi

ven

Mr.

Sinc

lair’

s ev

iden

ce

that

he

coul

d no

t rec

all h

avin

g re

ceiv

ed th

e th

ird

batc

h of

fent

anyl

pat

ches

from

the

appe

llant

. Th

e ap

peal

with

resp

ect t

o th

e co

nvic

tion

on

that

cou

nt o

nly

was

qua

shed

and

an

acqu

ittal

w

as e

nter

ed. T

he a

ppea

l was

dis

mis

sed

on th

e ot

her c

ount

s. Th

e ou

tcom

e of

this

app

eal d

id

not a

lter t

he a

ppel

lant

’s se

nten

ce -

thre

e ye

ars’

inca

rcer

atio

n, c

oncu

rren

t on

all c

ount

s.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

R. v.

Bak

s, 20

15 O

NCA

560

Ju

ly 2

8, 2

015

Amen

ded

- R. v

. Bak

s, 20

155 O

NCA

615

Sept

embe

r 16,

201

5

Base

d on

the

sam

e fa

cts

and

sche

me

as c

ited

abov

e (R

. v. F

orre

ster

);M

s. Ba

ks p

artic

ipat

ed in

a fe

ntan

yl tr

affick

ing

oper

atio

n, a

long

with

a M

r. G

odre

au

and

a M

r. Si

ncla

ir. T

he o

pera

tion

invo

lved

the

traffi

ckin

g of 9

90 fe

ntan

yl p

atch

es o

f th

e hi

ghes

t pot

ency

of 1

00 m

icro

gram

s.M

s. Ba

ks w

as e

mpl

oyed

in a

phy

sicia

n’s o

ffice

. She

cre

ated

false

pat

ient

pro

files

whi

ch

she

inpu

tted

into

her

em

ploy

er’s

com

pute

r sys

tem

with

out t

he p

hysic

ian’

s kno

wle

dge.

Sh

e th

en c

reat

ed fa

lse fe

ntan

yl p

resc

riptio

ns fo

r the

fict

itiou

s pat

ient

s. Sh

e ga

ve th

e pr

escr

iptio

ns to

Mr.

Sinc

lair.

The

y w

ere

pass

ed o

n by

Mr.

Sinc

lair,

or m

ore

ofte

n by

Mr.

God

reau

, to

the

fake

pat

ient

s, w

ho h

ad th

e pr

escr

iptio

ns fi

lled.

The

fent

anyl

pat

ches

wer

e gi

ven

to M

r. Si

ncla

ir or

Mr.

God

reau

, who

then

traffi

cked

them

for p

rofit

. [Ci

ted

in R

. v.

Imer

ovik

, 201

9 O

NSC

196

9]Ba

ks a

ppea

led

the

conv

ictio

ns e

nter

ed a

nd s

ente

nce

impo

sed

by th

e Ont

ario

Cou

rt

of Ju

stic

e M

ay 1

6, 2

014:

Conv

icti

on A

ppea

l:Ac

quitt

ed o

n 2

traffi

ckin

g co

unts

and

two

forg

ery

coun

ts w

ere

stay

ed.

Sent

ence

App

eal:

The

9 ye

ar s

ente

nce

was

bas

ed o

n a

join

t sub

mis

sion

. The

cou

rt n

otes

on

appe

al th

at

this

was

a s

erio

us o

ffenc

e in

volv

ing

a la

rge

amou

nt o

f a ve

ry d

ange

rous

dru

g. T

he

appe

llant

pla

yed

a ke

y ro

le in

the

som

ewha

t sop

hist

icat

ed s

chem

e th

at le

d to

the

acqu

isiti

on o

f the

dru

gs. I

n do

ing s

o, s

he b

etra

yed

the

trus

t of h

er e

mpl

oyer

, a d

octo

r in

who

se n

ame

the

frau

dule

nt p

resc

riptio

ns w

ere

writ

ten.

The

cou

rt n

oted

the

follo

win

g m

itiga

ting

fact

ors

that

wer

e co

nsid

ered

in a

llow

ing

the

appe

al a

nd v

aryi

ng

the

sent

ence

to s

ix y

ears

:(1

) The

app

ella

nt is

a y

oung

per

son

who

has

no

prio

r crim

inal

reco

rd an

d no

his

tory

of

crim

inal

invo

lvem

ent;

(2) T

he a

ppel

lant

’s re

habi

litat

ive

pros

pect

s ar

e, b

y an

y m

easu

re, e

xcel

lent

; (3)

She

act

ed at

the

inst

igat

ion

and

unde

r som

e pr

essu

re fr

om

one

of th

e “h

ighe

r ups

” in

the

sche

me

with

who

m sh

e ha

d a

rom

antic

rela

tions

hip;

an

d (4

) The

app

ella

nt p

rovi

ded

early

and

full

coop

erat

ion

to th

e po

lice.

She

gav

e a

stat

emen

t and

test

ified

aga

inst

the

two

“hig

her u

ps”.

One

of th

ose

two

has

sinc

e pl

ed

guilt

y. T

he ti

mel

y an

d va

luab

le a

ssis

tanc

e pro

vide

d by

the

appe

llant

had

to b

e gi

ven

sign

ifica

nt w

eigh

t on

sent

ence

.Th

e co

urt a

lso re

fere

nces

R. v

. Sin

clai

r and

not

es th

at th

e co

-acc

used

(Sin

clai

r) oc

cupi

ed a

hi

gher

rung

in th

e cr

imin

al e

nter

prise

than

did

the

appe

llant

. He

recr

uite

d he

r and

enl

isted

he

r inv

olve

men

t. It

was

reas

onab

le fo

r the

cour

t to

low

er th

is se

nten

ce th

an th

at im

pose

d on

the

co-a

ccus

ed.

It is

impo

rtan

t to

note

that

the

cour

t also

refe

renc

es th

e lim

ited

case

law

ava

ilabl

e in

resp

ect

of th

is dr

ug a

nd th

e ci

rcum

stan

ces p

rese

nt in

this

mat

ter.

The

cour

t allo

cate

d th

e to

tal s

ente

nce

of 6

yea

rs

amon

g th

e va

rious

con

vict

ions

:

On

the

one

coun

t of t

raffi

ckin

g in

Oxy

codo

ne:

3 yea

rs;

On

the

twen

ty c

ount

s of

traffi

ckin

g in

Fe

ntan

yl: 5

yea

rs c

oncu

rren

t to

each

oth

er a

nd

to th

e se

nten

ce o

n co

unt 1

;

On

the

rem

aini

ng fo

rger

y ch

arge

s, 1

yea

r on

each

coun

t con

curr

ent t

o ea

ch o

ther

, but

co

nsec

utiv

e to

the

sent

ence

s im

pose

d on

tr

affick

ing

char

ges

wit

h 4

½ m

onth

s’ cr

edit

for

pres

ente

nce

cust

ody,

leav

ing

a ne

t sen

tenc

e of

7 ½

mon

ths

on th

e fo

rger

y ch

arge

s.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

R. v.

Sin

clai

r, 20

16 O

NCA

68

3 Sep

tem

ber 1

3, 2

016

Base

d on

the

fact

s/sc

hem

e ci

ted

abov

e (R

. v. F

orre

ster

; R. v

. Bak

s), M

r. Si

ncla

ir ap

peal

ed

his s

ente

nce

of n

ine

year

s bas

ed o

n th

e co

urt’s

dec

isio

n in

R.v

. Bak

s, 20

15 O

NCA

560

, w

hich

redu

ced

the

sent

ence

of t

he a

ppel

lant

’s co

-acc

used

from

nin

e to

six

year

s. Th

e co

urt a

gree

d w

ith th

e co

re o

f the

app

ella

nt’s

subm

issi

on. “

The

parit

y be

twee

n M

s. Ba

ks

and

the

appe

llant

(Sin

clai

r) w

as a

t the

hea

rt o

f the

app

ella

nt’s

nine

-yea

r sen

tenc

e ba

sed

on a

join

t sub

mis

sion

.” Th

is co

urt r

educ

ed M

s. Ba

ks’ s

ente

nce

by th

ree

year

s bec

ause

of

a co

nste

llatio

n of

four

“pow

erfu

l miti

gatin

g fa

ctor

s”. T

he co

urt v

iew

ed th

at tw

o of

th

ose

fact

ors a

pplie

d to

the

appe

llant

. The

cour

t not

es th

at a

lthou

gh th

e ap

pella

nt

did

not c

o-op

erat

e w

ith th

e au

thor

ities

as e

arly

as M

s. Ba

ks, h

is co

-ope

ratio

n, n

otab

ly

by te

stify

ing

agai

nst t

he k

ingp

in o

f the

crim

inal

ent

erpr

ise,

was

ulti

mat

ely

full

and

impo

rtan

t.

9 Ye

ar S

ente

nce

redu

ced

to 8

yea

rs

R. v

. God

reau

, 201

6 O

NSC

6318

Oct

ober

12,

201

6

Base

d on

the

fact

s/sc

hem

e ci

ted

abov

e (R

. v. F

orre

ster

; R. v

. Bak

s; R.

v. Si

ncla

ir), M

r. G

odre

au w

as s

ente

nced

aft

er a

tria

l to

10 y

ears

in fe

dera

l pen

itent

iary

. The

tria

l ju

dge

relie

d on

the

sent

ence

s ar

rived

at b

y th

e Co

urt o

f App

eal f

or M

s. Ba

ks a

nd M

r. Si

ncla

ir. H

e no

ted

the

abse

nce

of m

itiga

ting

fact

ors

and

the

fact

that

Mr.

God

reau

ha

d a

prio

r crim

inal

reco

rd fo

r dru

g tr

affick

ing.

The

cou

rt a

lso

note

d th

at th

e ev

iden

ce

at tr

ial e

stab

lishe

d th

at th

e D

efen

dant

God

reau

, if n

ot th

e ki

ngpi

n of

the

sche

me,

was

ev

ery

bit a

n eq

ual p

artic

ipan

t in

ever

y as

pect

of t

he s

chem

e: th

e fr

audu

lent

sec

urin

g an

d co

nvey

ing

of h

ealth

car

d in

form

atio

n, th

e di

strib

utio

n of

fals

e pr

escr

iptio

ns a

nd

the

traffi

ckin

g in

Fen

tany

l for

pro

fit.

Sent

ence

d to

10

year

s

Conv

icte

d on

all

15 c

ount

s on

the

indi

ctm

ent

befo

re th

e co

urt:

f

five

coun

ts o

f tra

ffick

ing

in th

e co

ntro

lled s

ubst

ance

Fen

tany

l;

ffiv

e co

unts

of k

now

ingl

y m

akin

g a

fals

e doc

umen

t; an

d

ffiv

e co

unts

of k

now

ingl

y us

ing

or

utte

ring a

forg

ed d

ocum

ent.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

May

200

5

King

Wes

t Pha

rmac

y,

Aba

dir N

asr

Ham

ilton

, Ont

ario

Acco

rdin

g to

the

RCM

P, fo

r the

firs

t tim

e in

Can

ada,

a p

harm

acis

t was

char

ged

with

di

spen

sing

cou

nter

feit

med

ical

dru

gs to

pat

ient

s. Pfi

zer c

onta

cted

the

RCM

P ab

out

this

mat

ter i

n M

ay 2

005.

Ham

ilton

, Ont

ario

, pha

rmac

ist A

badi

r Nas

r, 28

, was

acc

used

of d

ispe

nsin

g fa

ke

Nor

vasc

-- a

med

icat

ion

used

to tr

eat h

igh

bloo

d pr

essu

re a

nd a

ngin

a –

follo

win

g a

com

plai

nt b

y a

Vict

im w

ho d

isco

vere

d he

r med

icat

ion

did

not l

ook

right

. Pfiz

er

confi

rmed

one

of t

he p

ills

sent

to th

em w

as c

ount

erfe

it an

d an

othe

r was

mea

nt fo

r di

strib

utio

n in

Tur

key.

Thi

s pr

ompt

ed a

n in

vest

igat

ion

by th

e re

gion

al co

rone

r of t

he

deat

hs o

f ind

ivid

uals

who

fille

d pr

escr

iptio

ns fo

r Nor

vasc

at t

his

phar

mac

y. N

asr w

as

char

ged

with

pos

sess

ion

of p

rope

rty

obta

ined

by

crim

e an

d fr

aud

unde

r $5,

000.

He

was

als

o ch

arge

d w

ith p

assi

ng o

ff w

ith re

spec

t to

the

supp

ly o

f Una

ppro

ved

Nor

vasc

an

d Co

unte

rfei

t Nor

vasc

.A

badi

r Nas

r ini

tially

sta

ted

that

he

boug

ht th

e pi

lls fr

om a

n “u

nkno

wn

sour

ce,

unkn

own

frie

nd” a

s te

stifi

ed b

y th

e Fo

rmer

Ow

ner o

f the

pha

rmac

y w

ho a

sked

Nas

r ab

out t

he m

edic

atio

n. N

asr s

ubm

itted

a s

wor

n st

atem

ent t

o w

hich

he

stat

ed th

at

he n

ever

kno

win

gly

sold

med

icat

ion

that

is n

ot li

cens

ed fo

r sal

e in

Can

ada

and/

or

that

was

Cou

nter

feit.

He

furt

her s

ubm

itted

that

he

boug

ht te

n bo

ttle

s fr

om a

Mr.

Ali

Hus

sein

who

iden

tified

him

self

as a

who

lesa

ler f

rom

Van

couv

er. H

usse

in a

dvis

ed N

asr

he w

as fr

om P

fizer

and

he

notic

ed ro

und

pills

in th

e fir

st b

atch

that

he

purc

hase

d,

how

ever

whe

n he

cal

led

Pfize

r (as

a p

atie

nt) h

e di

d no

t get

a c

all b

ack

and

disp

ense

d th

e ro

und

pills

. Nas

r sta

ted

that

whe

n he

not

iced

the

pills

in M

ay w

ere

a “li

ttle

dar

ker”

he

had

a fe

elin

g so

met

hing

was

wro

ng a

nd th

rew

the

pills

out

in a

dum

pste

r (to

w

hich

non

-legi

timat

e N

orva

sc w

as fo

und)

. Sev

eral

witn

esse

s (p

atie

nts

and

part

ners

of

pat

ient

s) te

stifi

ed to

the

num

erou

s in

stan

ces

of d

iscu

ssio

n w

ith N

asr r

egar

ding

th

e di

ffere

nces

in th

e co

lour

and

sha

pe o

f the

Nor

vasc

dis

pens

ed. T

he C

ourt

not

ed

the

“sig

nific

ant”

gap

in th

e re

gula

tory

pro

visi

ons

conc

erni

ng th

e sa

le a

nd p

urch

ase

of p

harm

aceu

tical

s in

its

deci

sion

. The

cou

rt a

lso

cons

ider

ed th

e cr

edib

le e

vide

nce

that

pha

rmac

eutic

al c

ompa

nies

occ

asio

nally

cha

nge

the

shap

e an

d/or

col

our o

f th

eir p

ills

– th

e co

urt c

ould

not

reas

onab

ly c

oncl

ude

that

the

chan

ges

in s

hape

and

co

lour

dem

ande

d fu

rthe

r inq

uiry

by

Nas

r. Th

e co

urt c

oncl

uded

that

ther

e as

at l

east

a

reas

onab

le d

oubt

that

Nas

r’s a

ctio

ns /

reac

tions

wer

e a

prod

uct o

f neg

ligen

ce a

nd/o

r la

ck o

f com

pete

nce

and

was

foun

d no

t gui

lty o

n al

l cou

nts.

Add

itio

nal D

rug/

Pati

ent D

etai

ls u

pon

furt

her I

nves

tiga

tion

:A

ppro

xim

atel

y 44

pat

ient

s ha

d co

unte

rfei

t Nor

vasc

on

hand

. The

dru

gs co

ntai

ned

talc

and

no

activ

e m

edic

inal

ingr

edie

nts.

Ano

ther

15

patie

nts

wer

e gi

ven

Nor

vasc

man

ufac

ture

d by

Pfiz

er, b

ut sp

ecifi

cally

for

Egyp

tian

and

Mex

ican

mar

kets

and

not

aut

horiz

ed fo

r sal

e in

Can

ada.

2 p

atie

nts

had

Nor

vasc

inte

nded

for t

he T

urki

sh m

arke

t.

In th

e cr

imin

al ca

se, A

badi

r Nas

r was

foun

d no

t gu

ilty

of se

lling

coun

terf

eit N

orva

sc. T

he ju

dge

rule

d th

at a

lthou

gh th

e dr

ug w

as co

unte

rfei

t and

co

ntai

ned

no m

edic

inal

ingr

edie

nts t

he C

row

n fa

iled

to p

rove

that

the

accu

sed

know

ingl

y so

ld

coun

terf

eit d

rugs

.

On

Sept

embe

r 6, 2

007,

the

Ont

ario

Col

lege

of

Phar

mac

ists

foun

d M

r. N

asr g

uilty

of p

rofe

ssio

nal

mis

cond

uct i

n hi

s cap

acity

as a

dis

pens

ing

phar

mac

ist a

nd a

s the

ow

ner a

nd d

esig

nate

d m

anag

er o

f the

pha

rmac

y. T

hey

rule

d th

at

Nas

r cou

ld g

et h

is li

cenc

e ba

ck a

fter a

one

-yea

r su

spen

sion

as l

ong

as h

e un

derw

ent a

pub

lic

repr

iman

d, p

aid

$12,

500

in co

sts t

o th

e co

llege

and

to

ok re

med

ial t

rain

ing.

His

dut

ies w

ere

rest

ricte

d fo

r an

addi

tiona

l five

yea

rs, i

nclu

ding

that

he

does

no

t ow

n a

phar

mac

y an

d no

t be

resp

onsi

ble

for

the

acqu

isiti

on o

f dru

gs a

t a p

harm

acy

or w

ork

in a

dr

ugst

ore

owne

d by

a fa

mily

mem

ber.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Sept

embe

r 200

5

Rich

mon

d H

ill

Phar

mac

ist,

Ont

ario

, A

ndre

w So

mm

erha

lder

The

RCM

P ex

ecut

ed s

earc

h w

arra

nts

on tw

o ph

arm

acie

s (o

ne o

nlin

e) a

fter

a 6

-mon

th

inve

stig

atio

n st

emm

ing

from

a d

isco

very

by

the

Cana

da B

orde

r Ser

vice

s Ag

ency

(C

usto

ms)

of t

wo

ship

men

ts o

f cou

nter

feit

Viag

ra ta

blet

s. Th

e ta

blet

s co

ntai

ned

sign

ifica

ntly

less

of t

he d

rug’

s ac

tive

ingr

edie

nt, w

hich

Pfiz

er c

onfir

med

thro

ugh

test

ing.

Andr

ew S

omm

erha

lder

was

cha

rged

with

11

offen

ces u

nder

the

Crim

inal

Cod

e, th

e Fo

od a

nd

Dru

gs A

ct, a

nd th

e Cu

stom

s Act

. for

alle

gedl

y se

lling

and

dist

ribut

ing

coun

terfe

it Vi

agra

at h

is tw

o ph

arm

acie

s (al

so d

istrib

uted

thro

ugh

the

inte

rnet

).Th

e O

ntar

io C

olle

ge o

f Pha

rmac

ists

shu

t dow

n D

irect

Com

poun

ding

, the

onl

ine

phar

mac

y w

hich

so

ld d

rugs

ove

r the

Inte

rnet

, and

ord

ered

Mr.

Som

mer

hald

er to

ste

p do

wn

as m

anag

er o

f O

ptim

um C

ompo

undi

ng, t

he s

tore

fron

t out

let.

CYPR

US

No

subm

issi

on h

as b

een

rece

ived

on

case

law

from

the

natio

nal c

onsu

ltant

CZEC

H R

EPU

BLIC

No

subm

issi

on h

as b

een

rece

ived

on

case

law

from

the

natio

nal c

onsu

ltant

DEN

MA

RK N

o su

bmis

sion

has

bee

n re

ceiv

ed o

n ca

se la

w fr

om th

e na

tiona

l con

sulta

nt


ECU

AD

OR

(pre

pare

d by

the

natio

nal c

onsu

ltant

Ms

Mar

ía F

erna

nda

ROM

ÁN

FER

RAN

D)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Dat

e: 0

2/12

/201

5,

Case

: “O

PERA

TIVO

FA

RMAC

O I”

, Co

untr

y: E

cuad

orPl

ace:

Citi

es Q

uito

, G

uaya

quil

and

Sant

o D

omin

go d

e lo

s Ts

hach

ilas

By m

eans

of a

n in

vest

igat

ion

carr

ied

out b

y th

e Ju

dici

al P

olic

e (U

DAT

), in

resp

onse

to a

n an

onym

ous

com

plai

nt, f

or m

ore

than

3

mon

ths,

Ope

ratio

n “F

arm

aco

I” w

as c

arrie

d ou

t in

thre

e ci

ties

in

Ecua

dor:

Qui

to, S

anto

Dom

ingo

de

los T

sach

ilas

and

Gua

yaqu

il,

in th

e Ci

ty o

f Qui

to, a

rudi

men

tary

labo

tariu

m is

raid

ed w

here

a

grea

t am

ount

of f

alsi

fied

med

icin

es is

foun

d, a

nd m

achi

nery

for

its e

labo

ratio

n, in

this

pla

ce tw

o pe

ople

are

det

aine

d, In

the

city

of

Sant

o D

omin

go d

e lo

s Tsa

chila

s, th

ere

is a

bui

ldin

g w

here

a la

rge

num

ber o

f cou

nter

feit

tabl

ets

wer

e dr

ied

to th

e en

viro

nmen

t with

th

e na

me

of L

ipito

r de

Pfyz

er a

nd A

rcox

ia o

f Mer

ck S

harp

and

Dom

e an

d in

the

city

of G

uaya

quil,

a b

uild

ing

with

a n

umbe

r of e

xpire

d m

edic

ines

.

In th

e fo

llow

ing

days

, an

inte

r-in

stitu

tiona

l mee

ting

was

con

vene

d,

in w

hich

the

Min

istr

y of

Pub

lic H

ealth

, the

Pub

lic P

rose

cuto

r’s

Offi

ce, t

he Ju

dici

al P

olic

e, th

e Cr

imin

al In

vest

igat

ion

Dep

artm

ent,

the

Hea

lth R

egul

atio

n Ag

ency

, Mar

ia F

erna

nda

Rom

an a

s an

exp

ert

and

repr

esen

tativ

es o

f the

affe

cted

pha

rmac

eutic

al c

ompa

nies

pa

rtic

ipat

ed, w

here

the

step

s to

be

take

n w

ere

deci

ded:

requ

est

of o

rigin

al p

rodu

cts

to th

e co

mpa

nies

Pfy

zer a

nd M

erck

Sha

rp

and

Dom

e, re

ques

ts o

f exp

ert r

epor

ts o

f rec

ogni

tion

of p

lace

and

do

cum

enta

ry to

crim

inal

istic

s, ch

emic

al a

naly

sis

of th

e ta

blet

to th

e la

bora

tory

of t

he C

entr

al U

nive

rsity

of E

cuad

or a

nd a

n an

alys

is o

f th

e m

achi

nery

foun

d to

an

expe

rt o

f the

Judi

ciar

y Co

unci

l, w

hich

m

arks

the

begi

nnin

g of

a c

rimin

al tr

ial f

or fa

lsifi

catio

n of

med

icin

es

with

the

artic

le 2

17 in

forc

e at

that

tim

e.

Succ

essf

ully

, the

dis

man

tling

of a

gan

g de

dica

ted

to th

e pr

oduc

tion

and

mar

ketin

g of

cou

nter

feit

med

icin

es in

the

city

of

Qui

to, w

here

abo

ut 3

mill

ion

dose

s w

ere

seiz

ed, a

mon

g th

em,

ARC

OXI

A, L

IPIT

OR

and

G00

, in

a cl

ande

stin

e la

bora

tory

in th

e ci

ty o

f Qui

to, 3

peo

ple

wer

e ar

rest

ed a

nd th

e Fi

scal

Inst

ruct

ion

was

initi

ated

, in

whi

ch th

e fo

llow

ing

advi

ce w

as g

iven

to th

e Pr

osec

utor

dur

ing

the

mon

ths

of th

e in

stru

ctio

n: A

rtic

ulat

ion

with

au

thor

ities

from

the

Min

istr

y of

Hea

lth, A

RCSA

, Nat

iona

l Pol

ice,

M

inis

try

of th

e In

terio

r, Ju

dici

al P

olic

e (U

DAT

), Cr

imin

alis

tics;

de

finiti

on o

f exp

erts

and

sur

veyo

rs, i

dent

ifica

tion

of la

bora

torie

s an

d st

udy

tech

niqu

es fo

r tes

ting,

am

ong

othe

rs.

With

the

supp

ort o

f ins

titut

ions

suc

h as

Crim

inal

istic

s, Ju

dici

al

Polic

e (U

DAT

), an

d th

e U

nive

rsid

ad C

entr

al d

el E

cuad

or, t

hey

allo

wed

the

first

sen

tenc

e in

Ecu

ador

to b

e is

sued

in M

ay 2

016

for c

ount

erfe

it m

edic

ines

to o

ne o

f the

det

aine

es, w

ho is

now

un

der t

he s

o-ca

lled

abbr

evia

ted

proc

edur

e of

the

Inte

gral

Crim

inal

O

rgan

ic C

ode,

gra

ntin

g hi

m a

12-

mon

th s

ente

nce.

In N

ovem

ber 2

016,

dur

ing

the

tria

l sta

ge, t

he s

econ

d de

tain

ee w

as

sent

ence

d to

6 y

ears

and

8 m

onth

s.Re

sult

s:3

deta

inee

s7

brea

k-in

s1

seiz

ed v

ehic

le3

mill

ion

coun

terf

eit m

edic

ines

sei

zed

2 se

nten

ced


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Dat

e: 0

5/04

/201

6

Case

: “O

PERA

TIVO

FA

RMAC

O II

”,

Coun

try:

Ecu

ador

Plac

e: C

uenc

a Ci

ty

The

Judi

cial

Pol

ice

(UD

AT),

Uni

t of t

ax a

nd c

usto

ms

crim

es o

f the

Ju

dici

al P

olic

e, th

roug

h an

inve

stig

atio

n of

mor

e th

an 6

mon

ths,

whi

ch b

egin

s w

ith th

e re

port

of t

he a

genc

y of

regu

latio

n an

d Sa

nita

ry C

ontr

ol th

at la

sts

appr

oxim

atel

y 6

mon

ths.

The

UD

AT

achi

eves

suc

cess

fully

, the

dis

man

tling

of a

gan

g de

dica

ted

to th

e pr

oduc

tion

and

com

mer

cial

izat

ion

of c

ount

erfe

it m

edic

ines

in th

e ci

ty o

f Cue

nca,

whe

re m

edic

ines

like

MA

BTH

ERA

and

AVA

STIN

of

ROCH

E an

d M

ERO

NEM

of A

STRA

ZEN

ECA

, am

ong

othe

rs, i

nsid

e a

labo

rato

ry a

nd in

a d

istr

ibut

or in

the

city

of C

uenc

a, 5

peo

ple

wer

e de

tain

ed a

nd th

e Fi

scal

Inst

ruct

ion

is in

itiat

ed, s

ampl

es o

f th

e m

edic

ines

sei

zed

in th

e ch

ain

of c

usto

dy a

re s

ent t

o th

e ci

ty

of Q

uito

, to

mak

e th

e do

cum

enta

l ana

lysi

s in

Crim

inal

istic

, who

pr

esen

t a re

port

whe

re it

is c

onfir

med

that

the

cont

aine

rs, l

abel

s an

d pa

ckag

es, a

re fa

lsifi

ed.

Des

pite

this

, a re

port

of t

he c

hem

ical

ana

lysi

s of

the

subs

tanc

e is

re

ques

ted,

sen

ding

the

sam

ple

to th

e he

adqu

arte

rs o

f the

RO

CHE

Phar

mac

eutic

al L

abor

ator

y, w

ho c

onfir

m th

e pr

esen

ce o

f the

act

ive

ingr

edie

nt, w

hich

mak

es it

diffi

cult

to p

roce

ss th

e ca

se.

Acco

rdin

g to

the

inve

stig

atio

ns, t

he d

rug

was

dilu

ted

to o

btai

n m

ore

prod

uct,

that

is

to s

ay fr

om a

n or

igin

al b

ottle

, the

y m

ade

3 co

unte

rfei

t pro

duct

s.

The

case

is c

lose

d an

d th

ere

is n

o se

nten

ce fo

r tho

se in

volv

ed,

it sh

ould

be

note

d th

at in

this

cas

e th

ere

was

no

part

icip

atio

n of

th

e ph

arm

aceu

tical

com

pani

es c

once

rned

.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Dat

e: 2

5/06

/201

7

Case

: «O

PERA

TIVO

FA

RMAC

O IV

- FO

RTA

LEZA

23»

,

Coun

try:

Ecu

ador

Plac

e: C

ities

Cue

nca,

Loj

a,

Mac

hala

As a

resu

lt of

a c

ompl

aint

by

the

Hea

lth R

egul

atio

n an

d Co

ntro

l Ag

ency

, whi

ch in

dica

tes t

hat i

n su

bseq

uent

con

trol

s car

ried

out

in p

harm

acie

s in

the

prov

ince

s of A

zuay

, Loj

a, E

l Oro

, Mor

ona

Sant

iago

and

Cañ

ar, m

edic

ines

of d

ubio

us o

rigin

wer

e fo

und,

w

hich

did

not

com

ply

with

the

char

acte

ristic

s of a

dul

y re

gist

ered

m

edic

ine,

whi

ch c

ause

s the

con

trol

age

ncy

to ta

ke a

long

tim

e, a

nd

an in

vest

igat

ion

last

ing

appr

oxim

atel

y 4

mon

ths i

s ini

tiate

d. O

n Ju

ly 2

5, 2

017,

in th

e op

erat

ion

“Dru

g IV

”, in

whi

ch th

e In

terv

entio

n an

d Re

scue

Gro

up (G

IR) o

f the

Nat

iona

l Pol

ice,

the

Judi

cial

Pol

ice,

th

e Pr

osec

utor

’s O

ffice

and

the

Cust

oms a

nd T

ax C

rimes

Uni

t pa

rtic

ipat

ed, n

early

18

tons

of a

llege

dly

coun

terf

eit m

edic

ines

w

ere

seiz

ed, w

hich

wer

e di

strib

uted

and

sold

thro

ugh

phar

mac

ies

and

othe

r poi

nts o

f sal

e in

the

prov

ince

s of t

he E

cuad

oria

n so

uth

terr

itory

(Azu

ay, E

l Oro

, Mor

ona

Sant

iago

, Loj

a an

d Ca

ñar).

The

Med

ivez

a ca

se is

the

mos

t im

port

ant c

ase

in E

cuad

or’s

hist

ory

rela

ted

to a

llege

d co

unte

rfei

t med

icin

es a

nd o

ne o

f the

mos

t re

leva

nt in

Lat

in A

mer

ica.

The

acc

usat

ion

is b

ased

on

Art

icle

217

of

the

Crim

inal

Cod

e in

forc

e at

the

time,

whi

ch c

rimin

aliz

es fo

r the

fir

st ti

me

the

coun

terf

eitin

g of

med

icin

es in

Ecu

ador

ian

terr

itory

. Th

e ju

dges

of t

he C

ourt

of C

rimin

al G

uara

ntee

s of C

uenc

a w

ill is

sue

a se

nten

ce o

n Tu

esda

y, Ja

nuar

y 8,

201

9, st

artin

g at

4:0

0 p.

m.

The

Min

istr

y of

Pub

lic H

ealth

and

the

Agen

cy fo

r Reg

ulat

ion,

Co

ntro

l and

San

itary

- A

RCSA

, con

tinue

to b

e vi

gila

nt in

th

e pr

oces

ses o

f im

port

ing,

man

ufac

turin

g, st

orin

g an

d co

mm

erci

aliz

ing

prod

ucts

for h

uman

use

and

con

sum

ptio

n. In

th

is w

ay, w

e gu

aran

tee

acce

ss to

safe

med

icin

es fo

r the

ent

ire

popu

latio

n.

Acco

rdin

g to

the

Pros

ecut

or’s

Offi

ce, t

his

is th

e la

rges

t cas

e of

co

unte

rfei

t med

icin

es in

Sou

th A

mer

ica.

The

Cour

t of P

enal

Gua

rant

ees

of C

uenc

a di

ctat

es in

firs

t ins

tanc

e fiv

e ye

ars

of p

rison

aga

inst

And

rés V

., m

anag

er o

f the

com

pany

, for

an

alle

ged

case

of f

alsi

ficat

ion

and

com

mer

cial

izat

ion

of m

edic

ines

w

ithou

t san

itary

regi

stra

tion

for h

uman

use

and

con

sum

ptio

n.

In th

e fir

st in

stan

ce, t

he C

ourt

of C

rimin

al G

uara

ntee

s of

Azu

ay

only

foun

d M

arce

lo V

. gui

lty a

nd a

cqui

tted

Mar

ía T

., co

nsid

erin

g th

at s

he w

as n

ot a

war

e of

the

activ

ities

, a d

ecis

ion

that

was

ap

peal

ed b

y th

e Pu

blic

Pro

secu

tor’s

Offi

ce a

nd th

e la

wye

rs o

f the

M

inis

try

of P

ublic

Hea

lth (M

SP) w

ho a

cted

as

priv

ate

pros

ecut

ors.

Thos

e in

volv

ed in

the

larg

est c

ase

of c

ount

erfe

iting

and

di

strib

utio

n of

med

icin

es in

the

hist

ory

of E

cuad

or w

ere

foun

d gu

ilty

in th

e se

cond

inst

ance

.

Mar

celo

V. a

nd M

aria

T.,

man

ager

and

pre

side

nt o

f MED

IVES

A,

wer

e ra

tified

with

a fi

ve-y

ear p

rison

sen

tenc

e fo

r bei

ng th

e al

lege

d pe

rpet

rato

rs o

f thi

s cr

ime.

The

rein

stat

emen

t of t

he a

ppea

l hea

ring

took

pla

ce in

the

Cour

t of

Just

ice

of A

zuay

and

was

con

duct

ed b

y th

e co

urt c

ompo

sed

of ju

dges

Julio

Inga

(spe

aker

), N

arci

sa R

amos

and

Jenn

y O

choa

. Bef

ore

givi

ng th

eir v

erdi

ct, t

he ju

dges

pre

sent

ed th

eir

cons

ider

atio

ns to

det

erm

ine

that

the

mat

eria

lity

of th

e cr

ime

and

the

part

icip

atio

n of

the

defe

ndan

ts d

id e

xist

.

Aft

er a

n an

alys

is, t

he ju

dges

una

nim

ousl

y co

nsid

ered

that

Mar

celo

V.

and

Mar

ía T

. did

inde

ed c

ompl

y w

ith th

e ve

rbs

incl

uded

in c

rime

insi

de th

e A

rtic

le 2

17 o

f the

Inte

gral

Crim

inal

Org

anic

Cod

e ,

whi

ch c

onde

mns

any

one

who

“im

port

s, pr

oduc

es, m

anuf

actu

res,

mar

kets

, dis

trib

utes

, or e

xpan

ds c

ount

erfe

it m

edic

ines

or m

edic

al

devi

ces.

The

judg

es a

lso

dete

rmin

ed th

at th

e dr

ugs

mus

t be

dest

roye

d.

Resu

lts:

9 de

tain

ees

17 b

reak

-ins

6 ve

hicl

es s

eize

d18

tons

of s

eize

d ill

egal

med

icin

es2

sent

ence

d w

ith th

e m

axim

um p

enal

ty


ESTO

NIA

(pre

pare

d by

the

natio

nal c

onsu

ltant

Dr K

ärt P

ORM

EIST

ER)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

09.0

9.20

11 H

arju

Cou

nty

Cour

t cas

e nr

1-1

1-95

23E.

N. w

as a

ccus

ed o

f ord

erin

g m

edic

inal

pro

duct

s fr

om T

aiw

an a

nd

Indi

a th

at in

frin

ged

upon

IP ri

ghts

of P

fizer

inc,

and

by

doin

g so

E.N

. w

as a

ccus

ed o

f im

port

ing

and

dist

ribut

ing

coun

terf

eit m

edic

inal

pr

oduc

ts w

ithou

t pro

per d

ocum

enta

tion

(or b

y us

ing

coun

terf

eit

docu

men

tatio

n).

E.N

. was

sen

tenc

ed to

3 y

ears

of i

mpr

ison

men

t with

a

prob

atio

nary

per

iod

of 3

yea

rs s

o in

cas

e th

ere

was

no

viol

atio

n of

the

prob

atio

n, E

.N. w

ould

not

hav

e to

ser

ve a

ny

pris

on ti

me.

05.0

9.20

13 P

ärnu

Cou

nty

Cour

t cas

e nr

1-1

3-61

40R.

V. w

as a

ccus

ed o

f ille

gally

pro

duci

ng c

ount

erfe

it m

edic

inal

pro

duct

s an

d se

lling

them

.

J.K. w

as a

ccus

ed o

f buy

ing

and

brok

erin

g th

ese

coun

terf

eit m

edic

inal

pr

oduc

ts

Both

R.V

. and

J.K.

wer

e se

nten

ced

to 1

yea

r of i

mpr

ison

men

t.

R.V.

was

giv

en a

pro

batio

nary

per

iod

of 3

yea

rs s

o in

cas

e th

ere

was

no

viol

atio

n of

the

prob

atio

n, R

.V. w

ould

not

hav

e to

ser

ve

any

pris

on ti

me.

For J

.K.,

the

pris

on s

ente

nce

was

sub

stitu

ted

with

730

hou

rs o

f co

mm

unity

ser

vice

.

05.0

1.20

15 P

ärnu

Cou

nty

Cour

t cas

e nr

1-1

4-10

149

E.L.

was

acc

used

of i

llega

lly o

btai

ning

from

an

unid

entifi

ed p

erso

n at

leas

t 162

,1 g

ram

s of

her

bal c

rum

bles

that

con

tain

ed s

ynth

etic

ca

nnab

inoi

ds. E

.L. m

ixed

this

with

pep

perm

int t

ea a

t hom

e an

d pa

ckag

ed it

for p

urpo

ses

of s

ellin

g it.

E.L

. was

acc

used

of i

llega

lly

man

ufac

turin

g, d

istr

ibut

ing

and

poss

essi

on w

ith in

tent

to d

istr

ibut

e co

unte

rfei

t med

icin

al p

rodu

cts.

E.L.

ent

ered

a p

lea

deal

and

was

sen

tenc

ed w

ith a

fine

of 8

00

euro

s.

22.0

4.20

15 H

arju

Cou

nty

Cour

t cas

e nr

1-1

5-24

75R.

D. w

as a

ccus

ed o

f ord

erin

g fr

om re

side

nts

of H

unga

ry (b

ut a

lso

from

un

iden

tified

indi

vidu

als

else

whe

re) c

ount

erfe

it po

tenc

y dr

ugs

(ille

gally

m

anuf

actu

red)

, whi

ch h

e im

port

ed to

Est

onia

with

out a

utho

risat

ion.

R.D

. was

sen

tenc

ed w

ith a

fine

of 6

277,

85 e

uros

, but

with

a

prob

atio

nary

per

iod

of 2

yea

rs 6

mon

ths

so th

at in

cas

e th

ere

wou

ld b

e no

vio

latio

n du

ring

the

prob

atio

n pe

riod,

R.D

. wou

ld

not h

ave

to p

ay th

is fi

ne.

08.0

9.20

15 T

artu

Cou

nty

Cour

t cas

e nr

1-1

5-18

56P.N

. was

acc

used

of i

mpo

rtin

g co

unte

rfei

t med

icin

al p

rodu

cts

whi

ch h

e ha

d or

dere

d vi

a m

ail f

rom

Hon

gkon

g.P.N

. was

sen

tenc

ed to

1 y

ear o

f im

pris

onm

ent w

ith a

pr

obat

iona

ry p

erio

d of

1 y

ear 6

mon

ths

so th

at in

cas

e of

no

viol

atio

ns o

f the

pro

batio

n P.N

. wou

ld n

ot h

ave

to s

erve

this

se

nten

ce.

P.N. w

as a

lso

orde

red

to p

ay 1

5,00

0 eu

ros

to th

e go

vern

men

t on

acc

ount

of e

arni

ngs

mad

e vi

a th

e cr

ime

com

mitt

ed.


06.0

7.20

16 H

arju

Cou

nty

Cour

t cas

e nr

1-1

6-55

43Am

ongs

t oth

er o

ffens

es, Y

.S. w

as a

ccus

ed o

f obt

aini

ng a

nd p

osse

ssio

n w

ith

the

inte

nt t

o di

strib

ute

of c

ount

erfe

it m

edic

inal

pro

duct

s (C

ialis

, Via

gra,

Ze

negr

a, K

amag

ra, K

amag

ra O

ral J

elly

).

Y.S.

ent

ered

a p

lea

deal

for a

2-y

ear s

ente

nce,

with

a p

roba

tiona

ry

perio

d of

3 y

ears

so

in c

ase

of n

o vi

olat

ion,

Y.S

. wou

ld n

ot h

ave

to s

erve

any

tim

e.

22.0

1.20

14 T

artu

Cou

nty

Cour

t cas

e nr

3-1

2-97

5Th

is c

ase

conc

erne

d a

disp

ute

over

Dol

o-A

ngin

tabl

ets

and

the

deci

sion

of

the

Stat

e Ag

ency

of M

edic

ines

to c

lass

ify th

em a

s a m

edic

inal

pro

duct

. Th

e pr

oduc

t had

bee

n re

gist

ered

in E

ston

ia a

s a

med

ical

dev

ice

and

had

unde

rgon

e co

nfor

mity

ass

essm

ent i

n Lu

xem

bour

g an

d ha

d re

ceiv

ed a

CE

mar

k. R

egar

dles

s of t

his,

the

Stat

e Ag

ency

of M

edic

ines

dec

ided

to c

lass

ify

the

prod

uct a

s a

med

icin

al p

rodu

ct (w

hich

trig

gere

d va

rious

obl

igat

ions

, lim

itatio

ns a

nd r

equi

rem

ents

tha

t ap

ply

to m

edic

inal

pro

duct

s, bu

t no

t m

edic

al d

evic

es).

The

Euro

pean

Cou

rt o

f Jus

tice

foun

d in

cas

e C-

109/

12

that

in o

rder

to c

lass

ify a

s a m

edic

inal

pro

duct

in a

ccor

danc

e w

ith D

irect

ive

2001

/83

a pr

oduc

t alre

ady

clas

sifie

d in

ano

ther

Mem

ber S

tate

as a

med

ical

de

vice

bea

ring

a C

E m

arki

ng in

acc

orda

nce

with

Dire

ctiv

e 93

/42,

the

co

mpe

tent

aut

horit

ies

of a

Mem

ber

Stat

e m

ust,

befo

re a

pply

ing

the

clas

sific

atio

n pr

oced

ure

unde

r D

irect

ive

2001

/83,

app

ly t

he p

roce

dure

un

der A

rtic

le 1

8 of

Dire

ctiv

e 93

/42

and,

whe

re a

ppro

pria

te, t

he p

roce

dure

un

der A

rtic

le 8

of D

irect

ive

93/4

2.

The

Tart

u Co

unty

Cou

rt re

peal

ed th

e de

cisi

on o

f the

Sta

te A

genc

y of

Med

icin

es r

egar

ding

the

cla

ssifi

catio

n of

the

pro

duct

as

a m

edic

inal

pro

duct

.

Alth

ough

this

case

doe

s not

conc

ern

coun

terf

eit m

edic

al p

rodu

cts

per s

e, m

arke

ting

a m

edic

inal

pro

duct

as a

med

ical

dev

ice

mig

ht

be d

eem

ed t

o fa

ll un

der

the

defin

ition

of c

ount

erfe

it m

edic

al

prod

ucts

with

in th

e m

eani

ng o

f the

Med

icrim

e co

nven

tion

(fals

e re

pres

enta

tion

as re

gard

s id

entit

y).


FIN

LAN

D (p

repa

red

by th

e na

tiona

l con

sulta

nt M

s A

nna-

Riik

ka R

UU

TH)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

YEA

R 20

19, “

CASE

H

ERTT

A”Ye

ar 2

019

the

Nar

cotic

s U

nit o

f the

Pol

ice

Dep

artm

ent o

f Hel

sink

i inv

estig

ated

an

aggr

avat

ed

narc

otic

s off

ence

. A g

roup

of R

oman

ians

impo

rted

sev

eral

tim

es R

ivot

ril-t

able

ts to

Fin

land

and

di

strib

uted

them

in H

elsi

nki a

rea.

Riv

otril

-tab

lets

con

tain

ed c

lona

tzep

am w

hich

is c

lass

ified

as

narc

otic

s in

Fin

land

. In

med

ical

use

the

com

mon

and

sim

ilar t

able

t in

Finl

and

is R

ivat

ril 2

mg.

Aft

er th

e la

st im

port

in M

ay 2

019

the

polic

e se

ized

307

.600

Riv

otril

-tab

lets

. A la

rge

num

ber

of ta

blet

s w

ere

sold

in s

tree

t mar

kets

in H

elsi

nki a

fter

the

prev

ious

impo

rts.

The

accu

sed

had

star

ted

thei

r jou

rney

from

Rom

ania

, and

driv

en to

Bud

apes

t, H

unga

ry to

get

the

tabl

ets.

The

impo

rt to

ok p

lace

in To

rnio

, Fin

land

whe

re th

e ac

cuse

d ha

d cr

osse

d th

e bo

arde

r of S

wed

en a

nd

Finl

and.

The

acc

used

had

two

cars

, one

in F

inni

sh li

cens

e pl

ates

and

ano

ther

in R

oman

ian

plat

es.

The

tabl

ets

wer

e hi

dden

in th

e ca

r with

Fin

nish

lice

nse

plat

es b

ecau

se m

ost l

ikel

y th

e ca

r with

Ro

man

ian

licen

se p

late

s w

ould

cat

ch th

e at

tent

ion

of th

e bo

arde

r gua

rds.

Thes

e ta

blet

s ha

ve n

ot b

een

lega

lly m

anuf

actu

red

by a

lega

l pha

rmac

eutic

al e

nter

pris

e bu

t the

co

nten

t is

equa

l to

the

real

clo

natz

epam

tabl

ets.

Smug

glin

g of

Riv

otril

-tab

lets

to F

inla

nd is

ong

oing

inte

rnat

iona

l org

aniz

ed c

rime

that

is d

eriv

ed

from

Rom

ania

. Sm

uggl

ing

of th

ese

tabl

ets

is a

ver

y go

od b

usin

ess

beca

use

the

smug

gler

s pa

y 3-

4 eu

ros

per 1

00 ta

blet

s an

d th

e pr

ice

for 1

00 ta

blet

s in

Fin

land

is 7

0-10

0 eu

ros.

Four

peo

ple

wer

e co

nvic

ted

for f

our

aggr

avat

ed n

arco

tics

offen

se fo

r im

pris

onm

ent,

thre

e of

them

for s

ix

year

s si

x m

onth

s an

d on

e fo

r five

ye

ars.

The

polic

e ha

ve a

lso

foun

d ou

t whe

re

the

illeg

al m

anuf

actu

rer o

f the

tabl

ets

is in

Hun

gary

.

YEA

R 20

18-2

020

“OP

HU

NA

JA” (

ongo

ing

inve

stig

atio

n)

Finn

ish

Cust

oms

is in

vest

igat

ing

a ca

se w

here

larg

e am

ount

s of

fals

ified

pot

ency

tabl

ets

wer

e im

port

ed fr

om th

ird c

ount

ry to

Eur

opea

n U

nion

alth

ough

acc

ordi

ng to

the

docu

men

ts, t

hey

shou

ld h

ave

been

goo

ds in

tran

sit o

n th

eir w

ay to

Fed

erat

ion

of R

ussi

a. In

all

the

indi

vidu

al

case

s th

e tr

ansi

t is

susp

ecte

d of

bei

ng u

sed

in c

rimin

al a

ctiv

ities

aim

ing

to g

et th

e ta

blet

s ou

t of

cus

tom

s co

ntro

l and

pla

cing

them

on

the

illeg

al m

arke

t in

Cent

ral E

urop

e. T

he ta

blet

s w

ere

ship

ped

to F

inla

nd fr

om a

third

cou

ntry

, pla

ced

to a

war

ehou

se in

Fin

land

for i

ndefi

nite

per

iod

of ti

me,

then

pos

sibl

y tr

ansf

erre

d to

ano

ther

EU

cou

ntry

and

then

bac

k to

Fin

land

bef

ore

they

w

ere

ship

ped

to s

ome

Cent

ral E

urop

ean

coun

try.

Usi

ng s

ever

al w

areh

ouse

s an

d se

ndin

g th

e go

ods

betw

een

the

EU c

ount

ries

the

susp

ects

wer

e tr

ying

to fa

de th

e or

igin

of t

he ta

blet

s (t

hird

co

untr

y) a

nd to

mak

e it

look

like

the

tabl

ets

wer

e or

igin

ally

from

an

EU c

ount

ry. A

t the

end

no

tabl

ets

have

bee

n de

clar

ed in

Rus

sia

and

the

tabl

ets

have

end

ed to

oth

er E

urop

ean

Uni

on

coun

trie

s or

sei

zed

in F

inla

nd.

Cust

oms

has

seve

ral s

uspe

cts

in F

inla

nd a

nd th

e Fi

nnis

h au

thor

ities

hav

e co

oper

ated

with

oth

er

EU c

ount

ries

in th

is m

atte

r. Th

e am

ount

of i

llega

l pot

ency

tabl

ets

is h

undr

eds

of k

ilos

/ hun

dred

s of

thou

sand

s of

tabl

ets.

The

inve

stig

atio

n is

stil

l ong

oing

. Fi

nnis

h Cu

stom

s ha

s se

ized

two

batc

hes

of ta

blet

s an

d th

e Be

lgiu

m

Cust

oms

one

base

d on

info

rmat

ion

exch

ange

and

one

for t

heir

own

obse

rvat

ion.


GER

MA

NY

(pre

pare

d by

the

natio

nal c

onsu

ltant

Mr A

lexa

nder

RO

TH)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

“Pill

endi

enst

Cas

e” (a

.k.a

“M

änne

rapo

thek

e” o

r “P

otsd

am C

ase”

), 20

11

Inve

stig

atio

n an

d pr

osec

utio

n ag

ains

t a la

rge-

scal

e ne

twor

k of

an

inte

rnat

iona

l crim

inal

org

anis

atio

n th

at d

istr

ibut

ed c

ount

erfe

it Vi

agra

an

d ot

her l

ifest

yle

med

icin

es, m

ainl

y in

Ger

man

y an

d Au

stria

. The

ac

tivity

of t

he o

rgan

isat

ion

was

200

8 to

201

1, w

hen

it w

as s

mas

hed

by a

law

enf

orce

men

t ope

ratio

n in

sev

eral

cou

ntrie

s. Le

adin

g la

w

enfo

rcem

ent a

genc

ies

was

the

Pots

dam

Pro

secu

tor’s

Offi

ce a

nd

Zollf

ahnd

ungs

amt B

erlin

-Bra

nden

burg

(reg

iona

l uni

t of Z

KA, i

.e. t

he

Ger

man

Cus

tom

’s Po

lice)

. N

o JI

T, b

ut in

tern

atio

nal j

udic

ial a

nd p

olic

e co

oper

atio

n w

ith a

roun

d 20

oth

er c

ount

ries.

Aro

und

12 s

uspe

cts

arre

sted

. Aro

und

2 m

illio

n eu

ro

confi

scat

ed. A

roun

d 10

0 m

embe

rs o

f the

crim

inal

org

anis

atio

n (in

clud

ing

all m

ajor

mem

bers

) pro

secu

ted,

tria

lled

and

sent

ence

d; p

rimar

ily fo

r com

mer

cial

-sty

le a

nd o

rgan

ized

tr

ade

in c

ount

erfe

it m

edic

ines

. Of t

he 4

lead

ers

of th

e cr

imin

al

orga

nisa

tion,

1 w

as s

ente

nced

to 6

yea

rs a

nd 3

mon

ths

and

anot

her o

ne to

5 y

ears

and

4 m

onth

s im

pris

onm

ent.

The

third

one

was

sen

tenc

ed s

imila

rly in

Aus

tria

. The

four

th o

ne

com

mitt

ed s

uici

de in

pris

on b

efor

e be

ing

brou

ght t

o tr

ial,

afte

r try

ing

to e

scap

e fr

om R

oman

ia to

Mol

dova

and

bei

ng

arre

sted

by

Rom

ania

n po

lice

and

tran

sfer

red

to G

erm

any

on

the

basi

s of

an

EAW

. Mos

t oth

er m

embe

rs w

ere

sent

ence

d to

pr

ison

term

s on

pro

batio

n an

d/or

a fi

ne a

nd/o

r con

fisca

tion

of g

oods

. The

mem

bers

with

a m

inor

sig

nific

ance

with

in th

e cr

imin

al o

rgan

istio

n us

ually

pai

d (in

stea

d of

bei

ng fo

rmal

ly

sent

ence

d) a

n am

ount

of m

oney

in fa

vour

of t

he s

tate

and

/or

non

-pro

fit o

rgan

isat

ions

, and

in re

turn

the

crim

inal

pr

ocee

ding

s w

ere

disc

ontin

ued.

Las

t tria

ls a

nd c

onvi

ctio

ns

wer

e as

late

as

2016

/201

7.

Luna

phar

m C

ase,

20

17/2

018

Inve

stig

atio

n an

d pr

osec

utio

n ag

ains

t, ba

sica

lly, a

Ger

man

com

pany

di

strib

utin

g a

high

-pric

e m

edic

ine

agai

nst c

ance

r. Th

ere

was

evi

denc

e fo

r man

ipul

atin

g th

e le

gal s

uppl

y ch

ain;

pro

babl

y th

e m

edic

ine

was

st

olen

in G

reec

e an

d la

ter r

e-in

trod

uced

into

the

lega

l sup

ply

chai

n in

G

erm

any.

Pos

sibl

y, th

e m

edic

ine

lost

its

effec

ts d

ue to

an

inte

rrup

tion

of

the

cold

cha

in. T

he h

uge

affai

r cau

sed

maj

or m

edia

inte

rest

and

pol

itica

l sc

anda

l, si

nce

it co

uld

not b

e ex

clud

ed (b

ut a

lso

not p

rove

d) th

at a

larg

e nu

mbe

r of c

ance

r pat

ient

s w

as tr

eate

d in

Ger

man

y w

ith a

n in

effec

tive

(spo

iled)

med

icin

e.

Aro

und

1 m

illio

n eu

ro c

rimin

al p

rofit

s fr

eeze

d, 3

mai

n su

pect

s br

ough

t to

tria

l in

2019

for “

orga

nize

d an

d co

mm

erci

al-s

tyle

tr

ade

in c

ount

erfe

it m

edic

ines

”. The

tria

l has

not

yet

sta

rted

du

e to

cap

acity

ove

rload

of t

he c

ompe

tent

cou

rt.

Land

geric

ht (R

egio

nal

Cour

t) E

ssen

, ver

dict

of

6th

July

201

8 (c

ited

in th

e La

w jo

urna

l: “N

JW”,

2020

, pa

ge 3

123)

A p

harm

acis

t was

pro

duci

ng m

edic

ines

aga

inst

can

cer o

n an

indi

vidu

al

basi

s. In

aro

und

15.0

00 c

ases

, he

used

eith

er n

o ac

tive

com

pone

nt, o

r a

too

smal

l dos

e of

the

activ

e co

mpo

nent

(in

orde

r to

mak

e m

ore

profi

t)

12 y

ears

impr

ison

men

t (fo

r fra

ud a

nd b

reac

h of

the

AM

G) a

nd

17 m

illio

n eu

ro c

onfis

catio

n.

Not

e: it

is n

ot m

entio

ned

in th

e jo

urna

l for

whi

ch e

xact

crim

e th

e ph

arm

acis

t was

con

vict

ed, b

ut I

gues

s fo

r “co

mm

erci

al-

styl

e tr

ade

with

cou

nter

feit

med

icin

es” (

and

frau

d)


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Land

geric

ht (R

egio

nal

Cour

t) K

refe

ld, v

erdi

ct

of 2

7th

Oct

ober

201

7 (c

ited

in th

e La

w Jo

urna

l Ph

arm

R 20

19, p

. 654

)

A m

an w

as s

ellin

g, v

ia th

e in

tern

et, d

isin

fect

ants

(con

tain

ing/

prod

ucin

g hy

droc

hlor

ic a

cid)

as “

Med

icin

e” (f

or o

ral a

pplic

atio

n).

Thre

e ye

ars

and

two

mon

ths

impr

ison

men

t for

“neg

ligen

t tr

ade

in q

uest

iona

ble

med

icin

es” a

nd ta

x ev

asio

n an

d ot

her

crim

es.

The

pros

ecut

or’s

office

file

d an

app

eal t

o th

e Fe

dera

l Cou

rt

of Ju

stic

e be

caus

e th

e de

fend

ant w

as n

ot c

onvi

cted

for

inte

ntio

nal t

rade

in q

uest

iona

ble

med

icin

es. T

he a

ppea

l was

re

ject

ed, b

ecau

se a

ccor

ding

to th

e Fe

dera

l Cou

rt, t

he re

gion

al

cour

t bel

ieve

d rig

htly

that

the

defe

ndan

t was

con

vinc

ed

(wro

ngly

, but

he

was

con

vinc

ed) t

hat,

even

if th

e us

e of

a

disi

nfec

tant

as

a m

edic

ine

is a

gain

st a

ll st

anda

rds

of m

edic

ine

“the

pos

itive

effe

cts

outw

eigh

ed th

e ne

gativ

e eff

ects

”. N

ote

1: T

he d

ecis

ion

of th

e Fe

dera

l Cou

rt o

f Jus

tice

is

obvi

ousl

y w

rong

and

was

crit

iciz

ed.

Not

e 2:

Com

mer

cial

izin

g “q

uest

iona

ble”

med

icin

es (a

nd

med

ical

dev

ices

) is

anot

her c

rime

(bes

ides

cou

nter

feit-

rela

ted

crim

es) i

n A

MG

and

MPG

. Que

stio

nabl

e m

eans

that

the

nega

tive

side

effe

cts

outw

eigh

the

posi

tive

effec

ts o

f the

m

edic

ine/

devi

ce.

Doc

umen

t B A

ppen

dix

Ger

man

y –

Case

Law

– M

edic

al D

evic

es

I. In

trod

ucti

on

From

my

own

prof

essi

onal

pra

ctic

e, I k

now

that

in q

uite

som

e ca

ses,

inve

stig

atio

ns a

re c

ondu

cted

in G

erm

any

for o

ffenc

es u

nder

the

Med

icin

al P

rodu

cts A

ct (A

MG

). Th

ere

are

also

not

man

y, b

ut a

few

pro

min

ent c

ases

in w

hich

offe

nces

und

er th

e M

edic

inal

Pro

duct

s Act

bec

ome

know

n ei

ther

thro

ugh

the

gene

ral m

edia

or t

hrou

gh th

e sp

ecia

lised

le

gal p

ress

or v

erdi

ct d

atab

ases

.

In c

ontr

ast,

I was

not

aw

are

of a

sin

gle

inve

stig

atio

n in

the

area

of o

ffenc

es u

nder

the

Med

ical

Dev

ices

Act

(MPG

). I w

as a

lso

unab

le to

find

a ju

dgem

ent i

n th

is a

rea

via

the

spec

ialis

ed p

ress

and

the

rele

vant

dat

abas

es.

I the

refo

re a

sked

all

Ger

man

Gen

eral

pub

lic p

rose

cuto

rs’ o

ffice

s how

man

y an

d w

hich

pre

limin

ary

proc

eedi

ngs f

or o

ffenc

es u

nder

the

MPG

wer

e pe

ndin

g th

ere

in th

e ye

ars

2016

to 2

020

and

wha

t the

out

com

e of

thes

e pr

ocee

ding

s w

as.


The

follo

win

g pr

elim

inar

y re

mar

ks a

re n

eces

sary

:Th

e M

PG (s

till v

alid

unt

il M

ay 2

021)

doe

s no

t inc

lude

the

crim

inal

offe

nce

of m

anuf

actu

ring

or tr

affick

ing

in c

ount

erfe

it m

edic

al d

evic

es. H

owev

er, i

t doe

s co

ntai

n ot

her

offen

ces

rela

ting

to m

edic

al d

evic

es in

§ 4

0, §

41

e.g.

pla

cing

obj

ectiv

ely

dang

erou

s m

edic

al d

evic

es o

n th

e m

arke

t or d

istr

ibut

ing

med

ical

dev

ices

with

out C

E m

arki

ng. I

t w

as th

eref

ore

to b

e ex

pect

ed th

at a

t lea

st s

ome

proc

eedi

ngs

for o

ffenc

es u

nder

§ 4

0 or

§ 4

1 M

PG w

ould

be

foun

d.Th

e G

erm

an p

ublic

pro

secu

tors

’ offi

ces o

r Gen

eral

pub

lic p

rose

cuto

rs’ o

ffice

s wor

k w

ith tw

o di

ffere

nt so

ftw

are

syst

ems f

or ca

se m

anag

emen

t, w

hich

are

also

use

d fo

r sta

tistic

al d

ata.

Bo

th so

ftwar

e pr

ogra

mm

es h

ave

in co

mm

on th

at e

ach

inve

stig

atio

n ca

se is

reco

rded

, usu

ally

, with

onl

y one

“lea

ding

” offe

nce.

For e

xam

ple,

if a

selle

r sel

ls a

coun

terfe

it m

edic

al d

evic

e as

gen

uine

, fra

ud m

ay p

ossib

ly h

ave

been

com

mitt

ed b

y th

e sa

me

act,

but a

lso a

n off

ence

und

er tr

adem

ark

law

(inf

ringe

men

t of i

ntel

lect

ual p

rope

rty)

and

an

offen

ce u

nder

the

MPG

(pla

cing

dan

gero

us m

edic

al d

evic

es o

n th

e m

arke

t). H

owev

er, o

nly

one

offen

ce is

ent

ered

into

the

case

man

agem

ent p

rogr

amm

e. T

his i

s usu

ally

the

offen

ce w

ith th

e hi

ghes

t pe

nalty

. Sin

ce th

e pe

nalti

es u

nder

the

MPG

are

rath

er lo

w (t

his w

ill c

hang

e w

ith th

e fu

ture

MPD

G),

it is

poss

ible

that

thes

e in

vest

igat

ive

proc

edur

es “d

isapp

ear”

in th

e st

atist

ics.

I the

refo

re a

lso

aske

d th

e Pr

osec

utor

s G

ener

al, i

f pos

sibl

e, to

ask

the

pros

ecut

ors

in th

eir d

istr

ict w

heth

er th

ey in

divi

dual

ly re

mem

bere

d ce

rtai

n in

vest

igat

ion

proc

eedi

ngs

in th

is a

rea.

If th

is w

as th

e ca

se, t

hese

cas

es a

lso

will

figu

re u

nder

II.

II. R

esul

ts o

f the

Sur

vey

The

surv

ey h

ad th

e fo

llow

ing

resu

lt (s

orte

d by

fede

ral s

tate

):

1. B

aden

-Wür

ttem

berg

In B

aden

-Wür

ttem

berg

, a to

tal o

f 44

prel

imin

ary

proc

eedi

ngs

wer

e pe

ndin

g fr

om 2

016

to 2

020.

In

8 o

f the

se 4

4 ca

ses,

char

ges w

ere

brou

ght a

nd th

e ac

cuse

d w

ere

sent

ence

d to

fine

s. Se

ven

of th

ese

8 ca

ses c

once

rned

the

inco

rrec

t dis

infe

ctio

n of

equ

ipm

ent b

y do

ctor

s or

den

tists

. In

som

e ca

ses

the

sent

ence

s ha

ve a

lread

y be

com

e fin

al, i

n ot

hers

the

defe

ndan

ts h

ave

appe

aled

.In

the

eigh

th c

ase,

a v

ery

high

fine

was

impo

sed

(the

exa

ct a

mou

nt w

as n

ot re

port

ed) b

ecau

se th

e de

fend

ant,

as th

e ow

ner o

f a c

ompa

ny, d

istr

ibut

ed p

rodu

cts f

or p

erfo

rmin

g co

loni

c irr

igat

ion

that

wer

e no

t CE-

cert

ified

. The

sen

tenc

e is

not

fina

l bec

ause

the

accu

sed

has

appe

aled

.In

the

othe

r cas

es, t

he p

roce

edin

gs a

re o

pen

(inve

stig

atio

ns a

re o

ngoi

ng) o

r the

pro

ceed

ings

hav

e be

en d

isco

ntin

ued

for v

ario

us re

ason

s (e

.g. n

o su

ffici

ent s

uspi

cion

or

insi

gnifi

canc

e).

2 Ba

varia

Onl

y 13

cas

es a

re re

port

ed fr

om B

avar

ia b

etw

een

2016

and

202

0.

In th

is c

onte

xt, t

he M

unic

h Pu

blic

Pro

secu

tor’s

Offi

ce m

entio

ns a

ver

y in

tere

stin

g ca

se th

at is

bei

ng c

ondu

cted

at t

he T

raun

stei

n Pu

blic

Pro

secu

tor’s

Offi

ce. H

ere,

the

two

accu

sed

are

accu

sed

of h

avin

g so

ld te

st st

rips f

or te

stin

g bl

ood

suga

r as “

orig

inal

goo

ds” t

o G

erm

an p

harm

acie

s, al

thou

gh th

ese

test

strip

s wer

e re

pack

aged

, re-

impo

rted

and

no

long

er fr

esh.

A c

orre

ct m

easu

rem

ent r

esul

t was

no

long

er g

uara

ntee

d. U

nfor

tuna

tely

, the

Mun

ich

Gen

eral

Pro

secu

tor’s

Offi

ce h

as n

ot in

dica

ted

whe

ther

the

proc

eedi

ngs

have

alre

ady

been

con

clud

ed, w

heth

er c

harg

es h

ave

been

bro

ught

and

wha

t the

ver

dict

is.

Mos

t of t

he o

ther

pro

ceed

ings

hav

e be

en d

isco

ntin

ued

for v

ario

us re

ason

s or

are

stil

l ope

n.

3 Be

rlin

The

Berli

n Pu

blic

Pro

secu

tor’s

Offi

ce re

port

s 22

prel

imin

ary

proc

eedi

ngs.

How

ever

, cha

rges

wer

e br

ough

t and

a v

erdi

ct re

ache

d in

onl

y 2

case

s (in

bot

h ca

ses fi

nes)

. Det

ails

ha

ve n

ot b

een

repo

rted

.


4 Br

ande

nbur

g

In B

rand

enbu

rg, t

hree

pre

limin

ary

proc

eedi

ngs

wer

e pe

ndin

g. N

o ch

arge

s w

ere

brou

ght i

n an

y of

thes

e th

ree

case

s.

5 Br

emen

No

case

s ar

e re

port

ed.

6 H

ambu

rg

One

cas

e is

repo

rted

for t

he p

erio

d 20

16 to

202

0. T

he o

wne

r of a

com

pany

sol

d m

edic

al d

evic

es w

ithou

t val

id C

E m

arki

ng in

26

case

s in

201

8. C

harg

es h

ave

been

bro

ught

to

cou

rt, b

ut n

o ve

rdic

t is

yet a

vaila

ble.

7. H

esse

In H

esse

, a to

tal o

f 24

inve

stig

atio

ns o

r crim

inal

cha

rges

und

er th

e M

PG w

ere

pend

ing

from

201

6 to

202

0. 6

pro

ceed

ings

are

still

ope

n. T

he o

ther

pro

ceed

ings

wer

e ha

nded

ov

er to

oth

er p

ublic

pro

secu

tors

’ offi

ces,

or d

isco

ntin

ued

for v

ario

us re

ason

s. N

o ch

arge

s ha

ve b

een

brou

ght s

o fa

r.

8 M

eckl

enbu

rg-W

este

rn P

omer

ania

Two

inve

stig

atio

ns a

re re

port

ed fr

om M

eckl

enbu

rg-W

este

rn P

omer

ania

, but

no

char

ges

wer

e br

ough

t and

no

conv

ictio

ns w

ere

hand

ed d

own

in a

ny o

f the

cas

es.

9. L

ower

Sax

ony

From

Low

er S

axon

y, d

ata

wer

e on

ly re

port

ed b

y in

divi

dual

pub

lic p

rose

cuto

r’s o

ffice

s. A

s a

rule

, the

re w

ere

no p

roce

edin

gs a

t the

se p

ublic

pro

secu

tor’s

offi

ces,

but i

n an

y ca

se n

o co

nvic

tions

.

10 N

orth

Rhi

ne-W

estp

halia

Nor

th R

hine

-Wes

tpha

lia d

id n

ot re

spon

d.

11. R

hine

land

-Pal

atin

ate

In R

hine

land

-Pal

atin

ate,

thre

e pr

elim

inar

y in

vest

igat

ions

wer

e pe

ndin

g in

201

6 to

202

0. T

wo

wer

e di

scon

tinue

d du

e to

insi

gnifi

canc

e. In

the

third

cas

e, th

e ac

t was

not

cl

assi

fied

as a

crim

inal

offe

nce

but a

s an

adm

inis

trat

ive

offen

ce (a

nd th

e ca

se w

as th

eref

ore

hand

ed o

ver t

o th

e ad

min

istr

ativ

e au

thor

ity).

12 S

aarla

nd

No

proc

eedi

ngs w

ere

pend

ing

durin

g th

is p

erio

d.

13 S

axon

y

Saxo

ny d

id n

ot re

ply.


14 S

axon

y-A

nhal

t

Ther

e w

ere

thre

e pr

ocee

ding

s, on

e of

whi

ch w

as tr

ansf

erre

d to

ano

ther

Lan

d. T

wo

are

still

pen

ding

.

15 S

chle

swig

-Hol

stei

n

Alth

ough

Sch

lesw

ig-H

olst

ein

is a

rath

er sm

all L

and,

it h

ad th

e hi

ghes

t num

ber o

f pro

ceed

ings

in th

e gi

ven

perio

d, n

amel

y 70.

As c

an b

e se

en fr

om th

e an

swer

of t

he A

ttor

ney

Gen

eral

’s O

ffice

of S

chle

swig

-Hol

stei

n, th

e re

ason

for t

his

seem

s to

be

that

the

com

pete

nt a

dmin

istr

ativ

e au

thor

ities

of S

chle

swig

-Hol

stei

n ca

rry

out a

n ab

ove-

aver

age

num

ber o

f ins

pect

ions

, e.g

. at h

ospi

tals

, doc

tors

and

den

tists

, whe

re th

ey c

heck

the

med

ical

dev

ices

ver

y cl

osel

y. If

the

devi

ces d

o no

t hav

e pr

oper

CE

mar

king

, are

not

hy

gien

ical

ly c

lean

ed, e

tc.,

char

ges a

re fi

led

with

the

publ

ic p

rose

cuto

r’s o

ffice

for c

rimin

al o

ffenc

es u

nder

the

MPG

. Suc

h pr

ecis

e co

ntro

ls a

re a

ppar

ently

not

com

mon

in

othe

r fed

eral

stat

es.

Seve

n ca

ses h

ave

been

dro

pped

due

to in

sign

ifica

nce.

Eigh

t cas

es h

ave

been

dro

pped

with

out f

orm

al c

harg

es a

gain

st p

aym

ent o

f a su

m o

f mon

ey to

the

publ

ic p

urse

or t

o a

char

itabl

e in

stitu

tion

or a

gain

st th

e pe

rfor

man

ce

of h

ours

of w

ork.

In tw

o ca

ses,

char

ges h

ave

been

bro

ught

bef

ore

the

cour

t. D

urin

g th

e tr

ial, h

owev

er, t

he co

urt,

the

defe

ndan

t and

the

publ

ic p

rose

cuto

r agr

eed

to te

rmin

ate

the

proc

eedi

ngs

with

out a

form

al v

erdi

ct a

gain

st p

aym

ent o

f a su

m o

f mon

ey to

the

publ

ic tr

easu

ry o

r a c

harit

able

inst

itutio

n.

In fo

ur ca

ses (

all f

or u

se o

f im

prop

erly

dis

infe

cted

equ

ipm

ent b

y doc

tors

or d

entis

ts),

ther

e w

ere

sent

ence

s of fi

nes (

betw

een

2000

eur

os a

nd 4

000

euro

s) p

lus c

onfis

catio

n of

the

equi

pmen

t. Th

ree

sent

ence

s are

fina

l. In

the

four

th c

ase,

the

accu

sed

has a

ppea

led.

16 T

hurin

gia

Two

prel

imin

ary

proc

eedi

ngs a

re re

port

ed fr

om T

hurin

gia.

In o

ne c

ase,

a m

edic

al d

evic

e w

ith a

n in

corr

ect C

E m

arki

ng w

as so

ld to

Ger

man

y fr

om th

e Cz

ech

Repu

blic

. The

co

urt i

mpo

sed

a fin

e of

150

0 eu

ros.

This

bec

ame

lega

lly b

indi

ng.

III. S

ome

Conc

lusi

ons

In G

erm

any,

ver

y fe

w p

relim

inar

y pr

ocee

ding

s are

con

duct

ed o

vera

ll fo

r crim

inal

offe

nces

und

er th

e M

edic

al D

evic

es A

ct.

As th

e ex

ampl

e of

Sch

lesw

ig-H

olst

ein

(sm

all f

eder

al st

ate,

very

hig

h nu

mbe

r of p

roce

edin

gs, a

lmos

t all b

ased

on

crim

inal

char

ges fi

led

by th

e su

rvei

llanc

e au

thor

ities

) sho

ws,

this

coul

d (a

mon

g ot

her t

hing

s) b

e du

e to

the

fact

that

the

surv

eilla

nce

auth

oriti

es (i

n th

e ot

her f

eder

al st

ates

) do

not c

oope

rate

opt

imal

ly w

ith th

e pu

blic

pro

secu

tors

(or

the

polic

e), i

.e. t

hey

do n

ot p

ass o

n th

eir fi

ndin

gs to

the

law

enf

orce

men

t aut

horit

ies.

In m

ost c

ases

whe

re in

vest

igat

ions

are

con

duct

ed, c

harg

es (i

ndic

tmen

ts) a

re n

ot b

roug

ht to

cou

rt a

nd a

ver

dict

is re

ache

d.

This

cou

ld b

e du

e (a

mon

g ot

her t

hing

s) to

the

fact

that

the

thre

aten

ed p

enal

ties u

nder

the

curr

ent l

aw a

re lo

w. I

f onl

y a

very

low

pen

alty

is th

reat

ened

any

way

, the

n th

e pu

blic

pro

secu

tor’s

offi

ce w

ill o

ften

dro

p th

e ca

se o

n gr

ound

s of i

nsig

nific

ance

. The

trou

ble

of b

ringi

ng c

harg

es a

nd c

ondu

ctin

g a

tria

l in

cour

t is “

not w

orth

it”.


GEO

RGIA

(pre

pare

d by

the

natio

nal c

onsu

ltant

Ms

Nin

o AG

LEM

ASH

VILI

)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

15.1

2.20

17

Case

№09

2191

0170

06

Crim

inal

cas

e in

to th

e cr

ime

com

mitt

ed o

n D

ecem

ber 1

5, 2

017,

in

the

nam

e of

BIO

PLIU

SI L

LC.

Inve

stig

atio

n re

veal

ed th

at A

rchi

l Ber

adze

, Man

ager

of B

IOPL

IUSI

LL

C, o

rgan

ized

the

purc

hase

of f

alsi

fied

med

icin

e (3

,520

bpa

ckag

es)

labe

led

as “A

ctim

ax”.

BIO

PLIU

SI L

LC w

as s

uppo

sed

to s

ell t

he

med

icin

e, b

ut th

e la

w-e

nfor

cem

ent a

genc

ies

prev

ente

d th

e cr

ime

befo

re it

was

com

mitt

ed.

Man

ager

of t

he c

ompa

ny w

as c

harg

ed u

nder

Art

icle

s 19

, 197

1 of

the

Crim

inal

Cod

e of

Geo

rgia

(att

empt

to s

ell a

fals

ified

/fo

rged

item

kno

win

gly)

. Und

er th

e fin

al d

ecis

ion

of th

e co

urt,

the

defe

ndan

t was

sen

tenc

ed to

a fi

ne in

the

amou

nt o

f GEL

3,0

00

(thr

ee th

ousa

nd) a

nd th

e co

nditi

onal

sen

tenc

e –

impr

ison

men

t for

a

term

of 2

(tw

o) y

ears

and

pro

batio

n fo

r a te

rm o

f 2 (t

wo)

yea

rs.

Not

e: L

aw-e

nfor

cem

ent a

genc

ies w

ere

unab

le to

brin

g ch

arge

s ag

ains

t the

com

pany

, bec

ause

Art

icle

197

1 of

the

Crim

inal

Cod

e do

es n

ot p

rovi

de fo

r the

crim

inal

liab

ility

of l

egal

ent

ities

(ple

ase,

see

docu

men

t A1,

com

men

ts to

par

agra

phs 1

1.1

and

11.2

).

04.0

7.20

18

N09

2030

8180

01

Zvia

d G

rigal

ashv

ili, D

irect

or o

f TES

T W

HO

LESA

LE L

LC, w

ith th

e he

lp

of P

ublis

hing

Hou

se G

rifon

i LLC

, man

ufac

ture

d 6,

442

units

of J

SC

KED

RIO

N tr

adem

ark

boxe

s (ve

rbal

par

t of t

he tr

adem

ark

– “K

EDRI

ON

”)

and

mar

ked

the

boxe

s with

the

regi

stra

tion

num

ber #

2428

0/3

issu

ed

by th

e G

eorg

ian

Nat

iona

l Int

elle

ctua

l Pro

pert

y Ce

nter

– S

AKP

ATEN

TI.

Furt

herm

ore,

he

used

the

forg

ed tr

adem

ark

boxe

s men

tione

d ab

ove

for p

acka

ging

the

fals

ified

med

icin

e “E

MO

CLO

T” a

nd o

n Au

gust

2,

2018

, put

the

fals

ified

med

icin

es m

arke

d as

“EM

OCL

OT”

(with

the

tota

l va

lue

of G

EL 5

23,7

98.8

) in

expo

rt c

omm

odity

ope

ratio

n un

der t

he

cust

oms d

ecla

ratio

n N

C210

22/1

1114

.

The

defe

ndan

t was

cha

rged

und

er A

rtic

le 1

96 (i

llega

l use

of

trad

emar

k) a

nd A

rtic

les

19, 2

14 (a

ttem

pt to

tran

spor

t goo

ds

over

the

bord

er b

y en

terin

g fa

lse

data

in c

usto

ms

decl

arat

ion)

of

the

Crim

inal

Cod

e. U

nder

the

cour

t dec

isio

n, th

e de

fend

ant w

as

sent

ence

d to

a fi

ne in

the

amou

nt o

f GEL

5,0

00 (fi

ve th

ousa

nd).

GRE

ECE

No

subm

issi

on h

as b

een

rece

ived

on

case

law

from

the

natio

nal c

onsu

ltant

GU

INEA

(pre

pare

d by

the

natio

nal c

onsu

ltant

Mr A

bdou

laye

KPO

GO

MO

U)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

02 Ja

nuar

y 20

19

Refe

renc

e: R

P N

o. 0

01/2

019

Mr B

anga

ly T

raor

é, a

trad

er b

y pr

ofes

sion

, was

arr

este

d w

ith a

truc

k lo

aded

with

co

unte

rfei

t pha

rmac

eutic

al p

rodu

cts

from

the

Fede

ral R

epub

lic o

f Nig

eria

.H

e w

as a

bout

to m

ove

the

good

s in

to th

e co

untr

y.H

e w

as th

eref

ore

arre

sted

by

the

MED

ICRI

ME

Brig

ade

and

the

load

was

sei

zed

and

plac

ed u

nder

the

cont

rol o

f the

cou

rts.

He

was

que

stio

ned

and

brou

ght b

efor

e th

e pr

osec

utor

at M

afan

co c

ourt

of fi

rst

inst

ance

.

Dire

ct s

umm

ons

proc

eedi

ngs

wer

e in

itiat

ed b

y th

e pr

osec

utio

n.

The

case

is s

till p

endi

ng b

efor

e th

e cr

imin

al c

ourt

, w

hich

has

alre

ady

cons

ider

ed th

e ca

se a

nd d

ebat

ed it

in

sev

eral

hea

rings


ICEL

AN

D N

o su

bmis

sion

has

bee

n re

ceiv

ed o

n ca

se la

w fr

om th

e na

tiona

l con

sulta

nt

IREL

AN

D (p

repa

red

by th

e na

tiona

l con

sulta

nt M

r Bria

n G

AGEB

Y)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

22 Ju

ne 2

018,

D

ublin

M

etro

polit

an

Dis

tric

t C

ourt

, Cou

rt o

f Fi

rst

Inst

ance

. Com

mon

Law

ju

risdi

ctio

n

HPR

A v

. Taj

A

ccur

a P

harm

aceu

tical

s

Ltd;

and

two

nam

ed

pers

ons

T aj

Acc

ura

Phar

mac

eutic

als

Ltd

(‘Taj

Acc

ura’

) was

a p

harm

aceu

tical

who

lesa

le c

ompa

ny

regi

ster

ed c

ompa

ny in

Irel

and.

It w

as re

late

d to

Taj

Pha

rmac

eutic

als

Ltd,

a c

ompa

ny re

gist

ered

in

Indi

a, w

hich

hel

d its

elf o

ut a

s a

supp

lier o

f onc

olog

y-in

dica

ted

med

icin

es. T

aj A

ccur

a he

ld

itsel

f out

as

bein

g re

spon

sibl

e fo

r the

sal

es a

nd m

arke

ting

of T

aj P

harm

aceu

tical

s Lt

d.

Follo

win

g th

e re

ceip

t of a

requ

est f

or a

ssis

tanc

e fr

om th

e Is

rael

i Min

istr

y of

Hea

lth o

n 29

Feb

ruar

y 20

16, t

he Ir

ish

Hea

lth P

rodu

cts

Regu

lato

ry A

utho

rity

(HPR

A) l

aunc

hed

an

inve

stig

atio

n in

to th

e de

alin

gs o

f Taj

Acc

ura

betw

een

June

201

5 an

d A

pril

2016

. Th

e H

PRA

laid

a n

umbe

r of c

harg

es a

gain

st T

aj A

ccur

a,(D

efen

dant

1, o

ne o

f its

dire

ctor

s, D

efen

dant

2 w

ho a

cted

as

the

sale

s an

d m

arke

ting

dire

ctor

, and

a s

hado

w d

irect

or, D

efen

dant

3

who

hel

d hi

mse

lf ou

t as

the

Chie

f Exe

cutiv

e an

d Ch

airm

an. T

hese

cha

rges

wer

e la

id u

nder

the

- M

edic

inal

Pro

duct

s (C

ontr

ol o

f Who

lesa

le D

istr

ibut

ion)

Reg

ulat

ions

200

7, R

egul

atio

n 14

B (s

ale

and

supp

ly b

y w

hole

sale

of 1

00,0

00 a

mpo

ules

of F

luor

oura

cil 5

0 In

ject

ion

250m

g to

Iran

in

circ

umst

ance

s w

here

the

defe

ndan

ts k

new

or t

here

wer

e su

ffici

ent g

roun

ds to

sus

pect

that

it

was

a fa

lsifi

ed m

edic

inal

pro

duct

); - M

edic

inal

Pro

duct

s (C

ontr

ol o

f Man

ufac

ture

) Reg

ulat

ions

200

7, re

gula

tion

14B

(1)

(impo

rtat

ion

into

Irel

and

from

out

side

the

EEA

whe

re th

e im

port

atio

n do

cum

enta

tion

cont

aine

d th

e Cu

stom

s de

clar

atio

ns th

at Ir

elan

d w

as th

e fin

al c

ount

ry o

f des

tinat

ion,

of A

fhla

n (M

elph

alan

Inje

ctio

n U

SP 5

0mg)

, the

in c

ircum

stan

ces

whe

re th

e de

fend

ants

kne

w o

r the

re

wer

e su

ffici

ent g

roun

ds to

sus

pect

that

it w

as a

fals

ified

med

icin

al p

rodu

ct (i

nste

ad re

labe

lled

the

cons

ignm

ent o

f Afh

lan

and

expo

rted

to K

uwai

t whi

lst l

istin

g Ire

land

as

the

coun

try

of

orig

in a

nd K

uwai

t as

the

coun

try

of d

estin

atio

n;

- Med

icin

al P

rodu

cts

(Con

trol

of W

hole

sale

Dis

trib

utio

n) R

egul

atio

ns 2

007,

Reg

ulat

ion

14B

(sal

e by

who

lesa

le o

f Afh

lan

(Mel

phal

an In

ject

ion

USP

50m

g) to

a U

K co

mpa

ny c

laim

ing

the

man

ufac

ture

r to

be a

UK

licen

sed

phar

mac

eutic

al m

anuf

actu

ring

com

pany

on

beha

lf of

Taj

Ac

cura

whi

lst k

now

ing

that

this

was

unt

rue

and

in c

ircum

stan

ces

whe

re th

e de

fend

ants

kne

w

or th

ere

wer

e su

ffici

ent g

roun

ds to

sus

pect

that

it w

as a

fals

ified

med

icin

al p

rodu

ct);

- Med

icin

al P

rodu

cts

(Con

trol

of W

hole

sale

Dis

trib

utio

n) R

egul

atio

ns 2

007,

Reg

ulat

ion,

Reg

39

(c) (

intr

oduc

tion

into

Irel

and

of A

fhla

n (M

elph

alan

Inje

ctio

n U

SP 5

0mg)

in c

ircum

stan

ces

whe

re th

e de

fend

ants

kne

w o

r the

re w

ere

suffi

cien

t gro

unds

to s

uspe

ct th

at it

was

a fa

lsifi

ed

med

icin

al p

rodu

ct

On

22 Ju

ne 2

018,

con

vict

ions

wer

e re

cord

ed a

gain

st e

ach

of th

e th

ree

accu

sed

for t

hese

cha

rges

and

the

rem

aini

ng c

harg

es w

ere

stru

ck o

ut

by c

onse

nt. T

he th

ree

accu

sed

wer

e or

dere

d to

pay

fine

of E

UR

1000

eac

h.

The

judg

e se

nten

ced

each

def

enda

nt

to a

fine

of E

UR

1000

. In

givi

ng s

uch

a se

nten

ce, t

he c

ourt

took

into

acc

ount

a

num

ber o

f miti

gatin

g fa

ctor

s. Th

ese

incl

uded

the

fact

that

this

was

the

first

off

ence

for e

ach

of th

e th

ree

accu

sed,

th

at th

ere

was

a lo

w p

roba

bilit

y of

re

offen

ding

, tha

t the

re w

as a

loss

of

pro

fess

iona

l sta

ndin

g fo

r bot

h D

efen

dant

s 2

and

3, a

com

mitm

ent

had

been

mad

e to

the

cour

t tha

t Taj

Ac

cura

wou

ld n

o lo

nger

trad

e, a

nd

that

com

mitm

ents

had

bee

n m

ade

by

Def

enda

nts

2 an

d 3

that

they

wou

ld

no lo

nger

eng

age

in a

ny b

usin

ess

rega

rdin

g he

alth

pro

duct

s re

gula

ted

by th

e H

PRA

. Fur

ther

mor

e, th

e fa

ct

that

the

thre

e ac

cuse

d ha

d en

tere

d gu

ilty

plea

s w

as a

sig

nific

ant m

itiga

ting

fact

or, a

nd th

e co

urt s

tate

d th

at h

ad

the

accu

sed

not p

lead

ed g

uilty

and

ha

d su

bseq

uent

ly b

een

conv

icte

d at

tria

l, a

sent

ence

of i

mpr

ison

men

t w

ould

hav

e be

en in

ord

er.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

- Med

icin

al P

rodu

cts

(Con

trol

of P

laci

ng o

n th

e M

arke

t) R

egul

atio

ns 2

007.

Reg

ulat

ion

39(c

) (in

trod

uctio

n in

to Ir

elan

d of

Afh

lan

(Mel

phal

an In

ject

ion

USP

50m

g) in

circ

umst

ance

s w

here

th

e de

fend

ants

kne

w o

r the

re w

ere

suffi

cien

t gro

unds

to s

uspe

ct th

at it

was

a fa

lsifi

ed

med

icin

al p

rodu

ctTh

e ch

arge

s re

late

d to

sel

ling

and

supp

ly b

y w

hole

sale

, bro

kerin

g by

who

lesa

le, i

mpo

rtin

g,

expo

rtin

g, p

laci

ng in

to c

ircul

atio

n an

d in

trod

ucin

g in

to Ir

elan

d fa

lsifi

ed m

edic

inal

pro

duct

s in

dica

ted

for t

he tr

eatm

ent o

f can

cers

. The

cha

rges

rela

ted

to m

edic

al p

rodu

cts

sold

to

phar

mac

eutic

al c

ompa

nies

in Ir

an, K

uwai

t, Is

rael

, and

the

Uni

ted

King

dom

whe

re th

e de

fend

ants

had

mad

e m

isre

pres

enta

tions

abo

ut th

e so

urce

of t

he m

edic

al p

rodu

cts.

The

thre

e ac

cuse

d ea

ch p

lead

ed g

uilty

to a

num

ber o

f the

cha

rges

laid

aga

inst

them

. Co

rrel

atio

n to

the

MED

ICRI

ME

Conv

entio

n:

Subs

tant

ive

Crim

inal

Law

: Art

icle

6,7

, 8, 1

1, 1

3 A

rtic

le 1

7,

ITA

LY (p

repa

red

by th

e na

tiona

l con

sulta

nt M

s G

iulia

na G

IULA

NO

)


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Cour

t of C

assa

tion

Sect

ion

1, ju

dgm

ent n

. 505

66 o

f th

e 0

7/11

/201

3 Cc

. (fil

ed

13/1

2/20

13) R

v. 2

5761

0 - 0

1

The

Cour

t of C

assa

tion,

Sec

tion

I, w

ith it

s ju

dgm

ent n

. 505

66 d

el

7.11

.201

3 an

nulle

d an

ord

er is

sued

by

the

Cour

t of R

ome,

in fu

nctio

n of

a re

view

judg

e,

reje

ctin

g th

e ap

peal

s bro

ught

by

thre

e pa

rtie

s, as

man

ager

s of t

he p

harm

aceu

tical

co

mpa

ny, q

ualit

y as

sura

nce

and

qual

ity c

ontr

ol o

f the

sam

e co

mpa

ny, t

o w

hich

the

prec

autio

nary

mea

sure

of h

ouse

arr

est h

ad b

een

appl

ied

by o

rder

of t

he G

IP o

f the

Co

urt o

f Fro

sino

ne fo

r the

crim

e re

ferr

ed to

in A

rt. 4

40 c

o. 1

and

3 c

.p. f

or a

dulte

ratio

n an

d co

unte

rfei

ting

of m

edic

inal

pro

duct

s cal

led

Ozo

pulm

in G

80

mg

for c

hild

ren

and

Ozo

pulm

in G

160

mg

for a

dults

, pla

ced

on th

e m

arke

t in

the

abse

nce

of th

e m

ain

com

pone

nt, t

he a

ctiv

e su

bsta

nce

so-c

alle

d P.O

.T. a

nd, f

or th

is re

ason

, acc

ordi

ng to

th

e in

dict

men

t, da

nger

ous t

o pu

blic

hea

lth. T

he a

pplic

ant d

efen

ces c

onsi

dere

d th

at,

in th

e pr

esen

t cas

e, th

e le

ast s

erio

us c

ase

refe

rred

to in

Art

icle

10

of th

e D

irect

ive

was

co

nfigu

rabl

e. 4

43 c

.p.

The

prod

uctio

n, d

epen

ding

on

the

subs

eque

nt

mar

ketin

g, o

f a d

rug

depr

ived

of i

ts a

ctiv

e in

gred

ient

, rep

lace

d w

ith o

ther

dru

gs o

f min

or

or n

o eff

ectiv

enes

s, w

hich

doe

s no

t mak

e it

dang

erou

s fo

r pub

lic h

ealth

sup

plem

ents

th

e cr

ime

refe

rred

to in

Art

. The

pro

duct

ion,

de

pend

ing

on th

e su

bseq

uent

mar

ketin

g, o

f a

drug

dep

rived

of i

ts a

ctiv

e in

gred

ient

, rep

lace

d w

ith o

ther

dru

gs o

f min

or o

r no

effec

tiven

ess,

whi

ch d

oes

not m

ake

it da

nger

ous

for p

ublic

he

alth

sup

plem

ents

the

crim

e re

ferr

ed to

in A

rt.

443

crim

inal

cod

e 44

3 cr

imin

al c

ode

beca

use

in

this

way

the

drug

itse

lf is

nei

ther

adu

ltera

ted

nor

coun

terf

eite

d bu

t mad

e on

ly im

perf

ect.

beca

use

in th

is w

ay th

e dr

ug it

self

is n

eith

er a

dulte

rate

d no

r cou

nter

feite

d bu

t mad

e on

ly im

perf

ect.

(In a

ccor

danc

e w

ith th

e pr

inci

ple,

the

Cour

t an

nulle

d th

e de

cisi

on o

f the

Rev

iew

Cou

rt w

hich

ha

d he

ld th

at th

e cr

ime

refe

rred

to in

Art

icle

440

of

the

Pen.

(In

acco

rdan

ce w

ith th

e pr

inci

ple,

the

Cour

t ann

ulle

d th

e de

cisi

on o

f the

Rev

iew

Cou

rt

whi

ch h

ad h

eld

that

the

crim

e re

ferr

ed to

in

Art

icle

440

of t

he d

omes

tic c

rimin

al la

w)

Cour

t of C

assa

tion

Sect

ion

6 ,

judg

men

t n. 2

4242

del

21/0

4/20

15

Cc. (

filed

05/

06/2

015

)

Rv. 2

6416

7 - 0

1

The

Cour

t of C

assa

tion,

Sec

tion

VI, w

ith it

s ju

dgm

ent n

. 242

42 d

el 2

1.4.

2015

reje

cted

th

e ap

peal

for C

assa

tion

brou

ght b

y th

e pa

rent

s of

a c

hild

, suff

erin

g fr

om m

uscu

lar

dyst

roph

y of

Duc

henn

e, w

ho h

ad b

egun

trea

tmen

t with

the

Stam

ina

met

hod,

aga

inst

th

e or

der o

f the

Cou

rt o

f Tur

in th

at h

ad c

onfir

med

the

decr

ee o

f pre

vent

ive

seiz

ure

of m

ater

ials

and

pro

duct

s de

posi

ted

at th

e st

em c

ell l

abor

ator

y of

the

Hos

pita

l “S

peda

li ci

vili

di B

resc

ia” i

n th

e co

ntex

t of c

rimin

al p

roce

edin

gs in

stitu

ted

for c

rimes

of

ass

ocia

tion

for d

elin

quen

cy ,

trad

e in

and

adm

inis

trat

ion

of im

perf

ect m

edic

ines

, in

a m

anne

r dan

gero

us to

pub

lic h

ealth

, agg

rava

ted

frau

d, a

buse

of o

ffice

, abu

sive

ex

erci

se o

f the

pro

fess

ion,

and

oth

er c

rimes

The

appe

al fo

r Cas

satio

n w

as d

ism

isse

d an

d th

e Su

prem

e Co

urt s

aid

that

“the

app

licat

ion

of th

e so

calle

d “s

tam

ina

met

hod”

con

figur

es

the

crim

e re

ferr

ed to

in a

rt. 4

43 c

od. p

en.,

as

an a

ctiv

ity fo

cuse

d on

the

adm

inis

trat

ion

of

prep

arat

ions

and

sub

stan

ces

cons

ider

ed to

be

devo

id o

f the

rape

utic

effi

cacy

by

the

gene

ral i

ty

of th

e in

tern

atio

nal s

cien

tific

com

mun

ity, a

nd,

ther

efor

e, a

s su

ch, a

ttrib

utab

le to

the

cate

gory

of

“impe

rfec

t med

icin

es”.

(Con

f. se

ntt.

n. 2

4243

/15

and

2424

4/15

, non

mas

s). (

Prin

cipl

e affi

rmed

in

the

cont

ext o

f rea

l pre

-tria

l pro

ceed

ings

).

http://www.italgiure.giustizia.it/xway/application/nif/isapi/hc.dll?host=&port=-1&_sid=%7b05F56067%7d&db=snpen&verbo=query&xverb=tit&query=%5bnumero%20decisione%5d=50566%20AND%20%5banno%20decisione%5d=2013%20AND%20%5bsezione%5d=1&user=&uri=/xway/application/nif/isapi/hc.dll&pwd=&cId=&cIsPublic=&cName=&cquery=165839&sele=&selid=&pos=&lang=it

http://www.italgiure.giustizia.it/xway/application/nif/isapi/hc.dll?host=&port=-1&_sid=%7b05F56067%7d&db=snpen&verbo=query&xverb=tit&query=%5bnumero%20decisione%5d=24242%20AND%20%5banno%20decisione%5d=2015%20AND%20%5bsezione%5d=6&user=&uri=/xway/application/nif/isapi/hc.dll&pwd=&cId=&cIsPublic=&cName=&cquery=86936&sele=&selid=&pos=&lang=it


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Crem

ona,

12

Sept

embe

r

2019

com

plex

inve

stig

atio

n

conv

entio

nally

cal

led

“DAW

AA”

, car

ried

out b

y

Cara

bini

eri

Ant

iSop

hist

icat

ion

and

Hea

lth

Uni

t of C

rem

ona

On

12 S

epte

mbe

r 201

9, a

t the

con

clus

ion

of a

com

plex

inve

stig

atio

n co

nven

tiona

lly

calle

d “D

AWA

A”, t

he C

arab

inie

ri of

the

NA

S of

Cre

mon

a ca

rrie

d ou

t 18

prec

autio

nary

m

easu

res,

of w

hich

14

cust

odia

l and

4 re

stric

tive

(obl

igat

ion

to s

ubm

it to

the

PG),

as w

ell a

s 34

dec

rees

of s

earc

hes,

agai

nst a

s m

any

subj

ects

und

er in

vest

igat

ion

as in

volv

ed in

var

ious

cap

aciti

es in

an

inte

rnat

iona

l tra

ffick

ing

of d

rugs

, mai

nly

onco

logi

cal,

antiv

iral a

nd in

tend

ed fo

r par

ticul

ar tr

eatm

ents

. Med

icin

al s

ubst

ance

s, al

l ch

arac

teriz

ed b

y a

high

ther

apeu

tic a

nd c

omm

erci

al v

alue

, con

stitu

te th

e pr

ocee

ds

of n

umer

ous

thef

ts c

omm

itted

bet

wee

n 20

17 a

nd 2

018

in h

ospi

tal p

harm

acie

s, lo

cal

heal

th c

ompa

nies

and

pha

rmac

eutic

al w

areh

ouse

s th

roug

hout

the

coun

try.

The

mea

sure

s, or

dere

d by

the

GIP

of t

he C

ourt

of C

rem

ona

at th

e re

ques

t at t

he

requ

est o

f the

loca

l Pub

lic P

rose

cuto

r’s O

ffice

, wer

e ca

rrie

d ou

t with

the

use

of a

de

vice

con

sist

ing

of 2

20 m

ilita

ry p

erso

nnel

from

the

NA

S an

d th

e te

rrito

rial w

eapo

n in

the

prov

ince

s of

Cre

mon

a, L

odi,

Mila

n, P

iace

nza,

Bol

ogna

, Nap

les

and

Sale

rno.

Th

e re

cipi

ents

of t

he m

easu

res,

who

are

par

t of a

crim

inal

ass

ocia

tion

base

d in

the

Crem

asco

are

a, a

re a

ttrib

utab

le to

var

ious

com

pone

nts

repr

esen

ted

by th

ieve

s, fe

nces

, cou

riers

and

tout

s, w

ho h

ad s

et u

p a

dens

e ne

twor

k of

ille

gal t

rade

in h

igh-

cost

dru

gs ,

all d

estin

ed fo

r the

fore

ign

mar

ket.

A p

art o

f the

ass

ocia

tion

was

invo

lved

in s

teal

ing

med

icin

es fr

om th

e ph

arm

acie

s of

lo

cal h

ealth

com

pani

es a

nd p

ublic

hos

pita

ls a

s w

ell a

s fr

om p

harm

aceu

tical

logi

stic

s, de

liver

ing

them

to th

e fir

st le

vel o

f fen

ces

mad

e up

of s

ubje

cts

of C

ampa

nia

orig

in

who

, in

turn

, gav

e th

em to

a fu

rthe

r lev

el o

f man

agem

ent ,

at t

he h

ead

of th

e en

tire

orga

niza

tion,

a ro

le p

laye

d by

two

Egyp

tian

citiz

ens

who

, tha

nks

to th

e co

llabo

ratio

n of

sup

port

ers

and

cour

iers

, wer

e in

volv

ed in

the

expo

rt p

hase

s of

dru

gs in

Fra

nce,

G

erm

any

and

espe

cial

ly in

Nor

th A

fric

a an

d th

e M

iddl

e Ea

st, i

n pa

rtic

ular

Egy

pt, S

yria

an

d Sa

udi A

rabi

a. T

he m

edic

ines

exp

orte

d in

air

ship

men

ts b

y co

urie

rs o

r pas

seng

ers

depa

rtin

g fr

om M

ilan

Mal

pens

a A

irpor

t, up

on re

achi

ng th

eir d

estin

atio

n, w

ere

take

n in

to c

usto

dy b

y th

e ac

com

plic

es w

ho d

ealt

with

the

logi

stic

s of

tran

spor

t and

pl

acem

ent i

n lo

cal w

areh

ouse

s or

del

iver

y to

priv

ate

indi

vidu

als

such

as

doct

ors

and

patie

nts

wea

lthy.

Dur

ing

the

inve

stig

atio

n 82

4 pa

cks

of m

edic

ines

wer

e se

ized

for a

tota

l am

ount

, ba

sed

on th

e hi

gh e

cono

mic

val

ue o

f eac

h si

ngle

ther

apeu

tic u

nit,

of a

lmos

t 4 m

illio

n eu

ros.

At p

rese

nt, t

he o

utco

me

of th

e pr

oces

s is

not

kn

own


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Of p

artic

ular

inve

stig

ativ

e im

port

ance

was

the

cont

ribut

ion

of th

e AI

FA C

arab

inie

ri N

ucle

us (t

he N

AS N

ucle

us lo

cate

d at

the

Italia

n M

edic

ines

Age

ncy)

, who

se fi

ndin

gs

mad

e it

poss

ible

to re

cons

truc

t and

iden

tify

the

illic

it or

igin

of t

he m

edic

ines

, sto

len

in

the

cour

se o

f bur

glar

y an

d bu

rgla

ry. c

omm

itted

bet

wee

n Se

ptem

ber 2

017

and

May

20

18 a

t the

inte

rnal

pha

rmac

ies o

f the

San

Gio

vann

i Bos

co a

nd A

scal

esi h

ospi

tals

in

Nap

les,

San

Tim

oteo

di T

erm

oli a

nd th

e Pr

ovin

cial

Hea

lth A

utho

ritie

s, ap

poin

ted

to

dist

ribut

e m

edic

ines

to p

ublic

stru

ctur

es o

n a

terr

itoria

l bas

is, in

Cat

anza

ro, C

alta

giro

ne

and

Rutig

liano

as w

ell a

s at a

wel

l-kno

wn

phar

mac

eutic

al lo

gist

ics c

ompa

ny in

Lod

i. Pr

ecise

ly fo

r the

pur

pose

of p

ublic

hea

lth fo

r whi

ch th

e st

olen

dru

gs w

ere

inte

nded

, the

in

vest

igat

ion

repr

esen

ts a

n im

port

ant r

epre

ssiv

e in

terv

entio

n to

cou

nter

a p

artic

ular

ly

insid

ious

crim

inal

phe

nom

enon

, bot

h fo

r the

con

sider

able

eco

nom

ic e

xpor

t to

the

detr

imen

t of t

he p

ublic

hea

lth se

rvic

e an

d fo

r the

thef

t of p

harm

acol

ogic

al p

rodu

cts.

inte

nded

for t

he tr

eatm

ent o

f im

port

ant p

atho

logi

es su

ch a

s onc

olog

ical

one

s and

with

ur

gent

ther

apeu

tic n

eeds

.

The

inve

stig

atio

ns a

lso

dem

onst

rate

d th

e fa

ilure

to a

pply

the

corr

ect m

etho

ds o

f cu

stod

y of

dru

gs s

ubje

ct to

illic

it tr

ade:

in fa

ct s

ome

cate

gorie

s of

dru

gs s

ubje

ct to

th

eft r

equi

red

bind

ing

stor

age

at re

frig

erat

ion

tem

pera

ture

, a n

eces

sary

con

ditio

n to

en

sure

the

effica

cy o

f the

act

ive

phar

mac

olog

ical

prin

cipl

e an

d th

erap

eutic

act

ion.

Th

is s

tora

ge te

mpe

ratu

re re

quire

men

t was

not

mai

ntai

ned,

thus

mak

ing

them

im

perf

ect a

nd b

ecom

ing

a po

tent

ial s

erio

us d

ange

r to

the

heal

th o

f uns

uspe

ctin

g pa

tient

s du

e, a

t bes

t, to

the

ineff

ectiv

enes

s of

the

cura

tive

func

tion.

Tho

se a

rres

ted,

as

soci

ated

in v

ario

us d

eten

tion

inst

itutio

ns in

Nor

ther

n an

d So

uthe

rn It

aly,

on

the

inst

ruct

ions

of t

he C

rem

ona

Publ

ic P

rose

cuto

r’s O

ffice

, will

hav

e to

ans

wer

for t

he

crim

es o

f con

spira

cy, r

ecei

ving

sto

len

good

s, ag

grav

ated

thef

t and

trad

e in

bro

ken

and

impe

rfec

t dru

gs.

Inte

rnat

iona

l ope

ratio

n “S

HIE

LD” e

nded

in

Dec

embe

r 202

0

The

Cara

bini

eri o

f the

NA

S ha

ve c

oncl

uded

“SH

IELD

”, a

vast

inte

rnat

iona

l ope

ratio

n ai

med

at p

rote

ctin

g he

alth

and

com

batin

g th

e cd

. pha

rma

crim

e, w

hich

invo

lved

19

Mem

ber S

tate

s of

the

Euro

pean

Uni

on, a

s w

ell a

s A

lban

ia, B

osni

a an

d H

erze

govi

na,

Colo

mbi

a, M

oldo

va, N

orw

ay, S

erbi

a, th

e Re

publ

ic o

f Nor

th M

aced

onia

, Ukr

aine

and

th

e Eu

rope

an A

nti-F

raud

Offi

ce (O

LAF)

, und

er th

e di

rect

ion

and

coor

dina

tion

of

Euro

pol.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Ope

ratio

n SH

IELD

, bor

n fr

om th

e ex

perie

nce

of th

e pr

evio

us E

urop

ean

oper

atio

ns

VIRI

BUS

and

MIS

MED

and

laun

ched

in e

arly

202

0 du

ring

the

kick

-off

mee

ting

held

in

Alic

ante

(Spa

in) a

t the

hea

dqua

rter

s of

the

Euro

pean

Uni

on O

ffice

for I

ntel

lect

ual

Prop

erty

(EU

IPO

), re

pres

ents

the

larg

est a

ctiv

ity c

ondu

cted

to p

rote

ct h

ealth

and

to

com

bat “

phar

mac

eutic

al c

rime”

, a p

heno

men

on n

ow o

f tra

nsac

tiona

l im

port

ance

ag

ains

t whi

ch th

ey h

ave

been

dev

elop

ed ,

with

in th

e fr

amew

ork

of th

e gu

idel

ines

es

tabl

ishe

d by

Eur

opol

, spe

cific

law

enf

orce

men

t act

iviti

es a

t nat

iona

l lev

el a

ccor

ding

to

an

effec

tive

orga

nisa

tiona

l mod

el o

f coo

rdin

atio

n, c

oope

ratio

n an

d ex

chan

ge o

f in

form

atio

n be

twee

n th

e St

ates

invo

lved

, aim

ed a

t pro

secu

ting

illic

it tr

affick

ing

in

dopi

ng s

ubst

ance

s an

d th

eir u

se in

spo

rts

com

petit

ions

, as

wel

l as

the

prod

uctio

n an

d di

strib

utio

n of

cou

nter

feit

drug

s or

the

proc

eeds

of i

llega

l act

iviti

es.

The

expl

osio

n of

the

COVI

D-1

9 pa

ndem

ic h

as a

lso

led

to th

e de

velo

pmen

t of a

ta

rget

ed la

w e

nfor

cem

ent a

ctio

n, in

a s

yner

gist

ic e

ffort

am

ong

the

part

icip

atin

g co

untr

ies

that

hav

e or

ient

ed in

vest

igat

ions

and

inve

stig

atio

ns a

lso

in th

e de

licat

e em

erge

ncy

sect

or.

Of n

ote

was

the

role

pla

yed

by It

aly,

and

in p

artic

ular

by

the

NA

S m

ilita

ry, w

ithin

“S

HIE

LD”.

The

Cara

bini

eri C

omm

and

for t

he P

rote

ctio

n of

Hea

lth w

as, i

n fa

ct, e

ntru

sted

with

the

delic

ate

role

of c

o-le

ader

of E

urop

ol: t

his

posi

tion

of re

spon

sibi

lity

allo

wed

the

NA

S to

take

its

plac

e in

the

“con

trol

room

” (al

so c

ompo

sed

of th

e N

atio

nal G

enda

rmer

ie

Fren

ch, t

he G

reek

Pol

ice

and

the

Finn

ish

Cust

oms)

whi

ch p

lann

ed, d

irect

ed a

nd

coor

dina

ted

the

part

icip

atin

g co

untr

ies

in th

e va

rious

are

as o

f int

erve

ntio

n.Th

e re

sults

ach

ieve

d by

the

vario

us jo

ints

of t

he C

arab

inie

ri Co

mm

and

for t

he

Prot

ectio

n of

Hea

lth d

urin

g O

pera

tion

“SH

IELD

”, he

ld d

urin

g 20

20, s

aw th

e ex

ecut

ion

of 2

20 in

spec

tion

and

cont

rol a

ctiv

ities

on

the

natio

nal t

errit

ory,

with

the

open

ing

of

166

judi

cial

and

adm

inis

trat

ive

proc

eedi

ngs,

for a

tota

l of 1

3 ar

rest

s an

d 48

5 re

port

s to

the

com

pete

nt A

utho

ritie

s. La

rge

seiz

ures

of m

edic

ines

and

dop

ing

subs

tanc

es, a

s wel

l as m

edic

al d

evic

es

and

prod

ucts

of v

ario

us k

inds

rela

ted

to th

e CO

VID

-19

emer

genc

y: o

ver 6

2,00

0 pa

ckag

es a

nd a

bout

1,5

00,0

00 u

nits

of m

edic

inal

pro

duct

s for

hum

an u

se in

diff

eren

t ph

arm

aceu

tical

form

s (ta

blet

s, in

ject

able

s, po

wde

rs),

cont

aini

ng a

ctiv

e in

gred

ient

s w

ith v

ario

us th

erap

eutic

indi

catio

ns, m

ainl

y at

trib

utab

le to

ana

bolic

age

nts,

antib

iotic

s, an

ti-in

flam

mat

orie

s, er

ectil

e dy

sfun

ctio

n an

d bo

astin

g pr

oper

ties f

or th

e tr

eatm

ent o

f CO

VID

-19.

Men

tion

shou

ld a

lso

be m

ade

of th

e se

izur

e of

som

e 3

quin

tals

of v

ario

us

subs

tanc

es in

pow

ders

and

cry

stal

s, in

clud

ing

cutt

ing

mat

eria

l and

oth

er a

llege

dly

narc

otic

mat

eria

l, w

hich

are

bei

ng a

naly

sed,

foun

d du

ring

an o

pera

tion

whi

ch, l

ast

Oct

ober

, led

to th

e di

scov

ery

of a

cla

ndes

tine

prin

ting

pres

s of e

uro

bank

note

s.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

In a

dditi

on, t

here

are

app

roxi

mat

ely

2 m

illio

n m

edic

al d

evic

es a

nd d

evic

es s

eize

d in

co

nnec

tion

with

the

COVI

D-1

9 em

erge

ncy

beca

use

they

do

not c

ompl

y or

ille

gally

im

port

ed, i

nclu

ding

mas

ks, g

love

s, pr

otec

tive

kits

and

PPE

, dia

gnos

tic te

sts

and

sani

tizin

g liq

uids

, for

a q

uant

ity o

f 15

tons

. Th

e co

mm

erci

al v

alue

of a

ll se

izur

es e

xcee

ds th

e fig

ure

of 6

,500

,000

eur

os.

At th

e sa

me

time,

targ

eted

con

trol

was

car

ried

out o

n th

e ill

icit

sale

and

adv

ertis

ing

of m

edic

ines

onl

ine.

The

spec

ific

scop

e of

the

cont

rast

to th

e cd

. pha

rmac

eutic

al

cybe

rcrim

e w

as, i

n fa

ct, c

onsi

dere

d pa

rtic

ular

ly se

nsiti

ve si

nce

the

citiz

ens’

fear

s es

peci

ally

with

rega

rd to

the

spre

ad o

f CO

VID

-19,

fuel

ing

a pr

obab

le fr

antic

sear

ch fo

r “D

O IT

YO

URS

ELF”

rem

edie

s on

the

net,

coul

d ha

ve b

een

expl

oite

d by

crim

inal

s who

fe

ed th

e ill

icitl

y so

urce

d dr

ug m

arke

t and

par

alle

l sup

ply

chan

nels.

In th

is c

onte

xt,

the

mili

tary

of t

he C

arab

inie

ri Co

mm

and

for t

he P

rote

ctio

n of

Hea

lth h

ave

ther

efor

e co

nduc

ted

targ

eted

ana

lyse

s of t

he w

eb th

at h

ave

allo

wed

to id

entif

y an

d “o

bscu

re”,

on m

easu

res o

f the

Min

istr

y of

Hea

lth a

s man

y as

132

web

site

s all

with

serv

ers l

ocat

ed

abro

ad a

nd w

ith fi

ctiti

ous d

ata

of th

e re

lativ

e m

anag

ers.

Of t

hese

site

s, 11

2 re

late

d to

m

edic

inal

pro

duct

s bas

ed o

n ac

tive

ingr

edie

nts (

hydr

oxyc

hlor

oqui

ne, c

hlor

oqui

ne,

lopi

navi

r/rit

onav

ir, a

zith

rom

ycin

) for

whi

ch o

ff-la

bel u

se w

as a

utho

rized

onl

y in

the

cont

ext o

f res

earc

h an

d cl

inic

al st

udie

s rel

ated

to C

OVI

D-1

9, w

hile

20

offer

ed fo

r sal

e an

d ad

vert

ised

med

icin

es w

ith v

ario

us th

erap

eutic

indi

catio

ns, m

ainl

y do

ping

, aga

inst

er

ectil

e dy

sfun

ctio

n, a

nti-i

nflam

mat

orie

s and

ant

ibio

tics,

all s

ubje

ct to

pre

scrip

tion.

Des

pite

the

limita

tions

of s

port

s ac

tiviti

es re

late

d to

the

pand

emic

em

erge

ncy,

42

anti-

dopi

ng c

heck

s w

ere

cond

ucte

d “in

” (36

) and

“out

” (6)

com

petit

ion

by th

e N

AS

Ant

i-Dop

ing

Inve

stig

atio

n In

spec

tors

, whi

ch a

llow

ed 1

54 a

thle

tes

to b

e ch

ecke

d (1

35 o

n th

e si

delin

es o

f rac

es a

nd 2

1 ou

t of c

ompe

titio

n), 1

3 of

whi

ch w

ere

posi

tive

(all “

in” c

ompe

titio

n). I

n th

is c

onte

xt, t

he m

ilita

ry h

as m

ade

use

at n

atio

nal l

evel

of

the

cons

olid

ated

col

labo

ratio

n of

NA

DO

ITA

LIA

, und

er w

hose

aeg

is th

ey h

ave

also

co

ntrib

uted

to th

e co

ntro

ls c

ondu

cted

by

the

UCI

dur

ing

the

2020

Giro

d’It

alia

, and

by

the

Dop

ing

Surv

eilla

nce

Sect

ion

of th

e M

inis

try

of H

ealth

. Th

e op

erat

iona

l opp

ortu

nity

was

also

frui

tful t

o pr

omot

e th

e re

latio

ns o

f ins

titut

iona

l co

oper

atio

n be

twee

n th

e Ca

rabi

nier

i of t

he N

AS a

nd th

e Cu

stom

s and

Mon

opol

ies A

genc

y in

the

area

s of r

espe

ctiv

e co

mpe

tenc

e, m

oreo

ver s

treng

then

ed b

y th

e re

cent

sign

ing

of a

sp

ecifi

c mem

oran

dum

of u

nder

stan

ding

bet

wee

n th

e G

ener

al C

omm

and

of th

e Ca

rabi

nier

i An

d th

e Sa

me

Agen

cy. In

this

rega

rd, m

entio

n sh

ould

be

mad

e of

the

join

t act

ivity

that

le

d to

the

disc

over

y, a

few

day

s ago

, of a

n un

derg

roun

d la

bora

tory

for t

he p

rodu

ctio

n an

d m

arke

ting

of d

opin

g su

bsta

nces

inte

nded

to b

e ta

ken

in a

dan

gero

us w

ay fo

r hea

lth, in

th

e ab

senc

e of

any

med

ical

pre

scrip

tion

and

in th

e ab

senc

e of

ther

apeu

tic n

eeds

, with

the

seiz

ure

of la

rge

quan

titie

s of p

rodu

cts o

f var

ious

kin

ds a

nd p

acka

ging

mat

eria

l.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

In to

tal,

Ope

ratio

n SH

IELD

, con

duct

ed in

the

terr

itorie

s of

the

vario

us a

cced

ing

coun

trie

s, ha

s m

ade

it po

ssib

le to

dis

man

tle 2

5 cr

imin

al g

roup

s, se

ize

thou

sand

s of

m

edic

ines

and

dop

ing

prod

ucts

of v

ario

us k

inds

, for

a to

tal o

f ove

r 25

mill

ion

units

an

d a

com

mer

cial

val

ue o

f alm

ost 7

3 m

illio

n eu

ros,

iden

tify

and

seiz

e 10

cla

ndes

tine

labo

rato

ries,

laun

ch 9

5 in

vest

igat

ions

, arr

est 6

67 p

eopl

e an

d re

port

a fu

rthe

r 1,2

82 ,

as w

ell a

s m

onito

r 4,0

09 w

ebsi

tes

by o

bscu

ring

453

of th

em. T

he a

ntid

opin

g ac

tivity

, on

the

othe

r han

d, re

sulte

d in

536

che

cks “

in” (

148)

and

“out

” (38

8) c

ompe

titio

n co

ntro

lling

650

ath

lete

s (2

47 o

n th

e si

delin

es o

f rac

es a

nd 4

03 o

ut o

f com

petit

ion)

, 17

of w

hich

wer

e po

sitiv

e re

sults

(13

follo

win

g ch

ecks

“in”

com

petit

ion

and

4 du

ring

“out

” co

mpe

titio

n ch

ecks

). Fi

nally

, the

targ

eted

act

ion

on C

OVI

D-1

9 al

one

led

to th

e se

izur

e of

ove

r 32

mill

ion

mas

ks, t

ests

, dia

gnos

tic k

its a

nd m

edic

al d

evic

es, 8

tons

bet

wee

n ch

emic

als

and

activ

e in

gred

ient

s an

d 70

tons

of h

and

sani

tizin

g liq

uid.

“Ope

ratio

n Ph

arm

alab

”, A

rzan

o Ju

ne 2

014

This

op

erat

ion

is p

art o

f the

ac

tiviti

es c

arrie

d ou

t with

th

e O

pera

tion

Volc

ano.

Th

e la

tter

ope

ratio

n co

ncer

ns a

num

ber o

f ac

tiviti

es c

arrie

d ou

t aft

er

a G

erm

an d

istr

ibut

or

rece

ived

def

ectiv

e vi

als

of

an a

ntic

ance

r med

icin

e H

erce

ptin

® 15

0 m

g fr

om a

U

K w

hole

sale

r. O

pera

tion

Vulc

ano

has

allo

wed

the

adop

tion

of b

oth

ad h

oc

tool

s (w

eb p

latf

orm

s fo

r da

ta s

harin

g, d

atab

ases

, “b

lack

lists

” of o

pera

tors

) an

d go

od p

ract

ices

in

the

EU M

embe

r Sta

tes

in o

rder

to p

reve

nt th

e re

curr

ence

of s

imila

r ca

ses.

AIF

A, f

or e

xam

ple,

co

ordi

nate

d an

impo

rtan

t EU

-wid

e ve

rifica

tion

cam

paig

n th

roug

h th

e Fa

kesh

are

web

pla

tfor

m,

The “

Ope

ratio

n Ph

arm

alab

” is p

art o

f the

act

iviti

es c

arrie

d ou

t with

the

Ope

ratio

n Vo

lcan

o.

The

inve

stig

atio

n w

as la

unch

ed a

fter t

he se

izur

e of

a la

rge

quan

tity

of m

edic

ines

(58,

222

pack

s of m

edic

ines

of d

iffer

ent t

ypes

, gen

era

and

orig

ins,

incl

udin

g ho

spita

l dru

gs, w

ith

an e

stim

ated

mar

ket v

alue

of E

UR

839,

530)

by

the

Fina

nce

Polic

e of

Fiu

mic

ino

(Rom

a),

in Ju

ne 2

014

at a

war

ehou

se lo

cate

d in

Arz

ano.

Arz

ano’

s war

ehou

se w

as u

sed

by tw

o su

bjec

ts, o

ne o

f who

m w

as a

pha

rmac

ist. T

he in

vest

igat

ions

wer

e co

ordi

nate

d by

the

Publ

ic P

rose

cuto

r’s O

ffice

at t

he C

ourt

of N

aple

s Nor

d an

d al

low

ed, t

hrou

gh c

heck

s on

seiz

ed a

sset

s, in

terc

eptio

n, in

terr

ogat

ion,

to c

lear

the

mem

bers

of a

crim

inal

ass

ocia

tion

that

rece

ived

and

then

pla

ced

on th

e m

arke

t sto

len

med

icin

es. T

o pl

ace

stol

en m

edic

ines

on

the

mar

ket,

false

fisc

al d

ocum

ents

wer

e pr

epar

ed th

at si

mul

ated

thei

r pur

chas

e fro

m It

alia

n su

pplie

rs a

nd p

harm

acie

s by

appa

rent

ly fo

reig

n co

mpa

nies

. The

crim

inal

ac

tivity

was

org

aniz

ed in

seve

ral s

tage

s: 1)

thef

t or r

obbe

ry o

f med

icin

es th

roug

hout

Ita

ly; 2

) pla

cem

ent i

n w

areh

ouse

s for

stor

age

in th

e Ca

mpa

nia;

3) p

repa

ratio

n of

false

do

cum

enta

tion

atte

stin

g to

the

orig

in o

f the

stol

en m

edic

ines

; 4) r

eloc

atio

n to

the

mar

ket t

hrou

gh a

ccom

plic

es (p

harm

acie

s, w

hole

sale

rs, d

istrib

utor

s). F

ollo

win

g a

sear

ch,

in N

ovem

ber 2

014,

of s

ome

prem

ises i

n th

e av

aila

bilit

y of

susp

ects

in th

e pr

ovin

ces o

f N

aple

s and

Cas

erta

, a fu

rthe

r 3,1

17 p

acka

ges o

f med

icin

es w

ere

seiz

ed.

The

offen

ces a

llege

d ag

ains

t the

susp

ects

with

the

exer

cise

of c

rimin

al p

roce

edin

gs

wer

e as

follo

ws:

purc

hase

or r

ecei

pt o

f goo

ds o

f crim

inal

orig

in -

art.

648

c.p.

; po

sses

sion

of n

arco

tic d

rugs

(Art

icle

73(

1) a

lso

rela

ting

to p

arag

raph

4 o

f Ita

lian

Repu

blic

Pre

side

ntia

l Dec

ree

No.

309

/199

0) fo

r cer

tain

pac

kage

s of m

edic

inal

pro

duct

s (1

191)

con

tain

ing

activ

e su

bsta

nces

whi

ch m

ay a

ppea

r in

the

tabl

es in

clud

ed in

the

Cons

olid

ated

Text

on

Nar

cotic

Dru

gs (i

n pa

rtic

ular

Tabl

e I,

Sect

ion

A a

nd Ta

ble

IV),

trad

e an

d ad

min

istr

atio

n of

def

ectiv

e or

def

ectiv

e m

edic

inal

pro

duct

s (Ar

ticle

443

of t

he

Crim

inal

Cod

e) in

rela

tion

to e

xpire

d dr

ugs f

ound

; crim

inal

ass

ocia

tion

final

ized

to th

e co

mm

issi

on o

f the

abo

ve c

rimes

(Art

. 416

of t

he C

rimin

al C

ode)

Thre

e de

fend

ants

ask

ed fo

r the

ir po

sitio

n to

be

defin

ed b

y a

plea

bar

gain

. In

part

icul

ar, 4

.3.2

016,

w

as a

pplie

d, p

ursu

ant t

o ar

t. 44

4 co

de o

f cr

imin

al p

roce

dure

(ple

a ba

rgai

n), f

rom

the

Cour

t of

Nap

les

Nor

th to

one

of t

he d

efen

dant

s th

e fin

al s

ente

nce

of th

ree

year

s an

d el

even

mon

ths

impr

ison

men

t and

eur

o 12

,000

.00

fine

whi

le

to a

noth

er d

efen

dant

the

final

oen

a of

yea

rs 4

m

onth

s si

x im

pris

onm

ent a

nd e

uro1

6,00

0 fin

e.

One

def

enda

nt w

as a

cqui

tted

and

for t

he o

ther

si

x de

fend

ants

, in

2019

, a fi

rst-

degr

ee s

ente

nce

was

han

ded

dow

n by

the

Cour

t of N

aple

s N

ord


JAPA

N N

o su

bmis

sion

has

bee

n re

ceiv

ed o

n ca

se la

w fr

om th

e na

tiona

l con

sulta

nt

LATV

IA (p

repa

red

by th

e na

tiona

l con

sulta

nt M

s Sa

nita

TIM

BARE

ZIL

VEST

ERE)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

29.1

1.20

19.

No.

1A

6801

6718

*

An

offici

al o

f the

Med

icin

es S

uper

visi

on a

nd C

ontr

ol D

ivis

ion

of th

e H

ealth

Insp

ecto

rate

on

20

Mar

ch 2

018

adop

ted

Dec

isio

n fo

r cal

ling

Com

pany

“H” a

s th

e ph

arm

aceu

tical

w

hole

sale

r adm

inis

trat

ivel

y lia

ble

for t

he c

omm

ittin

g an

adm

inis

trat

ive

offen

se

rega

rdin

g di

strib

utio

n of

fal

sifie

d m

edic

inal

pro

duct

s (o

ne fa

lsifi

ed b

atch

), im

posi

ng a

fin

e in

the

amou

nt o

f EU

R 60

70,0

0.O

n th

e de

cisi

on o

f the

offi

cial

of t

he M

edic

ines

Sup

ervi

sion

and

Con

trol

Div

isio

n of

th

e H

ealth

Insp

ecto

rate

Com

pany

“H” s

ubm

itted

a c

ompl

aint

to th

e di

rect

or o

f the

H

ealth

Insp

ecto

rate

as

a hi

gher

inst

itutio

n, re

ques

ting

to c

ance

l and

term

inat

e th

e ad

min

istr

ativ

e vi

olat

ion

proc

eedi

ngs.

The

Hea

lth In

spec

tora

te o

n 16

Aug

ust 2

018

mad

e de

cisi

on -

it w

as d

ecid

ed to

leav

e th

e ap

peal

ed d

ecis

ion

unch

ange

d, b

ut to

reje

ct th

e Co

mpa

ny’s

“H” c

ompl

aint

. Th

e Co

mpa

ny “H

” app

eale

d th

e de

cisi

on o

f the

Hea

lth In

spec

tora

te to

the

Cour

t.A

s th

e la

st in

stan

ce th

e Pa

nel o

f the

Rig

a Ci

ty C

rimin

al C

ourt

in 2

9.11

.201

9. w

ith

judg

men

t in

case

No.

1A

6801

6718

uph

eld

the

deci

sion

of t

he H

ealth

Insp

ecto

rate

and

re

ject

ed th

e Co

mpa

ny’s

“H” a

pplic

atio

n.

The

judg

men

t of t

he P

anel

of t

he R

iga

City

Cr

imin

al C

ourt

is fi

nal a

nd h

as e

nter

ed in

to

forc

e.

03.0

4.20

20.

No.

A42

0239

819*

Info

rmat

ion

abou

t rap

id a

lert

was

rece

ived

by

Rapi

d A

lert

nat

iona

l con

tact

poi

nt in

La

tvia

- H

ealth

Insp

ecto

rate

- on

Apr

il, 2

018

that

pha

rmac

eutic

al w

hole

sale

r Com

pany

“S”

dist

ribut

es c

ount

erfe

it m

edic

ines

“X” (

two

fals

ified

bat

ches

). La

tvia

n H

ealth

Insp

ecto

rate

la

unch

ed a

n in

vest

igat

ion

and

perf

orm

ed u

nsch

edul

ed in

spec

tions

at p

harm

aceu

tical

w

hole

sale

r (W

D) p

rem

ises

. Dur

ing

the

inve

stig

atio

n, th

e St

ate

Agen

cy o

f Med

icin

es

(SA

M) a

nd th

e H

ealth

Insp

ecto

rate

iden

tified

that

dis

trib

utio

n w

as p

erfo

rmed

out

side

m

edic

ines

“X” m

anuf

actu

rer’s

app

rove

d su

pply

cha

in a

nd m

edic

inal

pro

duct

“X” w

as

rece

ived

with

out s

uppo

rtin

g qu

ality

doc

umen

tatio

n bu

t nev

erth

eles

s ac

cept

ed to

sa

leab

le s

tock

, sol

d fu

rthe

r to

unlic

ense

d co

mpa

ny.

Com

pany

“S” d

id n

ot ta

ke a

ll po

ssib

le s

teps

to p

reve

nt th

e di

strib

utio

n of

fals

ified

med

icin

al p

rodu

cts

in th

e le

gal

supp

ly c

hain

. SA

M L

icen

sing

boa

rd o

n 18

Oct

ober

, 201

8 ad

opte

d de

cisi

on to

revo

ke

phar

mac

eutic

al W

D li

cens

e of

the

Com

pany

“S”. T

he S

AM

dec

isio

n to

revo

ke W

D li

cens

e ha

s be

en c

halle

nged

in th

e M

inis

try

of H

ealth

by

the

Com

pany

“S”.

Th

e M

inis

try

of H

ealth

uph

eld

the

deci

sion

of t

he S

tate

Age

ncy

of M

edic

ines

.Th

e co

mpa

ny “S

” app

eale

d th

e de

cisi

on o

f the

Min

istr

y of

Hea

lth to

the

Adm

inis

trat

ive

Dis

tric

t Cou

rt.

In th

e fir

st in

stan

ce, t

he A

dmin

istr

ativ

e D

istr

ict C

ourt

in 0

3.04

.202

0. in

cas

e N

o.

A42

0239

819

uphe

ld th

e de

cisi

on o

f the

Min

istr

y of

Hea

lth a

nd re

ject

ed th

e Co

mpa

ny’s

“S” a

pplic

atio

n.

The

judg

men

t of t

he A

dmin

istr

ativ

e D

istr

ict

Cour

t as

the

first

Inst

ance

has

bee

n ap

peal

ed

to th

e Re

gion

al C

ourt

and

has

not

ent

ered

into

fo

rce.


04.0

9.20

20.

No.

1A30

0478

18*

On

18 Ju

ly 2

018,

an

offici

al o

f the

Med

icin

es S

uper

visi

on a

nd C

ontr

ol D

ivis

ion

of th

e H

ealth

In

spec

tora

te a

dopt

ed D

ecis

ion

for c

allin

g Co

mpa

ny “S

” as t

he p

harm

aceu

tical

who

lesa

ler

adm

inis

trat

ivel

y lia

ble

for t

he c

omm

ittin

g an

adm

inis

trat

ive

offen

se re

gard

ing

dist

ribut

ion

of f

alsi

fied

med

icin

al p

rodu

cts,

impo

sing

a fi

ne in

the

amou

nt o

f EU

R 6,

070.

On

the

deci

sion

of t

he o

ffici

al o

f the

Med

icin

es S

uper

visi

on a

nd C

ontr

ol D

ivis

ion

of

the

Hea

lth In

spec

tora

te C

ompa

ny “S

” sub

mitt

ed a

com

plai

nt to

the

dire

ctor

of t

he

Hea

lth In

spec

tora

te a

s a

high

er in

stitu

tion,

requ

estin

g to

can

cel a

nd te

rmin

ate

the

adm

inis

trat

ive

viol

atio

n pr

ocee

ding

s. T

he H

ealth

Insp

ecto

rate

on

30 A

ugus

t 201

8 m

ade

deci

sion

- it

was

dec

ided

to le

ave

the

appe

aled

dec

isio

n un

chan

ged,

but

to re

ject

the

Com

pany

’s “S

” com

plai

nt.

The

Com

pany

“S” a

ppea

led

the

deci

sion

of t

he H

ealth

Insp

ecto

rate

to th

e Ri

ga C

ity

Vidz

eme

Subu

rb C

ourt

.

As

the

seco

nd in

stan

ce th

e Ri

ga C

ity V

idze

me

Subu

rb C

ourt

in 0

4.09

.202

0. in

cas

e N

o.

1A30

0478

18 u

phel

d th

e de

cisi

on o

f the

Hea

lth In

spec

tora

te a

nd re

ject

ed th

e Co

mpa

ny’s

“S” a

pplic

atio

n.

The

judg

men

t of t

he R

iga

City

Vid

zem

e Su

burb

Cou

rt a

s th

e se

cond

Inst

ance

has

bee

n ap

peal

ed to

the

Regi

onal

Cou

rt a

nd h

as n

ot

ente

red

into

forc

e.

13.1

1.20

20.

No.

A42

0257

019*

Info

rmat

ion

abou

t rap

id a

lert

was

rece

ived

by

natio

nal R

apid

Ale

rt c

onta

ct p

oint

in

Lat

via

- Hea

lth In

spec

tora

te -

on D

ecem

ber,

2017

that

Com

pany

“H” d

istr

ibut

es

coun

terf

eit m

edic

ines

“Y” (

one

fals

ified

bat

ch).

Latv

ian

Hea

lth In

spec

tora

te la

unch

ed a

n in

vest

igat

ion

and

perf

orm

ed u

nsch

edul

ed in

spec

tions

at p

harm

aceu

tical

who

lesa

ler

prem

ises

. Dur

ing

the

inve

stig

atio

n, th

e St

ate

Agen

cy o

f Med

icin

es (S

AM

) and

the

Hea

lth

Insp

ecto

rate

iden

tified

that

dis

trib

utio

n w

as p

erfo

rmed

out

side

med

icin

al p

rodu

ct “Y

” m

anuf

actu

rer’s

app

rove

d su

pply

cha

in a

nd m

edic

inal

pro

duct

“Y” w

as re

ceiv

ed w

ithou

t su

ppor

ting

qual

ity d

ocum

enta

tion

but n

ever

thel

ess

acce

pted

to s

alea

ble

stoc

k, s

old

furt

her t

o lic

ense

d w

hole

sale

dis

trib

utio

n (W

D) h

olde

r. C

ompa

ny “H

” did

not

take

all

poss

ible

ste

ps to

pre

vent

the

dist

ribut

ion

of fa

lsifi

ed m

edic

inal

pro

duct

s in

the

lega

l su

pply

cha

in. S

AM

Lic

ensi

ng b

oard

on

18 O

ctob

er, 2

018

adop

ted

deci

sion

to re

voke

ph

arm

aceu

tical

WD

lice

nse

of th

e C

ompa

ny “H

”. The

SA

M d

ecis

ion

to re

voke

WD

lice

nse

has

been

cha

lleng

ed in

the

Min

istr

y of

Hea

lth b

y th

e Co

mpa

ny “H

”. T

he M

inis

try

of

Hea

lth u

phel

d th

e de

cisi

on o

f the

Sta

te A

genc

y of

Med

icin

es.

The

com

pany

“H” a

ppea

led

the

deci

sion

of t

he M

inis

try

of H

ealth

to th

e Ad

min

istr

ativ

e D

istr

ict C

ourt

.

In th

e fir

st in

stan

ce, t

he A

dmin

istr

ativ

e D

istr

ict C

ourt

in 1

3.11

.202

0. in

cas

e N

o.

A42

0257

019

uphe

ld th

e de

cisi

on o

f the

Min

istr

y of

Hea

lth a

nd re

ject

ed th

e co

mpa

ny’s

“H” a

pplic

atio

n.

The

judg

men

t of t

he A

dmin

istr

ativ

e D

istr

ict

Cour

t as

the

first

Inst

ance

has

bee

n ap

peal

ed

to th

e Re

gion

al C

ourt

and

has

not

ent

ered

into

fo

rce.

* Co

urt r

ulin

gs a

nd ju

dgm

ents

in L

atvi

a ar

e an

onym

ized

.


LITH

UA

NIA

(pre

pare

d by

the

natio

nal c

onsu

ltant

Mr T

autv

ydas

ZEK

AS)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Crim

inal

cas

es re

gard

ing

Art

icle

202

(„U

naut

horis

ed E

ngag

emen

t in

Econ

omic

, Com

mer

cial

, Fi

nanc

ial o

r Pro

fess

iona

l Act

iviti

es“)

of t

he C

rimin

al C

ode

(her

eina

fter

in th

e te

xt –

the

CC)

3 M

ay 2

011

Crim

inal

cas

e N

o.

2K-1

93/2

011

V. N

. with

out e

stab

lishi

ng a

com

pany

and

with

out a

lice

nse

for p

harm

aceu

tical

act

iviti

es h

as

enga

ged

in p

rohi

bite

d co

mm

erci

al a

ctiv

ities

: acq

uire

d va

rious

med

icin

al p

rodu

cts w

hich

w

ere

illeg

ally

impo

rted

into

Lith

uani

a, tr

ansp

orte

d an

d di

strib

uted

pro

hibi

ted

med

icin

al

prod

ucts

thro

ugh

prim

ary

heal

th c

are

inst

itutio

ns in

rura

l are

as (m

edic

al p

oint

s, ou

tpat

ient

cl

inic

s), fi

nally

rece

ived

inco

me

from

thes

e ill

egal

act

iviti

es. T

hese

med

icin

al p

rodu

cts w

ere

not o

ffici

ally

regi

ster

ed a

nd d

id n

ot c

ompl

y w

ith th

e la

belli

ng re

quire

men

ts.

In su

ch a

way

V. N

. vio

late

d Pa

ragr

aph

1 of

Art

icle

2 o

f the

Law

on

Phar

mac

eutic

al A

ctiv

ities

, w

hich

pro

vide

s tha

t onl

y m

edic

inal

pro

duct

s reg

iste

red

in th

e Re

publ

ic o

f Lith

uani

a an

d th

e Eu

rope

an C

omm

unity

may

be

impo

rted

into

the

Repu

blic

of L

ithua

nia,

put

into

circ

ulat

ion

and

used

for h

ealth

car

e. V

. N. a

lso

viol

ated

Art

icle

44

of th

e Co

de o

f Goo

d Pr

actic

e fo

r the

D

istr

ibut

ion

of M

edic

inal

Pro

duct

s, ac

cord

ing

to w

hich

pha

rmac

ies m

ay b

e su

pplie

d w

ith

med

icin

al p

rodu

cts r

egis

tere

d or

oth

erw

ise

auth

oriz

ed in

Lith

uani

a w

hose

pac

kagi

ng te

xt,

labe

lling

and

info

rmat

ion

prov

ided

to th

e co

nsum

er c

ompl

y w

ith le

gal r

equi

rem

ents

.By

thes

e ac

tions

men

tione

d V.

N. c

omm

itted

a c

rimin

al o

ffenc

e fo

rese

en in

Par

agra

ph 2

of

Art

icle

202

of t

he C

C.

The

Supr

eme

Cour

t of L

ithua

nia

dism

isse

d th

e ca

ssat

ion

appe

al o

f the

con

vict

ed.

Thus

the

sent

ence

of i

mpr

ison

men

t for

six

m

onth

s w

hich

was

sus

pend

ed fo

r one

yea

r an

d si

x m

onth

s (w

ith th

e im

posi

tion

of p

enal

sa

nctio

ns) i

mpo

sed

by th

e Li

thua

nian

Cou

rt

of A

ppea

l rem

aine

d in

forc

e.

15 S

epte

mbe

r 201

4

Crim

inal

cas

e N

o.

1-11

4-51

9/20

14

V. M

. with

out h

avin

g a

nece

ssar

y lic

ense

for p

harm

aceu

tical

act

iviti

es w

as e

ngag

ed in

co

mm

erci

al a

ctiv

ities

suc

h as

impo

rtin

g lic

ense

d m

edic

inal

pro

duct

s, tr

adin

g in

lice

nsed

m

edic

inal

pro

duct

s, sy

stem

atic

ally

sel

ling

med

icin

es o

n th

e m

arke

t, br

ingi

ng a

nd s

ellin

g m

edic

ines

to c

usto

mer

s at

hom

e or

els

ewhe

re.

In a

dditi

on, f

or th

e pu

rpos

e of

dis

trib

utio

n, V

. M. h

eld

a ve

ry la

rge

quan

tity

of a

ps

ycho

trop

ic s

ubst

ance

(460

fena

zepa

m ta

blet

s) c

onta

inin

g a

tota

l of 1

.15

g of

the

psyc

hotr

opic

sub

stan

ce fe

naze

pam

etc

.

It sh

ould

be

also

not

ed th

at a

t the

beg

inni

ng V

. M. w

as p

unis

hed

for m

arke

ting

man

ufac

ture

d m

edic

ines

on

the

mar

ketp

lace

with

out h

avin

g a

licen

se fo

r tha

t acc

ordi

ng to

Ar

ticle

411

of t

he C

ode

of A

dmin

istr

ativ

e O

ffenc

es (t

he C

AO).

This

art

icle

of C

AO p

rovi

des f

or

liabi

lity

for a

ctiv

ities

rela

ted

to m

edic

inal

pro

duct

s for

whi

ch a

lice

nse

is re

quire

d, w

ithou

t a

licen

se o

r in

anot

her i

llega

l man

ner,

if th

is h

as n

ot c

ause

d se

rious

con

sequ

ence

s or h

as n

ot

been

don

e on

a la

rge

scal

e. S

o ac

cord

ing

to A

rtic

le 4

11 o

f the

CAO

, V. M

. was

pun

ishe

d fo

r a

one-

time

viol

atio

n of

the

law

– fo

r mar

ketin

g m

edic

ines

with

out a

lice

nse

to tr

ade

in th

em,

and

acco

rdin

g to

Art

icle

202

of t

he C

C –

for c

arry

ing

out t

hese

act

iviti

es in

a c

omm

erci

al

man

ner,

alth

ough

V. M

. als

o di

d no

t hav

e an

y lic

ense

requ

ired

for t

hat.

V. M

. was

foun

d gu

ilty

of th

e off

ence

s und

er

Artic

le 2

60(3

) (“U

nlaw

ful P

osse

ssio

n of

N

arco

tic o

r Psy

chot

ropi

c Su

bsta

nces

for t

he

Purp

ose

of D

istrib

utio

n Th

ereo

f or U

nlaw

ful

Poss

essio

n of

a L

arge

Qua

ntity

of N

arco

tic

or P

sych

otro

pic

Subs

tanc

es”)

and

unde

r Ar

ticle

202

(1) (

“Una

utho

rised

Eng

agem

ent

in E

cono

mic

, Com

mer

cial

, Fin

anci

al o

r Pr

ofes

siona

l Act

iviti

es”)

of th

e CC

and

fina

l se

nten

ce o

f 2 y

ears

of r

estr

ictio

n of

libe

rty

was

impo

sed

(obl

igin

g to

wor

k 30

hou

rs fr

ee

of c

harg

e w

ithin

a y

ear f

rom

the

date

of e

ntry

in

to fo

rce

of th

e se

nten

ce in

hea

lth c

are,

car

e an

d w

elfa

re in

stitu

tions

or n

on-g

over

nmen

tal

orga

niza

tions

car

ing

for d

isabl

ed, e

lder

ly o

r ot

her p

eopl

e in

nee

d an

d du

ring

this

perio

d of

a se

nten

ce im

pose

d do

not

go

to <

...> (d

ata

not a

vaila

ble)

.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

17 Ja

nuar

y 20

20

Crim

inal

cas

e N

o.

1-10

2-93

5/20

20

J. B.

was

acc

used

of f

ailin

g to

com

ply

with

the

prov

isio

n of

Par

agra

ph 1

of A

rtic

le 1

9 of

th

e La

w o

n Ph

arm

acy

whi

ch s

ays

that

“pro

duct

ion

of m

edic

inal

pro

duct

s, in

vest

igat

iona

l m

edic

inal

pro

duct

s, im

port

from

third

cou

ntrie

s, w

hole

sale

dis

trib

utio

n of

med

icin

al

prod

ucts

, pha

rmac

y ac

tiviti

es a

re li

cens

ed p

harm

aceu

tical

act

iviti

es”;

also

of f

ailin

g to

com

ply

with

the

prov

isio

n of

Par

agra

ph 2

of t

he s

ame

artic

le a

ccor

ding

to w

hich

“le

gal p

erso

ns <

…>

shal

l be

issu

ed th

e fo

llow

ing

type

s of

lice

nses

: pro

duct

ion

licen

se;

who

lesa

le d

istr

ibut

ion

licen

se; p

harm

acy

licen

se a

nd m

anuf

actu

ring

phar

mac

y lic

ense

”; an

d of

faili

ng to

com

ply

with

the

prov

isio

ns o

f Par

agra

ph 9

of A

rtic

le 3

5 w

hich

dec

lare

s th

at “m

edic

inal

pro

duct

s sh

all b

e so

ld (i

ssue

d) to

the

popu

latio

n in

acc

orda

nce

with

the

proc

edur

e es

tabl

ishe

d by

the

Min

iste

r of H

ealth

”.

With

out e

stab

lishi

ng a

lega

l ent

ity a

nd w

ithou

t hav

ing

a lic

ense

for a

ny li

cens

ed

phar

mac

eutic

al a

ctiv

ity is

sued

by

the

Stat

e M

edic

ines

Con

trol

Ser

vice

, J. B

. sen

t at l

east

17

38 p

osta

l ite

ms

usin

g th

e se

rvic

es o

f Lith

uani

a’s P

ost a

nd th

us s

old

med

icin

al p

rodu

cts

for a

t lea

st 1

0 54

6 EU

R (fo

r exa

mpl

e, K

amag

ra S

ilden

afil 1

00 m

g, C

enfo

rce-

100

Sild

enafi

l Ci

trat

e 10

0 m

g, T

adar

ise

60 T

adal

afil 6

0 m

g, T

adac

ip 2

0 Ta

dala

fil 2

0 m

g, e

tc.).

By th

ese

actio

ns, J

. B. w

as a

ccus

ed o

f hav

ing

com

mitt

ed a

crim

inal

offe

nce

prov

ided

for i

n Pa

ragr

aph

1 of

Art

icle

202

of t

he C

C. <

…>.

(Acc

usat

ions

rega

rdin

g Ar

ticle

260

(1) a

nd 1

99(3

) of t

he C

C w

ill n

ot b

e fu

rthe

r des

crib

ed in

de

tails

).

By a

rulin

g of

Viln

ius

Regi

onal

Cou

rt, a

cr

imin

al c

ase

in w

hich

J. B

. is

accu

sed

of

com

mitt

ing

crim

inal

offe

nses

pro

vide

d fo

r in

Art

icle

202

(1) (

“Una

utho

rised

En

gage

men

t in

Econ

omic

, Com

mer

cial

, Fi

nanc

ial o

r Pro

fess

iona

l Act

iviti

es”)

, Art

icle

26

0(1)

(“U

nlaw

ful P

osse

ssio

n of

Nar

cotic

or

Psyc

hotr

opic

Sub

stan

ces

for t

he P

urpo

se

of D

istr

ibut

ion

Ther

eof o

r Unl

awfu

l Po

sses

sion

of a

Lar

ge Q

uant

ity o

f Nar

cotic

or

Psy

chot

ropi

c Su

bsta

nces

”) (t

en c

rimin

al

offen

ses)

and

Art

icle

199

(3) (

“Sm

uggl

ing”

) of

the

CC <

…>

acco

rdin

g to

the

rule

s of

ju

risdi

ctio

n w

as tr

ansf

erre

d to

Kau

nas

Regi

onal

Cou

rt.

Fina

l dec

isio

n of

the

Cour

t is

yet t

o co

me.

Crim

inal

cas

es re

gard

ing

Art

icle

204

(„U

se o

f Ano

ther

’s Tr

adem

ark

or S

ervi

ce M

ark“

) of

the

CC


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

29 N

ovem

ber 2

018

Crim

inal

cas

e N

o. 1

-83-

458/

201

8

The

accu

sed

V. V

. was

cha

rged

und

er A

rtic

le 2

04 o

f the

CC

by s

ellin

g th

e go

ods

bear

ing

the

third

mar

k w

ithou

t per

mis

sion

. The

acc

used

sen

t med

icin

es (t

able

ts in

she

ets)

to

Italy

, Spa

in, F

ranc

e an

d ot

her c

ount

ries.

In s

uch

a w

ay V

. V. m

arke

ted

good

s be

arin

g a

third

par

ty’s

bran

d (m

edic

ines

Via

gra,

Cia

lis, L

evitr

a, th

e de

sign

of w

hich

(mar

king

, la

bels

, tra

dem

arks

and

oth

er d

etai

ls) d

id n

ot m

eet t

he re

quire

men

ts o

f the

legi

timat

e m

anuf

actu

rers

.

The

accu

sed

V. V

. was

acq

uitt

ed o

n th

e gr

ound

that

no

act h

avin

g th

e ch

arac

ter o

f a

crim

e or

mis

dem

eano

r has

bee

n co

mm

itted

. Ac

cord

ing

to th

e ch

arge

aga

inst

him

for t

he

crim

e pr

ovid

ed fo

r in

Art

icle

204

of t

he C

C,

he c

ould

not

be

foun

d gu

ilty

on th

e so

le

grou

nd th

at th

e ne

cess

ary

char

acte

ristic

of

the

offen

se o

f cau

sing

ser

ious

har

m h

ad

not b

een

prov

ed. T

he a

mou

nt o

f goo

ds

unde

r the

third

-par

ty tr

ade

mar

k ha

s al

so

not b

een

prov

ed in

this

crim

inal

cas

e, a

nd

it w

as n

ot c

lear

why

med

icin

al p

rodu

cts

such

as

Cial

is a

nd L

evitr

a w

ere

liste

d as

not

m

eetin

g th

e re

quire

men

ts o

f the

legi

timat

e m

anuf

actu

rer.

Crim

inal

cas

es re

gard

ing

Art

icle

300

(„Fo

rger

y of

a D

ocum

ent o

r Pos

sess

ion

of a

For

ged

Doc

umen

t“) o

f the

CC

4 Ju

ne 2

015

Crim

inal

cas

e N

o.

1A-2

17-4

83/2

015

V. L

. was

acc

used

of f

alsi

fyin

g at

leas

t 13

pres

crip

tions

ent

itlin

g to

obt

ain

med

icat

ions

co

ntai

ning

psy

chot

ropi

c su

bsta

nces

. In

the

pres

crip

tions

V. L

. rec

orde

d fa

lse

data

abo

ut

the

pers

ons

or p

lace

d an

inva

lid im

prin

t on

them

, and

thus

pas

sed

thes

e pr

escr

iptio

ns

to v

ario

us p

erso

ns, i

llega

lly d

istr

ibut

ing

vario

us p

sych

otro

pic

subs

tanc

es o

n th

e ba

sis

of

thes

e fa

lse

pres

crip

tions

.

V. L

. was

foun

d gu

ilty

of th

e off

ence

und

er

Art

icle

300

(1) o

f the

CC,

the

Cour

t im

pose

d a

sent

ence

of 1

yea

r of i

mpr

ison

men

t.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

7 M

ay 2

019

Crim

inal

cas

e N

o.

1-14

7-29

0/20

19

A. D

. fal

sifie

d 11

pre

scrip

tions

of K

auna

s cl

inic

s (h

ospi

tal)

gran

ting

the

right

to p

urch

ase

med

icat

ions

con

tain

ing

psyc

hotr

opic

sub

stan

ces

– “z

olpi

dem

”, w

hich

is a

llow

ed to

be

use

d fo

r med

ical

pur

pose

s –

that

is, e

nter

ed in

the

pres

crip

tion

form

s pr

inte

d by

el

ectr

ogra

phic

prin

ting

fake

dat

a ab

out p

erso

ns a

nd a

llege

dly

pres

crib

ed m

edic

atio

n. B

y th

ese

actio

ns A

. D. c

omm

itted

a c

rime

prov

ided

for i

n A

rtic

le 3

00(1

) of t

he C

C.

In a

dditi

on, A

. D. i

llega

lly o

btai

ned

and

disp

osed

of a

ver

y la

rge

quan

tity

of 3

.6 g

of t

he

psyc

hotr

opic

sub

stan

ce z

olpi

dem

, whi

ch is

aut

horiz

ed fo

r med

ical

pur

pose

s, us

ing

forg

ed

pres

crip

tion

docu

men

ts. B

y su

ch a

ctio

ns, A

. D. c

omm

itted

a c

rime

prov

ided

for i

n A

rtic

le

260(

3) o

f the

CC.

A. D

. was

foun

d gu

ilty

of th

e off

ence

s un

der

Art

icle

260

(3) (

“Unl

awfu

l Pos

sess

ion

of

Nar

cotic

or P

sych

otro

pic

Subs

tanc

es fo

r the

Pu

rpos

e of

Dis

trib

utio

n Th

ereo

f or U

nlaw

ful

Poss

essi

on o

f a L

arge

Qua

ntity

of N

arco

tic

or P

sych

otro

pic

Subs

tanc

es”)

and

und

er

Art

icle

300

(1) (

“For

gery

of a

Doc

umen

t or

Poss

essi

on o

f a F

orge

d D

ocum

ent”

) of t

he

CC a

nd fi

nal a

ggre

gate

sen

tenc

e of

2 y

ears

of

rest

rictio

n of

libe

rty

was

impo

sed

oblig

ing

durin

g th

is p

erio

d to

be

at h

ome

from

24

:00

until

06:

00, i

f it i

s no

t rel

ated

to w

ork;

af

ter t

he e

nd o

f mat

erni

ty le

ave,

con

tinue

w

orki

ng o

r sta

rt w

orki

ng o

r reg

iste

ring

with

the

Empl

oym

ent S

ervi

ce; c

ontin

ue

trea

tmen

t for

dep

ende

nce

on p

sych

otro

pic

subs

tanc

es.


MEX

ICO

(pre

pare

d by

the

natio

nal c

onsu

ltant

Mr O

scar

GU

IZA

R)

Aft

er re

view

ing

seve

ral d

atab

ases

of o

pene

d offi

cial

sou

rces

from

diff

eren

t au

thor

ities

in M

exic

o in

term

s of

pub

lic in

form

atio

n, t

here

are

no

case

-law

or r

elev

ant

case

s av

aila

ble

to g

ener

al p

ublic

for c

onsu

ltatio

n, re

late

d to

crim

inal

pro

ceed

ings

for c

rimes

of f

alsi

fied

med

ical

pro

duct

or o

ther

sim

ilar o

ffens

es.

How

ever

, the

Per

man

ent M

issi

on o

f Mex

ico

to th

e Co

unci

l of E

urop

e pr

ovid

ed s

ome

info

rmat

ion

on P

ange

a O

pera

tion

in 2

020,

in w

hich

Mex

ican

aut

horit

ies

part

icip

ated

in

com

batin

g m

edic

ines

fals

ifyin

g cr

imes

. In

addi

tion,

som

e re

leva

nt n

ews

on th

is to

pic

wer

e fo

und

on th

e in

tern

et. I

t was

con

side

red

impo

rtan

t to

men

tion

them

in th

is

docu

men

t.

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

From

Mar

ch 3

rd to

10t

h,

2020

Mex

ican

aut

horit

ies

part

icip

ated

in “P

ange

a XI

II O

pera

tion”

. The

Gua

rdia

N

acio

nal (

fede

ral p

olic

e) c

arrie

d ou

t cyb

erse

curit

y ac

tions

(to

keep

the

inte

rnet

und

er o

bser

vatio

n), i

mpl

emen

ted

for t

he C

ovid

-19

pand

emic

, in

ord

er to

iden

tify

poss

ible

crim

es.

The

resu

lt of

thes

e ac

tiviti

es w

as th

e id

entifi

catio

n of

diff

eren

t pu

blic

atio

ns in

pro

files

of F

aceb

ook,

You

Tube

and

ano

nym

ous

web

site

s in

whi

ch fa

lsifi

ed m

edic

ines

, tes

ts a

nd tr

eatm

ents

ab

out C

ovid

-19

or o

ther

pro

duct

s of

Nov

irsa

and

Mes

ofra

nce

wer

e off

ered

and

sel

l ille

gally

. How

ever

, the

re is

no

info

rmat

ion

on a

ny c

rimin

al p

roce

edin

gs a

risin

g fr

om th

is o

pera

tion.

Mar

ch 1

8th,

202

18In

an

artic

le p

ublis

hed

in th

e ne

wsp

aper

El P

aís;

Mex

ican

aut

horit

ies

seiz

ed 5

,775

fake

dos

es o

f Spu

tnik

V v

acci

ne a

t the

inte

rnat

iona

l airp

ort

of C

ampe

che,

in th

e so

uth

of th

e co

untr

y, w

hich

wer

e on

a p

rivat

e ai

rcra

ft b

ound

for S

an P

edro

Sul

a, H

ondu

ras.

Ther

e ar

e st

ill n

o re

sults

from

the

crim

inal

pro

ceed

ings

in

stitu

ted

in th

is c

ase.

Mar

ch 7

th, 2

0209

Fift

y-fiv

e pa

tient

s un

derg

oing

hem

odia

lysi

s tr

eatm

ent i

n a

publ

ic

hosp

ital i

n Vi

llahe

rmos

a, M

exic

o, w

ere

adm

inis

tere

d a

cont

amin

ated

m

edic

ine

(Hep

arin

Sod

ium

). Th

ree

peop

le d

ied

and

fort

y-th

ree

wer

e ho

spita

lized

, six

of t

hem

in in

tens

ive

care

.

Com

plai

nts

wer

e fil

ed, b

ut th

e ou

tcom

e of

the

inve

stig

atio

ns

resu

lting

from

the

crim

inal

pro

ceed

ings

is u

nkno

wn.

Janu

ary

16th

, 201

710

Child

ren

suffe

ring

from

can

cer r

ecei

ved

fake

che

mot

hera

py in

pub

lic

hosp

itals

dur

ing

the

adm

inis

trat

ion

of G

over

nor J

avie

r Dua

rte

in th

e M

exic

an s

tate

of V

erac

ruz.

Dis

tille

d w

ater

, ins

tead

of m

edic

ines

, was

gi

ven

to th

em.

Ther

e is

stil

l no

resu

lt on

this

cas

e in

the

crim

inal

pro

ceed

ings

in

itiat

ed fo

r thi

s cr

ime.

The

info

rmat

ion

on th

is p

roce

edin

g is

no

t ava

ilabl

e to

gen

eral

pub

lic b

ecau

se it

is re

serv

ed.

8.

Thi

s ne

ws

is a

vaila

ble

at: h

ttps

://el

pais

.com

/mex

ico/

2021

-03-

18/d

ecom

isad

as-e

n-m

exic

o-m

as-d

e-50

00-d

osis

-fals

as-d

e-la

-vac

una-

rusa

-spu

tnik

-v.h

tml#

:~:te

xt=L

as%

20au

torid

ades

%20

mex

ican

as%

20ha

n%20

anun

ciad

o,V%

20co

n%20

dest

ino%

20a%

20H

ondu

ras.

9.

Thi

s ne

ws

can

be c

onsu

lted

at: h

ttps

://ar

iste

guin

otic

ias.c

om/0

703/

mex

ico/

pem

ex-c

onfir

ma-

terc

era-

mue

rte-

por-

med

icam

ento

s-co

ntam

inad

os/

10.

Thi

s ne

ws

is a

vaila

ble

at: h

ttps

://w

ww

.ani

mal

polit

ico.

com

/201

7/01

/yun

es-v

erac

ruz-

fals

as-q

uim

iote

rapi

as/

https://aristeguinoticias.com/0703/mexico/pemex-confirma-tercera-muerte-por-medicamentos-contaminados/

https://www.animalpolitico.com/2017/01/yunes-veracruz-falsas-quimioterapias/


MO

NTE

NEG

RO (p

repa

red

by th

e na

tiona

l con

sulta

nt M

r Milo

rad

MA

RKO

VIC)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

5 M

arch

202

0

Basi

c Co

urt i

n Ro

žaje

, Ca

se a

gain

st N

.J. fo

r cr

imin

al o

ffens

e of

U

nlaw

ful t

rade

und

er

Art

. 284

. par

a. 3

. in

conn

ectio

n w

ith p

aras

. 1

and

2 of

the

Crim

inal

Co

de o

f Mon

tene

gro

and

ML,

for t

he c

rimin

al

offen

se o

f U

nlaw

ful t

rade

in

aid

ing

unde

r Art

. 284

. pa

ra. 3

. in

conn

ectio

n w

ith p

aras

. 1 a

nd 2

in

conj

unct

ion

with

Art

. 25.

of

the

Crim

inal

Cod

e of

M

onte

negr

o.

On

15 Ja

nuar

y 20

20 in

Rož

aje,

N.J.

bou

ght g

oods

- m

edic

ines

with

out a

utho

rizat

ion,

who

se tr

ade

is

proh

ibite

d pu

rsua

nt to

the

prov

isio

ns o

f Art

icle

s 2 a

nd 3

of t

he L

aw o

n M

edic

inal

Pro

duct

s (O

ffici

al

Gaz

ette

of M

onte

negr

o N

o. 5

6/20

11 a

nd N

o. 6

/201

3), a

s fol

low

s: 8

boxe

s of c

otto

n w

ool (

Flas

ter)

“Fuc

idin

Inte

rtul

le”, 1

0 bo

xes o

f tre

atm

ent fl

uid

(360

ml)

“Ren

u “,

10 b

oxes

of t

reat

men

t liq

uid

(120

m

l)” R

enu

“, 8

boxe

s of t

able

ts (3

00 m

l)” P

ropa

ten

“, 8

boxe

s of c

apsu

les (

600

mg)

” Ber

lithi

n “,

18 b

oxes

of

tabl

ets (

15 m

g)” T

rittic

o re

tard

“, 10

pie

ces o

f eye

dro

ps (5

ml),

smal

l bot

tles o

f Ful

ucon

, 2 b

oxes

of

tabl

ets (

5 gm

/ 80

mg)

“Exf

orge

”, 58

boxe

s of c

apsu

les “

Cefa

lesk

in H

F”, 2

0 bo

xes o

f tab

lets

(4 m

g)

“Med

rol”,

19

boxe

s tab

let (

300

mg)

“Clin

dam

ycin

MIP

”, 25

boxe

s of t

able

ts (6

00 m

g) “C

linda

myc

in”

MIP

“, 20

box

es (3

00 m

g) a

mpo

ules

of”

Clin

dam

ycin

“, 50

box

es (4

mg)

of t

able

ts” C

intr

om “,

10 b

oxes

) Fr

isiu

m ta

blet

s, 30

box

es (5

mg)

Cos

pot e

ye d

rops

, 3 b

oxes

(20

mg)

Hyd

roco

rtis

one

tabl

ets,

40 b

oxes

(5

00 m

g) C

ipro

cina

l tab

lets

, 29

boxe

s (50

mg)

gel

1 %

“Vol

tare

n Em

vleg

el”, 1

0 bo

xes (

25 m

g) ta

blet

s “P

razi

ne”, 1

01 b

oxes

(0.5

mg

/ 1 m

g / 1

0 m

g) o

intm

ent “

Trid

erm

”, 5 b

oxes

of f

ood

for s

peci

al h

oney

in

tent

ions

“Car

tlnom

”, 3 b

oxes

of g

el 2

% “V

olta

ren

Emul

gel”,

3 b

oxes

(150

mg)

tabl

ets “

Irben

ida”

, 106

bo

xes o

f fat

0.1

% (1

5 g)

“Elo

com

”, 5 b

oxes

of t

albe

t (60

mg)

“ D

laap

rel M

R “,

48 b

oxes

of e

ye d

rops

(5

ml)

0.2%

” Alp

haga

n “,

5 bo

xes o

f am

poul

es” D

epos

elin

“, 9

boxe

s of t

able

ts (2

mg)

” Ris

sar “

, 5 b

oxes

of

tabl

ets (

75 m

g)” V

elaf

ax “,

7 bo

xes o

f cap

sule

s (15

0 m

g) “D

ifluc

an”, 2

box

es o

f tab

lets

(2 m

g / 0

.03

mg)

“Jea

nin”

, 2 b

oxes

of t

able

ts (3

7.5)

“Vel

afax

”, 5 b

oxes

of t

able

ts (5

00 m

g) “S

umam

ed”, 1

0 bo

xes o

f ta

blet

s (20

mg)

“Hpl

lest

a”, 1

0 bo

xes o

f eye

dro

ps (1

mg

/ ml)

“Nev

anac

”, 14

boxe

s of t

able

ts (4

00 m

g)

“Pan

ce”, 1

00 b

oxes

of t

able

ts (4

00 m

g) “B

actr

im”, 5

box

es ta

blet

s (16

0 m

g / 1

2.5

mg)

“Val

saco

mbi

”, 13

box

es o

f tab

lets

(50

mg)

“Zol

oft”,

24

boxe

s of t

able

ts (3

5 m

g) “P

rodu

ctal

MR”

, 5 b

oxes

of t

able

ts

(2.5

mg

/ 6.2

5 m

g ) “

Lodo

z”, 3

box

es o

f cap

sule

s (75

mg)

“Lyr

ica”

, 10

boxe

s of t

able

ts (2

mg)

“Riv

atril

”, 5

boxe

s of t

able

ts (5

mg)

“Nor

vasc

”, 8 b

oxes

of t

able

ts (1

0 m

g) “N

orva

sc”, 6

box

of t

able

ts (4

0 m

g)

“Sor

tis”, 6

box

es o

f tab

lets

(2 0

mg)

“Sor

tis”, 2

9 bo

xes o

f sol

utio

n fo

r inh

alat

ion

(5 m

g / m

l) “S

palm

otil”

, 14

box

es o

f tab

lets

(500

mg)

“Orv

agil”

, 40

boxe

s of c

apsu

les (

100

mg)

“Gab

agam

ma

100”

,2 b

oxes

of

tabl

ets m

g) V

elaf

ax, 5

box

es o

f Row

acho

l cap

sule

s, 20

box

es o

f tab

lets

(30

mg)

Cal

ixt,

50 b

oxes

of

tabl

ets

(5 m

g) X

yzal

, 8 b

oxes

of R

oacc

utab

cap

sule

s, 15

box

es o

f cap

sule

s 20

mg)

“Roa

ccut

ab”,

5 bo

xes

of c

apsu

les

(120

mg)

“Xen

ical

”, 6

boxe

s of

tabl

ets

(4 m

g) “S

irdal

ud”,

4 bo

xes

of o

intm

ent

(1x5

0 g)

“Ben

gal”,

4 b

oxes

of t

able

ts “N

imul

id M

D”,

10 b

oxes

of t

able

ts (2

50 m

g) O

rvag

il, 1

0 bo

xes

of ta

blet

s (5

0 m

g) H

emop

ress

, 10

boxe

s of

1%

gel

(20

mg)

Clin

daso

me,

20

boxe

s of

tabl

ets

(60

mg

/ 2.5

mg)

Rin

asec

, 40

boxe

s ta

blet

(2 m

g) “C

lona

zepa

m R

emed

ica”

, 70

boxe

s of

tabl

ets

(20

mg)

“F

amat

idin

e H

F”, 4

0 bo

xes

of e

ye d

rops

(1 m

g / m

l 3.5

mg)

“Neo

dexa

cin”

, 30

boxe

s of

eye

oin

tmen

t 1%

(5 g

) “C

hlor

amph

enco

l”, 4

6 bo

xes

of ta

blet

s (5

mg)

“Dia

zepa

m H

F”, 4

0 bo

xes

of o

intm

ents

(10

ml)

“Dex

amet

haso

n”, 1

0 bo

xes

of ta

blet

s (2

0 m

g) “C

ialis

”, 10

box

es o

f tab

lets

(50

mg)

“Im

i gra

n ‘,2

0 bo

xes

of ta

blet

s (5

mg)

’ Neb

ilet ‘,

18

boxe

s of

nas

al s

pray

s (1

8 g)

’ Nas

onex

‘, 4

pain

kille

rs (5

9 m

l)’

Biof

reez

e ‘, 5

box

es o

f nas

al s

pray

s’ Av

amys

’, 50

box

of ta

blet

s (5

mg

/ 25

mg)

“Trit

ace”

, 11

boxe

s of

ta

blet

s (7

5 m

g) “P

lavi

x”, 5

box

es o

f tab

lets

(5 m

g) “V

azot

al”,

15 b

oxes

of t

able

ts (5

mg)

“Aer

ius”,

N.J.

was

sen

tenc

ed to

impr

ison

men

t fo

r a te

rm o

f 3 (t

hree

) mon

ths.

M.L

. was

impo

sed

a Co

nditi

onal

Se

nten

ce m

eani

ng th

at th

e Co

urt

sent

ence

d hi

m to

impr

ison

men

t for

a

term

of 3

(thr

ee) m

onth

s w

hich

se

nten

ce s

hall

not b

e ex

ecut

ed if

the

defe

ndan

t doe

s no

t com

mit

a ne

w

crim

inal

offe

nse

with

in o

ne y

ear.

The

good

s of

unl

awfu

l tra

de w

ere

confi

scat

ed.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

40 b

oxes

of t

able

ts (

100

mg)

“Nim

ulid

”, 10

box

es o

f tab

lets

(6.2

5 m

g) “D

ilatr

end”

, 5 b

oxes

of

tabl

ets

(50

mic

rogr

ams)

“Let

rox

50”,

10 b

oxes

of t

able

ts (2

00 m

g) F

ebric

it, 3

box

es o

f tab

lets

(300

m

g) “I

rben

id “,

3 bo

xes

of c

apsu

les

(22%

gam

ma)

” Ala

nerv

“, 5

boxe

s of

tabl

ets

(24

mg)

” Bet

aser

c “,

9 bo

xes

of e

ye d

rops

(2.5

ml)”

Xal

atan

“, 80

box

es o

f tab

lets

(500

mg)

” Ede

mid

“ , 2

box

es o

f syr

up

(0.5

mg

/ ml)

“Aer

ius”,

as

wel

l as

good

s in

gen

eral

use

(lis

ted

in ju

dgm

ent)

s fo

r the

pur

pose

of

selli

ng th

e sa

me

on th

e te

rrito

ry o

f Mon

tene

gro.

On

15 Ja

nuar

y 20

20, i

n Ro

žaje

, M. L

., be

ing

fully

aw

are

of h

is a

ctio

ns w

hich

he

will

ingl

y co

mm

itted

, kno

win

g th

em to

be

proh

ibite

d, h

elpe

d N

.J. in

the

com

mis

sion

of t

he c

rimin

al

offen

se o

f unl

awfu

l tra

de u

nder

Art

. 284

, par

a. 3

in c

onne

ctio

n w

ith p

aras

. 1 a

nd 2

of t

he

Crim

inal

Cod

e of

Mon

tene

gro,

by

mak

ing

avai

labl

e to

him

a m

otor

veh

icle

bra

nd “V

W”,

type

“P.”,

regi

stra

tion

num

ber R

O ..

., by

whi

ch h

e tr

ansp

orte

d go

ods

that

he

had

prev

ious

ly ta

ken

over

fr

om a

n un

know

n pe

rson

, and

whi

ch w

as b

ough

t by

N.J.

11 Ju

ne 2

019

Basi

c Co

urt i

n Bi

jelo

Po

lje: C

ase

agai

nst D

.B.

for c

rimin

al o

ffens

e of

U

nlaw

ful t

rade

und

er

Art

. 284

. Par

a. 3

in

conn

ectio

n w

ith p

ara.

2

of th

e Cr

imin

al C

ode

of

Mon

tene

gro

On

3 M

arch

201

9, in

Bel

grad

e, R

epub

lic o

f Ser

bia,

D.B

. una

utho

rized

ly b

ough

t goo

ds w

hose

tr

ade

is p

rohi

bite

d, p

ursu

ant t

o th

e pr

ovis

ions

of A

rts.

2 an

d 3

of th

e La

w o

n M

edic

inal

Pro

duct

s (“

Offi

cial

Gaz

ette

of M

onte

negr

o”, N

o. 5

6/20

11 a

nd N

o. 6

/201

3), a

s fo

llow

s: 1

7 bo

xes

of 1

2 ta

blet

s an

d on

e bo

x of

8 ta

blet

s “Ka

mag

re 1

00 g

old”

, as

wel

l as

30 a

box

of 4

“Kam

agra

” can

dies

, in

the

tota

l val

ue o

f EU

R 38

0.00

, for

the

purp

ose

of s

ale

on th

e te

rrito

ry o

f Mon

tene

go.

D.B

. was

foun

d gu

ilty

and

impo

sed

a Co

mm

unity

Ser

vice

sen

tenc

e fo

r a p

erio

d of

180

(one

hun

dred

an

d ei

ghty

) hou

rs, w

hich

is to

be

exec

uted

in a

per

iod

of 3

(thr

ee)

mon

ths

afte

r the

judg

men

t bec

omes

fin

al.

If th

e de

fend

ant d

oes

not s

erve

Co

mm

unity

Ser

vice

sen

tenc

e,

the

sent

ence

sha

ll be

repl

aced

by

impr

ison

men

t sen

tenc

e, b

y re

plac

ing

ever

y st

arte

d 60

(six

ty) h

ours

of w

ork

in th

e pu

blic

inte

rest

with

a 1

(one

) m

onth

of i

mpr

ison

men

t sen

tenc

e.

The

good

s of

unl

awfu

l tra

de w

ere

confi

scat

ed.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

6 Ju

ne 2

019

Basi

c Co

urt i

n Bi

jelo

Pol

je:

Case

aga

inst

A.H

. for

th

e cr

imin

al o

ffens

e of

U

nlaw

ful t

rade

und

er A

rt.

284

para

. 3 in

con

nect

ion

with

par

as. 1

and

2 o

f th

e Cr

imin

al C

ode

of

Mon

tene

gro.

On

16 M

arch

201

9, in

B. -

RS,

for t

he p

urpo

se o

f sal

e on

the

terr

itory

of t

he M

unic

ipal

ity o

f B.,

A.H

. un

auth

oris

edly

bou

ght d

rugs

of a

tota

l val

ue o

f EU

R 5,

406.

39, a

s fo

llow

s: 1

5 pi

eces

of t

ape

for

mea

surin

g su

gar “

AKK

YČEK

”, 58

pie

ces

of d

rops

for e

yes “

Alm

agan

”, 16

pie

ces “

Fris

ivm

” of 1

0mg,

62

pie

ces

of “V

erm

ox” o

f 100

mg,

10

piec

es o

f “D

ieyn

one”

of 2

50m

g, 1

0 pi

eces

of “

Tens

ec” o

f 5m

g,

5 pi

eces

of “

Lior

esal

” of 2

5mg,

30

piec

es o

f “Tr

usco

pt” 2

%, 2

pie

ces

of “N

imul

id M

D” o

f 100

mg,

5

piec

es o

f “Li

ores

al” o

f 10m

g, 1

0 pi

eces

of “

Mol

dam

in”,

22 p

iece

s of

“Nib

elet

plu

s” o

f 5 /

5mg,

20

piec

es o

f “Tr

imet

acor

MR”

of 3

5mg,

10

piec

es o

f “Ta

naka

n “o

f 40m

g, 5

pie

ces

of” L

etro

x “of

50m

g,

3 pi

eces

of”

Let

rox “

of 1

00m

g, 1

5 pi

eces

of”

Tan

akan

40

“MG

/ 30

, 45

piec

es o

f” C

ontr

oloc

“of

40m

g, 2

5 pi

eces

of”

Imig

ran

“of 5

0mg,

40

piec

es o

f” S

erox

at 2

0mg,

53

piec

es “C

limar

a”, 1

0 pi

eces

“A

lane

rv”,

10 p

iece

s “Lo

doz”

2,5

mg

/ 6,2

5mg,

20

piec

es “F

lasi

n” o

f 0,4

mg,

30

piec

es “P

redu

ctal

M

R” o

f 35m

g, 5

0 pi

eces

“Nim

ulid

” of 1

00m

g, 2

0 pi

eces

of “

Reso

com

in”,

6 pi

eces

of “

Nim

ulid

MD

” of

100

mg,

20

piec

es o

f “Ri

votr

il” o

f 2 m

g, 2

0 pi

eces

of “

Espe

ral”

of 5

00m

g, 1

0 pi

eces

of “

Tren

tal”

of 4

00m

g, 2

5 pi

eces

of “

Tam

sol”

of 0

.4m

g, 2

0 pi

eces

of “

Panc

ef” o

f 400

mg,

20

piec

es o

f “La

ta” o

f 10

mg,

15

piec

es o

f “A

toris

” of 1

0mg,

30

piec

es o

f “Co

ncor

cor

” of 2

.5m

g, 4

5 pi

eces

of “

Neb

ilet”

of

5mg,

16

piec

es o

f “Le

tizen

S” o

f 10m

g, 4

pie

ces

of “V

alsa

cor”

of 1

60m

g, 2

0 pi

eces

of “

Conc

or” o

f 5m

g, 1

5 pi

eces

of “

Oik

amid

“of 4

00m

g, 1

pie

ce o

f” V

elaf

ax “o

f 75m

g, 7

pie

ces

of” X

vzal

“of 5

mg

/ 10,

6 p

iece

s of

” Xvz

al “o

f 5m

g / 3

0, 2

pie

ces

of” L

oris

ta H

D “1

00m

g / 2

5, 4

0 pi

eces

of”

Pla

vix “

of

75m

g, 1

0 pi

eces

of “

Lodo

z” o

f 5 m

g / 6

.25

mg

and

20 p

iece

s of

“Hem

omye

in” o

f 500

mg,

trad

e of

w

hich

dru

gs fo

r ind

ivid

uals

is p

rohi

bite

d, p

ursu

ant t

o A

rt. 2

of t

he L

aw o

n M

edic

inal

Pro

duct

s (“

Offi

cial

Gaz

ette

of M

onte

negr

o” N

o. 5

6/11

of 2

5 N

ovem

ber 2

011,

No.

6/1

3 of

31

Janu

ary

2013

), an

d w

hich

med

icin

al p

rodu

cts

wer

e fo

und

in h

is p

osse

ssio

n du

ring

the

cont

rol c

arrie

d ou

t by

Bord

er P

olic

e offi

cers

.

A.H

. was

foun

d gu

ilty

and

sent

ence

d fo

r o

n im

pris

onm

ent f

or a

term

of 3

(t

hree

) mon

ths.

The

good

s of

unl

awfu

l tra

de w

ere

confi

scat

ed.

4 Se

ptem

ber 2

018

Basi

c Co

urt i

n Bi

jelo

Po

lje: C

ase

agai

nst I

.S.A

fo

r crim

inal

offe

nse

of

Unl

awfu

l tra

de u

nder

A

rt. 2

84 p

ara.

3. i

n co

nnec

tion

with

par

a. 2

of

the

Crim

inal

Cod

e of

M

onte

negr

o

On

13 Ju

ne 2

018,

in N

.P., R

epub

lic o

f Ser

bia,

alth

ough

he

knew

that

his

act

was

pro

hibi

ted,

I.S.

A.

boug

ht u

naut

horiz

ed g

oods

who

se tr

ade

is li

mite

d, p

ursu

ant t

o th

e pr

ovis

ions

of A

rt. 2

and

3 o

f th

e La

w o

n M

edic

inal

Pro

duct

s (O

ffici

al G

azet

te o

f Mon

tene

gro

No.

56/

2011

and

No.

6/1

2013

), va

rious

type

s of

med

icin

al p

rodu

cts,

as fo

llow

s: 1

0 bo

xes

of “H

ypol

ip” 1

0 m

g; 1

0 bo

xes

of

“Hyp

olip

” 20

mg;

5 b

oxes

of D

iapr

el 6

0 m

g; 5

box

es o

f Riv

otril

2 m

g; 5

box

es o

f ‘’ A

lpha

gan

‘’ 5 m

l. 3

boxe

s of

‘’ Ve

lafa

x ‘’ 7

5 m

g; 4

box

es o

f ‘’ X

enic

al ‘’

120

mg.

10

boxe

s of

Ber

lithi

on 6

00 m

g; 1

3 bo

xes

of D

ilatr

end

12.5

mg;

10

boxe

s “Ri

sar”

2 m

g; 9

box

es o

f “Le

pone

x” 2

5 m

g; 2

box

es o

f Roa

ccut

an 2

0 m

g; 4

5 bo

xes ‘

’ Dee

p Re

lief ‘

’ 50

gr; 5

box

es o

f “Va

lsac

ombi

” 80

mg

and

30 b

oxes

of “

Xyza

l” 5

mg,

in

the

tota

l val

ue o

f EU

R 1,

084.

50, f

or th

e pu

rpos

e of

sel

ling

it on

the

terr

itory

of M

onte

negr

o.

I.S.A

. was

impo

sed

a Co

nditi

onal

Se

nten

ce.

Cour

t sen

tenc

ed h

im to

im

pris

onm

ent f

or a

term

of 3

(thr

ee)

mon

ths

whi

ch s

ente

nce

shal

l not

be

exec

uted

if th

e de

fend

ant d

oes

not

com

mit

a ne

w c

rimin

al o

ffens

e w

ithin

on

e ye

ar.

The

good

s of

unl

awfu

l tra

de w

ere

confi

scat

ed.

MO

ROCC

O N

o su

bmis

sion

has

bee

n re

ceiv

ed o

n ca

se la

w fr

om th

e na

tiona

l con

sulta

nt


NO

RTH

MA

CED

ON

IA (p

repa

red

by th

e na

tiona

l con

sulta

nt M

s A

leks

andr

a D

EAN

OSK

A –

TRE

ND

AFI

LOVA

)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Publ

ic P

rose

cutio

n O

ffice

for

Pros

ecut

ion

of O

rgan

ized

Crim

e an

d Co

rrup

tion,

Nov

embe

r 202

0

The

Publ

ic P

rose

cutio

n O

ffice

for P

rose

cutio

n of

Org

aniz

ed C

rime

and

Corr

uptio

n (P

POPO

CC) t

ook

the

(bel

ow m

entio

ned)

cas

e fr

om th

e Pu

blic

Pro

secu

tion

Offi

ce a

s th

e pr

e-in

vest

igat

ion

sugg

este

d po

ssib

le p

artic

ipat

ion

of m

any

subj

ects

and

in N

ovem

ber

2020

sei

zed

docu

men

ts fr

om s

ever

al d

rug/

med

ical

who

lesa

lers

in re

spec

t of p

aral

lel

impo

rt o

f med

icin

al p

rodu

ct a

nd a

llega

tions

of f

alsi

fied

med

icin

es im

port

.

Ong

oing

pro

cedu

re (T

he p

re-

inve

stig

atio

n pr

oced

ure

is s

ecre

t ac

cord

ing

to th

e la

w a

nd n

o de

tails

can

be

dis

clos

ed).

Publ

ic P

rose

cutio

n O

ffice

, D

ecem

ber 2

017

The

Publ

ic P

rose

cutio

n O

ffice

ope

ned

a ca

se/in

vest

igat

ion

in re

spec

t of d

oubt

s on

pa

ralle

l im

port

of m

edic

al p

rodu

cts

with

sus

pici

ous

qual

ity, p

ossi

bly

fals

ified

med

ical

pr

oduc

ts.

The

case

was

initi

ated

by

the

PPO

but

th

en ta

ken

by th

e PP

OO

C an

d is

stil

l in

proc

edur

e (s

ee e

xpla

natio

n ab

ove)

.

Cust

oms

Adm

inis

trat

ion,

201

9Th

e Cu

stom

s Ad

min

istr

atio

n offi

ce in

the

annu

al re

port

for 2

019

stat

ed th

at it

has

de

terr

ed 7

cas

es o

f med

icin

es a

nd m

edic

al p

rodu

cts

smug

glin

g an

d se

ized

819

pie

ces

of s

urgi

cal m

ater

ials

and

inst

rum

ents

.(S

ourc

e: C

usto

ms

Adm

inis

trat

ion

Ann

ual R

epor

ts, a

vaila

ble

only

in M

aced

onia

n La

ngua

ge o

n: h

ttps

://cu

stom

s.gov

.mk)

N/A

Cust

oms

Adm

inis

trat

ion,

201

8Th

e Cu

stom

s Ad

min

istr

atio

n offi

ce in

the

annu

al re

port

for 2

018

stat

ed th

at it

has

de

terr

ed 1

3 ca

ses

of m

edic

ines

and

med

ical

pro

duct

s sm

uggl

ing

and

seiz

ed 4

1.78

6 pi

eces

of m

edic

inal

pro

duct

s.(S

ourc

e: C

usto

ms

Adm

inis

trat

ion

Ann

ual R

epor

ts, a

vaila

ble

only

in M

aced

onia

n La

ngua

ge o

n: h

ttps

://cu

stom

s.gov

.mk)

Crim

inal

or m

isde

mea

nour

repo

rts

have

be

en fi

led

resp

ectiv

e to

the

case

. 11

Cust

oms

Adm

inis

trat

ion,

201

756

.000

pie

ces

of m

edic

inal

pro

duct

s ha

ve b

een

seiz

ed in

10

case

s by

the

Cust

oms

Adm

inis

trat

ion.

(S

ourc

e: C

usto

ms

Adm

inis

trat

ion

Ann

ual R

epor

ts, a

vaila

ble

only

in M

aced

onia

n La

ngua

ge o

n: h

ttps

://cu

stom

s.gov

.mk)

Crim

inal

or m

isde

mea

nour

repo

rts

have

be

en fi

led

resp

ectiv

e to

the

case

.

Cust

oms

Adm

inis

trat

ion,

201

617

.400

pie

ces

of m

edic

inal

pro

duct

s ha

ve b

een

seiz

ed in

17

case

s by

the

Cust

oms

Adm

inis

trat

ion.

(S

ourc

e: C

usto

ms

Adm

inis

trat

ion

Ann

ual R

epor

ts, a

vaila

ble

only

in M

aced

onia

n La

ngua

ge o

n: h

ttps

://cu

stom

s.gov

.mk)

Crim

inal

or m

isde

mea

nour

repo

rts

have

be

en fi

led

resp

ectiv

e to

the

case

.

11.

Sin

ce th

ere

is n

o sp

ecifi

c in

crim

inat

ion

for c

usto

ms r

elat

ed c

rimes

in re

spec

t of m

edic

inal

pro

duct

s, no

follo

w u

p in

form

atio

n is

pro

vide

d or

can

be o

btai

ned,

unl

ess a

larg

e –

scal

e re

sear

ch is

und

erta

ken

cove

ring

all t

he

cour

ts a

nd sm

uggl

ing

case

s in

the

coun

try

in o

rder

to d

eter

min

e ho

w m

any

and

whi

ch o

nes i

nclu

de m

edic

inal

pro

duct

s. Th

e au

thor

of t

his a

sses

smen

t mad

e in

terv

iew

s and

cont

acts

in th

is re

spec

t reg

ardi

ng th

e bi

gges

t cr

imin

al co

urt i

n th

e co

untr

y (C

rimin

al C

ourt

of S

kopj

e) a

nd n

o su

ch ca

ses a

ppea

red

to e

xist

in th

e ju

dici

al p

ract

ice

of th

is c

ourt

.)


NO

RWAY

(pre

pare

d by

the

natio

nal c

onsu

ltant

Ms

Belin

da F

ORS

STEN

)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

2015

-06-

01

TGJO

V-20

15-2

6193

http

s://

lovd

ata.

no/p

ro/a

vgjo

rels

e/tg

jov-

201

5-26

193

Pers

on A

was

sen

tenc

ed to

com

mun

ity s

ervi

ce fo

r the

sal

e an

d st

orag

e of

dop

ing

subs

tanc

es, a

s w

ell a

s th

e im

port

and

sal

e of

m

elan

otan

thro

ugh

his

own

onlin

e st

ore.

He

was

als

o co

nvic

ted

of n

eglig

ent p

osse

ssio

n of

dr

ugs.

Ano

ther

man

was

als

o se

nten

ced

to c

omm

unity

ser

vice

for

com

plic

ity.

Viol

atio

n of

ECH

R ar

t. 6

(tria

l with

in a

reas

onab

le ti

me)

, whi

ch w

as

com

pens

ated

for i

n th

e se

nten

cing

. Sta

tem

ents

abo

ut w

hat t

he

norm

al le

vel o

f pun

ishm

ent f

or a

sim

ilar c

rime

wou

ld h

ave

been

if

the

ECH

R ar

t. 6

had

been

com

plie

d w

ith.

A a

dmitt

ed to

hav

ing

sold

Mel

anot

an a

nd d

opin

g su

bsta

nces

for a

to

tal o

f NO

K 1,

032,

975.

Gro

ss p

rofit

s ar

e su

bjec

t to

confi

scat

ion,

but

it is

not

per

mis

sibl

e to

co

nfisc

ate

the

sam

e am

ount

repe

ated

ly.

Aft

er a

dis

cret

iona

ry a

sses

smen

t, w

here

spe

cial

em

phas

is is

pl

aced

on

the

limite

d pi

ctur

e of

evi

denc

e pr

esen

ted

to th

e co

urt

rega

rdin

g th

e ba

sis

for t

he c

onfis

catio

n, th

e co

urt h

as c

ome

to

the

confi

scat

ion

set i

n lin

e w

ith th

e pr

osec

utio

n’s

prop

osal

of N

OK

400,

000.

Pers

on B

adm

itted

to h

avin

g re

ceiv

ed m

oney

for t

he se

rvic

es h

e pe

rfor

med

for A

and

thes

e w

ere

a pr

ereq

uisi

te fo

r the

impo

rt

and

sale

of M

elan

otan

. A e

stim

ated

that

the

cons

ider

atio

n w

as

betw

een

NO

K 10

,000

and

15,

000.

The

cou

rt fo

und

the

cond

ition

s for

co

nfisc

atio

n to

be

pres

ent a

nd th

e co

nfisc

atio

n am

ount

for p

erso

n B

wer

e se

t to

NO

K 10

,000

.

The

pers

on A

wer

e co

nvic

ted

of v

iola

tion

of th

e M

edic

ines

Act

§ 3

1 (1

) and

(2),

cf. (

3) a

nd §

16

as w

ell a

s th

e M

edic

ines

Act

§ 3

1 (1

), cf

. §

13, c

f. re

gula

tions

on

the

man

ufac

ture

and

impo

rt o

f med

icin

es §

3-

2.

Pers

on A

wer

e se

nten

ced

to c

omm

unity

pun

ishm

ent f

or 6

8 ho

urs

with

an

exec

utio

n tim

e of

90

days

. The

sub

sidi

ary

pris

on s

ente

nce

was

impr

ison

men

t for

75

days

.

NO

K 40

0,00

0 w

hich

per

son

A a

cqui

red

from

the

sale

s of

bot

h dr

ugs

and

med

ical

pro

duct

s w

ere

confi

scat

ed.

Plea

se n

ote

that

the

pers

on a

lso

was

con

vict

ed o

f oth

er d

rug

rela

ted

crim

es, w

hich

wer

e a

part

of t

he p

unis

hmen

t as

stat

ed

abov

e.

The

pers

on B

wer

e co

nvic

ted

of c

ontr

ibut

ion

of th

e vi

olat

ion

of th

e M

edic

ines

Act

§ 3

1 (1

), cf

. (3)

, cf.

§ 16

. T M

edic

ines

Act

§ 3

1 (1

), cf

. §

13, c

f. re

gula

tions

on

the

man

ufac

ture

and

impo

rt o

f med

icin

es §

3-

2.

Pers

on A

wer

e se

nten

ced

to c

omm

unity

pun

ishm

ent f

or 3

0 ho

urs

with

an

exec

utio

n tim

e of

75

days

. The

sub

sidi

ary

pris

on s

ente

nce

wer

e im

pris

onm

ent f

or 3

3 da

ys.

Pers

on B

wer

e se

nten

ced

to e

ndur

e co

nfisc

atio

n of

NO

K 10

,000

.

https://lovdata.no/pro/avgjorelse/tgjov-%202015-26193




PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

2014

-05-

16

LG-2

014-

3888

4

http

s://

lovd

ata.

no/p

ro/a

vgjo

rels

e/lg

- 201

4-38

884

The

Dis

tric

t Cou

rt s

ente

nced

the

45-y

ear-

old

pers

on fo

r vio

latio

n of

the

Med

icin

es A

ct §

31

(1),

cf. t

hird

par

agra

ph c

f. §

16. T

he

Med

icin

es A

ct §

31

(1),

cf. §

13

cf. r

egul

atio

ns o

n m

anuf

actu

re a

nd

impo

rt o

f med

icin

es §

3-2

, to

impr

ison

men

t for

90

days

.N

OK

500,

000

wer

e co

nfisc

ated

.Th

e pe

rson

app

eale

d to

the

Cour

t of A

ppea

l.Th

e pe

rson

wer

e se

nten

ced

to 6

0 da

ys p

roba

tion

with

the

addi

tion

of

a fin

e of

NO

K. 1

0.00

0 fo

r ille

gal i

mpo

rt a

nd re

sale

of a

n un

appr

oved

dr

ug, M

elan

otan

, whi

ch i.a

. was

mar

kete

d to

giv

e us

ers t

an.

Due

to th

e ca

se’s

stay

with

the

polic

e, th

e pr

ison

sen

tenc

e w

as

mad

e co

nditi

onal

, cf.

ECH

R ar

t. 6

and

art.

13.

The

Cour

t of A

ppea

l rej

ecte

d th

e ap

peal

aga

inst

the

dist

rict c

ourt

’s co

nfisc

atio

n of

div

iden

ds o

f NO

K 50

0 00

0.

The

pris

on s

ente

nce

wer

e th

en s

et a

t 60

days

, whi

ch w

ere

mad

e co

nditi

onal

on

a pr

obat

iona

ry p

erio

d of

2 y

ears

.

In a

dditi

on, a

n un

cond

ition

al fi

ne o

f NO

K 10

.000

wer

e im

pose

d,

subs

idia

ry im

pris

onm

ent f

or 1

5 da

ys.

Oth

erw

ise,

the

appe

al is

reje

cted

2014

-05-

06

TSTR

O-2

013-

8302

1

http

s://

lovd

ata.

no/p

ro/a

vgjo

rels

e/ts

tro-

201

3-83

021

The

case

con

cern

s th

e pr

oduc

tion,

sto

rage

and

sal

e of

dop

ing

subs

tanc

es, d

opin

g-re

late

d dr

ugs

and

coun

terf

eit d

rugs

in

the

perio

d 20

05 -

2012

, as

wel

l as

crim

inal

act

s co

mm

itted

in

conn

ectio

n w

ith th

is a

ctiv

ity. F

or s

ix o

f the

sev

en d

efen

dant

s, it

is

a ce

ntra

l iss

ue w

heth

er th

e cr

imin

al a

cts

have

bee

n co

mm

itted

as

part

of t

he a

ctiv

ities

of a

n or

gani

zed

crim

inal

gro

up.

Serio

us v

iola

tion

of th

e do

ping

pro

visi

on. O

rgan

ized

crim

inal

gr

oup.

Pro

duct

ion

and

sale

of d

opin

g su

bsta

nces

(app

rox.

50

kg

activ

e su

bsta

nce)

. The

pun

ishm

ent e

spec

ially

sha

rpen

ed fo

r tho

se

with

lead

ing

role

s, al

so s

harp

ened

pun

ishm

ent f

or th

e cu

lprit

. Im

pris

onm

ent f

or a

pris

oner

of 7

yea

rs, a

nd c

onfis

catio

n of

3

mill

ion.

The

ver

dict

dis

cuss

es th

e Su

prem

e Co

urt’s

cas

e la

w o

n se

nten

cing

for d

opin

g off

ense

s

Pers

on A

wer

e se

nten

ced

to p

rison

for 6

mon

ths

and

confi

scat

ion

of N

OK

450.

000

in a

dditi

on to

the

drug

s as

list

ed in

the

judg

men

t.Pe

rson

B w

ere

sent

ence

d to

pris

on fo

r 7 y

ears

and

con

fisca

tion

of

NO

K 3

000

000

in a

dditi

on to

the

drug

s as

list

ed in

the

judg

men

t.Pe

rson

C w

ere

sent

ence

d to

pris

on fo

r 6 y

ears

and

the

confi

scat

ion

of N

OK

2.60

0.00

0 in

add

ition

to th

e dr

ugs

as li

sted

in th

e ju

dgm

ent.

Pers

on D

wer

e se

nten

ced

to p

rison

for 5

yea

rs a

nd 2

mon

ths,

and

the

confi

scat

ion

of N

OK

1.70

0.00

0 in

add

ition

to th

e dr

ugs

and

item

s re

late

d to

the

crim

e as

list

ed in

the

judg

men

t.Pe

rson

E w

ere

sent

ence

d to

com

mun

ity p

unis

hmen

t for

250

ho

urs.

The

exec

utio

n tim

e an

d th

e su

bsid

iary

pris

on s

ente

nce

– im

pris

onm

ent –

wer

e se

t to

1 ye

ar a

nd 6

mon

ths.

NO

K 30

.000

in

addi

tion

to th

e dr

ugs

and

item

s re

late

d to

the

crim

e as

list

ed in

the

judg

men

t wer

e co

nfisc

ated

.Pe

rson

F w

ere

sent

ence

d to

com

mun

ity p

unis

hmen

t for

327

ho

urs.

The

exec

utio

n tim

e an

d th

e su

bsid

iary

pris

on se

nten

ce –

im

pris

onm

ent –

wer

e se

t to

1 ye

ar a

nd 4

mon

ths.

NO

K 27

.500

in

addi

tion

to th

e dr

ugs a

nd it

ems r

elat

ed to

the

crim

e as

list

ed in

the

judg

men

t wer

e co

nfisc

ated

.Pe

rson

G w

ere

sent

ence

d to

pris

on fo

r 2 y

ears

. NO

K70

.000

as

wee

k as

dru

gs a

nd it

ems

rela

ted

to th

e cr

ime

wer

e co

nfisc

ated

.

https://lovdata.no/pro/avgjorelse/lg-2014-38884




https://lovdata.no/pro/avgjorelse/tstro-2013-83021





PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

2020

-07-

01

LE-2

020-

1174

7

http

s://

lovd

ata.

no/

avgj

orel

se/le

-202

0- 1

1747

A 2

3-ye

ar-o

ld w

oman

was

sen

tenc

ed b

y th

e Co

urt o

f App

eal t

o fiv

e m

onth

s in

pris

on fo

r im

port

ing

a dr

ug th

at w

ere

not o

n th

e dr

ug

list.

The

case

con

cern

ed 8

1,87

0 10

0 m

g Tr

amad

ol c

apsu

les.

The

Dis

tric

t Cou

rt ru

led

in th

e ca

se in

201

9 w

ere

the

pers

on w

ere

sent

ence

d to

pris

on fo

r 1 y

ear.

The

pers

on w

ere

also

sen

tenc

ed to

en

dure

the

confi

scat

ion

of 8

1,87

0 Tr

amad

ol ta

blet

s 10

0 m

g. a

nd

two

suitc

ases

. The

per

son

wer

e se

nten

ced

to p

ay le

gal c

osts

of N

OK

5.00

0. -

five

thou

sand

- kr

oner

.

The

pers

on a

ppea

led

the

dist

rict c

ourt

’s ju

dgem

ent t

o th

e Co

urt o

f A

ppea

l. A

has

app

eale

d th

e di

stric

t cou

rt’s

judg

men

t.

Onl

y th

e se

nten

ce o

f im

pris

onm

ent w

as re

ferr

ed to

an

appe

al

hear

ing.

The

oth

er g

roun

ds fo

r app

eal w

ere

refu

sed.

The

Cour

t of A

ppea

l fou

nd th

at im

pris

onm

ent f

or 5

mot

hs w

ere

the

corr

ect p

unis

hmen

t.

The

pers

on w

ere

sent

ence

d to

5 m

onth

s pr

ison

2012

-01-

26

LB-2

011-

1176

86

http

s://

lovd

ata.

no/p

ro/a

vgjo

rels

e/lb

- 201

1-11

7686

A p

erso

n w

ere

char

ged

for s

tora

ge o

f 106

.7 g

ram

s of

m

etha

mph

etam

ine,

impo

rt a

nd s

tora

ge o

f bet

wee

n 40

- 50

lite

rs

of G

BL a

nd G

HB,

and

sev

eral

oth

er v

iola

tions

of p

rovi

sion

s of

the

Pena

l Cod

e, th

e M

edic

ines

Act

and

the

Road

Tra

ffic

Act.

Som

e of

the

impo

rts

of G

BL to

ok p

lace

bef

ore

GBL

was

on

the

drug

lis

t, an

d th

ese

acts

wer

e as

sess

ed a

s a

viol

atio

n of

the

Med

icin

es

Act §

31

(1) ,

cf.

sect

ion

13 (4

).

The

impo

rts

of G

BL w

ere

cons

ider

ed a

con

tinui

ng c

rimin

al o

ffens

e.

The

Dist

rict c

ourt

sent

ence

d th

e pe

rson

to im

priso

nmen

t for

1 y

ear a

nd

4 m

onth

s. Th

e pe

rson

app

eale

d to

the

Cour

t of A

ppea

l.

The

Cour

t of A

ppea

l men

tione

d in

the

judg

emen

t tha

t GBL

is

conv

erte

d to

GH

B by

inge

stio

n in

the

body

and

whi

ch c

an h

ave

an

into

xica

ting

effec

t. Al

so, t

hat c

onve

rsio

n ca

n be

car

ried

out r

elat

ivel

y ea

sily

by m

eans

of,

for e

xam

ple,

cau

stic

soda

.

https://lovdata.no/avgjorelse/le-2020-11747



https://lovdata.no/pro/avgjorelse/lb-2011-117686





PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

The

Supr

eme

Cour

t rul

ed in

a ju

dgm

ent o

f 12

June

200

9 (R

t-20

09-

780)

that

GBL

can

not b

e re

gard

ed a

s a

deriv

ativ

e of

GH

B, w

hich

is

liste

d on

the

drug

list

, det

erm

ined

by

the

Nor

weg

ian

Med

icin

es

Agen

cy. T

he S

upre

me

Cour

t the

refo

re c

oncl

uded

that

impo

rtat

ion

and

stor

age

of G

BL is

not

affe

cted

by

the

Pena

l Cod

e. In

stea

d,

impo

rtat

ion

with

out a

ppro

val c

ould

be

puni

shed

acc

ordi

ng to

the

Med

icin

es A

ct §

31

(1),

cf. §

13

(4).

GBL

wer

e lis

ted

on th

e dr

ug li

st

a fe

w d

ays

late

r, an

d it

wer

e fr

om th

at d

ay p

ossi

ble

to p

unis

h th

e im

port

atio

n of

GLB

acc

ordi

ng to

the

Pena

l Cod

e.

The

pers

ons

first

sev

en im

port

atio

ns o

f GBL

wer

e do

ne b

efor

e it

wer

e lis

ted

on th

e dr

ug li

st, a

nd th

e ac

ts th

eref

ore

wer

e pu

nish

ed

as a

vio

latio

n of

the

Med

icin

es A

ct §

31

(1).

The

Med

icin

es A

ct

§ 31

ope

ns fo

r pen

alty

with

fine

s or

impr

ison

men

t for

up

to 3

m

onth

s - o

r bot

h. T

he c

ircum

stan

ces

wer

e re

gard

ed a

s ag

grav

atin

g ci

rcum

stan

ces

purs

uant

to th

e Pe

nal C

ode.

The

pers

on w

ere

sent

ence

d to

impr

ison

men

t for

1 y

ear a

nd 4

m

onth

s. Th

e se

nten

ce w

ere

an a

dditi

onal

sen

tenc

e in

rela

tion

to

the

Dis

tric

t Cou

rt’s

judg

men

t.

The

pers

on w

ere

also

rega

rded

as

disq

ualifi

ed fr

om d

rivin

g a

mot

or

vehi

cle

subj

ect t

o a

driv

ing

licen

se fo

r a p

erio

d of

6 m

onth

s as

the

resu

lt of

vio

latio

ns o

f the

Roa

d Tr

affic

Act.

2018

-06-

26

LB-2

017-

2005

14

http

s://

lovd

ata.

no/p

ro/a

vgjo

rels

e/lb

- 201

7-20

0514

A 3

0-ye

ar-o

ld p

revi

ousl

y pu

nish

ed m

an w

ere

conv

icte

d of

im

port

ing

fena

zepa

m fr

om C

hina

equ

ival

ent t

o 1.

2 m

illio

n us

er

dose

s.

It w

ere

assu

med

that

the

star

ting

poin

t for

pun

ishm

ent w

as

impr

ison

men

t for

up

to 9

yea

rs.

Ded

uctio

ns w

ere

give

n fo

r con

fess

ion

and

for l

ong

case

pro

cess

ing

time.

The

sent

ence

was

by

the

Dis

tric

t Cou

rt. s

et a

t 6 y

ears

and

6 m

onth

s, as

wel

l as

the

confi

scat

ion

of a

com

pute

r, a

mob

ile p

hone

and

a

scal

e us

ed to

com

mit

the

crim

e.

The

sent

ence

was

set

at 6

yea

rs in

pris

on b

y th

e Co

urt o

f App

eal.

The

Cour

t of A

ppea

l men

tione

d th

at g

ener

al p

reve

ntiv

e co

nsid

erat

ions

wei

gh h

eavi

ly w

hen

deal

ing

with

larg

e am

ount

s of

narc

otic

dru

gs. T

his a

pplie

d al

so to

impo

rts f

rom

abr

oad

whe

re th

e m

otiv

e w

as p

rofit

, eve

n th

ough

the

profi

t was

rela

tivel

y lim

ited.

Sm

uggl

ing

of su

ch a

larg

e qu

antit

y an

d nu

mbe

r of u

ser d

oses

ent

ails

a pa

rtic

ular

ly e

xten

sive

spre

ad o

f dru

gs a

nd m

ust b

e co

nsid

ered

hig

hly

harm

ful t

o so

ciet

y. At

the

sam

e tim

e, th

is m

eant

that

the

pers

onal

ci

rcum

stan

ces o

f the

acc

used

cam

e m

ore

into

the

back

grou

nd

The

sent

ence

was

set

at 6

yea

rs in

pris

on a

s w

ell a

s th

e co

nfisc

atio

n of

a c

ompu

ter,

a m

obile

pho

ne a

nd a

sca

le u

sed

to c

omm

it th

e cr

ime.






PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

2020

-03-

03

LB-2

020-

1371

http

s://

lovd

ata.

no/

avgj

orel

se/lb

-202

0- 1

371

A 3

0-ye

ar-o

ld p

erso

n w

as s

ente

nced

by

the

Cour

t of A

ppea

l to

3 y

ears

and

6 m

onth

s in

pris

on fo

r im

port

ing

99,3

20 ta

blet

s co

ntai

ning

the

narc

otic

dru

g di

azep

am a

nd fo

r vio

latin

g cu

stom

s le

gisl

atio

n by

impo

rtin

g 16

2.71

0 Tr

amad

ol ta

blet

s an

d vi

olat

ion

of th

e M

edic

ines

Act

for h

avin

g im

port

ed m

edic

ines

from

sta

tes

outs

ide

the

EEA

with

out a

per

mit.

Dia

zepa

m is

list

ed o

n th

e dr

ug li

st, w

hile

tram

adol

is n

ot. T

he

seiz

ure

of th

e Tr

amad

ol ta

blet

s w

ere

ther

efor

e no

t ana

lyze

d or

in

vest

igat

ed fu

rthe

r.

How

ever

, a q

uick

test

take

n by

the

Cust

oms

show

ed th

at th

e ta

blet

s co

ntai

ned

Tram

adol

.

The

pers

on re

ceiv

ed th

e ta

blet

s an

d th

e m

oney

in S

erbi

a.

The

star

ting

poin

t for

the

puni

shm

ent f

or th

e im

port

of d

iaze

pam

, co

rres

pond

ing

to 6

6,00

0 dr

ug d

oses

, was

, in

the

opin

ion

of a

join

t Co

urt o

f App

eal,

impr

ison

men

t for

abo

ut th

ree

and

a ha

lf ye

ars.

Tram

adol

is n

ot o

n th

e dr

ug li

st in

Nor

way

, but

the

impo

rt o

f th

e ta

blet

s w

as a

par

ticul

arly

ser

ious

cus

tom

s off

ense

whi

ch in

is

olat

ion

enta

iled

a se

nten

ce o

f im

pris

onm

ent f

or 1

yea

r and

6

mon

ths.

Afte

r a d

educ

tion

of a

ppro

x. 2

0% fo

r con

fess

ion

and

cont

ribut

ion

to

the

repr

iman

d in

a c

ase

adju

dica

ted

in S

wed

en, t

he se

nten

ce w

as

impr

isone

d fo

r 3 y

ears

and

6 m

onth

s.

The

pers

on w

ere

sent

ence

d to

impr

ison

men

t for

3 y

ears

and

6

mon

ths.

Tram

adol

tabl

ets,

two

mob

ile p

hone

s as

wel

l as

SEK

296.

000

wer

e co

nfisc

ated

.

The

pers

on w

ere

sent

ence

d to

the

of th

e rig

ht to

driv

e a

mot

or

vehi

cle

subj

ect t

o a

driv

ing

licen

se in

Nor

way

fore

ver o

n th

e ba

sis

of th

e vi

olat

ions

of t

he R

oad

Traffi

c Ac

t.

https://lovdata.no/avgjorelse/lb-2020-1371




PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

2011

-11-

08

LG-2

010-

1987

74

http

s://

lovd

ata.

no/p

ro/a

vgjo

rels

e/lg

- 201

0-19

8774

A 4

9-ye

ar-o

ld p

erso

n w

oman

wer

e se

nten

ced

to 3

0 da

ys in

pris

on

on fa

lsifi

catio

n of

pre

scrip

tions

for p

repa

ratio

ns b

y th

e Co

urt o

f A

ppea

l.

The

pers

on h

ad b

een

give

n a

tota

l of 4

00 ta

blet

s of

Pin

ex fo

rte

and

400

tabl

ets

of V

aliu

m. I

n ad

ditio

n, s

he h

ad b

een

give

n 15

0 ta

blet

s of

Imov

ane,

whi

ch is

not

on

the

drug

list

.

The

Cour

t of A

ppea

l men

tione

d th

at a

ccor

ding

to c

ase

law

, the

re

mus

t be

a st

rict r

eact

ion

whe

re p

resc

riptio

n co

unte

rfei

ting

is u

sed

as a

mea

ns o

f ille

gal a

cqui

sitio

n of

tabl

ets

with

nar

cotic

act

ive

subs

tanc

es.

The

pers

on w

ere

in th

e D

istric

t Cou

rt se

nten

ced

to im

priso

nmen

t for

60

day

s, an

d to

pay

lega

l cos

ts o

f NO

K 3.

000.

30 d

ays

in p

rison

.

2015

-01-

13

LF-2

014-

1036

57-4

http

s://

lovd

ata.

no/p

ro/a

vgjo

rels

e/lf-

201

4-10

3657

-4

The

so-c

alle

d «G

ilde

case

».

Prod

uctio

n an

d sa

le o

f 3.2

68.8

00 d

opin

g ta

blet

s (a

nabo

lic

andr

ogen

ic s

tero

ids)

whi

ch w

ere

prod

uced

from

50

kg o

f act

ive

subs

tanc

e.

The

Cour

t of A

ppea

l set

pris

on s

ente

nces

bet

wee

n 4,

5 an

d 6,

5 ye

ars

for t

he m

ain

offen

ders

.

The

sect

ion

of th

e Pe

nal C

ode

on o

rgan

ized

crim

inal

gro

ups

cam

e in

to fo

rce.

The

Cour

t of A

ppea

l mad

e ce

rtai

n de

duct

ions

in th

e co

nfisc

atio

n pu

rsua

nt to

the

Pena

l Cod

e in

ord

er to

avo

id d

oubl

e co

nfisc

atio

n.

Pers

on A

wer

e se

nten

ced

to p

rison

for 4

yea

rs a

nd 6

mon

ths,

as w

ell

as c

onfis

catio

n of

pro

fits

of N

OK

650.

000.

Pers

on B

wer

e se

nten

ced

to im

pris

onm

ent f

or 6

yea

rs a

nd 6

m

onth

s, as

wel

l as

confi

scat

ion

of p

rofit

s of

NO

K 2.

700.

000.

Pers

on C

wer

e se

nten

ced

to im

pris

onm

ent f

or 6

yea

rs, a

s w

ell a

s co

nfisc

atio

n of

pro

fits

with

NO

K 3.

100.

000.

Pers

on D

wer

e se

nten

ced

to im

pris

onm

ent f

or 5

yea

rs a

nd 9

m

onth

s, as

wel

l as

confi

scat

ion

of p

rofit

s of

NO

K 1.

800.

000.

Pers

on G

wer

e se

nten

ced

to im

pris

onm

ent f

or 1

yea

r and

6 m

onth

s.

The

drug

s an

d ite

ms

used

to c

omm

it th

e cr

imes

wer

e co

nfisc

ated

by

the

judg

emen

t of t

he D

istr

ict C

ourt

.





https://lovdata.no/pro/avgjorelse/lf-2014-103657-4





PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

2006

-10-

10

Rt-2

006-

1190

http

s://

lovd

ata.

no/p

ro/a

vgjo

rels

e/hr

- 200

6-17

28-a

A d

octo

r had

rece

ived

100

tabl

ets

of H

exal

id fr

om a

broa

d w

ithou

t pe

rmis

sion

.

Acco

rdin

g to

a c

onve

rsio

n ta

ble

the

rece

ived

tabl

ets

corr

espo

nded

to

12.

5 gr

ams

of h

ashi

sh.

The

impo

rt w

as a

vio

latio

n of

pro

cedu

res

laid

dow

n in

regu

latio

ns

conc

erni

ng th

e m

anuf

actu

re a

nd im

port

of d

rugs

of 2

004

and

the

Dru

gs R

egul

atio

ns o

f 197

8.

The

Supr

eme

Cour

t con

clud

ed th

at th

e do

ctor

’s ci

rcum

stan

ces

wer

e al

so a

ffect

ed b

y th

e Pe

nal C

ode

for i

llega

l im

port

atio

n of

dr

ugs

The

Dis

tric

t cou

rt s

ente

nced

the

pers

on to

impr

ison

men

t for

20

days

and

a fi

ned

of N

OK

5.00

0, a

s w

ell a

s th

e co

nfisc

atio

n of

100

ta

blet

s of

Hex

alid

à 5

mg.

The

per

son

wer

e al

so s

ente

nced

to p

ay

the

lega

l fee

s of

NO

K 2.

000.

Impr

ison

men

t for

20

days

, the

con

fisca

tion

of 1

00 ta

blet

s of

H

exal

id, a

fine

of N

OK

5.00

0 an

d le

gal f

ees

of a

tota

l NO

K 4.

000.

POLA

ND

No

subm

issi

on h

as b

een

rece

ived

on

case

law

from

the

natio

nal c

onsu

ltant


ROM

AN

IA (p

repa

red

by th

e na

tiona

l con

sulta

nt M

r Adr

ian

SAN

DRU

)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Dec

isio

n 13

15/2

014

date

d 28

Oct

ober

201

4,

pass

ed b

y th

e Bu

char

est

Cour

t of A

ppea

l – F

inal

D

ecis

ion

The

crim

inal

inve

stig

atio

ns fo

und

that

an

orga

nise

d cr

ime

grou

p w

as

cond

uctin

g its

elf a

n ac

tivity

thro

ugh

a co

mpa

ny c

alle

d N

atur

al G

reen

, w

hich

mad

e se

vera

l im

port

s of

cou

nter

feit

prod

ucts

, bel

ongi

ng to

au

thor

ized

war

ehou

ses

for t

he m

arke

ting

of p

harm

aceu

tical

pro

duct

s an

d/or

sup

plem

ents

food

, bei

ng u

sed

herb

al s

tore

s, dr

ugst

ores

or e

ven

phar

mac

ies.

The

Nat

iona

l San

itary

Vet

erin

ary

and

Food

Saf

ety

Auth

ority

st

arte

d a

serie

s of

con

trol

s an

d ve

rifica

tions

at t

he h

eadq

uart

ers/

war

ehou

ses

of c

ompa

ny A

F S.

R.L.

, in

view

of t

he a

lert

issu

ed b

y th

e Be

lgia

n Fe

dera

l Age

ncy

for F

ood

Chai

n Sa

fety

rega

rdin

g th

e pr

esen

ce o

f si

butr

amin

e in

the

com

posi

tion

of s

ever

al fo

od s

uppl

emen

t pro

duct

s. Sp

ecifi

cally

, the

not

ifica

tions

refe

rred

to th

e pr

esen

ce o

f sib

utra

min

e in

th

e pr

oduc

t bat

ches

“Slim

min

g Ca

psul

e” im

port

ed b

y C

and

sold

on

the

Rom

ania

n m

arke

t by

the

com

pany

AF

S.R.

L., a

s w

ell a

s in

the

prod

uct

Supe

r Slim

Pom

egra

nate

Wei

ght L

oss,

also

impo

rted

by

C an

d so

ld o

n th

e Ro

man

ian

mar

ket b

y th

e co

mpa

ny T

EM F

S.R.

L.

The

insp

ecto

rs o

f the

Pub

lic H

ealth

Dire

ctio

n, a

s re

sult

of th

e in

spec

tions

th

ey h

ad p

erfo

rmed

, did

not

iden

tify

the

batc

h of

the

prod

uct S

limm

ing

Caps

ule

in th

e re

cord

s of

com

pany

AF

S.R.

L., t

hus

conc

ludi

ng th

at th

is

prod

uct h

ad n

ot b

een

impo

rted

by

this

com

pany

.

As

a sa

fety

mea

sure

, the

San

itary

Vet

erin

ary

and

Food

Saf

ety

Dire

ctor

ate

orde

red

bann

ed A

F S.

R.L.

to fu

rthe

r sal

e 54

box

es o

f the

Slim

min

g Ca

psul

e pr

oduc

t.

In 2

009,

def

enda

nt F

I D

was

foun

d on

the

high

way

, tra

nspo

rtin

g, in

hi

s ca

r, se

vera

l slim

min

g pr

oduc

ts, r

espe

ctiv

ely:

2 b

oxes

of t

he C

hine

se

slim

min

g ta

blet

and

500

box

es o

f the

AF

S.R.

L. s

limm

ing

caps

ule,

w

ithou

t pos

sess

ing

the

corr

espo

ndin

g le

gal d

ocum

ents

.

In th

is c

ase,

the

“con

stitu

ting

of th

e gr

oup”

was

don

e by

mea

ns o

f se

ttin

g up

a c

ompa

ny, n

amel

y N

atur

al G

reen

Life

on

18.0

9.20

08, h

avin

g as

ass

ocia

tes

and

adm

inis

trat

ors

the

defe

ndan

ts, m

ost o

f the

crim

inal

ac

tivity

bei

ng c

arrie

d ou

t by

the

two.

The

ir cr

imin

al a

ctiv

ity c

onsi

sted

of

: the

use

at t

he c

usto

ms

auth

ority

of s

ome

forg

ed c

omm

erci

al

docu

men

ts, t

he in

trod

uctio

n in

the

coun

try

thro

ugh

the

plac

es

esta

blis

hed

for c

usto

ms

cont

rol,

by a

void

ing

cust

oms

cont

rol o

f goo

ds

to b

e pl

aced

und

er a

cus

tom

s pr

oced

ure.

The

reaf

ter,

the

prod

ucts

wer

e be

ing

sold

on

the

inte

rnet

.

All

the

pers

ons

inve

stig

ated

and

pro

secu

ted

wer

e fo

und

guilt

y of

the

offen

ce o

f unf

air c

ompe

titio

n (a

rt. 5

Law

no.

11

/199

1), t

he o

ffenc

es a

gain

st in

telle

ctua

l pro

pert

y (a

rt. 5

2 La

w n

o. 1

29/1

992)

, the

offe

nce

of p

repa

ring

coun

terf

eit f

ood

or d

rink,

alte

red

or p

rohi

bite

d fo

r con

sum

ptio

n, h

arm

ful t

o he

alth

, exp

osur

e to

sal

e or

sal

e of

suc

h fo

od o

r bev

erag

e,

know

ing

that

they

are

cou

nter

feit

or a

ltere

d or

pro

hibi

ted

for

cons

umpt

ion

(art

. 313

par

a. 1

of t

he fo

rmer

Crim

inal

Cod

e 19

68),

the

offen

ce o

f fal

sify

ing

or s

ubst

itutin

g ot

her g

oods

or

prod

ucts

, if b

y fa

lsifi

catio

n or

sub

stitu

tion

they

hav

e be

com

e ha

rmfu

l to

heal

th (a

rt. 3

13 p

ara.

2 o

f the

form

er C

rimin

al C

ode

1968

), th

e off

ence

of t

ax e

vasi

on (a

rt. 9

Law

. no.

241

/200

5),

the

offen

ce o

f usi

ng fa

lsifi

ed tr

ansp

ort o

r com

mer

cial

cus

tom

s do

cum

ents

bef

ore

the

cust

oms

auth

ority

(art

. 273

Law

no.

86

/200

6, th

e off

ence

of i

ntro

duci

ng g

oods

in th

e co

untr

y,

thro

ugh

plac

es o

ther

than

thos

e es

tabl

ishe

d fo

r cus

tom

s co

ntro

l (ar

t. 27

0 La

w n

o. 8

6/20

06).

All

defe

ndan

ts w

ere

each

sen

tenc

ed to

a to

tal p

enal

ty o

f 3

year

s in

pris

on, b

ut th

e en

forc

emen

t of t

he s

ente

nce

was

su

spen

ded

and

a pe

riod

of p

roba

tion

of 8

yea

rs w

as im

pose

d to

the

defe

ndan

ts, p

erio

d in

whi

ch th

ey h

ad to

com

ply

with

se

vera

l obl

igat

ions

est

ablis

hed

by th

e co

urt (

to g

o to

the

Polic

e St

atio

n on

cer

tain

dat

es, t

o an

noun

ce th

e ch

ange

of

addr

ess,

etc.

).


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Sent

ence

no.

614

/201

8 da

ted

8 A

pril

2018

, pa

ssed

by

the

Buch

ares

t Tr

ibun

al –

Fin

al S

ente

nce

The

defe

ndan

ts (G

and

V) c

reat

ed a

nd im

plem

ente

d a

crim

inal

m

echa

nism

thro

ugh

whi

ch th

ey s

ough

t, on

the

one

hand

, the

in

trod

uctio

n to

the

lega

l mar

ketin

g ci

rcui

t of c

ount

erfe

it m

edic

inal

pr

oduc

ts fo

r hum

an u

se (b

earin

g th

e PE

GA

SYS

bran

d, a

pro

tect

ed

trad

emar

k at

Com

mun

ity le

vel),

and

the

evas

ion

of th

e pa

ymen

t of t

axes

ow

ed to

the

stat

e bu

dget

by

the

com

pany

VER

DA

N F

ARM

SRL

(in

the

amou

nt o

f 945

,389

lei).

The

gro

up a

lso

soug

ht th

e co

ncea

ling

of th

e re

al s

ourc

e of

orig

in o

f the

goo

ds (w

hich

wer

e pu

rcha

sed,

in re

ality

, by

defe

ndan

t G w

ithou

t sup

port

ing

docu

men

ts a

nd w

ithou

t pay

ing

VAT

on th

e” b

lack

mar

ket”

), cr

eatin

g th

e ap

pear

ance

that

thes

e go

ods

wou

ld

have

bee

n pu

rcha

sed

at h

ighe

r pric

es (v

ery

clos

e to

the

deliv

ery

ones

) an

d w

ith th

e pa

ymen

t of V

AT, f

rom

the

lega

l per

son

adm

inis

tere

d by

de

fend

ant V

.

The

defe

ndan

ts a

gree

d to

con

clud

e a

plea

bar

gain

ing,

pl

eadi

ng g

uilty

for t

ax e

vasi

on o

ffenc

es b

oth

in th

e fo

rm o

f au

thor

ship

and

in th

e fo

rm o

f com

plic

ity (a

rt. 9

Law

241

/200

5)

and

trad

emar

k cr

imin

al o

ffenc

es (a

rt. 9

0 La

w 9

4/20

08).

The

plea

bar

gain

ing

was

app

rove

d by

the

cour

t.

G w

as c

onvi

cted

to a

tota

l sen

tenc

e of

2 y

ears

in p

rison

, bu

t the

enf

orce

men

t of t

he s

ente

nce

was

sus

pend

ed a

nd a

pr

obat

ion

perio

d of

4 y

ears

was

impo

sed

to h

im, h

avin

g to

co

mpl

y w

ith s

ever

al o

blig

atio

ns s

et b

y th

e co

urt (

to g

o to

the

Polic

e St

atio

n on

cer

tain

dat

es, t

o an

noun

ce th

e ch

ange

of

addr

ess,

etc.

)

V w

as c

onvi

cted

to a

tota

l sen

tenc

e of

1 y

ear a

nd 6

mon

ths

in

pris

on, b

ut th

e en

forc

emen

t of s

ente

nce

was

sus

pend

ed a

nd a

pr

obat

ion

perio

d of

3 y

ears

and

6 m

onth

s w

as im

pose

d fo

r the

de

fend

ant i

n w

hich

he

had

to c

ompl

y w

ith s

ever

al o

blig

atio

ns

set b

y th

e co

urt (

to g

o to

the

Polic

e St

atio

n on

cer

tain

dat

es,

to a

nnou

nce

the

chan

ge o

f add

ress

, etc

.)

Dec

isio

n no

. 46/

2011

da

ted

15 F

ebru

ary

2011

, pa

ssed

by

the

Buch

ares

t Co

urt o

f App

eal,

Fina

l de

cisi

on

Betw

een

the

end

of 2

005

and

the

mid

dle

of 2

006,

def

enda

nt G

co

rres

pond

ed w

ith w

itnes

s A

, offe

ring

him

and

del

iver

ing

to h

im

dire

ctly

or t

hrou

gh in

term

edia

ries,

seve

ral t

ypes

of m

edic

ines

, inc

ludi

ng

the

prod

uct w

ith u

nmar

ked

insc

riptio

n, th

e si

gn o

f Cia

lis.

The

defe

ndan

t’s s

tate

men

t con

firm

ed th

is fa

ctua

l situ

atio

n, th

e de

fend

ant a

dmitt

ing

that

he

acte

d as

an

inte

rmed

iary

, in

exch

ange

of a

fe

e.

Def

enda

nt G

was

pro

secu

ted

and

trie

d fo

r com

mitt

ing

trad

emar

k cr

imes

and

the

offen

ce o

f cou

nter

feiti

ng o

f m

edic

ines

(as

form

erly

pro

vide

d by

art

icle

of 8

34 L

aw n

o.

95/2

006

on th

e he

alth

care

refo

rm).

The

defe

ndan

t was

con

vict

ed fo

r tra

dem

ark

crim

es to

a

sent

ence

of 3

in p

rison

, but

the

enfo

rcem

ent o

f the

sen

tenc

e w

as s

uspe

nded

and

a p

erio

d of

7 y

ears

was

impo

sed

for t

he

defe

ndan

t in

whi

ch h

e ha

d to

com

ply

with

sev

eral

obl

igat

ions

es

tabl

ishe

d by

the

cour

t (to

go

to th

e Po

lice

Stat

ion

on c

erta

in

date

s, to

ann

ounc

e th

e ch

ange

of a

ddre

ss, e

tc.)

Rega

rdin

g th

e ac

cusa

tion

of c

ount

erfe

iting

of m

edic

ines

, de

fend

ant G

was

acq

uitt

ed fo

r the

reas

on th

at th

e off

ence

pr

ovid

ed b

y ar

t. 83

4 of

Law

95/

2006

is c

over

ing

only

sel

ling

coun

terf

eitin

g m

edic

ines

on

the

terr

itory

of R

oman

ia a

nd th

e de

fend

ant w

as s

ellin

g th

e m

edic

ines

abr

oad.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Dec

isio

n no

. 107

1/20

19

date

d 15

Mar

ch 2

019,

pa

ssed

by

Cluj

Nap

oca

Cour

t – F

inal

by

Dec

isio

n no

. 658

/201

9 da

ted

31

May

201

9, p

asse

d by

Clu

j Co

urt o

f App

eal.

Dur

ing

2014

-201

5 th

e de

fend

ant t

rade

d an

d he

ld fo

r sal

e co

unte

rfei

t dr

ugs

by re

gist

erin

g th

e tr

adem

arks

Via

gra

and

Cial

is w

ithou

t the

co

nsen

t of t

he tr

adem

ark

right

s ho

lder

s an

d he

exh

ibite

d fo

r sal

e co

unte

rfei

t med

icin

es b

earin

g th

e in

scrip

tions

of t

he tr

adem

arks

Vi

agra

and

Cia

lis, w

hich

are

har

mfu

l to

heal

th g

iven

the

activ

e su

bsta

nce

- sild

enafi

l. Th

e de

fend

ant p

urch

ased

from

the

web

site

w

ww

.via

gra1

00m

g.hu

pro

duct

s be

arin

g th

e m

arks

of t

he re

gist

ered

tr

adem

arks

Via

gra

and

Cial

is, w

hich

he

knew

to b

e co

unte

rfei

t and

w

hich

he

deci

ded

to fu

rthe

r sel

l, on

the

grou

nds

that

he

had

initi

ally

us

ed th

em fo

r his

ow

n us

e, a

nd s

ubse

quen

tly, fi

ndin

g th

at th

ey h

ave

bene

ficia

l effe

cts

on h

im, h

e de

cide

d to

incr

ease

his

inco

me,

resp

ectiv

ely

the

disa

bilit

y pe

nsio

n.

In th

is c

onte

xt, t

he d

efen

dant

pos

ted

ads

on th

e w

ebsi

tes

ww

w.

anun

turip

enet

.gsp

.ro a

nd w

ww

.anu

ncur

i.cer

e.ro

, offe

ring

for s

ale

the

prod

ucts

with

the

abov

e-m

entio

ned

bran

ds.

The

actio

n of

the

defe

ndan

t to

expo

se fo

r sal

e co

unte

rfei

t dr

ugs

bear

ing

the

insc

riptio

ns o

f the

bra

nds V

iagr

a an

d Ci

alis

, ha

rmfu

l to

heal

th g

iven

the

activ

e su

bsta

nce

(sild

enafi

l),

was

foun

d to

mee

t the

con

stitu

ent e

lem

ents

of t

he c

rimin

al

offen

ce o

f pre

para

tion,

offe

ring

or d

ispl

ay fo

r sal

e of

co

unte

rfei

t or s

ubst

itute

d m

edic

ines

pro

vide

d by

art

. 357

pa

ra. 2

of t

he R

oman

ian

Crim

inal

Cod

e. T

he d

efen

dant

was

co

nvic

ted

for t

his

offen

ce.

Mor

eove

r, th

e de

fend

ant w

as a

lso

conv

icte

d fo

r com

mitt

ing

the

crim

e of

put

ting

into

circ

ulat

ion

a pr

oduc

t bea

ring

an

iden

tical

or s

imila

r tra

dem

ark

with

a tr

adem

ark

for i

dent

ical

or

sim

ilar p

rodu

cts

in c

ontin

uous

form

(2 a

ctio

ns re

late

d to

the

VIAG

RA a

nd C

IALI

S tr

adem

arks

), pr

ovid

ed b

y ar

t. 90

pa

ra. 1

) b o

f Law

84/

1998

. The

def

enda

nt w

as c

onvi

cted

to

a to

tal s

ente

nce

of 1

yea

r and

one

mon

th in

pris

on, b

ut th

e en

forc

emen

t of t

he s

ente

nce

was

pos

tpon

ed a

nd a

pro

batio

n pe

riod

of 2

yea

rs w

as im

pose

d to

the

defe

ndan

t to

com

ply

with

sev

eral

obl

igat

ions

est

ablis

hed

by th

e ju

dge

(to

go to

the

Polic

e St

atio

n on

cer

tain

dat

es, t

o an

noun

ce th

e ch

ange

of

addr

ess,

etc.

).

SERB

IA (p

repa

red

by th

e na

tiona

l con

sulta

nts

Ms

Ned

a M

ARK

OVI

C, M

r Jov

an Ć

OSI

Ć an

d M

r Bož

idar

BLA

GO

JEVI

Ć)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

KTO

VTK

23/

20Ill

icit

trad

e of

face

mas

ks o

n th

e in

tern

etO

n 25

May

202

0 m

otio

n to

indi

ct s

ubm

itted

– c

ourt

pr

ocee

ding

s un

derw

ay

KTO

VTK

18/

20)

Illic

it tr

ade

of fa

ce m

asks

on

the

inte

rnet

On

27 M

arch

202

0 pl

ea a

gree

men

t with

the

defe

ndan

t co

nclu

ded

On

7 A

pril

2020

– th

e Co

urt a

ccep

ted

the

plea

agr

eem

ent a

nd

pron

ounc

ed a

con

vict

ion


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

KT.N

o.53

6/19

On

17 Ju

ne 2

019,

in th

e ve

hicl

e of

the

susp

ect,

142

pack

s of

3 a

mpo

ules

of

blo

cker

s ea

ch, u

sed

for h

eroi

n ad

dict

s, w

ere

foun

d w

ithou

t any

ac

com

pany

ing

docu

men

ts o

n th

e go

ods

orig

in a

nd d

istr

ibut

ion.

On

16 A

ugus

t 201

9 th

e D

ecis

ion

to re

ject

the

crim

inal

co

mpl

aint

ado

pted

KTKo

No.

539

/19

A c

rimin

al c

ompl

aint

aga

inst

thre

e pe

rson

s w

as s

ubm

itted

bas

ed o

n gr

ound

ed s

uspi

cion

that

dur

ing

the

perio

d of

tim

e fr

om 1

0 D

ecem

ber

2015

to 3

0 A

pril

2019

, as

resp

onsi

ble

pers

ons

in a

com

pany

, the

y pu

t in

circ

ulat

ion

med

ical

dev

ices

- di

gita

l the

rmom

eter

s, w

hich

did

not

co

nfor

m to

bas

ic re

quire

men

ts; a

lso,

thei

r con

form

ity a

sses

smen

t in

acco

rdan

ce w

ith th

e la

w w

as n

ot p

erfo

rmed

, the

y di

d no

t bea

r the

CE

mar

king

, and

they

wer

e no

t reg

iste

red

in th

e Re

publ

ic o

f Ser

bia.

The

proc

edur

e is

in th

e in

vest

igat

ion

phas

e.

Kt 6

415/

19A

crim

inal

com

plai

nt a

gain

st o

ne p

erso

n w

as s

ubm

itted

on

grou

nded

su

spic

ion

that

on

25 S

epte

mbe

r 201

9 he

pro

duce

d si

gnifi

cant

qua

ntiti

es

of m

edic

inal

pro

duct

s w

ithou

t the

app

rova

l of t

he M

inis

try

of H

ealth

, w

hich

he

then

sol

d th

roug

h th

e co

mpa

ny h

e ow

ns.

The

proc

edur

e is

in th

e in

vest

igat

ion

phas

e.

The

requ

est f

or th

e co

llect

ion

of n

eces

sary

info

rmat

ion

was

su

bmitt

ed to

the

Sect

or fo

r the

insp

ectio

n of

Med

icin

al

Prod

ucts

and

Psy

choa

ctiv

e Co

ntro

lled

Subs

tanc

es a

nd

Prec

urso

rs o

f the

Min

istr

y of

Hea

lth

Kt 1

30/2

0Cr

imin

al o

ffenc

e of

Pro

duct

ion

and

Putt

ing

in C

ircul

atio

n of

Har

mfu

l Pr

oduc

ts u

nder

Art

icle

256

of t

he C

rimin

al C

ode

On

10 Ju

ne 2

020

mot

ion

to in

dict

sub

mitt

ed –

cou

rt

proc

eedi

ngs

unde

rway

SLO

VAK

REPU

BLIC

(pre

pare

d by

the

natio

nal c

onsu

ltant

Mr P

eter

KLA

ND

UCH

)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

2018

-201

9O

ffici

al d

ata

of th

e M

inis

try

of Ju

stic

e an

d th

e Pr

osec

utor

Gen

eral

’s O

ffice

indi

cate

that

on

ly a

han

dful

of c

ases

rela

ted

to p

harm

aceu

tical

crim

inal

offe

nces

(Sec

tions

170

, 170

a an

d 17

0b o

f the

Crim

inal

Cod

e) w

ere

trie

d be

fore

Slo

vaki

an c

ourt

s in

the

two-

year

per

iod

of 2

018-

2019

. Thr

ee c

ases

wer

e tr

ied

in 2

018

and

five

case

s in

201

9. N

o cr

imin

al c

ase

unde

r Sec

tion

170b

(Cou

nter

feiti

ng o

f med

icin

al p

rodu

cts

and

med

ical

dev

ices

) was

tr

ied

in th

e re

port

ed p

erio

d. N

o de

tails

con

cern

ing

the

abov

e ca

ses

have

bee

n fo

und

from

whi

ch to

infe

r the

key

cha

ract

eris

tic fe

atur

es, p

atte

rns

of th

is ty

pe o

f crim

inal

ity

or lo

ng-t

erm

tren

ds. I

t see

ms

to b

e ha

rd to

det

erm

ine

wha

t are

the

caus

es o

f low

leve

l of

att

entio

n to

pha

rmac

eutic

al c

rimin

ality

(lac

k of

fina

ncia

l and

/or h

uman

reso

urce

s, in

suffi

cien

t exp

ertis

e of

law

-enf

orce

men

t aut

horit

ies,

evid

entia

ry p

robl

ems,

etc.

?)

The

cour

t pro

ceed

ings

resu

lted

in th

ree

conv

ictio

ns in

201

8 (o

ne c

onvi

ctio

n un

der

Sect

ion

170

and

two

conv

ictio

ns u

nder

Se

ctio

n 17

0a o

f the

Crim

inal

Cod

e) a

nd

five

conv

ictio

ns in

201

9 (o

ne c

onvi

ctio

n un

der S

ectio

n 17

0 an

d fo

ur c

onvi

ctio

ns

unde

r Sec

tion

170a

of t

he C

rimin

al C

ode)

. Th

e sa

nctio

ns in

clud

ed p

rison

sen

tenc

es,

forf

eitu

re o

f ite

m a

nd p

rote

ctiv

e m

easu

res.

http://web.ac-mssr.sk/statisticke-rocenky/

https://www.genpro.gov.sk/statistiky-12c1.html


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

2017

On

13 S

epte

mbe

r 201

7, th

e Po

lice

Forc

e of

the

Slov

ak R

epub

lic in

form

ed o

n its

Fac

eboo

k pa

ge o

f the

cas

e of

a 2

6-ye

ar o

ld m

an c

harg

ed w

ith th

e co

unte

rfei

ting

of m

edic

inal

pr

oduc

t and

med

ical

dev

ice.

Dur

ing

rout

ine

polic

e ch

eck

pills

and

the

pack

s w

ith

unkn

own

med

icam

ents

wer

e fo

und.

The

exp

ert a

naly

sis

confi

rmed

that

thre

e pi

lls

wer

e co

unte

rfei

ts o

f the

orig

inal

med

icin

al p

rodu

ct re

gist

ered

in th

e co

untr

y fo

r the

ED

tr

eatm

ent.

The

item

s di

d no

t con

tain

the

sam

e eff

ectiv

e su

bsta

nce

as th

e or

igin

al. T

he

rem

aini

ng d

rugs

wer

e no

t reg

iste

red

in S

lova

kia

nor i

n an

y ot

her E

U M

embe

r Sta

te.

Not

kno

wn.

SLO

VEN

IA (p

repa

red

by th

e na

tiona

l con

sulta

nt M

s Ja

smin

a A

RNU

S TA

BAKO

VIC)

Base

d on

ava

ilabl

e da

ta, o

btai

ned

by th

e Ce

ntre

of E

xper

tise

and

IT a

t the

Sup

rem

e St

ate

Pros

ecut

or’s

Offi

ce12

the

pros

ecut

ion

at th

e st

ate

leve

l fro

m y

ear 2

005

to 2

018

deal

w

ith le

ss th

an 1

0 ca

ses w

here

the

subj

ect o

f the

seiz

ure

was

cou

nter

feit

erec

tile

drug

s dys

func

tion

such

as V

iagr

a, C

ialis

in K

amag

ra g

el. F

rom

the

poin

t of v

iew

of p

rose

cuto

rial

case

s w

e m

ay d

efine

cou

nter

feit

med

icin

al p

rodu

cts

as m

edic

inal

pro

duct

s th

at d

evia

te fr

om th

e or

igin

al in

this

way

in q

ualit

y as

wel

l as

in q

uant

ity o

f act

ive

subs

tanc

es,

they

diff

er fr

om th

em in

ser

ial f

orm

num

bers

and

aft

er th

e da

te o

f use

, the

med

icin

al p

rodu

cts

conc

erne

d ar

e no

t reg

iste

red,

etc

. In

the

perio

d fr

om 2

018

to 2

020,

the

stat

e pr

osec

utor

’s offi

ces

in th

e Re

publ

ic o

f Slo

veni

a re

ceiv

ed a

tota

l of 1

6 cr

imin

al c

ompl

aint

s in

con

nect

ion

with

a c

rimin

al o

ffens

e un

der A

rtic

le 1

83 o

f the

Cri

min

al C

ode

(KZ-

1, 2

012)

- A

rtic

le 1

83 -

Man

ufac

ture

and

Trad

e in

Har

mfu

l Rem

edie

s.13

In 1

1 ca

ses,

the

char

ges w

ere

dism

isse

d (m

ostly

on

the

grou

nds t

hat t

he re

port

ed a

ct is

not

a c

rimin

al o

ffens

e pr

osec

uted

ex o

ffici

o (p

osse

ssio

n of

har

mfu

l med

icin

al p

rodu

ct is

not

pun

isha

ble,

it is

not

pos

sibl

e to

pro

ve m

anuf

actu

ring

or sa

les o

f har

mfu

l med

icin

al p

rodu

ct, t

he q

uant

ity se

ized

doe

s not

indi

cate

a sa

le, n

o m

edic

inal

pro

duct

as s

erio

usly

end

ange

r hea

lth h

as b

een

iden

tified

) and

bec

ause

ther

e is

no

reas

onab

le s

uspi

cion

), w

hich

sho

ws

on th

e sh

ortc

omin

gs o

f inc

rimin

atio

n.14

In 5

cas

es th

e pr

osec

utio

n fil

ed a

n in

dict

men

t.Th

e nu

mbe

r of p

roce

edin

gs w

ith t

he p

olic

e an

d th

e pr

osec

utio

n on

the

bas

is o

f the

Art

icle

183

of C

C-1

does

not

refle

ct t

he a

ctua

l sco

pe o

f the

pro

blem

of c

ount

erfe

it m

edic

ines

, if t

his

is n

eces

sary

for t

he p

urpo

se o

f pro

ving

har

mfu

lnes

s to

hea

lth.

15

Alre

ady

in 2

016,

201

8 an

d 20

19 th

e po

lice

and

the

stat

e pr

osec

utor

’s offi

ce d

rew

att

entio

n to

inad

equa

te cr

imin

al la

w le

gisla

tion

and

sugg

este

d be

tter

crim

inal

isatio

n. In

202

0, th

e M

inist

ry o

f Jus

tice

prop

osed

an

amen

dmen

t to

the

crim

inal

law

of t

he C

rimin

al C

ode

(am

endm

ent t

o th

e Cr

imin

al C

ode

- KZ-

1H) a

nd in

Sep

tem

ber 2

020

a di

scus

sion

was

hel

d on

am

endm

ents

to a

rtic

les i

n KZ

-1 to

impl

emen

t the

pro

visio

ns o

f the

MED

ICRI

ME

Conv

entio

n16. A

men

dmen

ts to

KZ-

1H, r

elat

ing

to th

e M

EDIC

RIM

E Co

nven

tion,

are

har

mon

ized

at t

he

prof

essi

onal

leve

l,17 w

hich

is a

lso

one

of th

e ob

ject

ives

of t

he R

esol

utio

n on

the

Nat

iona

l Pro

gram

for t

he P

reve

ntio

n an

d Su

ppre

ssio

n of

Cri

me

for t

he p

erio

d 20

19-2

023.

18

12.

Cen

tre

of E

xper

tise

and

IT a

t the

Sup

rem

e St

ate

Pros

ecut

or’s

Offi

ce, a

vaila

ble

at th

e fo

llow

ing

link

http

s://

ww

w.d

t-rs

.si/u

nits

-and

-dep

artm

ents

.13

. S

love

nian

Crim

inal

Cod

e (K

azen

ski z

akon

ik K

Z-1,

Offi

cial

Gaz

ette

RS,

no.

50/

12, 6

/16,

54/

15, 3

8/16

, 27/

17, 2

3/20

in 9

1/20

) ava

ilabl

e at

the

follo

win

g lin

k ht

tp://

ww

w.p

isrs

.si/P

is.w

eb/p

regl

edPr

edpi

sa?i

d=ZA

KO50

50.

14.

The

art

icle

cite

d in

the

first

par

agra

ph p

rovi

des

for o

nly

two

form

s of

enf

orce

men

t, i.e

. act

s: 1

) the

man

ufac

ture

of d

rugs

or o

ther

med

icin

al p

rodu

cts

that

are

so

harm

ful t

o he

alth

and

2) t

he p

laci

ng o

n th

e m

arke

t of s

uch

med

icin

al p

rodu

cts

or m

edic

inal

pro

duct

s fo

r tre

atm

ent o

r in

som

e ot

her w

ay.

15.

The

cru

cial

for p

rose

cutio

n is

the

inte

rpre

tatio

n of

the

lega

l sig

n in

Art

icle

183

: har

mfu

l to

heal

th.

16.

The

Rep

ublic

of S

love

nia

has

alre

ady

sign

ed th

e Co

nven

tion

in M

arch

201

9, a

nd b

efor

e ra

tifica

tion

- in

addi

tion

to c

hang

es in

sec

tora

l leg

isla

tion

- am

endm

ents

to C

rimin

al C

ode

(CC-

1) a

re n

eede

d.17

. D

raft

of t

he la

w: G

iven

the

abov

e an

d th

e fa

ct th

at c

ount

erfe

it m

edic

ines

cer

tain

ly p

ose

a th

reat

to p

ublic

hea

lth, a

lthou

gh in

this

par

ticul

ar c

ase

it is

not

pos

sibl

e to

pro

ve a

t lea

st a

n ab

stra

ct h

ealth

thre

at

in c

rimin

al la

w, a

new

crim

inal

offe

nse

of “p

rodu

ctio

n an

d tr

affick

ing

of c

ount

erfe

it m

edic

ines

” mus

t be

esta

blis

hed.

A n

ew c

rimin

al o

ffens

e in

pro

pose

d in

Art

icle

183

.a o

f the

CC-

1 (a

s su

bsid

iary

offe

nse)

“p

rodu

ctio

n an

d tr

ade

in c

ount

erfe

it re

med

ies

for t

reat

men

t” fo

r med

icin

al p

rodu

cts

whi

ch a

re fa

lse,

forg

ed o

r fal

sifie

d an

d no

ser

ious

crim

e ha

s be

en c

omm

itted

und

er K

Z-1.

In A

rtic

le 1

83 o

f the

CC-

1 ne

w

form

of a

cts

will

be

adde

d su

ch a

s m

anuf

actu

res,

sells

or o

ffers

for s

ale

or, f

or sa

le o

r pla

cing

on

the

mar

ket,

buys

or s

tore

s, or

med

iate

s in

the

sale

or p

urch

ase,

or i

mpo

rts o

r exp

orts

or o

ther

wis

e.18

. (R

esol

utio

n on

the

natio

nal p

rogr

amm

e fo

r the

pre

vent

ion

and

supp

ress

ion

of c

rime

2019

–202

3, O

ffici

al G

azet

te, n

o. 4

3/19

, ava

ilabl

e on

the

web

site

htt

p://

ww

w.p

isrs

.si/P

is.w

eb/p

regl

edPr

edpi

sa?i

d=RE

SO11

9).

https://www.facebook.com/policiaslovakia/photos/dajte-si-pozor:-falŠovanie-liekov/1716820598348155/

https://www.facebook.com/policiaslovakia/photos/dajte-si-pozor:-falŠovanie-liekov/1716820598348155/

https://www.dt-rs.si/units-and-departments

http://www.uradni-list.si/1/objava.jsp?sop=2012-01-2065






http://www.pisrs.si/Pis.web/pregledPredpisa?id=ZAKO5050

http://www.pisrs.si/Pis.web/pregledPredpisa?id=RESO119


Crim

inal

legi

slat

ion

of th

e Re

publ

ic o

f Slo

veni

a or

the

Crim

inal

Cod

e (K

Z-1,

201

2) c

onta

ins c

rimin

al o

ffens

es th

at c

ould

be

clas

sifie

d as

crim

inal

indi

vidu

al p

ract

ices

in th

e fie

ld

of c

ount

erfe

iting

of m

edic

al (m

edic

inal

) pro

duct

s. To

per

secu

te su

ch o

ffens

es a

re th

e m

ost a

ppro

pria

te o

ffens

es: M

anuf

actu

re a

nd tr

ade

in h

arm

ful r

emed

ies f

or tr

eatm

ent

unde

r Art

icle

183

of t

he C

rimin

al C

ode,

Unj

ustifi

ed u

se o

f a fo

reig

n m

ark

or m

odel

und

er A

rtic

le 2

33 o

f the

Crim

inal

Cod

e, S

mug

glin

g un

der A

rtic

le 2

50 o

f the

Crim

inal

Co

de, D

ecei

ving

cos

tum

ers u

nder

Art

icle

232

of t

he C

rimin

al C

ode,

Fra

ud u

nder

Art

icle

211

of t

he C

rimin

al C

ode

or c

rimin

al o

ffens

es in

the

field

of c

opyr

ight

infr

inge

men

t.

Rega

rdin

g A

rtic

le 1

83 o

f the

Cri

min

al C

ode

(Art

icle

183

- M

anuf

actu

re a

nd T

rade

in H

arm

ful R

emed

ies)

we

note

thre

e (3

) fina

l jud

gem

ents

; one

from

201

3 an

d tw

o fin

al ju

dgem

ent i

n 20

19 a

s st

ated

bel

ow. R

egar

ding

Med

icin

al P

rodu

cts

Act

(Zak

on o

zdr

avili

h, Z

Zdr-

2)19

we

note

one

(1) fi

nal a

dmin

istr

ativ

e ju

dgem

ent.

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Mar

ibor

Hig

her C

ourt

no.

II K

p 31

98/2

010,

10.

1. 2

013,

avai

labl

e at

the

follo

win

g lin

k

http

://w

ww

.sod

isce

.si/v

ism

b/od

loci

tve/

2012

0321

1306

0855

/

The

Dis

tric

t Sta

te P

rose

cuto

r’s

Offi

ce in

Mar

ibor

(DSP

O M

B)

good

pro

secu

tori

al p

ract

ice

first

and

pilo

t con

vict

ion

first

judg

emen

t reg

ardi

ng

Art

icle

183

of C

C-1

The

Dis

tric

t Sta

te P

rose

cuto

r’s O

ffice

in M

arib

or (h

ttps

://w

ww

.dt-

rs.s

i/dsp

o-m

arib

or) p

rose

cute

d th

e pe

rpet

rato

r of

the

crim

inal

offe

nse

of p

rodu

ctio

n an

d tr

ade

of

harm

ful m

eans

of t

reat

men

t und

er A

rtic

le 1

83 o

f the

Cr

imin

al C

ode

(Art

icle

183

- M

anuf

actu

re a

nd T

rade

in

Har

mfu

l Rem

edie

s), w

hich

end

ed w

ith a

con

vict

ion.

A

s an

exa

mpl

e of

goo

d pr

osec

utor

ial p

ract

ice,

it

repr

esen

ts fi

rst a

nd p

ilot c

onvi

ctio

n in

rela

tion

to

coun

terf

eit m

edic

ines

.

Age

ncy

for M

edic

inal

Pro

duct

s an

d M

edic

al D

evic

es

of th

e Re

publ

ic o

f Slo

veni

a (h

erei

naft

er J

AZM

P,

http

s://

ww

w.ja

zmp.

si/e

n/) i

s du

e to

a v

iola

tion

of la

bor

law

; sal

e of

med

icin

es il

lega

lly, o

rder

ed th

e pe

rpet

rato

r to

pay

a fi

ne. A

fter

re-e

xam

inin

g th

e sa

le o

f dru

gs, a

pr

elim

inar

y an

alys

is fo

und

that

the

drug

s so

ld b

y th

e sa

me

perp

etra

tor o

nlin

e w

ere

coun

terf

eit,

so J

AZM

P fil

ed a

com

plai

nt to

the

pros

ecut

or’s

office

, acc

usin

g th

e su

spec

t of s

ellin

g a

coun

terf

eit d

rug

for e

rect

ile

dysf

unct

ion

onlin

e.

The

Cour

t of F

irst

Inst

ance

is in

dec

idin

g on

the

crim

inal

san

ctio

n to

ok

into

acc

ount

that

the

accu

sed

sold

cou

nter

feit

drug

s no

mor

e th

an 2

6 pe

ople

and

that

no

cust

omer

has

bee

n sh

own

to h

ave

it be

caus

e of

th

em h

ealth

pro

blem

s, ex

cept

for o

ne th

at a

ssoc

iate

d hi

gher

blo

od

pres

sure

with

taki

ng C

ialis

tabl

ets

and

nose

blee

ds, b

ut fo

und

no

spec

ific

aggr

avat

ing

circ

umst

ance

s su

ch a

s st

ated

in th

e gr

ound

s of

th

e ju

dgm

ent u

nder

app

eal.

The

Cour

t fou

nd th

e ac

cuse

d gu

ilty

of

com

mitt

ing

the

crim

inal

offe

nse

and

sent

ence

d hi

m to

a s

uspe

nded

se

nten

ce, w

hich

sen

tenc

ed h

im to

7 m

onth

s in

pris

on w

ith a

pro

batio

n pe

riod

of 2

yea

rs a

nd c

onfis

cate

d hi

s co

nfisc

ated

pill

s an

d ill

egal

pr

oper

ty.

The

pros

ecut

or a

ppea

led

agai

nst t

he d

ecis

ion

on th

e cr

imin

al s

anct

ion,

as

the

sanc

tion

of a

war

ning

nat

ure

was

not

app

ropr

iate

in v

iew

of t

he

serio

usly

dan

ger t

hat c

an b

e ca

used

. It a

lso

drew

att

entio

n to

the

grav

ity

of th

e cr

ime,

whi

ch w

as in

dica

ted

by th

e da

nger

of t

akin

g co

unte

rfei

t m

edic

ines

, whi

ch th

e de

fend

ant’s

cou

nsel

obj

ecte

d to

on

the

grou

nds

that

the

coun

terf

eits

con

tain

ed fe

wer

har

mfu

l sub

stan

ces

than

the

orig

inal

s.

Follo

win

g th

e ap

peal

of t

he p

rose

cutio

n, th

e H

igh

Cour

t in

Mar

ibor

ch

ange

d th

e cr

imin

al s

anct

ion

by s

ente

ncin

g th

e co

nvic

t to

7 m

onth

s in

pri

son.

19.

Med

icin

al P

rodu

cts

Act

- M

PA (Z

akon

o z

drav

ilih,

ZZd

r-2,

Offi

cial

Gaz

ette

RS,

no.

17/

14 in

66/

19) a

vaila

ble

at th

e fo

llow

ing

link

http

://w

ww

.pis

rs.s

i/Pis

.web

/pre

gled

Pred

pisa

?id=

ZAKO

6295

.

http://www.sodisce.si/vismb/odlocitve/2012032113060855/

http://www.sodisce.si/vismb/odlocitve/2012032113060855/

https://www.dt-rs.si/dspo-maribor

https://www.dt-rs.si/dspo-maribor

https://www.jazmp.si/en/





PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Base

d on

pol

ice

initi

ativ

es, t

he p

rose

cuto

r pro

pose

d is

suin

g co

urt o

rder

s fo

r hou

se s

earc

h an

d ca

r, in

spec

t ph

ones

and

com

pute

rs, a

nd o

btai

n ba

nk a

ccou

nt

info

rmat

ion.

The

sus

pect

was

sei

zed

seve

ral b

oxes

of

cou

nter

feit

med

icin

es a

nd je

llies

, cer

tifica

tes

of

deliv

ery,

cas

h in

the

amou

nt o

f EU

R 25

,500

,00

and

copi

es o

f ins

truc

tions

for t

he u

se o

f Via

gra

and

Cial

is.

An

insp

ectio

n of

the

seiz

ed m

obile

pho

nes

and

a co

mpu

ter r

evea

led

that

the

susp

ect h

ad re

cord

ed

cust

omer

s. A

t the

sam

e tim

e fil

es w

ere

foun

d th

at w

ere

used

to c

reat

e w

ebsi

tes

in C

roat

ian

and

Ger

man

, whi

ch

indi

cate

d its

ope

ratio

n in

fore

ign

mar

kets

as

wel

l. Ba

sed

on th

e ob

tain

ed b

ank

data

, it w

as e

stab

lishe

d th

at

he s

old

med

icin

es to

at l

east

19

cust

omer

s al

thou

gh

thou

sand

s of

add

ress

es w

ere

foun

d to

whi

ch h

e se

nt

pack

ages

.

The

JAZM

P ca

rrie

d ou

t an

qual

ity c

ontr

ol o

f the

seiz

ed

med

icin

es a

nd fo

und

that

the

cont

ent o

f the

act

ive

subs

tanc

e in

Cia

lis 2

0 m

g di

d no

t cor

resp

ond

to th

e de

clar

ed c

onte

nt, a

s the

med

icin

e co

ntai

ned

25 %

le

ss ta

dala

fil. C

ialis

25

mg

was

foun

d no

t to

mee

t the

re

quire

men

ts o

f the

orig

inal

pro

duct

in te

rms o

f pur

ity

and

quan

tifica

tion

and

wei

ght,

and

the

tada

lafil

con

tent

w

as 1

36%

of t

he d

ecla

red

valu

e, i.e

. the

pro

duct

con

tain

ed

36 %

mor

e ta

dala

fil. T

he c

oncl

usio

n of

the

anal

ysis

co

nclu

ded

that

cou

nter

feit

med

icin

es c

ould

pos

e a

serio

us th

reat

to h

uman

hea

lth a

nd li

fe a

nd th

at th

e se

ized

m

edic

ines

wer

e un

doub

tedl

y co

unte

rfeits

, as t

hey

diffe

red

from

the

orig

inal

s in

term

s of b

oth

qual

ity a

nd q

uant

ity o

f ac

tive

ingr

edie

nts,

by se

rial n

umbe

r and

exp

iratio

n da

te.

Six

mon

ths l

ater

, the

pro

secu

tor r

ecei

ved

a cr

imin

al

com

plai

nt fr

om th

e po

lice,

whi

ch w

as c

arry

ing

out a

secr

et

surv

eilla

nce

mea

sure

aga

inst

ano

ther

per

son,

with

who

m

the

sam

e su

spec

t was

on

that

day

, who

was

stop

ped

and

cont

rolle

d. H

e su

spec

ted

was

seiz

ed: 2

box

es o

f Cia

lis 2

0 m

g ta

blet

s, a

box

of Ta

dalis

SX2

0, a

box

of V

iagr

a an

d 18

m

ail m

essa

ges t

o va

rious

peo

ple.

The

Hig

h Co

urt t

hus

agre

ed w

ith th

e po

sitio

n of

the

publ

ic p

rose

cuto

r th

at th

e im

posi

tion

of a

sus

pend

ed s

ente

nce,

whi

ch is

a c

rimin

al

sanc

tion

of a

pur

ely

war

ning

nat

ure,

is n

ot s

ubst

antia

ted

in th

e ca

se o

f th

e ac

cuse

d.

The

Cour

t of F

irst I

nsta

nce

disr

egar

ded

the

high

obj

ectiv

e ris

k of

sale

co

unte

rfei

t tab

lets

for h

uman

hea

lth, w

hich

is a

ppar

ent f

rom

the

expe

rt

opin

ion.

The

Hig

h Co

urt r

elie

d on

an

expe

rt o

pini

on a

nd to

ok th

e vi

ew th

at th

e ap

peal

war

ns th

e pu

blic

pro

secu

tor o

f the

dan

gers

of

taki

ng c

ount

erfe

it m

edic

ines

and

thus

the

grav

ity o

f the

alle

ged

offen

se to

the

defe

ndan

t, an

d in

doi

ng so

the

alle

gatio

ns a

dvoc

ate

that

th

e co

unte

rfei

ts c

onta

ined

few

er h

arm

ful s

ubst

ance

s tha

n th

e or

igin

als,

by w

eigh

t and

do

not r

educ

e th

e ris

k of

the

alle

ged

offen

se. I

n as

sess

ing

harm

fuln

ess t

here

fore

did

not

onl

y co

nsid

er th

e ac

tual

am

ount

of

subs

tanc

es h

arm

ful t

o he

alth

, as i

t fol

low

s fro

m th

e ex

pert

opi

nion

, an

d th

e ac

tual

pot

enti

al a

dver

se e

ffec

ts o

n hu

man

hea

lth,

but

als

o ot

her c

ircu

mst

ance

s. C

onsi

dere

d is

that

such

med

icat

ions

can

onl

y be

pr

escr

ibed

by

a do

ctor

who

is ta

king

the

appr

opria

tene

ss su

ch m

edic

ines

ac

cord

ing

to th

e pa

tient

’s st

ate

of h

ealth

and

that

he

can

disp

ense

them

on

ly a

pha

rmac

ist o

n a

pres

crip

tion,

and

, as i

s cle

ar fr

om th

e ex

pert

op

inio

n, y

es p

oses

a d

ange

r to

hum

an h

ealth

, esp

ecia

lly th

e un

cont

rolle

d in

take

of t

hese

med

icin

es, n

ot ju

st th

eir c

ompo

sitio

n. A

ccor

ding

to th

e ex

pert

, it i

s fro

m th

e op

inio

n of

the

expe

rt th

e co

urts

show

that

thos

e m

edic

inal

pro

duct

s, w

hen

used

inco

rrec

tly o

r with

out m

edic

al su

perv

isio

n po

se a

n in

crea

sed

risk

to th

e he

alth

of t

he u

ser,

whi

ch m

eans

that

sa

les a

nd u

se m

ust b

e st

rict

ly c

ontr

olle

d by

cus

tom

ers c

ount

erfe

it

med

icin

es so

ld b

y th

e de

fend

ant w

ere

not b

elow

the

rele

vant

leve

l m

edic

al su

perv

isio

n an

d us

ed c

ount

erfe

its th

at c

ould

pos

e a

serio

us th

reat

us

er h

ealth

. Fin

ding

that

the

witn

esse

s who

wer

e he

ard

in th

e he

arin

g cr

imin

al c

ase,

did

not

hav

e he

alth

pro

blem

s, do

es n

ot re

duce

the

dang

er

and

wei

ght t

he o

ffens

e in

que

stio

n, n

or th

e ci

rcum

stan

ce o

f who

car

ried

out t

he a

naly

sis t

o th

e de

fend

ant o

f the

seiz

ed c

ount

erfe

its.

The

deci

sion

it is

bas

ed o

n th

e fa

ct th

at s

uch

med

icin

es c

an o

nly

be

pres

crib

ed b

y a

doct

or w

ho a

sses

ses

the

suit

abili

ty o

f med

icin

es

acco

rdin

g to

the

pati

ent’s

hea

lth,

that

med

icin

es c

an o

nly

be

disp

ense

d by

a p

harm

acis

t and

that

unc

ontr

olle

d us

e of

thes

e m

edic

ines

pos

es a

dan

ger t

o hu

man

hea

lth,

alb

eit w

ith

a lo

wer

co

nten

t of a

ctiv

e su

bsta

nce.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Aft

er tw

o in

vest

igat

ions

, the

pro

secu

tor’s

offi

ce fi

led

an in

dict

men

t and

the

cour

t mer

ged

and

cond

ucte

d a

sing

le p

roce

edin

g ag

ains

t the

acc

used

for a

crim

inal

off

ense

und

er A

rtic

le 1

83 o

f the

Cri

min

al C

ode

due

to a

sin

gle

hear

ing.

He

was

acc

used

of s

ellin

g er

ectil

e dy

sfun

ctio

n m

edic

ines

(Via

gra,

Cia

lis a

t a p

rice

of E

UR

54.0

0/pc

s) o

nlin

e, w

hich

cou

ld o

nly

be o

btai

ned

with

a

pres

crip

tion

and

whi

ch d

iffer

ed fr

om th

e or

igin

al

med

icin

es in

term

s of

qua

ntity

and

qua

lity

of a

ctiv

e in

gred

ient

s, an

d th

at th

ereb

y en

dang

erin

g th

e he

alth

of

at l

east

27

cust

omer

s w

ho re

spon

ded

to h

is o

ffer.

The

fore

nsic

toxi

colo

gist

wro

te in

the

opin

ion

that

ta

king

dru

gs fo

r ere

ctile

dys

func

tion

wit

h th

e ac

tive

ingr

edie

nts

sild

enafi

l and

tada

lafil

at t

heir

ow

n di

scre

tion

wit

hout

med

ical

sup

ervi

sion

can

se

riou

sly

enda

nger

the

heal

th o

f the

use

r, es

peci

ally

w

hen

it co

mes

to im

prop

er d

osin

g an

d di

sreg

ardi

ng

cont

rain

dica

tions

in c

erta

in d

isea

ses

and

inte

ract

ions

w

ith o

ther

dru

gs. H

owev

er, i

n th

e ca

se o

f the

use

of

coun

terf

eit m

edic

ines

, the

risk

is e

ven

high

er.

Dis

tric

t Cou

rt K

ranj

, no.

I K

4721

9/20

17, 3

. 9. 2

018

in re

gard

Lj

ublja

na H

ighe

r Cou

rt n

o. II

I Kp

4721

9/20

17, 1

0. 4

. 201

9,

web

page

not

ava

ilabl

e

The

Dis

tric

t Sta

te P

rose

cuto

r’s

Offi

ce in

Kra

nj (D

SPO

KR)

The

pros

ecut

ion

filed

an

indi

ctm

ent a

gain

st 5

de

fend

ants

for s

ever

al c

rimes

. Acc

ordi

ng to

Art

icle

211

(F

raud

), A

rtic

le 2

13 (B

lack

mai

l) an

d A

rtic

le 1

83 o

f the

Cr

imin

al C

ode

(Art

icle

183

- M

anuf

actu

re a

nd T

rade

in

Har

mfu

l Rem

edie

s).

One

of t

he d

efen

dant

s, w

ho w

as in

cus

tody

, was

als

o ac

cuse

d, a

mon

g ot

her t

hing

s, of

sel

ling

drug

s an

d m

edic

ines

that

are

har

mfu

l to

heal

th. H

e so

ld 1

20 b

oxes

of

Via

gra

tabl

ets

to o

ne b

uyer

for E

UR

7,20

0 an

d 2,

780

Cial

is ta

blet

s, 1,

104

Cial

is ta

blet

s, 1,

183

Kam

agra

bag

s, 17

2 Vi

agra

tabl

ets,

800

Viza

rsin

tabl

ets,

68 V

izar

sin

tabl

ets,

80 S

ildeH

EXAL

tabl

ets

and

1,42

9 Si

lden

afil

tabl

ets.

Acco

rdin

g to

the

expe

rt o

pini

on o

f for

ensi

c exp

ert t

he c

ourt

foun

d th

at th

e ac

tive

subs

tanc

es si

lden

afil, w

hich

is h

ealth

y fo

r the

trea

tmen

t of

ere

ctile

dys

func

tion,

was

foun

d to

be

esse

ntia

l in

all s

eize

d ite

ms.

The

seiz

ed m

edic

ines

, exc

ept f

or th

e m

anuf

actu

rers

Via

gra

Pfize

r and

Viz

arsin

a m

anuf

actu

red

by K

rka,

are

not

regi

ster

ed in

Slo

veni

a. M

edic

inal

pro

duct

s re

gist

ered

in S

love

nia

are

thus

regi

ster

ed o

nly

as a

tabl

et a

nd a

re th

us

only

ava

ilabl

e on

a d

octo

r’s p

resc

riptio

n, a

s the

y ha

ve th

e pr

escr

iptio

n of

med

icin

es, c

erta

in re

stric

tions

or s

afet

y m

easu

res.

The

patie

nt’s

abili

ty

to e

ngag

e in

phy

sical

act

ivity

or s

exua

l act

ivity

shou

ld b

e as

sess

ed. S

ide

effec

ts su

ch a

s hea

dach

e, re

dnes

s, in

dige

stio

n, n

asal

cong

estio

n, u

rinar

y tra

ct in

fect

ions

, visu

al d

istur

banc

es a

nd d

iarrh

ea ca

n be

exp

ecte

d w

ith th

e pr

escr

ibed

use

of s

ilden

afil. A

t hig

her d

oses

, the

re a

re m

ore

dige

stiv

e an

d vi

sual

dist

urba

nces

in te

rms o

f sym

ptom

s tha

n w

ith lo

wer

dos

es. I

f it i

s tak

en

heal

thily

in se

vera

l qua

ntiti

es w

ithou

t the

supe

rvisi

on o

f a d

octo

r, se

vera

l he

alth

com

plic

atio

ns c

an o

ccur

.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

All

of th

e ab

ove

tabl

ets

and

gels

con

tain

sild

enafi

l, w

hich

is a

dru

g to

trea

t ere

ctile

dys

func

tion

as a

lread

y m

entio

ned.

The

fact

that

Via

gra

from

Pfiz

er a

nd V

izar

sin

tabl

ets

from

Krk

a ar

e no

t reg

iste

red

drug

s in

Slo

veni

a at

all,

and

the

sale

and

del

iver

y by

una

utho

rized

sel

lers

is

thus

alle

ged,

is h

arm

ful t

o hu

man

hea

lth a

nd li

fe

with

out p

rior a

ppro

val a

nd a

doc

tor’s

pre

scrip

tion.

The

pr

osec

utor

pro

pose

d th

at fo

r the

firs

t alle

ged

crim

e 2

year

s an

d 6

mon

ths

impr

ison

men

t, fo

r the

sec

ond

2 ye

ars

and

2 m

onth

s im

pris

onm

ent a

nd fo

r the

third

1

year

and

6 m

onth

s im

pris

onm

ent.

He

also

pro

pose

d th

e re

voca

tion

of th

e su

spen

ded

sent

ence

and

the

impo

sitio

n of

a to

tal s

ente

nce

of 7

yea

rs in

pris

on.

The

conc

entr

atio

n of

act

ive

subs

tanc

es w

ith th

is p

ossi

bilit

y of

sta

tus

effec

ts is

furt

her a

ltere

d by

a d

ecre

ase

in re

nal f

unct

ion

or im

paire

d liv

er fu

nctio

n. It

is c

lear

from

all

of th

e ab

ove

that

thes

e m

edic

ines

are

m

edic

ines

that

con

tain

sub

stan

ces

that

are

har

mfu

l to

heal

th. T

hey

can

only

be

pres

crib

ed b

y a

doct

or (o

n pr

escr

iptio

n).

The

pros

ecut

or p

ropo

sed

a 1

year

and

6 m

onth

s in

pri

son

sent

ence

to

the

accu

sed

for t

he c

rime

unde

r Art

icle

183

of t

he C

rimin

al C

ode.

Th

e co

urt s

ente

nced

the

accu

sed

to 1

yea

r and

1 m

onth

s in

pris

on a

nd

sent

ence

d th

e de

fend

ant t

o a

unifo

rm s

ente

nce

of 6

yea

rs in

pris

on.

Mar

ibor

Hig

her C

ourt

no.

X K

10

580/

2017

, 5. 4

. 201

9

web

page

not

ava

ilabl

e

The

Spec

ialis

ed S

tate

Pr

osec

utor

’s O

ffice

of t

he

Repu

blic

of S

love

nia

The

pros

ecut

or p

rose

cute

d se

vera

l per

petr

ator

s of

cr

imin

al o

ffens

es u

nder

Art

icle

s 11

3 of

the

Crim

inal

Co

de (h

uman

traffi

ckin

g), A

rtic

le 1

86 o

f the

Crim

inal

Co

de (U

njus

tified

pro

duct

ion

and

traffi

ckin

g of

illic

it dr

ugs,

illic

it su

bsta

nces

in s

port

and

pre

curs

ors

for

the

man

ufac

ture

of i

llici

t dru

gs) a

nd A

rtic

le 1

83 o

f the

Cr

imin

al C

ode

(Art

icle

183

- M

anuf

actu

re a

nd T

rade

in

Har

mfu

l Rem

edie

s) a

nd A

rtic

le 1

87 (E

nabl

ing

the

use

of

illic

it dr

ugs

or il

licit

subs

tanc

es in

spo

rts)

.

For t

he o

ffens

e un

der A

rtic

le 1

83 o

f the

Crim

inal

Co

de, o

ne p

erpe

trat

or w

as c

harg

ed w

ith s

ellin

g to

an

und

erco

ver p

olic

e offi

cer 4

pie

ces

of K

amag

ra g

el

cont

aini

ng th

e ac

tive

subs

tanc

es S

ilden

afil t

o tr

eat

erec

tile

dysf

unct

ion.

In S

love

nia

med

icin

al p

rodu

cts

with

sild

enafi

l are

allo

wed

onl

y un

der c

ontr

olle

d sa

le

if it

is p

revi

ousl

y pr

escr

ibed

by

a do

ctor

and

issu

ed o

n th

e ba

sis

of a

pre

scrip

tion

by a

pha

rmac

ist b

ecau

se

sild

enafi

l is

harm

ful t

o hu

man

hea

lth if

con

sum

ed

unco

ntro

lled.

The

opin

ion

of a

fore

nsic

exp

ert i

n th

e fie

ld o

f med

icin

e, d

opin

g an

d la

bora

tory

med

icin

e sh

ows t

hat K

amag

ra is

a m

edic

ine

that

is n

ot

regi

ster

ed in

the

Repu

blic

of S

love

nia

and

ther

efor

e m

ay n

ot b

e so

ld

in th

e Re

publ

ic o

f Slo

veni

a. K

amag

ra c

onta

ins t

he a

ctiv

e su

bsta

nce

sild

enafi

l - a

n PD

E5 in

hibi

tor,

whi

ch is

a m

edic

ine

used

to tr

eat e

rect

ile

dysf

unct

ion

and

whi

ch c

an c

ause

side

effe

cts s

uch

as h

eada

che,

diz

zine

ss,

nasa

l con

desp

ia, h

yper

tens

ion,

faci

al, o

cula

r hyp

erae

mia

. It c

an b

e ha

rmfu

l to

hea

lth,

esp

ecia

lly w

hen

used

unc

ontr

olle

d an

d in

indi

vidu

als w

ith

prev

ious

illn

esse

s. W

hole

sale

or r

etai

l tra

de o

f med

icin

al p

rodu

cts m

ust

be li

cens

ed b

y th

e JA

ZMP,

and

per

sons

wis

hing

to p

erfo

rm th

is a

ctiv

ity

in a

noth

er E

U M

embe

r Sta

te m

ust n

otify

the

Agen

cy. S

ilden

afil s

houl

d no

t be

take

n by

peo

ple

who

do

not h

ave

erec

tile

dysf

unct

ion

and

shou

ld

ther

efor

e on

ly b

e gi

ven

with

a p

resc

riptio

n. In

the

Repu

blic

of S

love

nia,

si

lden

afil c

an o

nly

be o

btai

ned

in p

harm

acie

s and

on

pres

crip

tion,

oth

er

sale

s are

not

per

mitt

ed. T

he fo

rens

ic e

xper

t als

o ex

plai

ned

that

sild

enafi

l-co

ntai

ning

med

icin

es w

ere

regi

ster

ed in

the

Repu

blic

of S

love

nia,

nam

ely

Reva

tio fi

lm-c

oate

d ta

blet

s, Si

lden

afil L

ek ta

blet

s, Si

lden

afil T

eva

film

-co

ated

tabl

ets,

Viag

ra, V

izar

sin

film

-coa

ted

tabl

ets.

They

are

pre

scri

bed

on a

whi

te p

resc

ript

ion,

whi

ch th

e pa

tien

t use

s for

one

yea

r.

The

pros

ecut

or p

ropo

sed

a 6-

mon

th p

rison

sen

tenc

e to

the

accu

sed

for

this

crim

e. T

he c

ourt

sen

tenc

ed th

e ac

cuse

d to

5 m

onth

s in

pri

son.

Thi

s sa

me

perp

etra

tor w

as a

lso

char

ged

with

sev

eral

crim

inal

offe

nses

und

er

abov

e m

entio

ned

artic

les

of th

e Cr

imin

al C

ode.

The

cou

rt s

ente

nced

him

to

2 y

ears

and

3 m

onth

s in

pris

on fo

r all

crim

inal

offe

nses

.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

Judg

men

t of t

he A

dmin

istr

ativ

e Co

urt,

III U

63/

2018

, 21.

3. 2

019

Adm

inis

trat

ive

proc

edur

e

Insp

ectio

n Su

perv

isio

n, h

ealth

ac

tivity

avai

labl

e at

the

follo

win

g lin

k

http

://w

ww

.sod

isce

.si/u

srs/

odlo

citv

e/20

1508

1111

4315

10/

Crim

inal

inve

stig

ator

s fr

om th

e Cr

imin

al P

olic

e Se

ctor

of

the

Ljub

ljana

Pol

ice

Adm

inis

trat

ion

seiz

ed s

hipm

ents

fr

om P

ost o

f Slo

veni

a on

sus

pici

on th

at th

e co

nsig

nor’s

pa

ckag

es fr

om H

ong

Kong

con

tain

ed il

licit

drug

s or

ill

icit

subs

tanc

es in

spo

rts,

whi

ch is

a c

rimin

al o

ffens

e un

der A

rtic

le 1

86 o

f the

Crim

inal

Cod

e (K

Z-1)

. A re

port

w

as d

raw

n up

on

the

seiz

ure.

It w

as fo

und

that

in a

ll ca

ses

ther

e w

ere

ship

men

ts w

eigh

ing

abou

t 8 k

g, in

w

hich

ther

e w

ere

plas

tic b

ottle

s, an

d in

eac

h of

them

ab

out 2

0 pu

rple

cap

sule

s. D

ue to

the

larg

e am

ount

of

item

s, a

rand

om s

ampl

e of

one

of t

he s

hipm

ents

w

as ta

ken

and

exam

ined

at t

he N

atio

nal F

oren

sic

Labo

rato

ry. T

he re

port

from

this

labo

rato

ry s

how

s th

at

sibu

tram

ine

was

iden

tified

in th

e sa

mpl

e, w

hich

is

not o

n th

e lis

t of i

llici

t dru

gs o

r on

the

list o

f ban

ned

subs

tanc

es in

spo

rt, b

ut is

an

appe

tite

supp

ress

ant t

hat

the

Euro

pean

Med

icin

es A

genc

y ha

s al

read

y 20

10 fr

om

the

list o

f aut

horiz

ed m

edic

ines

in th

e Eu

rope

an U

nion

. Ac

cord

ing

to th

e Ag

ency

’s w

ebsi

te, t

he C

omm

ittee

for

Med

icin

al P

rodu

cts

for H

uman

Use

of t

he E

urop

ean

Med

icin

es A

genc

y co

nclu

ded

that

the

bene

fits

of

sibu

tram

ine

do n

ot o

utw

eigh

the

risk

s as

soci

ated

w

ith

it a

nd th

eref

ore

all m

arke

ting

aut

hori

zati

ons

for m

edic

inal

pro

duct

s co

ntai

ning

this

sub

stan

ce

have

bee

n w

ithd

raw

n. T

he li

st o

f med

icin

al p

rodu

cts

in th

e Re

publ

ic o

f Slo

veni

a al

so s

how

s th

at n

one

of th

e m

edic

inal

pro

duct

s co

ntai

ning

sib

utra

min

e ha

s a

valid

mar

keti

ng a

utho

riza

tion

.

In v

iew

of t

he v

olum

e of

the

cons

ignm

ent a

t iss

ue (2

2 po

stal

item

s of

8

kg o

r a to

tal o

f 176

kg,

eac

h co

ntai

ning

pla

stic

bot

tles,

each

con

tain

ing

20 c

apsu

les)

, the

firs

t ins

tanc

e au

thor

ity ri

ghtly

con

clud

ed th

at

sibu

tram

ine

was

not

inte

nded

for p

erso

nal u

se, b

ut fo

r fur

ther

sal

e. T

he

orde

r to

dest

roy

the

cons

ignm

ent i

n qu

esti

on is

just

ified

.

http://www.sodisce.si/usrs/odlocitve/2015081111431510/

http://www.sodisce.si/usrs/odlocitve/2015081111431510/


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

A m

edic

inal

pro

duct

may

be

mar

kete

d in

the

Repu

blic

of

Slo

veni

a if

it ha

s a

mar

keti

ng a

utho

riza

tion

(the

fir

st p

arag

raph

of A

rtic

le 2

0 of

the

Med

icin

al

Prod

ucts

Act

(ZZd

r-2)

. If h

e do

es n

ot h

ave

such

a

perm

it, tr

ade

with

him

is p

rohi

bite

d (A

rtic

le 2

1 of

ZZ

dr-2

). Pl

acin

g m

edic

inal

pro

duct

s on

the

mar

ket

mea

ns s

uppl

ying

the

mar

ket w

ith m

edic

inal

pro

duct

s fo

r fre

e or

free

of c

harg

e, o

r mak

ing

a m

edic

inal

pr

oduc

t ava

ilabl

e in

the

Repu

blic

of S

love

nia

(Item

4

of A

rtic

le 6

of Z

Zdr-

2), a

nd th

e ar

rival

of a

med

icin

al

prod

uct o

n th

e m

arke

t mea

ns th

e fir

st a

ctiv

ity. t

hese

m

edic

inal

pro

duct

s an

d th

eir a

vaila

bilit

y to

the

end

user

(poi

nt 7

3 of

Art

icle

6 o

f ZZd

r-2)

. Tra

de in

m

edic

ines

can

be

carr

ied

out a

s w

hole

sale

or r

etai

l tr

ade.

Who

lesa

le tr

ade

in m

edic

inal

pro

duct

s is

the

activ

ity o

f pur

chas

e, im

port

, sto

rage

, exp

ort,

expo

rt,

sale

of m

edic

inal

pro

duct

s, ex

cept

for t

he is

suan

ce o

f m

edic

inal

pro

duct

s in

reta

il tr

ade

to e

nd u

sers

(Ite

m

75 o

f Art

icle

6 o

f ZZd

r-2,

als

o A

rtic

le 3

of t

he R

ules

20),

trad

e in

reta

il m

edic

ines

, the

act

iviti

es o

f pur

chas

ing,

st

orin

g an

d di

spen

sing

a m

edic

inal

pro

duct

or u

sing

a

med

icin

al p

rodu

ct in

add

ition

to a

hea

lth o

r vet

erin

ary

serv

ice

(Item

76

of A

rtic

le 6

of Z

Zdr-

2).

SWED

EN N

o su

bmis

sion

has

bee

n re

ceiv

ed o

n ca

se la

w fr

om th

e na

tiona

l con

sulta

nt

20.

Rul

es o

n de

taile

d co

nditi

ons o

f who

lesa

le o

f med

icin

al p

rodu

cts a

nd d

eter

min

ing

of fu

lfilm

ent o

f the

se c

ondi

tions

and

pro

cedu

re o

f gai

n th

e pe

rmis

sion

for t

raffi

c of

who

lesa

le o

f med

icin

al p

rodu

cts,

avai

labl

e at

the

follo

win

g lin

k ht

tp://

ww

w.p

isrs

.si/P

is.w

eb/p

regl

edPr

edpi

sa?i

d=PR

AV87

57

http://www.pisrs.si/Pis.web/pregledPredpisa?id=PRAV8757


TUN

ISIA

(pre

pare

d by

the

natio

nal c

onsu

ltant

Mr Y

assi

ne Y

OU

NSI

)

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

28-0

5-20

20Th

e ju

dges

of A

riana

Cou

rt o

f Firs

t Ins

tanc

e ru

ling

on c

ase

num

ber 3

0929

/201

7 be

twee

n N

ovar

tis a

nd T

aha

Phar

ma

(GIL

ENYA

/ FI

NG

OLI

NE)

del

iber

ated

follo

win

g th

e he

arin

g of

28

May

202

0 an

d ru

led

in fa

vour

of N

OVA

RTIS

.

The

cour

t prim

arily

:

§ H

eld

that

Tah

a Ph

arm

a ha

d in

frin

ged

a N

ovar

tis p

aten

t reg

iste

red

and

prot

ecte

d in

Tun

isia

§ O

rder

ed T

aha

Phar

ma

to s

top

mar

ketin

g an

d m

anuf

actu

ring

coun

terf

eit F

ING

OLI

NE

prod

ucts

25-0

6-20

20Th

e ju

dges

of T

unis

2 C

ourt

of F

irst I

nsta

nce

rulin

g on

ca

se n

umbe

r 570

3 be

twee

n Se

rvie

r and

Thé

ra d

elib

erat

ed

follo

win

g th

e he

arin

g of

26

June

202

0 an

d ru

led

in fa

vour

of

Serv

ier.

1 - A

t firs

t ins

tanc

e, th

e co

urt o

rder

ed th

e de

fend

ant,

in th

e pe

rson

of i

ts

lega

l rep

rese

ntat

ive,

to re

frai

n fr

om m

akin

g an

y us

e of

the

proc

ess

for

man

ufac

turin

g th

e pa

tent

ed p

rodu

ct, p

erin

dopr

il ar

gini

ne, a

nd fr

om a

ny

man

ufac

turin

g or

mar

ketin

g of

that

pro

duct

in th

e fo

llow

ing

med

icin

es:

f

The

rapr

il 10

g

fBI

-The

rapr

il (5

mg

/ 1.2

5)

fBi

-The

rapr

il (1

0 m

g / 2

.5)

And

in th

e ev

ent o

f non

-com

plia

nce,

ord

ered

it to

pay

a fi

ne o

f 10

din

ars

a da

y (a

lso

allo

win

g th

e co

mpl

aina

nt to

sei

ze a

nd d

estr

oy

the

afor

emen

tione

d m

edic

ines

), to

pub

lish

the

judg

men

t in

two

daily

ne

wsp

aper

s in

Ara

bic

and

Fren

ch fo

r thr

ee d

ays

at th

e de

fend

ant’s

ex

pens

e, a

nd to

pay

TN

D 6

000

in c

ompe

nsat

ion

for t

he n

on-p

ecun

iary

da

mag

e su

ffere

d by

the

com

plai

nant

.

The

cour

t of fi

rst i

nsta

nce

also

ord

ered

the

defe

ndan

t to

pay

TND

2 0

00.0

00 in

resp

ect o

f the

cos

t of e

xper

t rep

orts

and

TN

D 1

07 4

50

in re

spec

t of t

he c

ost o

f Rec

ord

No.

357

1; o

rder

ed th

e co

mpl

aina

nt to

pay

TN

D 2

00 fo

r the

cos

ts o

f the

ord

er o

n ap

plic

atio

n N

o. 2

0018

bor

ne b

y th

e co

mpl

aina

nt, T

ND

64

150

in re

spec

t of t

he c

osts

of r

ecor

ding

the

serv

ice

of

the

orde

r on

requ

est;

paym

ent o

f TN

D 4

00 0

00 fo

r leg

al a

nd la

wye

rs’ fe

es.

The

cour

t acc

epte

d th

e co

unte

rcla

im a

s to

form

and

dis

mis

sed

it on

the

mer

its.

03-2

019

Com

plai

nt to

the

publ

ic p

rose

cuto

r at B

en A

rous

Cou

rt o

f Firs

t In

stan

ce a

gain

st fi

ve p

erso

ns u

sing

a w

areh

ouse

to c

ount

erfe

it m

edic

ines

The

case

is s

till u

nder

inve

stig

atio

n.


UN

ITED

KIN

GD

OM

(pre

pare

d by

the

natio

nal c

onsu

ltant

Ms

Mui

rean

n Q

UIG

LEY)

Expl

anat

ory

Not

es fr

om th

e Re

sear

cher

It is

impo

rtan

t to

unde

rsta

nd th

e re

gula

tors

in th

e U

K ar

e ve

ry a

ctiv

e in

thei

r inv

estig

atio

n an

d pr

osec

utio

n of

thos

e in

volv

ed w

ith fa

lsifi

ed m

edic

ine

and

sim

ilar c

rimes

. H

owev

er, t

he n

atur

e of

lega

l rep

ortin

g in

this

juris

dict

ion

is s

uch

that

whe

re c

ases

are

dec

ided

in th

e lo

wer

cou

rts

and

no a

ppea

l is

mad

e th

ere

is o

ften

not

a p

ublis

hed

reco

rd o

f the

cas

e. A

s suc

h, I

have

incl

uded

bot

h th

ose

case

s whi

ch a

re fu

lly re

port

ed in

the

trad

ition

al se

nse

and

a nu

mbe

r of e

xam

ples

of t

hose

whi

ch h

ave

been

repo

rted

on

ly th

roug

h th

e re

gula

tor’s

ow

n w

ebsi

tes

or b

y la

wye

rs in

volv

ed in

the

case

.

In re

ality

, it i

s lik

ely

that

ther

e ar

e si

gnifi

cant

ly m

ore

of th

ese

‘unr

epor

ted’

cas

es –

par

ticul

arly

whe

re it

com

es to

less

serio

us/s

izea

ble

inst

ance

s of o

ffenc

es re

late

d to

fals

ified

m

edic

al p

rodu

cts

and

sim

ilar c

rimes

bei

ng c

omm

itted

. How

ever

, I h

ope

that

the

info

rmat

ion

incl

uded

in th

is d

ocum

ent g

ives

a h

elpf

ul p

ictu

re o

f the

act

ive

com

mitm

ent

of th

e re

gula

tors

in th

e U

K to

find

and

pro

secu

te p

eopl

e in

volv

ed in

suc

h cr

imes

.

PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

DAT

E A

ND

CA

SED

ESCR

IPTI

ON

RESU

LT

REPO

RTED

CO

URT

CA

SES

R v

Pate

l and

an

othe

r 200

9Th

is w

as a

n ap

peal

s ca

se b

roug

ht b

y fo

ur a

pplic

ants

. The

app

lican

ts w

ere

four

of o

ver t

en

defe

ndan

ts (t

his

is th

e fig

ure

give

n in

the

judg

emen

t) w

ho h

ad b

een

char

ged

with

crim

es re

late

d to

the

glob

al s

uppl

y of

cou

nter

feit

med

icin

al p

rodu

cts.

The

cha

rges

wer

e br

ough

t fol

low

ing

a co

mpl

ex in

vest

igat

ion

by th

e M

HRA

, whi

ch b

egan

in 2

003.

The

first

two

appl

ican

ts (H

itend

ra P

atel

an

Shaa

n H

ussa

in) w

ere

gran

ted

leav

e to

app

eal,

and

as

such

thei

r cas

es w

ere

not d

iscu

ssed

in th

is ju

dgem

ent a

t any

leng

th. T

his

case

focu

ssed

on

the

appe

als

of A

shw

in P

atel

and

Ket

an M

etha

, whi

ch a

re d

etai

led

in tu

rn:

Ash

win

Pat

el

He

has

been

foun

d gu

ilty

of:

f

One

cou

nt o

f con

spira

cy t

o ev

ade

the

proh

ibiti

on o

f an

unau

thor

ised

use

of a

tra

dem

ark

in

conn

ectio

n w

ith c

ount

erfe

it Vi

agra

f

One

cou

nt o

f con

spira

cy to

pla

ce a

med

icin

al p

rodu

ct o

n th

e m

arke

t, co

ntra

ry to

the

regu

latio

ns

to w

hich

we

have

just

refe

rred

, and

that

rela

ted

to S

ilden

afil C

itrat

e

Hite

ndra

Pat

el &

Sha

an H

ussa

in

The

cour

t allo

wed

thes

e ap

peal

s. Th

e re

sults

of

the

rele

vant

Cou

rt o

f App

eal c

ase

are

incl

uded

be

low

.

Ash

win

Pat

el

The

cour

t did

not

gra

nt M

r Ash

win

Pat

el le

ave

to a

ppea

l. T

hey

held

that

the

tria

l cou

rt ju

dge

had

been

ent

itled

to fi

nd –

as

he d

id –

that

any

de

ficie

ncie

s w

hich

did

exi

st w

ith re

gard

s to

the

proc

edur

al o

pera

tion

of th

e in

vest

igat

ion

did

not a

mou

nt to

a re

ason

to s

tay

proc

eedi

ngs.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

f

One

cou

nt o

f con

spira

cy t

o ev

ade

the

proh

ibiti

on o

f the

una

utho

rised

use

of a

tra

dem

ark

in

rela

tion

to C

ialis

f

One

cou

nt o

f con

spira

cy to

pla

ce a

med

icin

al p

rodu

ct o

n th

e m

arke

t, na

mel

y Ta

dala

fil

He

argu

ed th

at th

e ca

se fo

r app

eal o

n th

e fo

llow

ing

grou

nds:

1.

The

conv

ictio

n w

as u

nsaf

e be

caus

e th

e m

inis

ter w

ho d

eleg

ated

the

pow

er to

pro

secu

te to

the

MH

RA h

ad fa

iled

to e

nsur

e th

at th

e ag

ency

had

rece

ived

suffi

cien

t res

ourc

es, t

rain

ing

and

othe

r he

lp to

com

ply

with

the

vario

us o

blig

atio

ns u

pon

thos

e w

ho in

vest

igat

e cr

ime

2.

That

the

failu

re o

n th

e pa

rt o

f the

MH

RA to

com

ply

with

the

oblig

atio

ns im

pose

d up

on

inve

stig

ator

s un

derm

ined

the

safe

ty o

f the

con

vict

ions

.

Keta

n M

etha

He

had

initi

ally

ple

d gu

ilty

to:

f

Thre

e co

unts

of e

vadi

ng t

he p

rohi

bitio

n on

who

lesa

le d

ealin

g, c

ontr

ary

to s

ectio

n 8(

3)(a

) and

se

ctio

n 45

(1) o

f the

Med

icin

es A

ct 1

968.

In a

ppea

ling

the

conv

ictio

n, M

etha

’s la

wye

r ech

oed

the

safe

ty o

f the

con

vict

ions

as

a gr

ound

of

app

eal.

He

also

arg

ued

that

ther

e ha

d be

en a

mis

carr

iage

of j

ustic

e, d

ue to

the

fact

that

the

subs

tant

ive

char

ges

to w

hich

his

clie

nt p

lead

gui

lty h

ad o

nly

been

add

ed b

y th

e pr

osec

utio

n af

ter

the

jury

faile

d to

agr

ee o

n w

heth

er h

e w

as g

uilty

for c

onsp

iracy

to e

vade

pro

hibi

tion

on w

hole

sale

de

alin

g.

Keta

n M

etha

The

cour

t did

not

gra

nt M

r Met

ha l

leav

e to

ap

peal

. O

n th

e sa

fety

of t

he c

onvi

ctio

ns, t

hey

echo

ed w

hat t

hey

had

said

in re

spon

se to

Mr

Pate

l’s a

ppea

l. O

n th

e m

isca

rria

ge o

f jus

tice,

th

ey h

eld

that

the

pros

ecut

ion

had

not d

one

anyt

hing

that

am

ount

ed to

a m

isca

rria

ge o

f ju

stic

e, n

otin

g th

at it

was

not

unc

omm

on fo

r th

e pr

osec

utio

n to

see

k pe

rmis

sion

to a

dd

subs

tant

ive

coun

ts to

whi

ch th

e de

fend

ant

then

ple

ads

guilt

y w

here

the

jury

are

una

ble

to a

gree

on

thei

r gui

lt w

ith re

gard

s to

a

cons

pira

cy.

[200

9] E

WCA

Cr

im 2

311

Hite

ndra

Pat

el (p

led

guilt

y)

fTw

o co

unts

of p

laci

ng a

med

icin

al p

rodu

ct o

n th

e m

arke

t, co

ntra

ry to

sect

ion

3(1)

of t

he M

edic

ines

fo

r Hum

an U

se R

egul

atio

ns 1

994.

Shaa

n H

ussa

in (p

lead

gui

lty)

One

cou

nt o

f pla

cing

a m

edic

inal

pro

duct

on

the

mar

ket,

cont

rary

to s

ectio

n 3(

1) o

f the

Med

icin

es

for H

uman

Use

Reg

ulat

ions

199

4.

Both

con

vict

ions

wer

e se

t asi

de.

With

rega

rds

to th

e se

cond

cou

nt fo

r whi

ch

Pate

l had

ple

d gu

ilty,

the

appe

al c

ourt

foun

d th

at th

e re

leva

nt tr

ansa

ctio

ns h

ad n

eith

er

inte

nded

to, n

or h

ad th

e eff

ect o

f rel

easi

ng a

m

edic

inal

pro

duct

into

a d

istr

ibut

ion

syst

em

whi

ch le

d to

its

sale

to e

nd u

sers

with

in th

e Eu

rope

an E

cono

mic

Are

a.


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

R v

Pete

r Hug

h G

illes

pie

[201

1]

EWCA

Crim

31

52

The

Pros

ecut

ion’

s Ca

se

The

pros

ecut

ion

alle

ged

that

thro

ugh

his b

usin

ess i

n th

e U

K, P

eter

Gill

espi

e ha

d be

en h

ad b

een

resp

onsi

ble

for i

mpo

rtin

g la

rge

quan

titie

s of p

resc

riptio

n dr

ugs i

nto

the

UK

mar

ket b

etw

een

Dec

embe

r 200

6 an

d M

ay 2

007.

The

se m

edic

ines

, whi

ch w

ere

purp

orte

d to

be

Fren

ch m

edic

ines

, w

ere

actu

ally

cou

nter

feit

med

icin

es w

hich

had

bee

n m

anuf

actu

red

in C

hina

and

impo

rted

into

to

Euro

pe v

ia S

inga

pore

. The

incl

uded

dru

gs u

sed

for t

he tr

eatm

ent o

f sch

izop

hren

ia, p

rost

ate

canc

er

and

hear

t dis

ease

. It w

as fo

und

that

the

drug

s con

tain

ed si

gnifi

cant

ly le

ss o

f the

rele

vant

act

ive

ingr

edie

nts t

han

the

genu

ine

drug

s wou

ld h

ave.

They

furt

her c

onte

nded

that

the

defe

ndan

t had

then

bee

n in

volv

ed in

a to

tal o

f eig

ht tr

ansa

ctio

ns

to s

ell t

his

med

icin

e. T

he p

rose

cutio

n al

lege

d th

at h

e la

belle

d th

e bo

xes

whi

ch h

e kn

ew to

con

tain

co

unte

rfei

t med

icin

e w

ith a

spe

cial

ist s

ticke

r use

d in

Fra

nce

inte

ndin

g to

cau

se th

e pu

rcha

ser o

f th

e to

bel

ieve

they

wer

e ge

nuin

e.

It w

as n

oted

that

a p

ropo

rtio

n of

the

med

icin

e w

hich

has

bee

n so

ld h

ad b

een

used

on

sick

pa

tient

s. W

hils

t the

MH

RA w

ere

able

to re

cove

r som

e of

the

stoc

k, a

sig

nific

ant p

ortio

n re

mai

ned

unac

coun

ted

for.

The

Def

ence

Mr G

illes

pie

clai

med

that

he

had

not b

een

dish

ones

t, as

he

had

not k

now

n th

at th

e dr

ugs

wer

e co

unte

rfei

t . H

e cl

aim

ed th

at h

e ha

d pu

rcha

sed

them

from

the

son

of a

bus

ines

s co

lleag

ue a

nd

belie

ved

them

to b

e ge

nuin

e m

edic

ines

. Whi

le h

e ad

mitt

ed to

alte

ring

the

pack

agin

g, h

e cl

aim

ed

that

this

was

sim

ply

a m

arke

ting

ploy

.

This

cas

e ar

ose

out o

f an

inve

stig

atio

n ru

n by

the

MH

RA a

nd ti

tled

‘Ope

ratio

n Si

ngap

ore’

Mr G

illes

pie

was

foun

d gu

ilty

of th

e fo

llow

ing

offen

ces:

f

One

cou

nt o

f con

spira

cy to

def

raud

f

Thre

e co

unts

of s

uppl

ying

a m

edic

inal

pro

duct

w

ithou

t mar

ketin

g au

thor

isat

ion

f

Thre

e co

unts

of s

ellin

g co

unte

rfei

t goo

ds

fO

ne c

ount

of a

ctin

g as

a c

ompa

ny d

irect

or

whe

n di

squa

lified

.

He

was

sen

tenc

ed to

a to

tal o

f 8 y

ears

in

pris

on, w

ith th

e se

nten

cing

judg

e no

ting

that

a

“gen

uine

det

erre

nt” s

ente

nce

was

requ

ired,

gi

ven

the

circ

umst

ance

s of

the

case

.

His

app

eal o

f bot

h th

e co

nvic

tions

and

th

e se

nten

cing

was

uns

ucce

ssfu

l. In

his

ju

dgem

ent,

LJ E

lias

ackn

owle

dged

the

part

icul

ar h

arm

s as

soci

ated

with

cou

nter

feit

(thi

s w

as th

e te

rmin

olog

y us

ed in

the

case

) m

edic

ine:

“On

any

view

thes

e w

ere

extr

emel

y se

rious

off

ence

s. Pe

ople

had

bee

n pr

escr

ibed

wha

t th

ey b

elie

ved

to b

e ge

nuin

e dr

ugs

whi

ch

may

ass

ist t

hem

in fu

ll re

cove

ry w

hen

they

wer

e no

t. Fo

r the

mos

t par

t the

dru

gs

are

wor

thle

ss. I

n so

me

case

s th

ey m

ay b

e po

sitiv

ely

dam

agin

g. T

hat m

ay d

epen

d up

on

thei

r pre

cise

mak

e-up

. In

any

even

t, th

e sa

le o

f cou

nter

feit

drug

s un

derm

ines

pub

lic

confi

denc

e an

d ca

uses

par

ticul

ar g

rief t

o th

ose

who

thou

ght t

hey

wer

e ta

king

gen

uine

dru

gs

whe

n th

ey w

ere

not”

[Lor

d Ju

stic

e El

ias,

at 5

5]


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

R v

Mar

tin

Hic

kman

[2

018]

EW

CA

Crim

271

7

Mr H

ickm

an h

ad b

een

runn

ing

an o

nlin

e bu

sine

ss s

ellin

g un

licen

sed

and

coun

terf

eit V

iagr

a an

d si

mila

r med

ical

pro

duct

s fo

r a n

umbe

r of y

ears

. Whe

n - f

ollo

win

g an

inve

stig

atio

n - M

HRA

en

forc

emen

t offi

ces

atte

nded

his

hom

e an

d se

arch

ed th

e pr

emis

es th

ey fo

und

a qu

antit

y of

the

unlic

ense

d m

edic

ines

and

iden

tified

larg

e sc

ale

mov

emen

ts o

f mon

ey fr

om th

e U

nite

d Ki

ngdo

m to

th

e Is

le o

f Man

and

then

thro

ugh

to M

alta

.

At fi

rst i

nsta

nce

(200

9) p

led

guilt

y to

five

cou

nts

of s

uppl

ying

unl

icen

sed

med

icin

es a

nd o

ne

rela

ted

offen

ce o

f mon

ey la

unde

ring,

for w

hich

he

was

sen

tenc

ed to

a to

tal o

f tw

o ye

ars

impr

ison

men

t. In

201

2 co

nfisc

atio

n or

der w

as m

ade

requ

iring

him

to p

ay £

14,4

07,8

50.2

8 w

ithin

si

x m

onth

s. H

e fa

iled

to d

o so

, at w

hich

poi

nt th

e de

faul

t sen

tenc

e of

ten

year

s w

as im

pose

d up

on

in h

im in

his

abs

ence

. H

e w

as th

en a

rres

ted

in S

pain

(whe

re h

e ha

d be

en li

ving

) und

er a

Eur

opea

n A

rres

t War

rant

and

retu

rned

to c

usto

dy in

the

Uni

ted

King

dom

on

13 A

ugus

t 201

4.

He

had

initi

ally

soug

ht le

ave

to a

ppea

l the

confi

scat

ion

orde

r and

def

ault

whe

n it

was

mad

e in

201

2 bu

t w

as re

fuse

d. T

he is

sue

rest

ed u

ntil 2

018

whe

n he

bot

h so

ught

to re

new

his

appl

icat

ion

for l

eave

to th

is co

urt a

nd a

lso m

ade

an a

pplic

atio

n fo

r an

exte

nsio

n of

tim

e of

app

roxi

mat

ely

five

year

s.

His

app

eals

wer

e di

smis

sed.

NO

FU

LL R

EPO

RT O

F CA

SE: R

EGU

LATO

RS /

POLI

CE R

EPO

RTS

ON

LY

Polic

e In

telle

ctua

l Pro

pert

y U

nit (

PIPC

U) R

epor

t on

the

Conv

ictio

n of

Fra

nk L

udlo

w

(9th

July

202

0)

http

s://

ww

w.c

ityofl

ondo

n.po

lice.

uk/n

ews/

city

-of

-lond

on/n

ews/

2020

/te

mpl

ate3

/pip

cu/

man

-sen

tenc

ed-fo

r-m

akin

g-an

d-se

lling

-fake

-co

vid-

19-t

reat

men

t-ki

ts/

Mr L

udlo

w w

as a

ccus

ed o

f mak

ing

coun

terf

eit t

reat

men

t kits

for C

OVI

D-1

9 (la

belle

d ‘T

rinity

CO

VID

-19

SARS

: Ant

i-Pat

hoge

nic

Trea

tmen

t) a

nd s

endi

ng th

ese

acro

ss th

e w

orld

. Thi

s ki

ts a

re k

now

n to

hav

e co

ntai

ned

hydr

ogen

per

oxid

e co

ncen

trat

ion

of

6.5

%; p

otas

sium

thio

cyan

ate,

an

acid

, an

unkn

own

enzy

me

as w

ell a

s be

e po

llen.

H

e ha

d be

en m

akin

g th

e ki

ts fo

r a n

umbe

r of y

ears

, and

had

pre

viou

sly

mad

e un

supp

orte

d cl

aim

s ab

out t

heir

abili

ty to

cur

e ot

her i

nfec

tions

.

This

cas

e or

igin

ated

whe

n th

e U

.S. C

usto

ms

and

Bord

er P

rote

ctio

n Ag

ency

in L

os

Ang

eles

inte

rcep

ted

a pa

ckag

e fr

om U

K, w

hich

con

tain

ed 6

0 of

thes

e tr

eatm

ent

kits

whi

ch w

ere

sent

from

the

UK

and

pass

ed th

em o

n to

the

FDA

. The

FD

A th

en

dete

rmin

ed th

at th

ey w

ere

unap

prov

ed d

rugs

, bas

ed o

n th

e la

belli

ng a

nd d

irect

ions

fo

r use

, rai

sed

the

issu

e w

ith th

e M

HRA

.

A jo

int o

pera

tion

betw

een

the

MH

RA, P

IPCU

and

the

US

FDA

was

car

ried

out,

the

resu

lt of

whi

ch w

as th

e di

scov

ery

of m

ore

than

300

kits

and

20

litre

s of

the

chem

ical

s us

ed to

cre

ate

thes

e in

Mr L

udlo

w’s

hom

e.

Mr L

udlo

w p

led

guilt

y to

the

follo

win

g ch

arge

s:

One

cou

nt to

att

empt

ing

to s

uppl

y an

un

auth

oris

ed m

edic

inal

pro

duct

One

cou

nt o

f pos

sess

ing

an u

naut

horis

ed

med

icin

al p

rodu

ct

One

cou

nt a

ssem

blin

g an

una

utho

rised

pr

oduc

t

He

was

sen

tenc

ed to

a te

n m

onth

sus

pend

ed

pris

on s

ente

nce,

and

als

o or

dere

d to

car

ry o

ut

170

hour

s of

unp

aid

com

mun

ity s

ervi

ce.

He

furt

her f

aces

pro

secu

tion

in th

e U

nite

d St

ates

, whe

re h

e w

as h

as b

een

char

ged

with

on

e co

unt o

f int

rodu

cing

mis

bran

ded

drug

s in

to in

ters

tate

com

mer

ce. T

his

is a

felo

ny

char

ge w

hich

car

ries

a m

axim

um s

ente

nce

of

thre

e ye

ars

in p

rison

.

https://www.cityoflondon.police.uk/news/city-of-london/news/2020/template3/pipcu/man-sentenced-for-making-and-selling-fake-covid-19-treatment-kits/








PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

MH

RA R

epor

t on

the

Conv

ictio

n of

Leon

ard

Cosg

rove

(25t

h Ju

ly 2

019)

http

s://

ww

w.g

ov.u

k/go

vern

men

t/ne

ws/

east

-lo

ndon

-cro

ok-c

harg

ed-

with

-med

s-cr

imes

Mr C

osgr

ove

was

par

t of a

net

wor

k in

volv

ed w

ith th

e ill

egal

impo

rt a

nd s

uppl

y of

m

edic

ines

– in

clud

ing

Viag

ra a

nd a

ppet

ite s

uppr

essa

nts.

Mr C

osgr

ove

was

foun

d gu

ilty

of:

Cons

pira

cy to

sup

ply

auth

oris

ed m

edic

al

prod

ucts

The

supp

ly o

f pre

scrip

tion

only

med

icin

es

The

supp

ly o

f Cla

ss C

dru

gs.

He

was

sen

tenc

ed to

2 y

ears

and

9 m

onth

s in

pr

ison

.

MH

RA R

epor

t on

the

Conv

ictio

n D

avid

Noa

kes

(5th

June

202

0)

http

s://

ww

w.g

ov.u

k/go

vern

men

t/ne

ws/

davi

d-no

akes

-judg

e-or

ders

-se

izur

e-of

-14-

mill

ion

Mr N

oake

s ow

ned

Gue

rnse

y-ba

sed

Imm

uno

Biot

ech,

thro

ugh

whi

ch h

e so

ld G

cMA

F (a

n un

licen

sed

med

icin

e). G

cMA

F is

a p

rodu

ct d

eriv

ed fr

om H

uman

Blo

od, w

hich

Mr

Noa

kes

adve

rtis

ed a

s be

ing

a ‘m

iracl

e cu

re’ f

or a

rang

e of

con

ditio

ns in

clud

ing

canc

er,

HIV

and

aut

ism

. How

ever

, the

se c

laim

s w

ere

not b

acke

d by

sci

entifi

c ev

iden

ce. M

r N

ovak

pro

fited

sig

nific

antly

from

the

sale

s of

GcM

AF,

mak

ing

over

£13

mill

ion

from

th

e pe

riod

betw

een

2013

and

201

5.

In 2

019

Mr N

oake

s pl

ed g

uilty

to th

e fo

llow

ing

char

ges:

Four

cha

rges

rela

ting

to th

e m

anuf

actu

re, s

ale,

an

d su

pply

of a

n un

licen

sed

med

icin

e

One

cou

nt o

f mon

ey la

unde

ring

He

was

sen

tenc

ed to

a to

tal o

f 15

mon

ths

in

pris

on. I

n 20

20 h

e w

as fu

rthe

r sub

ject

to a

co

nfisc

atio

n or

der,

tota

lling

just

und

er £

1.4

mill

ion.

Conv

ictio

ns R

elat

ed to

MH

RA

Ope

ratio

n Ca

lla

See

also

: htt

ps://

ww

w.5

pb.

co.u

k/pr

int/

pdf/

node

/67

(p3)

.

Indu

stry

par

tner

s su

bmitt

ed a

refe

rral

to th

e M

HRA

rega

rdin

g a

mai

l for

war

ding

co

mpa

ny in

the

UK,

who

they

bel

ieve

wer

e ac

ting

as a

n im

port

er a

nd d

istr

ibut

er

of m

edic

ines

ent

erin

g th

e U

K ill

egal

ly. O

n th

is b

asis

, the

MH

RA s

tart

ed O

pera

tion

Calla

– d

urin

g th

e co

urse

of w

hich

they

iden

tified

a c

rimin

al n

etw

ork

was

iden

tified

. Th

is in

clud

ed b

oth

UK

indi

vidu

als,

and

thos

e re

sidi

ng o

utsi

de o

f the

UK

who

wer

e re

spon

sibl

e fo

r ful

fillin

g de

man

d fr

om E

urop

ean

cust

omer

s vi

a ov

erse

as w

ebsi

tes.

The

UK

aspe

ct o

f the

ope

ratio

n in

volv

ed fi

ve in

divi

dual

s w

ho w

ere

arre

sted

in 2

016.

MH

RA 2

016

Boar

d M

eetin

g –

Item

06

Crim

inal

Enf

orce

men

t Rep

ort

“Tria

ls w

ere

held

at S

outh

war

k cr

own

cour

t in

2018

and

201

9...F

ollo

win

g de

liber

atio

n, fo

ur

defe

ndan

ts w

ere

foun

d gu

ilty

of o

ffenc

es o

f im

port

atio

n, s

ale

and

supp

ly o

f unl

icen

sed

med

icin

es, i

nclu

ding

con

trol

led

drug

s. Th

ese

defe

ndan

ts w

ere

subs

eque

ntly

sen

tenc

ed to

im

pris

onm

ent t

otal

ling

nine

yea

rs.”

MH

RA 2

016

Boar

d M

eetin

g –

Item

06

Crim

inal

En

forc

emen

t Rep

ort

https://www.gov.uk/government/news/east-london-crook-charged-with-meds-crimes




https://www.gov.uk/government/news/david-noakes-judge-orders-seizure-of-14-million




https://www.5pb.co.uk/print/pdf/node/67

https://www.5pb.co.uk/print/pdf/node/67

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/831448/Item_06__IES__Criminal_Enforcement_within_the_MHRA.pdf




PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

Conv

ictio

ns R

elat

ed to

MH

RA

Ope

ratio

n D

anie

l

http

s://

asse

ts.p

ublis

hing

.se

rvic

e.go

v.uk

/gov

ernm

ent/

uplo

ads/

syst

em/u

ploa

ds/

atta

chm

ent_

data

/fil

e/65

2376

/Ite

m_1

0__2

017-

OB-

11__

Ope

ratio

n_Pa

ngea

_201

7.pd

f

http

s://

rusi

.org

/site

s/de

faul

t/fil

es/2

0141

2_w

hr_

on_t

ap.p

df (p

63)

A la

rge

grou

p of

indi

vidu

als

wer

e in

volv

ed w

ith th

e sa

le o

f unl

icen

ced

med

icin

al

prod

ucts

for t

reat

ing

erec

tile

disf

unct

ion

and

impo

tenc

e ov

er th

e in

tern

et a

nd

the

‘face

-to-

face

’ sal

e of

cou

nter

feit

med

icat

ion

(nam

ely

Viag

ra a

nd V

aliu

m).

Thes

e pr

oduc

ts o

rigin

ated

from

a v

arie

ty o

f sou

rces

in H

ong

Kong

, Ind

ia, a

nd C

hina

.

A n

umbe

r of f

ront

com

pani

es h

ad b

een

set u

p –

two

of w

hich

did

som

e le

gitim

ate

trad

e in

cos

met

ics

as w

ell a

s th

e ill

icit

med

icin

al tr

adin

g, a

nd th

eir n

ames

and

det

ails

w

ere

used

to re

nt th

ree

stor

age

units

and

two

dist

ribut

ion

cent

res.

The

activ

ity la

sted

from

200

4 –

2012

. In

that

tim

e th

e gr

oup’

s sa

les

of il

licit

med

icin

es

are

susp

ecte

d to

hav

e ge

nera

ted

over

£11

mill

ion.

[The

fact

s of

this

ope

ratio

n w

ere

repo

rted

in a

201

4 Re

port

by

the

Thin

k Ta

nk: R

oyal

U

nite

d Se

rvic

es In

stitu

te fo

r Def

ence

and

Sec

urity

Stu

dies

(p63

)]

“Ope

ratio

n D

anie

l res

ulte

d in

the

conv

ictio

n of

12

susp

ects

at t

he C

entr

al C

rimin

al C

ourt

or

igin

ated

from

the

activ

ity d

urin

g th

e w

eek

of a

ctio

n so

me

year

s ag

o. S

ix s

uspe

cts

wer

e to

geth

er s

ente

nced

to o

ver t

wen

ty-fi

ve y

ears

im

pris

onm

ent a

nd s

ix d

efen

dant

s re

ceiv

ed

susp

ende

d se

nten

ces

tota

lling

ove

r fou

r yea

rs

for t

he s

ale

of c

ount

erfe

it an

d un

licen

sed

drug

s in

clud

ing

Viag

ra.”

[MH

RA O

pen

Boar

d M

eetin

g, O

ctob

er 2

017

– Ite

m 1

0, p

2]

Dilb

ar D

isha

d

http

s://

ww

w.

dent

istr

ytod

ay.c

om/n

ews/

toda

ys-d

enta

l-new

s/ite

m/9

14-m

an-a

rres

ted-

for-

selli

ng-c

ount

erfe

it-dr

ills#

:~:te

xt=A

utho

ritie

s%20

in%

20th

e%20

Uni

ted%

20Ki

ngdo

m,(a

bout

%20

%24

110)

%20

on%

20eB

ay

Mr.

Dis

had

had

been

sel

ling

fake

den

tal d

rills

on

ebay

. H

e us

ed s

ticke

rs to

mak

e th

em a

ppea

r as

thou

gh th

ey w

ere

legi

timat

e dr

ills

from

a re

puta

ble

bran

d. H

e w

as

purc

hsin

g th

e dr

ills

for a

bout

£10

eac

h fr

om a

Chi

nese

com

pany

, and

sel

ling

them

for

£75;

far l

ess

that

the

legi

timat

e dr

ills

whi

ch re

taile

d at

abo

ut £

335.

He

had

purc

hase

d th

em fo

r abo

ut £

10 (a

bout

$15

) fro

m a

Chi

nese

com

pany

and

usi

ng s

ticke

rs to

mak

e th

em a

ppea

r leg

itim

ate.

He

was

cau

ght b

ecau

se a

pot

entia

l cus

tom

er re

alis

ed w

hat

was

hap

peni

ng, a

nd c

onta

ct th

e ac

tual

man

ufac

ture

r.

Not

e th

at th

is h

as o

nly

been

repo

rted

by

indu

stry

sou

rces

, but

is in

clud

ed b

ecau

se it

is

one

of t

he fe

w re

port

ed e

xam

ples

of s

omeo

ne b

eing

cha

rged

with

crim

es re

late

d to

cou

nter

feit

med

ical

dev

ices

.

Mr D

isha

d w

as fo

und

guilt

y of

the

illeg

al s

ale

and

supp

ly o

f cou

nter

feit

dent

al d

rills

(spe

cific

ch

arge

s no

t kno

wn)

and

was

sen

tenc

ed to

a

9 m

onth

s pr

ison

sen

tenc

e, s

uspe

nded

for

2 ye

ars.

He

was

als

o re

quire

d to

com

plet

e 20

0 ho

urs

of u

npai

d w

ork

with

in 1

2 m

onth

s, an

d w

as d

isqu

alifi

ed fr

om b

eing

a c

ompa

ny

dire

ctor

for 5

yea

rs

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/652376/Item_10__2017-OB-11__Operation_Pangea_2017.pdf








https://rusi.org/sites/default/files/201412_whr_on_tap.pdf




https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/652376/Item_10__2017-OB-11__Operation_Pangea_2017.pdf)


PLEA

SE C

OLL

ECT

ON

LY R

ELEV

AN

T CA

SES

ON

TH

E FA

LSIF

ICAT

ION

OF

MED

ICA

L PR

OD

UCT

S O

R SI

MIL

AR

CRIM

ES

MRG

Cou

rt R

epor

t

Case

Con

cern

ing

Chris

toph

er N

oel L

ogan

(1

8th

Nov

embe

r 201

5)

http

s://

ww

w.h

ealth

-ni.

gov.

uk/n

ews/

clou

ghm

ills-

man

-rec

eive

s-su

spen

ded-

sent

ence

-sup

plyi

ng-il

lega

l-ve

terin

ary-

med

icin

es

Mr L

ogan

was

acc

used

of h

avin

g a

long

-ter

m in

volv

emen

t (5

year

s) in

a la

rge

scal

e ill

egal

vet

erin

ary

med

icin

es s

uppl

y ne

twor

k. H

e al

lege

dly

sold

the

pres

crip

tion

only

m

edic

ines

, wor

th u

pwar

ds o

f £68

1,00

0, il

lega

lly fr

om h

is h

ardw

are

shop

.

Mr L

ogan

was

foun

d gu

ilty

of th

e fo

llow

ing

offen

ces:

f

Four

coun

ts o

f sup

plyi

ng v

eter

inar

y m

edic

inal

pr

oduc

ts o

ther

than

in a

ccor

danc

e w

ith th

e Ve

terin

ary

Med

icin

es R

egul

atio

ns 2

008

f

Two

coun

ts o

f pos

sess

ion

of cr

imin

al p

rope

rty

He

was

sen

tenc

ed to

8 m

onth

s im

pris

onm

ent

susp

ende

d fo

r five

yea

rs o

n ea

ch o

f the

six

ch

arge

s (t

o ru

n co

ncur

rent

ly) a

nd th

e pr

ocee

ds

of h

is c

rimin

al a

ctiv

ity w

ere

confi

scat

ed b

y re

leva

nt d

ivis

ion

of th

e Po

lice

Serv

ice

of

Nor

ther

n Ire

land

.

MRG

Rep

ort

Case

Con

cern

ing

Karl

Spen

cer H

ewitt

(6

Dec

embe

r 201

6)

http

s://

ww

w.h

ealth

-ni.

gov.

uk/n

ews/

lurg

an-

man

-rec

eive

s-su

spen

ded-

sent

ence

-impo

rtat

ion-

and-

poss

essi

on-il

lega

l-ve

terin

ary-

med

icin

es

Illeg

al p

resc

riptio

n-on

ly v

eter

inar

y m

edic

ines

wer

e fo

und

durin

g a

sear

ch o

f Mr

Hew

itt’s

hom

e an

d fu

rthe

r inv

estig

atio

n by

the

MRG

est

ablis

hed

that

thes

e ha

s be

en

illeg

ally

impo

rted

from

Aus

tral

ia, E

urop

e an

d th

e U

SA b

etw

een

2013

and

201

5. T

he

prim

ary

purp

ose

of th

ese

drug

s w

as d

eem

ed to

be

the

grey

houn

d m

arke

t, bu

t it w

as

note

d th

at th

ey a

lso

had

wid

er v

eter

inar

y us

e.

Mr H

ewitt

was

foun

d gu

ilty

of th

e fo

llow

ing

offen

ces:

3 co

unts

of i

mpo

rtat

ion

of u

naut

horis

ed

vete

rinar

y m

edic

inal

pro

duct

s ot

her t

han

in

acco

rdan

ce w

ith th

e Ve

terin

ary

Med

icin

es

Regu

latio

ns 2

013

4 co

unts

of p

osse

ssio

n of

una

utho

rised

ve

terin

ary

med

icin

al p

rodu

cts

othe

r tha

n in

ac

cord

ance

with

the

Vete

rinar

y M

edic

ines

Re

gula

tions

201

3

He

was

sen

tenc

ed to

2 m

onth

s im

pris

onm

ent,

susp

ende

d fo

r 12

mon

ths

on e

ach

of th

e se

ven

char

ges

(to

run

conc

urre

ntly

).

UN

ITED

STA

TES

OF

AM

ERIC

A N

o su

bmis

sion

has

bee

n re

ceiv

ed o

n ca

se la

w fr

om th

e na

tiona

l con

sulta

nt

https://www.health-ni.gov.uk/news/cloughmills-man-receives-suspended-sentence-supplying-illegal-veterinary-medicines





https://www.health-ni.gov.uk/news/lurgan-man-receives-suspended-sentence-importation-and-possession-illegal-veterinary-medicines







App

endi

x 5

- Lin

ks to

cou

ntry

law

s by

Nat

iona

l Con

sult

ants

Link

s to

cou

ntry

law

s pr

ovid

ed b

y N

atio

nal C

onsu

ltan

ts

Arm

enia

: ht

tp://

ww

w.p

harm

.am

/att

achm

ents

/art

icle

/89/

Law

%20

on%

20M

edic

ines

_EN

G_%

2027

.06.

2017

_2.p

dfht

tps:

//w

ww

.legi

slat

ionl

ine.

org/

dow

nloa

d/id

/635

8/fil

e/A

rmen

ia_C

PC_1

998_

am20

16_e

n.pd

fht

tps:

//w

ww

.legi

slat

ionl

ine.

org/

docu

men

ts/s

ectio

n/cr

imin

al-c

odes

/cou

ntry

/45/

Arm

enia

/sho

ww

ww

.arli

s.am

(in

Arm

enia

n)

Aus

tria

: M

edic

inal

Pro

duct

Act

ht

tps:

//w

ww

.ris.b

ka.g

v.at

/Gel

tend

eFas

sung

.wxe

?Abf

rage

=Bun

desn

orm

en&

Ges

etze

snum

mer

=100

1044

1

Med

ical

Dev

ice

Act

http

s://

ww

w.ri

s.bka

.gv.

at/G

elte

ndeF

assu

ng.w

xe?A

bfra

ge=B

unde

snor

men

&G

eset

zesn

umm

er=1

0011

003

Aust

rian

Ord

inan

ce o

n G

ood

Man

ufac

turin

g Pr

actic

es -

AM

BO 2

009

http

s://

ww

w.ri

s.bka

.gv.

at/e

li/bg

bl/ii

/200

8/32

4/P2

/NO

R402

0082

1Cr

imin

al P

roce

dure

s Co

de –

htt

ps://

ww

w.ri

s.bka

.gv.

at/e

li/bg

bl/1

975/

631/

P65/

NO

R401

8102

6Cr

imin

al C

ode

- htt

ps://

ww

w.ri

s.bka

.gv.

at/e

li/bg

bl/1

974/

60/P

12/N

OR1

2029

553

Ass

ocia

tion

Resp

onsi

bilit

y Ac

t (Ve

rban

dsve

rant

wor

tlich

keits

gese

tz) h

ttps

://w

ww

.ris.b

ka.g

v.at

/eli/

bgbl

/i/20

05/1

51/P

0/N

OR3

0004

820

Aze

rbai

jan:

Crim

inal

Cod

e of

the

Repu

blic

of A

zerb

aija

n ht

tp://

e-qa

nun.

gov.

az/c

ode/

11Co

de o

f Adm

inis

trat

ive

Offe

nces

of t

he R

epub

lic o

f Aze

rbai

jan

htt

p://

e-qa

nun.

gov.

az/c

ode/

24Co

de o

f Crim

inal

Pro

cedu

re o

f the

Rep

ublic

of A

zerb

aija

n ht

tp://

e-qa

nun.

gov.

az/c

ode/

14

Bulg

aria

:Cr

imin

al C

ode

http

s://

ww

w.le

x.bg

/bg/

law

s/ld

oc/1

5896

5452

9La

w o

n m

edic

inal

pro

duct

s in

hum

an m

edic

ine

http

s://

ww

w.le

x.bg

/bg/

law

s/ld

oc/2

1355

4953

6

Law

on

Med

ical

Dev

ices

htt

ps://

ww

w.le

x.bg

/bg/

law

s/ld

oc/2

1355

5544

4.Pe

nal P

roce

dure

Cod

e ht

tps:

//w

ww

.lex.

bg/b

g/la

ws/

ldoc

/213

5512

224

Cana

da:

Med

ical

Dev

ices

Reg

ulat

ions

Med

ical

Dev

ices

Reg

ulat

ions

(jus

tice.

gc.c

a)Fo

od a

nd D

rugs

Act

R.S

.C.,

1985

Foo

d an

d D

rugs

Act

(jus

tice.

gc.c

a)Fo

od a

nd D

rug

Regu

latio

ns C

.R.C

., c.

870

Foo

d an

d D

rug

Regu

latio

ns (j

ustic

e.gc

.ca)

Med

ical

Dev

ices

Reg

ulat

ions

(SO

R/98

-282

) Med

ical

Dev

ices

Reg

ulat

ions

(jus

tice.

gc.c

a)Cr

imin

al C

ode

R.S.

C., 1

985,

c. C

-46

Crim

inal

Cod

e (ju

stic

e.gc

.ca)

http://www.pharm.am/attachments/article/89/Law%20on%20Medicines_ENG_%2027.06.2017_2.pdf

https://www.legislationline.org/download/id/6358/file/Armenia_CPC_1998_am2016_en.pdf

https://www.legislationline.org/documents/section/criminal-codes/country/45/Armenia/show

https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10010441



https://www.ris.bka.gv.at/eli/bgbl/ii/2008/324/P2/NOR40200821

https://www.ris.bka.gv.at/eli/bgbl/1975/631/P65/NOR40181026

https://www.ris.bka.gv.at/eli/bgbl/1974/60/P12/NOR12029553

https://www.ris.bka.gv.at/eli/bgbl/i/2005/151/P0/NOR30004820

http://e-qanun.gov.az/code/11







https://laws-lois.justice.gc.ca/eng/acts/F-27/FullText.html

https://laws-lois.justice.gc.ca/eng/regulations/c.r.c.%2C_c._870/FullText.html

https://laws-lois.justice.gc.ca/eng/acts/c-46/FullText.html


Cypr

us:

The

Med

icin

al P

rodu

cts

for H

uman

Use

(Con

trol

of Q

ualit

y, S

uppl

y an

d Pr

ices

) Law

of 2

001

to 2

020.

http

://w

ww

.cyl

aw.o

rg/n

omoi

/eno

p/in

d/20

01_1

_70/

sect

ion-

sc30

44b5

e3-3

656-

00a4

-d67

8 0e

8675

6ba8

3c.h

tml

The

Vete

rinar

y M

edic

inal

Pro

duct

s (C

ontr

ol o

f Qua

lity,

Reg

istr

atio

n, C

ircul

atio

n, M

anuf

actu

ring,

Pr

ovid

ing

and

Use

) Law

of 2

006

to 2

011.

http

://w

ww

.cyl

aw.o

rg/n

omoi

/eno

p/in

d/20

06_1

_10/

sect

ion-

scac

1a31

90-0

888-

89d4

-636

e -b6b

29b4

6e04

c.ht

ml

The

Basi

c Re

quire

men

ts fo

r Spe

cific

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http://www.cylaw.org/nomoi/enop/ind/2006_1_10/section-scac1a3190-0888-89d4-636e-b6b29b46e04c.html

http://www.cylaw.org/nomoi/enop/ind/2002_1_30/section-sc9b7b8dbb-a26b-d812-aeee-c64361e72320.html

http://www.retsinformation.dk/eli/lta/2018/99

http://www.retsinformation.dk/eli/lta/2016/139

https://www.retsinformation.dk/eli/ft/201012L00118

https://www.retsinformation.dk/eli/lta/2012/1360

https://www.retsinformation.dk/eli/lta/2012/1360

https://www.riigiteataja.ee/en/eli/528052020007/consolide

https://www.riigiteataja.ee/en/eli/518052020007/consolide

https://www.fimea.fi/documents/160140/765540/18580_Laakelaki_englanniksi_paivitetty_5_2011.pdf

https://finlex.fi/fi/laki/ajantasa/2010/20100629?search%5Btype%5D=pika&search%5Bpika%5D=laki%20terveydenhuollon%20laitteista%2A

https://finlex.fi/en/laki/kaannokset/1889/en18890039_20150766.pdf

http://www.gesetze-im-internet.de/englisch_amg/

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https://matsne.gov.ge/en/document/download/29836/21/en/pdf

https://matsne.gov.ge/ka/document/download/90034/64/en/pdf

https://www.government.is/library/01-Ministries/Ministry-of-HealTh/PDF-skjol/Lyfjal%c3%b6g%20nr.%20100.2020%20%20ensk%20%c3%be%c3%bd%c3%b0ing.pdf


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https://www.government.is/media/velferdarraduneyti-media/media/Reglugerdir-enska/Regulation-on-Medical-Devices-No-934-2010.pdf

https://www.government.is/library/01-Ministries/Ministry-of-Justice/Generlal%20Penal%20Code,%20No.19%201940.pdf

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https://likumi.lv/ta/en/en/id/88966-the-criminal-law

https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.280067/asr



https://www.legislationline.org/download/id/8272/file/Lithuania_CC_2000_am2017_en.pdf

https://www.e-tar.lt/portal/lt/legalAct/TAR.8A39C83848CB/asr

http://www.sgg.gov.ma/Professionsreglementees/ProfessionsPharmaceutiques/Pharmaciens.aspx

https://www.sante.gov.ma/Reglementation/REGLEMENTATIONAPPLICABLEAUPRODUITSDESANTE/2-14-841.pdf

https://www.sante.gov.ma/Reglementation/REGLEMENTATIONAPPLICABLEAUPRODUITSDESANTE/2-14-841.pdf

http://dmp.sante.gov.ma/upload/textes_legislatifs_et_reglementaires/1Loi/Loi%2084-12%20relative%20aux%20Dispositives%20Medicaux_Fr.pdf

http://dmp.sante.gov.ma/upload/textes_legislatifs_et_reglementaires/1Loi/Loi%2084-12%20relative%20aux%20Dispositives%20Medicaux_Fr.pdf

https://pharmacie.ma/uploads/pdfs/dahir_1-13-90_du_19_09_2013_fr.pdf



http://www.icpc.ma/SITE/legislation.html

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https://www.ilo.org/dyn/natlex/docs/SERIAL/69975/69182/F1186528577/MAR-69975.pdf

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https://adala.justice.gov.ma/production/legislation/fr/Nouveautes/Code%20des%20Obligations%20et%20des%20Contrats.pdf

https://adala.justice.gov.ma/production/legislation/fr/Nouveautes/Code%20des%20Obligations%20et%20des%20Contrats.pdf

https://malmed.gov.mk/%d0%b7%d0%b0%d0%ba%d0%be%d0%bd%d0%b8/

https://lovdata.no/lov/1992-12-04-132/


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https://lovdata.no/forskrift/2013-11-29-1373

https://lovdata.no/forskrift/1993-12-21-1219/§1

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https://lovdata.no/lov/1995-01-12-6/§3


https://lovdata.no/forskrift/2013-11-29-1373/§4


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https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20101070679/U/D20100679Lj.pdf



https://www.alims.gov.rs/eng/regulations/law-on-medicines-and-medical-devices/

https://www.alims.gov.rs/eng/files/2012/10/Law-on-Medicines-and-Medical-Devices-teacher2010.pdf

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ectio

n/92

Fr

aud

Act 2

006

http

s://

ww

w.le

gisl

atio

n.go

v.uk

/ukp

ga/2

006/

35/s

ectio

n/2

Crim

inal

Just

ice

and

Lice

nsin

g (S

cotla

nd) A

ct 2

010

http

s://

ww

w.le

gisl

atio

n.go

v.uk

/asp

/201

0/13

/sec

tion/

49

Med

icin

es A

ct 1

968

http

s://

ww

w.le

gisl

atio

n.go

v.uk

/ukp

ga/1

968/

67/s

ectio

n/67

Serio

us C

rime

Act 2

007

http

s://

ww

w.le

gisl

atio

n.go

v.uk

/ukp

ga/2

007/

27/s

ched

ule/

1Fo

rger

y an

d Co

unte

rfei

ting

Act 1

981

http

s://

ww

w.le

gisl

atio

n.go

v.uk

/ukp

ga/1

981/

45/s

ectio

n/1

Crim

inal

Att

empt

s Ac

t 198

1 ht

tps:

//w

ww

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ion.

gov.

uk/u

kpga

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ther

n Ire

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atio

n.go

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i/198

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rap=

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ww

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gov.

uk/u

kpga

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ww

.cps

.gov

.uk/

lega

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Crim

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w.le

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atio

n.go

v.uk

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/201

0/13

/sec

tion/

1

Uni

ted

Stat

es o

f Am

eric

a:Ch

apte

r 9 –

Fed

eral

Foo

d, D

rugs

and

Cos

met

ic A

ct 2

1 U

SC [U

SC02

] 21

USC

CH

APT

ER 9

, SU

BCH

APT

ER II

: DEF

INIT

ION

S (h

ouse

.gov

)Co

de o

f Fed

eral

Reg

ulat

ions

Titl

e 21

Ele

ctro

nic

Code

of F

eder

al R

egul

atio

ns (e

CFR)

18 U

SC –

Crim

es a

nd C

rimin

al P

roce

dure

[USC

02] 1

8 U

SC 2

320:

Tra

ffick

ing

in c

ount

erfe

it go

ods

or s

ervi

ces

(hou

se.g

ov)





https://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lakemedelslag-2015315_sfs-2015-315

https://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lag-1993584-om-medicintekniska-produkter_sfs-1993-584

https://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/brottsbalk-1962700_sfs-1962-700

https://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lag-20001225-om-straff-for-smuggling_sfs-2000-1225

https://www.riksdagen.se/sv/dokument-lagar/dokument/svensk-forfattningssamling/lag-2009366-om-handel-med-lakemedel_sfs-2009-366

https://www.legislation.gov.uk/ukpga/2021/3/contents/enacted

https://www.legislation.gov.uk/uksi/2012/1916/regulation/2




https://www.legislation.gov.uk/ukpga/1994/26/section/92%20

https://www.legislation.gov.uk/ukpga/2006/35/section/2%20

https://www.legislation.gov.uk/asp/2010/13/section/49

https://www.legislation.gov.uk/ukpga/1968/67/section/67

https://www.legislation.gov.uk/ukpga/2007/27/schedule/1


https://www.legislation.gov.uk/ukpga/1981/47

https://www.legislation.gov.uk/nisi/1983/1120/part/II?wrap=true&view=extent


https://www.cps.gov.uk/legal-guidance/corporate-prosecutions


https://www.legislation.gov.uk/asp/2010/13/section/1

https://uscode.house.gov/view.xhtml?hl=false&edition=prelim&req=granuleid%3AUSC-prelim-title21-chapter9-subchapter2&num=0&saved=%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGUyMS1jaGFwdGVyOS1mcm9udA%3D%3D%7C%7C%7C0%7Cfalse%7Cprelim

https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=519bbed96af05e9fc458646ace8bc8cd&ty=HTML&h=L&mc=true&r=SECTION&n=se21.4.207_11

https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section2320&num=0&edition=prelim


App

endi

x 6

– Li

st o

f Nat

iona

l Con

sult

ants

GA

P A

NA

LYSI

S SU

RVEY

- NAT

ION

AL

CON

SULT

AN

TS

LIST

OF

36 C

OU

NTR

IES

PART

ICIP

ATIN

G

CoE

mem

ber S

tate

s: A

ndor

ra, A

rmen

ia, A

ustr

ia, A

zerb

aija

n, B

ulga

ria, C

ypru

s, Cz

ech

Repu

blic

, Den

mar

k, F

inla

nd, E

ston

ia, G

reec

e, G

eorg

ia, G

erm

any,

Icel

and,

Ital

y, L

atvi

a,

Lith

uani

a, M

onte

negr

o, N

orth

Mac

edon

ia, N

orw

ay, P

olan

d, R

oman

ia, S

erbi

a, S

lova

k Re

publ

ic, S

love

nia,

Sw

eden

, Uni

ted

King

dom

.

Obs

erve

r Sta

tes:

Can

ada,

Japa

n, M

exic

o, U

nite

d St

ates

of A

mer

ica.

Oth

er 3

rd c

ount

ries

: Ecu

ador

, Gui

nea,

Mor

occo

, Tun

isia

COU

NTR

IES

SELE

CTED

SELE

CTED

NAT

ION

AL

CON

SULT

AN

TPR

OFE

SIO

NA

L TI

TLE

AN

DO

RRA

Mr O

riol G

IRÓ

CA

NTU

RRI

Part

ner a

nd c

orpo

rate

law

yer a

t Em

inds

etla

w

ARM

ENIA

Ms

Alv

ina

GYU

LUM

YAN

Form

er ju

dge

of th

e Co

nstit

utio

nal C

ourt

of A

rmen

ia a

nd th

e Eu

rope

an C

ourt

of H

uman

Rig

hts

AU

STRI

AM

s M

artin

a H

OFM

AN

NLa

wye

r at t

he A

ustr

ian

Med

icin

es a

nd M

edic

al D

evic

e Ag

ency

(AG

ES)

AZE

RBA

IJA

NM

s RU

HIY

YA IS

AYEV

ALe

gal e

xper

t/ M

embe

r of t

he A

zerb

aija

ni B

ar A

ssoc

iatio

n

BULG

ARI

AM

s M

omia

na G

ENEV

ATe

nure

d pr

ofes

sor o

f Crim

inal

Law

, hea

d of

dep

artm

ent a

t the

Bur

gas

Free

Uni

vers

ity

CAN

AD

A

Mr D

avid

LIP

KUS

Law

yer a

t Kes

tenb

erg

Sieg

al L

ipku

s LL

P

CYPR

US

Ms

Den

a M

aria

ERG

ATO

UD

ICo

unse

l for

the

Law

Offi

ce o

f the

Rep

ublic

of C

ypru

s

CZEC

H R

EPU

BLIC

Ms.

Barb

ora

ŠVÁC

HO

VÁSe

nior

Leg

al C

ouns

ello

r, Le

gal D

epar

tmen

t, M

inis

try

of Ju

stic

e

DEN

MA

RKM

s Ka

thar

ina

Ó C

ATH

AOIR

Ass

ista

nt P

rofe

ssor

in H

ealth

Law

, Cen

tre

for L

egal

Stu

dies

in W

elfa

re a

nd M

arke

t Int

egra

tion

(Wel

ma)

Facu

lty o

f Law

, Uni

vers

ity o

f Cop

enha

gen


ECU

AD

OR

Ms

Mar

ía F

erna

nda

ROM

ÁN

FE

RRA

ND

Dire

ctor

of t

he L

egal

Com

mer

ce P

roje

ct o

f the

Uni

vers

idad

de

los

Hem

isfe

rios

ESTO

NIA

Dr K

ärt P

ORM

EIST

ERLe

ctur

er o

f Priv

ate

Law

at T

allin

n U

nive

rsity

and

ow

ner o

f KP

Hol

ding

OÜ

FIN

LAN

DM

s A

nna-

Riik

ka R

UU

THSp

ecia

lized

pro

secu

tor,

Pros

ecut

or’s

Offi

ce o

f Eas

tern

Uus

imaa

, Van

taa

(from

1.1

0.20

19 N

atio

nal P

rose

cutio

n Ag

ency

, Sou

ther

n Pr

osec

utio

n D

istr

ict)

GER

MA

NY

Mr A

lexa

nder

RO

THPu

blic

pro

secu

tor a

t the

Offi

ce o

f the

Pro

secu

tor G

ener

al o

f the

Lan

d Br

ande

nbur

g

GEO

RGIA

Ms

Nin

o AG

LEM

ASH

VILI

Hea

d of

the

Uni

t for

Effe

ctiv

e Su

ppor

t of S

tate

Pro

secu

tion

in Ju

ry T

rial C

ases

And

invi

ted

lect

urer

at T

bilis

i Sta

te

Uni

vers

ity, T

bilis

i Eur

opea

n U

nive

rsity

and

Cau

casu

s U

nive

rsity

GRE

ECE

Mr N

ikos

PA

SSA

SPr

ofes

sor o

f Crim

inol

ogy

and

Crim

inal

Just

ice

at N

orth

east

ern

Uni

vers

ity

GU

INEA

Mr A

bdou

laye

KPO

GO

MO

UM

agis

trat

e, 1

st D

eput

y Pu

blic

Pro

secu

tor a

t the

Cou

rt o

f Kal

oum

, Rep

ublic

of G

uine

a

ICEL

AN

DM

r Sin

dri K

RIST

JÁN

SSO

NSe

nior

lega

l adv

isor

and

Spe

cial

adv

isor

to E

xecu

tive

Dire

ctor

of t

he Ic

elan

dic

Med

icin

es A

genc

y

IREL

AN

DM

r Bria

n G

AGEB

YBa

rris

ter i

n th

e La

w L

ibra

ry s

peci

alis

e in

crim

inal

and

regu

lato

ry la

w

ITA

LYM

s G

iulia

na G

IULA

NO

Publ

ic P

rose

cuto

r’s O

ffice

at t

he C

ourt

of N

aple

s

JAPA

ND

r. Ka

zuko

KIM

URA

Prof

esso

r of t

he M

edi-Q

ualit

y Se

curit

y In

stitu

te a

nd P

rofe

ssor

Em

erita

at K

anaz

awa

Uni

vers

ity

LATV

IAM

s Sa

nita

TIM

BARE

ZI

LVES

TERE

Hea

d of

Leg

al U

nit,

Stat

e Ag

ency

of M

edic

ines

LITH

UA

NIA

Mr T

autv

ydas

ZEK

AS

Seni

or a

dvis

or to

the

Gro

up o

f Crim

inal

Just

ice

of th

e M

inis

try

of Ju

stic

e

MEX

ICO

Mr O

scar

GU

IZA

RLe

gal c

onsu

ltant

and

law

yer i

n th

e fie

ld o

f hea

lth la

w

MO

NTE

NEG

ROM

r Milo

rad

MA

RKO

VIC

Lega

l adv

isor

in th

e fie

ld o

f cou

nter

ing

serio

us c

rime

in th

e W

este

rn B

alka

ns IP

A a

nd lo

ng-t

erm

exp

erie

nce

in

educ

atio

n in

the

field

of C

rimin

al P

roce

dure

Law

and

Inte

rnat

iona

l Crim

inal

Law

MO

ROCC

OM

r Abd

elhn

ine

TOU

ZAN

I A

ttor

ney

Gen

eral

at t

he C

ourt

of C

assa

tion

and

trai

ner s

peci

alis

ing

in c

rimin

al la

w

NO

RTH

M

ACE

DO

NIA

Ms

Ale

ksan

dra

DEA

NO

SKA

- T

REN

DA

FILO

VAPr

ofes

sor i

n m

edic

al c

rimin

al la

w, F

acul

ty o

f Law

“Ius

tinia

nus

Prim

us”, “

Ss.C

yril

and

Met

hodi

us” U

nive

rsity

, Sko

pje


NO

RWAY

Ms

Belin

da F

ORS

STEN

Law

yer a

t the

law

firm

of B

FF

POLA

ND

Ms

Joan

na P

ILEW

SKA

Law

yer a

t Mis

iew

icz,

Mos

ek &

Par

tner

s, O

ffice

of L

egal

Adv

iser

s

ROM

AN

IAM

r Adr

ian

SAN

DRU

PhD

can

dida

te in

Crim

inal

Pro

cedu

re L

aw

Scho

ol o

f Adv

ance

d St

udie

s of

the

Rom

ania

n Ac

adem

y

SERB

IA

Ms

Ned

a M

ARK

OVI

C,

Mr J

ovan

ĆO

SIĆ,

Mr B

ožid

ar B

LAG

OJE

VIĆ

Min

istr

y of

Just

ice

of th

e Re

publ

ic o

f Ser

bia

SLO

VAK

REPU

BLIC

Mr P

eter

KLA

ND

UCH

Le

gal a

dvis

er fo

r the

Min

istr

y of

Just

ice

SLO

VEN

IAM

s Ja

smin

a A

RNU

S TA

BAKO

VIC

Stat

e Pr

osec

utor

at t

he D

istr

ict S

tate

Pro

secu

tor’s

Offi

ce

SWED

ENM

r Tom

as N

ILSS

ON

Ass

esso

r, Sw

edis

h M

edic

al P

rodu

cts

Agen

cy

and

Del

egat

e in

Com

mitt

ee o

f Exp

erts

CD

-P-P

H/C

MED

TUN

ISIA

Mr Y

assi

ne Y

OU

NSI

Att

orne

y at

law

- Pa

rtne

r at Y

OU

NSI

& Y

OU

NSI

Inte

rnat

iona

l Law

Firm

UN

ITED

KIN

GD

OM

Ms

Mui

rean

n Q

UIG

LEY

Prof

esso

r of L

aw, M

edic

ine,

& Te

chno

logy

, Birm

ingh

am L

aw S

choo

l, U

nive

rsity

of B

irmin

gham

UN

ITED

STA

TES

OF

AM

ERIC

AM

r Nik

os P

ASS

AS

Prof

esso

r of C

rimin

olog

y an

d Cr

imin

al Ju

stic

e at

Nor

thea

ster

n U

nive

rsity

PREM

S 08

9721

ENG

The Council of Europe is the continent’s leading human rights organisation. It comprises 47 member states, including all members of the European Union. All Council of Europe member states have signed up to the European Convention on Human Rights, a treaty designed to protect human rights, democracy and the rule of law. The European Court of Human Rights oversees the implementation of the Convention in the member states.

The multiregional Council of Europe project entitled “Needs assessment– Falsified Medical Products” (NA-FAMED) supports Council of Europe member States and other countries, Parties to the MEDICRIME Convention, to fight against the falsification of medical products and similar crimes involving threats to public health. It is a preparatory project that aims at establishing a baseline for future projects aimed at promoting and implementing the MEDICRIME Convention.

The MEDICRIME NA-FAMED project’s Gap Analysis report aims to support Council of Europe member States and other countries by identifying technical gaps that need to be addressed to implement and ratify the MEDICRIME Convention. It also aims to improve and strengthen legal, regulatory and policy frameworks of those countries by assessing the level to which current national criminal law and other relevant laws support the prohibition of the falsification of medical products as criminal offences, for the purposes of protecting public health.

36 countries have been targeted by the NA-FAMED project. The following 28 Council of Europe member States participated in the project: Andorra, Armenia, Austria, Azerbaijan, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Georgia, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, Montenegro, North Macedonia, Norway, Poland, Romania, Serbia, Slovak Republic, Slovenia, Sweden and United Kingdom. The following 8 non-Council of Europe member States also participated in the study: Canada, Ecuador, Guinea, Japan, Mexico, Morocco, Tunisia and the United States of America.