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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 publishing@coe.int).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: medicrime@coe.int
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
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.
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.
Page 13
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
Page 14 Gap analysis report
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.
Page 16 Gap analysis report
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.
Page 17
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.
Page 18 Gap analysis report
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
Article 4 - Definitions
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.
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CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Further action is needed to fully correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Further action is needed to fully correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
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.
Article 8 – Similar crimes involving threats to public health
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.
Further action is needed to correspond with Article 8, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
No provision in internal law corresponds with Article 11, MEDICRIME Convention.
Action is needed to correspond with Article 11, MEDICRIME Convention.
Article 13 – Aggravating circumstances
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.
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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
Article 4 - Definitions
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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
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Article 5 – Manufacturing of counterfeits
§ 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.
Further action is needed to fully correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
§ 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.
Further action is needed to fully correspond with Article 6 MEDICRIME Convention.
Article 7 – Falsification of documents
§ 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.
Further action is needed to fully correspond with Article 7 MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
§§ 12 and 15, StGB correspond with Article 9, MEDICRIME Convention.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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.
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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
Article 4 - Definitions
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.
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Further action is needed to fully correspond with Article 6 MEDICRIME Convention.
Article 7 – Falsification of documents
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.
Article 8 – Similar crimes involving threats to public health
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.
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Action is required to fully correspond with Article 8.b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
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Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Article 7 – Falsification of documents
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.
Further action is needed to fully correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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.
Action is needed to correspond with Article 13, MEDICRIME Convention.
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3. 6 Canada
Article 4 - Definitions
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.
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CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
No provision in internal law could be found corresponding with Article 5, MEDICRIME Convention.Action is needed to correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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 7 – Falsification of documents
Article 366 (1) and (2), Criminal Code, correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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 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.
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
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Article 7 – Falsification of documents
No provision could be found in internal laws corresponding with Article 7, MEDICRIME Convention.
Action is needed to correspond with Art 7 MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Action is needed to correspond with Art 8.b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
No provision could be found in internal laws corresponding with Article 9, MEDICRIME Convention. Action is needed to correspond with Art 9 MEDICRIME Convention.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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.
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Action is needed to correspond with Art 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Article 7 – Falsification of documents
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.
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Article 8 – Similar crimes involving threats to public health
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.
8.b: No provision could be found in internal laws corresponding with Article 8.b, MEDICRIME Convention.
Action is needed to correspond with Art 8.b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
Action is needed to correspond with Art 9, MEDICRIME Convention.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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.
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
§ 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.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
§ 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.
Further action is needed to fully correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
§ 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.
Further action is needed to fully correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
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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.
8.b: No provision could be found in internal laws corresponding with Article 8.b, MEDICRIME Convention.
Further action is needed to fully correspond with Article 8. a and b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
§ 21 (1) and § 23 (1), CC correspond with Article 9.2 and 9.1, MEDICRIME Convention, respectively.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
§ 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
Article 4 - Definitions
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.
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
Article 217.1, Integral Criminal Organic Code, except for medicinal products for veterinary use, substantially corresponds with Article 5, MEDICRIME Convention.
Further action is needed to fully correspond with Art 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
Article 217.1, Integral Criminal Organic Code, except for medicinal products for veterinary use, substantially corresponds with Article 6, MEDICRIME Convention.
Further action is needed to fully correspond with Art 6, MEDICRIME Convention.
Article 7 – Falsification of documents
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.
Further action is needed to fully correspond with Art 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
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Action is required to correspond with Art 8. a and b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
Article 43 and 39, Integral Criminal Organic Code, as regards accomplices and attempts, respectively, correspond with Article 9, MEDICRIME Convention.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
§ 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.
Action is needed to correspond with Article 5, MEDICRIME Convention.
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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.
Action is needed to correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
§§ 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.
Further action is needed to fully correspond with 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.
Action is needed to correspond with Article 8.b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
Further action is needed to fully correspond with Article 9.1, MEDICRIME Convention.
9.2: § 25 and § 25.1 Penal Code corresponds with Article 9.2, MEDICRIME Convention.
Article 11 – Corporate liability
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.
Further action is needed to fully 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.
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Article 13 – Aggravating circumstances
§ 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.
Further action is needed to fully correspond with Article 13, 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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
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Article 5 – Manufacturing of counterfeits
No provision, as regards the manufacturing of counterfeits, could be found in internal laws corresponding with Article 5, MEDICRIME Convention.
Action is needed to correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Article 7 – Falsification of documents
Section 1, Chapter 33, Criminal Code (CC) provides the offence of ‘forgery’. This corresponds with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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.
Action is needed to correspond with Article 9, MEDICRIME Convention.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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.
Further action is needed to fully correspond with Article 13, MEDICRIME Convention.
3.13 Germany
Article 4 - Definitions
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.
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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.
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CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
§ 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.
Further action is needed to correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
§ 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.
Article 7 – Falsification of documents
§ 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.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
11.1: § 30 para 1, 2 and 3, Law on Administrative Contraventions (OWiG) corresponds with Article 11.1.a, b and c, MEDICRIME Convention.
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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.
Article 13 – Aggravating circumstances
§ 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
Article 4 - Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Further action is needed to fully correspond with Article 5, MEDICRIME Convention.
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Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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 7 – Falsification of documents
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.
Further action is needed to fully correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Action is needed to correspond with Article 8.b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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.
Further action is needed to fully correspond 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 13 – Aggravating circumstances
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:
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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
Article 4 - Definitions
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.
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Further action is needed to fully correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
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.
Article 8 – Similar crimes involving threats to public health
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.
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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.
Article 9 – Aiding or abetting and attempt
Articles 45 and 46, Penal Code, as regards aiding and abetting, correspond with Article 9, MEDICRIME Convention.
Article 11 – Corporate liability
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.
Action is needed to correspond with Article 11, MEDICRIME Convention.
Article 13 – Aggravating circumstances
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.
Further action is needed to correspond with Article 13, MEDICRIME Convention.
3.16 Guinea
Article 4 – Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Further action is needed to fully correspond with Article 5 MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
Article 170 Law L/2018/024/AN 2018, and Article 880 Criminal Code do not sufficiently correspond with Article 6, MEDICRIME Convention.
Further action is needed to fully correspond with Article 6 MEDICRIME Convention.
Article 7 – Falsification of documents
Art. 585 Criminal Code corresponds with Article 7 MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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).
Article 11 – Corporate liability
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.
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Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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.
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CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
No provision could be found in internal law that corresponds with Article 5, MEDICRIME Convention.
Action is needed to correspond with Article 5 MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Further action is needed to fully correspond with Article 6 MEDICRIME Convention.
Article 7 – Falsification of documents
Articles 155-159, Criminal Code, 1940, as amended, correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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.
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Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Further action is needed to fully correspond with Article 5, MEDICRIME Convention.
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.
Further action is needed to fully correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
Articles 25, 26, 27, 28, 29 and 30, Criminal Justice (Theft and Fraud Offences) Act 2001 correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
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Article 11 – Corporate liability
Section 33, Irish Medicines Board Acts 1995 and 2006, correspond with Articles 11.1, 11.2, 11.3 and 11.4 MEDICRIME Conventions.
Article 13 – Aggravating circumstances
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.
Action is needed to correspond with Article 13, MEDICRIME Convention.
3.19 Italy
Article 4 - Definitions
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.
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CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Further action is needed to fully correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
No provision in internal law corresponds with Article 7, MEDICRIME Convention.Action is needed to correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
8.b: No provision in internal law can be found to correspond with Article 8.b, MEDICRIME Convention.
Action is needed to correspond with Article 8.b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
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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.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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.
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Further action is needed to fully correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
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.
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Article 8 – Similar crimes involving threats to public health
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.
Action is needed 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.
Further action is needed to fully correspond with Article 9.2, MEDICRIME Convention.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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.
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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
Article 4 - Definitions
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.
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Article 7 – Falsification of documents
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.
Action is required to correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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.
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Article 11 – Corporate liability
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.
Action is required to correspond with Article 11, MEDICRIME Convention.
Article 13 – Aggravating circumstances
No provision in internal law can be found which corresponds with Article 13, MEDICRIME Convention.
Action is required to correspond with Article 13, MEDICRIME Convention.
3.22 Lithuania
Article 4 - Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Action is needed to correspond with Article 5 MEDICRIME Convention.
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.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Further action is needed to fully correspond with Article 6 MEDICRIME Convention.
Article 7 – Falsification of documents
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.
Article 8 – Similar crimes involving threats to public health
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.
8.b: No provision in internal law can be found to correspond with Article 8.b, MEDICRIME Convention.
Further action is required to fully correspond with Article 8 MEDICRIME Convention.
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Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Further action is needed for the internal law to fully correspond with Article 6, MEDICRIME Convention.
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Article 7 – Falsification of documents
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.
Article 8 – Similar crimes involving threats to public health
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.
8.b: No provision in internal law could be found to correspond with Article 8.b, MEDICRIME Convention.
Action is needed for the internal law to fully correspond with Article 8.b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
No provision in internal law could be found to correspond with Article 13, MEDICRIME Convention.
Further action is needed for the internal law to fully correspond with Article 13, MEDICRIME Convention.
3.24 Montenegro
Article 4 - Definitions
a. Article 4.a MEDICRIME Convention – Medical Product
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Further action is needed to fully correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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
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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.
Further action is needed to fully correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
Articles 412-415, Criminal Code of Montenegro corresponds with the intent of Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Further action is needed to fully correspond with Article 8, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
Action is needed to correspond with Article 9, MEDICRIME Convention.
Article 11 – Corporate liability
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.
Further action is needed to correspond with Article 11, MEDICRIME Convention.
Article 13 – Aggravating circumstances
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.
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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
Article 4 - Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Further action is needed to fully correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
No provision in internal law could be found to correspond with Article 6, MEDICRIME Convention.
Action is needed to correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
No provision in internal law could be found to correspond with Article 7, MEDICRIME Convention.
Action is needed to correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
8.b: No provision in internal law could be found to correspond with Article 8.b, MEDICRIME Convention.
Action is needed to correspond with Article 8.a and b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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).
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Further action is needed to fully correspond with Article 9, MEDICRIME Convention.
Article 11 – Corporate liability
No provision in internal law could be found to correspond with Article 11, MEDICRIME Convention.
Action is needed to correspond with Article 11, MEDICRIME Convention
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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 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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Action is required to correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Action is required to correspond with Article 5, MEDICRIME Convention.
Article 7 – Falsification of documents
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.
Article 8 – Similar crimes involving threats to public health
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.
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Article 9 – Aiding or abetting and attempt
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.
Further action is needed to fully correspond with Article 9.2, MEDICRIME Convention.
Article 11 – Corporate liability
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 13 – Aggravating circumstances
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.
Further action is needed to fully correspond with Article 13, MEDICRIME Convention.
3.27 Norway
Article 4 - Definitions
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.
d. Article 4.d MEDICRIME Convention – Excipient
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§ 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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
No provision in internal law could be found corresponding with Article 5, MEDICRIME Convention.
Action is required to correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
No provision in internal law could be found corresponding with Article 6, MEDICRIME Convention.
Action is required to correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
Section 361, Penal Code, while not being specific to documents related to medical products, corresponds with the intent of Article 7, MEDICRIME Convention.
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Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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.
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Further action is needed to fully correspond with Article 5, MEDICRIME Convention.
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Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Further action is needed to fully correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
Article 270, Penal Code corresponds with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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.
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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
Article 4 - Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Further action is needed to fully correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Further action is needed to fully correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
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.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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.
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Article 11 – Corporate liability
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.
Action is needed to correspond with Article 11, MEDICRIME Convention.
Article 13 – Aggravating circumstances
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.b: No provision in internal law could be found to correspond with Article 13.b, MEDICRIME Convention.
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).
Further action is needed to fully correspond with Article 13, MEDICRIME Convention.
3.30 Serbia
Article 4 - Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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 6 – Supplying, offering to supply, and trafficking in counterfeits
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
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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.
Article 7 – Falsification of documents
The Articles 355 and 356 Criminal Code, correspond with Article 7.1, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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 13 – Aggravating circumstances
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.
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3.31 Slovak Republic
Article 4 - Definitions
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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Further action is needed to fully correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Article 7 – Falsification of documents
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.
Further action is needed to fully correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Action is needed to correspond with Article 8.b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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.
Further action is needed to fully correspond with Article 11.1, MEDICRIME Convention.
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.
Further action is needed to fully correspond with Article 11.2, MEDICRIME Convention.
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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.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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 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
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Action is needed to correspond with Art 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Action is needed to correspond with Art 6, MEDICRIME Convention.
Article 7 – Falsification of documents
Article 251. (1) and (3), Criminal Code, as regards the falsification of documents, corresponds with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
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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.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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 13 – Aggravating circumstances
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
Article 4 – Definitions
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 Product
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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 II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
No provision in internal law could be found to correspond with Article 5, MEDICRIME Convention.
Action is needed to correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
No provision in internal law could be found to correspond with Article 6, MEDICRIME Convention.
Action is needed to correspond with Article 6, MEDICRIME Convention.
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Article 7 – Falsification of documents
Chapter 14, Sections 1 and 2; Swedish Criminal Code correspond with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
Article 9 – Aiding or abetting and attempt
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.
Action is required to correspond with Article 9, MEDICRIME Convention.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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.
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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
Article 4 - Definitions
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,
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Action is needed to correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Action is needed to correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
Article 172, Criminal Code corresponds with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
8.b: No provision in internal law could be found to correspond with Article 8.b, MEDICRIME Convention.
Action is needed to correspond with Article 8. a and b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
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Article 11 – Corporate liability
No provision in internal law could be found to correspond with Article 11, MEDICRIME Convention.
Action is needed to correspond with Article 11, MEDICRIME Convention.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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 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.
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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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Action is needed to correspond with Article 5, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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.
Action is needed to correspond with Article 6, MEDICRIME Convention.
Article 7 – Falsification of documents
There is no correspondence with Article 7, MEDICRIME Convention.
Action is needed to correspond fully with Article 7, MEDICRIME Convention.
Article 8 – Similar crimes involving threats to public health
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.
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Article 9 – Aiding or abetting and attempt
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.
Action is needed to correspond with Article 9, MEDICRIME Convention.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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
Article 4 - Definitions
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.
d. Article 4.d MEDICRIME Convention – Excipient
III. Country reports Page 95
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.
CHAPTER II – SUBSTANTIVE CRIMINAL LAW
Article 5 – Manufacturing of counterfeits
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.
Further action is needed to fully correspond with Article 5.2, MEDICRIME Convention.
Article 6 – Supplying, offering to supply, and trafficking in counterfeits
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).
Article 7 – Falsification of documents
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.
Page 96 Gap analysis report
Article 8 – Similar crimes involving threats to public health
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.
Action is needed to correspond with Article 8.b, MEDICRIME Convention.
Article 9 – Aiding or abetting and attempt
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.
Article 11 – Corporate liability
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.
Article 13 – Aggravating circumstances
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
-FA
MED
-0- G
ap A
naly
sis
Surv
ey
Gap
Ana
lysi
s Su
rvey
Coun
cil o
f Eur
ope
Conv
enti
on o
n th
e co
unte
rfei
ting
of m
edic
al p
rodu
cts
and
sim
ilar c
rim
es in
volv
ing
thre
ats
to p
ublic
hea
lth
(The
MED
ICRI
ME
Conv
enti
on)
Mos
cow
, 28.
X.20
11
NA
ME
OF
COU
NTR
Y
Nam
e of
per
son
Posi
tion
e-m
ail
Tele
phon
e
Twit
ter a
ccou
nt
Link
edIn
acc
ount
I. In
trod
ucti
on
In th
e fr
amew
ork
of th
e Pr
ojec
t ent
itled
“Nee
ds A
sses
smen
t - F
alsi
fied
Med
ical
Pro
duct
s” (N
A-F
AM
ED),
the
Coun
cil o
f Eur
ope
is c
ondu
ctin
g th
is G
ap A
naly
sis S
urve
y to
ass
ess
the
leve
l to
whi
ch c
urre
nt d
omes
tic c
rimin
al a
nd o
ther
law
s sup
port
the
proh
ibiti
on a
nd e
nfor
cem
ent a
gain
st c
ount
erfe
it/fa
lsifi
ed m
edic
al p
rodu
cts a
s crim
inal
offe
nces
for
the
purp
ose
of p
rote
ctin
g pu
blic
hea
lth.
This
is th
e fir
st p
art o
f a tw
o-pa
rt s
urve
y. T
he fo
cus
of th
is fi
rst p
art i
s on
the
defin
ition
s an
d th
e su
bsta
ntiv
e cr
imin
al la
w. P
art 2
may
be
circ
ulat
ed a
t a fu
ture
dat
e an
d w
ill
focu
s on
the
non-
subs
tant
ive
crim
inal
law
asp
ects
of t
he M
EDIC
RIM
E.
Plea
se n
ote
the
obje
ct a
nd p
urpo
se o
f the
MED
ICRI
ME
Conv
entio
n, a
s pr
ovid
ed b
y its
Art
icle
1.1
, whi
le c
ompl
etin
g th
e G
ap A
naly
sis
Surv
ey
Artic
le 1
– O
bjec
t and
pur
pose
1
T
he p
urpo
se o
f thi
s Con
vent
ion
is to
pre
vent
and
com
bat t
hrea
ts to
pub
lic h
ealth
by:
a.
prov
idin
g fo
r the
crim
inal
isat
ion
of ce
rtai
n ac
ts;
b.
p
rote
ctin
g th
e rig
hts o
f vic
tims o
f the
offe
nces
est
ablis
hed
unde
r thi
s Con
vent
ion;
c.
p
rom
otin
g na
tiona
l and
inte
rnat
iona
l co-
oper
atio
n
Page 98 Gap analysis report
II. P
urpo
se o
f the
Gap
Ana
lysi
s Su
rvey
The
purp
ose
of th
is G
ap A
naly
sis
Surv
ey is
to id
entif
y fo
r the
Cou
ncil
of E
urop
e ho
w b
est i
t can
sup
port
its
Mem
ber S
tate
s an
d ot
her c
ount
ries
build
a c
rimin
al la
w a
nd
supp
ortin
g fr
amew
ork
unde
r the
MED
ICRI
ME
Conv
entio
n to
com
bat c
ount
erfe
it/fa
lsifi
ed m
edic
al p
rodu
cts a
nd si
mila
r crim
es in
volv
ing
thre
ats t
o pu
blic
hea
lth. T
his i
s the
cr
imin
al la
w a
ppro
ach,
whi
ch a
ims
at c
rimin
alis
ing
beha
viou
r tha
t bal
ance
s an
d co
mpl
emen
ts th
e pu
blic
hea
lth a
ppro
ach,
whi
ch a
ims
at p
rote
ctin
g th
e m
edic
al p
rodu
ct.
Item
s th
at y
ou w
ill n
eed
to p
rovi
de
Doc
umen
t A: L
egis
lati
ve G
ap A
naly
sis
Tabl
e to
fill-
in1. A
ppen
dix
to D
ocum
ent A
E
xpla
natio
n to
be
prov
ided
Doc
umen
t B: C
ase-
law
ana
lysi
s2.
Dat
a co
llect
ion
of re
leva
nt c
ases
on
the
fals
ifica
tion
of m
edic
al p
rodu
cts
or s
imila
r crim
es. C
lear
des
crip
tion
and
conc
lusi
on o
f it (
is th
ere
a ju
dgem
ent?
)
Doc
umen
t C: O
verv
iew
doc
umen
t
Tab
le to
fill-
in3. III
. Met
hodo
logy
Onl
y on
e co
nsol
idat
ed re
spon
se to
the
Surv
ey s
houl
d be
sub
mitt
ed b
y ea
ch c
onsu
ltant
/ass
esso
r. Th
is s
ubm
issi
on s
houl
d be
in th
e En
glis
h an
d/or
Fre
nch
lang
uage
as
the
Gap
Ana
lysi
s Sur
vey
asse
ssor
s will
not
be
in a
pos
ition
to p
rope
rly tr
ansl
ate
and
inte
rpre
t fro
m a
diff
eren
t lan
guag
e. T
he c
onsu
ltant
/ass
esso
r is f
ree
to c
onta
ct h
is/h
er n
atio
nal
Min
istr
ies/
agen
cies
tha
t ar
e no
rmal
ly in
volv
ed in
com
batin
g co
unte
rfei
t/fa
lsifi
ed m
edic
al p
rodu
cts
(Jus
tice,
Hea
lth, P
olic
e se
rvic
e, C
usto
ms,
Hea
lth P
rodu
ct R
egul
ator
y Ag
ency
, etc
).
IV. I
nstr
ucti
ons
to c
ompl
ete
the
Legi
slat
ive
Gap
Ana
lysi
s
The
Legi
slat
ive
Gap
Ana
lysi
s req
uire
s res
pons
es to
be
prov
ided
in th
e Co
lum
n 2
and
in C
olum
n 3.
In y
our r
espo
nses
in C
olum
ns 2
and
3, p
leas
e st
ate
only
the
refe
renc
e to
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
n 14
B (1
), M
edic
inal
Pro
duct
s (Co
ntro
l of M
anuf
actu
re) R
egul
atio
ns 2
013.
(htt
p://
ww
w.ir
ishs
tatu
tebo
ok.ie
/eli/
2013
/si/1
63/m
ade/
en/p
rint )
. Add
the
refe
renc
e to
App
endi
x (N
o.),
page
1(N
o.) f
or sp
ecifi
cs o
n th
is p
rovi
sion
).
1.
Colu
mn
1: p
rovi
des
a qu
ote
of th
e M
EDIC
RIM
E Co
nven
tion
prov
isio
n2.
Co
lum
n 2:
Pla
ce y
our
resp
onse
s fo
r yo
ur c
ount
ry’s
dom
esti
c Cr
imin
al L
aws
that
spe
cific
ally
cor
resp
onds
to
the
MED
ICRI
ME
Conv
entio
n (i.
e. o
nly
resp
onse
s th
at
spec
ifica
lly im
plem
ent t
he C
rimin
al L
aw o
f the
Con
vent
ion
are
plac
ed h
ere)
3.
Colu
mn
3: P
lace
you
r res
pons
e he
re fo
r you
r gen
eral
dom
esti
c Law
s (in
clud
ing
Crim
inal
Law
s/Re
gula
tory
Law
s/Ad
min
istr
ativ
e La
ws e
nact
ed o
r put
in p
lace
for d
iffer
ent
obje
ctiv
es to
the
MED
ICRI
ME
Conv
entio
n an
d w
hich
will
att
ain
an o
bjec
tive
corr
espo
ndin
g to
the
prov
isio
n of
the
MED
ICRI
ME
Conv
entio
n)
(e
.g.,
for E
U M
embe
r Sta
tes,
the
tran
spos
ition
of D
irect
ive
2011
/62/
EU –
Fal
sifie
d M
edic
ines
Dire
ctiv
e th
at h
as th
e ob
ject
of p
rote
ctin
g pu
blic
hea
lth th
roug
h pr
otec
ting
the
med
icin
al p
rodu
ct)
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
h la
ngua
ges
a.
The
text
of t
he le
gisl
ativ
e pr
ovis
ion
that
you
refe
r to
in C
olum
ns 2
and
/or 3
(e
.g. “
14B.
(1) A
per
son
shal
l not
man
ufac
ture
, im
port
or e
xpor
t a m
edic
inal
pro
duct
if h
e or
she
kno
ws,
or th
ere
are
suffi
cien
t gro
unds
to s
uspe
ct, t
hat i
t is
a fa
lsifi
ed
med
icin
al p
rodu
ct”)
.b.
st
ate
clea
rly w
hy th
e ge
nera
l law
s (C
olum
n 3)
ade
quat
ely
impl
emen
t the
cor
resp
ondi
ng p
rovi
sion
of t
he M
EDIC
RIM
E Co
nven
tion
(Col
umn
1).
(e.g
. Thi
s pr
ovis
ion
is s
econ
dary
law
and
was
impl
emen
ted
to tr
ansp
ose
the
Dire
ctiv
e 20
11/6
2/EU
(fal
sifie
d m
edic
ines
dire
ctiv
e), t
he p
enal
ties
for w
hich
, on
sum
mar
y co
nvic
tion,
are
a fi
ne n
ot e
xcee
ding
€4,
000
or a
term
of i
mpr
ison
men
t not
exc
eedi
ng 1
year
, or b
oth;
on
conv
ictio
n on
indi
ctm
ent,
for a
firs
t offe
nce
to a
fine
not
exc
eedi
ng
€120
,000
or i
mpr
ison
men
t for
a te
rm n
ot e
xcee
ding
10
year
s or b
oth;
on
conv
ictio
n on
indi
ctm
ent,
for a
seco
nd o
r sub
sequ
ent o
ffenc
e, to
a fi
ne n
ot e
xcee
ding
€30
0,00
0 or
impr
ison
men
t for
a te
rm n
ot e
xcee
ding
10
year
s or
bot
h. It
is s
econ
dary
legi
slat
ion
prov
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
Page 100 Gap analysis report
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
IV. Appendices Page 101
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
Page 102 Gap analysis report
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
IV. Appendices Page 103
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
Page 104 Gap analysis report
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
IV. Appendices Page 105
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.
Page 106 Gap analysis report
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
IV. Appendices Page 107
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
Page 108 Gap analysis report
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
IV. Appendices Page 109
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.
Page 110 Gap analysis report
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
.
IV. Appendices Page 111
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.
Page 112 Gap analysis report
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
IV. Appendices Page 113
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.
Page 114 Gap analysis report
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.
IV. Appendices Page 115
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.
Page 116 Gap analysis report
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.
IV. Appendices Page 117
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
Page 118 Gap analysis report
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
IV. Appendices Page 119
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
.
Page 120 Gap analysis report
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
IV. Appendices Page 121
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.
Page 122 Gap analysis report
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).
IV. Appendices Page 123
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.
Page 124 Gap analysis report
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)
IV. Appendices Page 125
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.
Page 126 Gap analysis report
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
.
IV. Appendices Page 127
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.
Page 128 Gap analysis report
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”.
IV. Appendices Page 129
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
Page 130 Gap analysis report
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.
IV. Appendices Page 131
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
)
Page 132 Gap analysis report
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
).
IV. Appendices Page 133
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
Page 134 Gap analysis report
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.
IV. Appendices Page 135
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.
Page 136 Gap analysis report
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.
IV. Appendices Page 137
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
Page 138 Gap analysis report
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.
IV. Appendices Page 139
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
.
Page 140 Gap analysis report
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)
.
IV. Appendices Page 141
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
Page 142 Gap analysis report
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.
IV. Appendices Page 143
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.
Page 144 Gap analysis report
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/
IV. Appendices Page 145
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.
Page 146 Gap analysis report
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.
IV. Appendices Page 147
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
Page 148 Gap analysis report
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
.)
IV. Appendices Page 149
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
.
Page 150 Gap analysis report
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
.
IV. Appendices Page 151
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://
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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
.
Page 152 Gap analysis report
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.
IV. Appendices Page 153
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.
Page 154 Gap analysis report
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
.
IV. Appendices Page 155
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
Page 156 Gap analysis report
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.
).
IV. Appendices Page 157
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.
Page 158 Gap analysis report
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
IV. Appendices Page 159
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.
Page 160 Gap analysis report
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).
IV. Appendices Page 161
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
.
Page 162 Gap analysis report
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.
IV. Appendices Page 163
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
.
Page 164 Gap analysis report
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
.
IV. Appendices Page 165
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
.
Page 166 Gap analysis report
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
IV. Appendices Page 167
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.
Page 168 Gap analysis report
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.
IV. Appendices Page 169
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.
Page 170 Gap analysis report
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]
IV. Appendices Page 171
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
.
Page 172 Gap analysis report
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
IV. Appendices Page 173
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
Page 174 Gap analysis report
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
IV. Appendices Page 175
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)
Page 176 Gap analysis report
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
Pro
duct
s Ca
tego
ries
Law
of 2
002
to 2
013
http
://w
ww
.cyl
aw.o
rg/n
omoi
/eno
p/in
d/20
02_1
_30/
sect
ion-
sc9b
7b8d
bb-a
26b-
d812
-aee
e-c6
4361
e723
20.h
tml
Den
mar
k:Th
e M
edic
ines
Act
ww
w.re
tsin
form
atio
n.dk
/eli/
lta/2
018/
99
Law
on
Med
ical
Dev
ices
ww
w.re
tsin
form
atio
n.dk
/eli/
lta/2
016/
139
http
s://
ww
w.re
tsin
form
atio
n.dk
/eli/
ft/2
0101
2L00
118
Exec
utiv
e O
rder
on
the
man
ufac
ture
, im
port
and
dis
trib
utio
n of
act
ive
subs
tanc
es fo
r the
man
ufac
ture
of m
edic
inal
pro
duct
s no
. 136
0 (1
8 D
ecem
ber 2
012)
htt
ps://
ww
w.
rets
info
rmat
ion.
dk/e
li/lta
/201
2/13
60
Esto
nia:
Med
icin
al P
rodu
cts
Act h
ttps
://w
ww
.riig
iteat
aja.
ee/e
n/el
i/518
0520
2000
5/co
nsol
ide#
para
10b1
Med
ical
Dev
ices
Act
htt
ps://
ww
w.ri
igite
ataj
a.ee
/en/
eli/5
2805
2020
007/
cons
olid
e Co
de o
f Crim
inal
Pro
cedu
re h
ttps
://w
ww
.riig
iteat
aja.
ee/e
n/el
i/518
0520
2000
7/co
nsol
ide
Pena
l Cod
e ht
tps:
//w
ww
.riig
iteat
aja.
ee/e
n/el
i/515
0720
2001
1/co
nsol
ide#
para
1
Finl
and:
Med
icin
es A
ct h
ttps
://w
ww
.fim
ea.fi
/doc
umen
ts/1
6014
0/76
5540
/185
80_L
aake
laki
_eng
lann
iksi
_pai
vite
tty_
5_20
11.p
df
Med
ical
Dev
ices
Act
http
s://
finle
x.fi/
fi/la
ki/a
jant
asa/
2010
/201
0062
9?se
arch
%5B
type
%5D
=pik
a&se
arch
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pika
%5D
=lak
i%20
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nhuo
llon%
20la
ittei
sta%
2A
Crim
inal
Cod
e ht
tps:
//fin
lex.
fi/en
/laki
/kaa
nnok
set/
1889
/en1
8890
039_
2015
0766
Ger
man
y:M
edic
inal
Pro
duct
s Ac
t (A
rzne
imitt
elge
setz
– A
MG
) 201
9 ht
tp://
ww
w.g
eset
ze-im
-inte
rnet
.de/
engl
isch
_am
g/
Ger
man
Crim
inal
Cod
e (S
traf
gese
tzbu
ch –
StG
B)
http
s://
ww
w.g
eset
ze-im
-inte
rnet
.de/
engl
isch
_stg
b/en
glis
ch_s
tgb.
htm
l
Geo
rgia
:La
w o
f Geo
rgia
on
Med
icin
es a
nd P
harm
aceu
tical
Act
iviti
es h
ttps
://m
atsn
e.go
v.ge
/en/
docu
men
t/do
wnl
oad/
2983
6/21
/en/
Crim
inal
Pro
cedu
re C
ode
of G
eorg
ia h
ttps
://m
atsn
e.go
v.ge
/ka/
docu
men
t/do
wnl
oad/
9003
4/64
/en/
Icel
and:
Med
icin
al P
rodu
cts
Act N
o 10
0/20
20
http
s://
ww
w.g
over
nmen
t.is/
libra
ry/0
1-M
inis
trie
s/M
inis
try-
of-H
ealT
h/PD
F-sk
jol/L
yfjal
%c3
%b6
g%20
nr.%
2010
0.20
20%
20%
20en
sk%
20%
c3%
be%
c3%
bd%
c3%
b0in
g.pd
f
IV. Appendices Page 177
Act o
n M
edic
al D
evic
es N
o 16
/200
1 ht
tps:
//w
ww
.gov
ernm
ent.i
s/m
edia
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ferd
arra
dune
yti-m
edia
/med
ia/a
crob
at-e
nska
r_si
dur/
Act_
on_M
edic
al_D
evic
es_N
o_16
2001
Re
gula
tion o
n Med
ical
Dev
ices
No 9
34/2
010 h
ttps
://w
ww
.gov
ernm
ent.i
s/m
edia
/vel
ferd
arra
dune
yti-m
edia
/med
ia/R
eglu
gerd
ir-en
ska/
Regu
latio
n-on
-Med
ical
-Dev
ices
-No-
934-
2010
G
ener
al P
enal
Cod
e N
o 19
/194
0 ht
tps:
//w
ww
.gov
ernm
ent.i
s/lib
rary
/01-
Min
istr
ies/
Min
istr
y-of
-Jus
tice/
Gen
erla
l%20
Pena
l%20
Code
,%20
No.
19%
2019
40.p
df
Irel
and:
Irish
Med
icin
es B
oard
Act
, 199
5 ht
tp://
ww
w.ir
ishs
tatu
tebo
ok.ie
/eli/
1995
/act
/29/
enac
ted/
en/h
tml
Irish
Med
icin
es B
oard
(Mis
cella
neou
s Pr
ovis
ions
) Act
200
6 ht
tp://
ww
w.ir
ishs
tatu
tebo
ok.ie
/eli/
2006
/act
/3/e
nact
ed/e
n/ht
ml
Med
icin
al P
rodu
cts
(Con
trol
of M
anuf
actu
re) R
egul
atio
ns, S
.I. N
o. 5
39/2
007
- Med
icin
al P
rodu
cts
(Con
trol
of M
anuf
actu
re) R
egul
atio
ns 2
007
Euro
pean
Com
mun
ities
(Med
ical
Dev
ices
) (A
men
dmen
t)
Regu
latio
ns 2
009
S.I.
No.
110
/200
9 - E
urop
ean
Com
mun
ities
(Med
ical
Dev
ices
) (A
men
dmen
t) R
egul
atio
ns 2
009
Euro
pean
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mun
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Slov
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lic:
Law
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Med
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Swed
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Med
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ttps
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cont
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The
Hum
an M
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Regu
latio
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http
s://
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v.uk
/uks
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s://
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s://
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atio
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Att
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s Ac
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1 ht
tps:
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slat
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gov.
uk/u
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The
Crim
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Att
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s an
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(Nor
ther
n Ire
land
) Ord
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983
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s://
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gisl
atio
n.go
v.uk
/nis
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294
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010
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Uni
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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
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Reg
ulat
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Titl
e 21
Ele
ctro
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Code
of F
eder
al R
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CFR)
18 U
SC –
Crim
es a
nd C
rimin
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roce
dure
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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)
IV. Appendices Page 181
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
Page 182 Gap analysis report
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
IV. Appendices Page 183
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.
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