Detailed guidance on the electronic submission of ... · 9/1/2011 · Detailed guidance on the electronic submission of information on medicinal products for human use by marketing

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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

1 September 2011 EMA/721630/2011 Patient Health Protection

Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 Chapter 4: Structured substance information

Version 2.0

Date of coming into force: 1 September 2011

Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004

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Table of Contents

4. Structured Substance Information ..........................................................3 4.1. Introduction.......................................................................................................3 4.1.1. Controlled Vocabularies ....................................................................................3 4.1.2. Naming Conventions ........................................................................................4 4.2. The Structured Substance Information Overview.....................................................4 4.2.1. The Structured Substance Information for Chemicals ............................................5 4.2.2. The Structured Substance Information for Proteins ...............................................6 4.2.3. The Structured Substance Information for Nucleic Acids ........................................7 4.2.4. The Structured Substance Information for Polymers..............................................8 4.2.5. The Structured Substance Information for Structurally Diverse Substances ..............9 4.2.6. The Structured Substance Information for Mixtures............................................. 10 4.2.7. The Structured Substance Information for Specified Substance Group 1................. 11 4.2.8. The Structured Substance Information for Specified Substance Group 2................. 12 4.2.9. The Structured Substance Information for Specified Substance Group 3................. 13 4.3. The Structured Substance Information Data Element Description............................. 14 4.3.1. SSI for Chemicals .......................................................................................... 14 4.3.2. SSI for Proteins ............................................................................................. 58 4.3.3. SSI for nucleic acids..................................................................................... 123 4.3.4. SSI for Polymers.......................................................................................... 182 4.3.5. SSI for Structurally Diverse Substances .......................................................... 256 4.3.6. SSI for Mixtures........................................................................................... 328 4.3.7. SSI for Specified Substance Group 1............................................................... 387 4.3.8. SSI for Specified Substance Group 2............................................................... 426 4.3.9. SSI for Specified Substance Group 3............................................................... 455


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4. Structured Substance Information

4.1. Introduction

The Structured Substance Information (SSI) refers to the data elements that describe

detailed characteristics of the substance(s), which are ingredients of medicinal products.

An SSI file shall be created for each substance, which is an ingredient of a medicinal

product.

The SSI file shall be incorporated in the XEVPRM as outlined in chapter 3 published at

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/docum

ent_listing_000336.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580410

138.

The set of characteristics that shall be provided in the SSI are based on the type of

substance class specified in the XEVPRM. The classification of the substance shall be based

on the principles outlined in the Annex published at



138.

4.1.1. Controlled Vocabularies

The provision of certain information within the Structured Substance Information (SSI) is

based on the use of Controlled Vocabularies (CVs) and reference sources. The CVs to be

used are outlined in chapter 4.1. . For each data element where a CV applies, the name of

the CV that shall be used is described in the CV reference column in square brackets.

The CVs and the examples of reference sources are published at



138

The CVs contain the following information:

List-name referring to the name of the CV, which is referenced throughout the

detailed guidance as applicable.

Term-ID referring to the unique identifier associated with each term of the CV.

Term-name (English) referring to the name of the controlled term in English.

Examples of Reference Sources are provided, where applicable.

Latin-name referring to the name of the controlled term in Latin, where applicable.

Synonym 1, 2 referring to the columns in the table that are repeated to describe

any other name or common name or synonym associated with the English term.

Description referring to the description of the term, where applicable.

The CVs will be regularly updated und new versions will be published at


http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000336.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580410138











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138.

4.1.2. Naming Conventions

The provision of substance and specified substance names within the XEVPRM and the SSI

relies on the use of various reference sources and conventions for the naming of

substances. Instructions on the naming conventions and examples of reference sources

are published at



138.

4.2. The Structured Substance Information Overview

The characteristics to be defined for each substance class are specified in the chapters 4.1.

Depending on the nature of the substance, each substance shall be described based on the

3.

ned in chapter 4.3.5.

pecified Substance – Group 3 - characteristics are outlined in chapter 4.3.9.

following substance classes:

Chemical - characteristics are outlined in chapter 4.3.1.

Protein - characteristics are outlined in chapter 4.3.2.

Nucleic Acid - characteristics are outlined in chapter 4.3.

Polymer - characteristics are outlined in chapter 4.3.4.

Structurally Diverse Substance – characteristics are outli

Mixture - characteristics are outlined in chapter 4.3.6.

Specified Substance – Group 1 - characteristics are outlined in chapter 4.3.7.

Specified Substance – Group 2 - characteristics are outlined in chapter 4.3.8.

S






4.2.1. The Structured Substance Information for Chemicals

Figure 1 –Structured Substance Information (SSI) Chemical


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4.2.2. The Structured Substance Information for Proteins

Figure 2 - Structured Substance Information (SSI) Protein


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4.2.3. The Structured Substance Information for Nucleic Acids

Figure 3 -Structured Substance Information (SSI) Nucleic Acid


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4.2.4. The Structured Substance Information for Polymers

Figure 4 - Structured Substance Information (SSI) Polymer


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4.2.5. The Structured Substance Information for Structurally Diverse Substances

Figure 5 - Structured Substance Information (SSI) Structurally Diverse Substance


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4.2.6. The Structured Substance Information for Mixtures

Figure 6 - Structured Substance Information (SSI) Mixture


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4.2.7. The Structured Substance Information for Specified Substance Group 1

Figure 7 - Structured Substance Information (SSI) Specified Substance Group 1


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4.3. The Structured Substance Information Data Element Description

4.3.1. SSI for Chemicals

For chemical substances the SSI shall be based on the following data elements:

SSI level Data Element Name

Ref Code Data Element Description and Notes

CV Reference

Mandatory

Type Field Length

Business Rules

substance

SUB

Language

SUB.LANG The language used to provide the structure substance information shall be specified according to ISO 639-2 alpha-3 codes. EXAMPLE: eng – English deu (T) - German

CV [Language]

Y text 3 Note: ISO 639-2 is the alpha-3 code in Codes for the representation of names of languages-- Part 2. There are 21 languages that have alternative codes for bibliographic or terminology purposes. In those cases, each is listed separately and they are designated as "B" (bibliographic) or "T" (terminology).


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CV Reference

Mandatory

Type Field Length

Business Rules

For the purpose of describing “Language”, “T” shall be used. In all other cases there is only one ISO 639-2 code. Multiple codes assigned to the same language are to be considered synonyms.

Substance_id

COM.1 The substance identifier shall be described based on a controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N Alphanumeric

12

Substance_Clas

COM.2.CV Type of substance based on a controlled vocabulary.

CV

Y Text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

sification

EXAMPLE: Single, Mixture

[Substance Class]

substance_name (1..n)

COM.SNM The substance name section This section contains the set of elements for the description of the name of the substance. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

Y

Substance_name

SNM.1 The name of the substance shall be specified.

Y Text 4000

Substance_name_type

SNM.2.CV The type of the name shall be specified based on a controlled vocabulary. EXAMPLE: Official name, Code

CV [Substance Name Type]

Y text 250

Language

SNM.3.CV The language used to provide the structure substance information shall be specified according to ISO 639-2 alpha-3 codes.

CV [Language]

Y text 3 Note: ISO 639-2 is the alpha-3 code in Codes for the representation of names of languages-- Part 2. There are 21 languages that have


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CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: eng – English deu (T) - German

alternative codes for bibliographic or terminology purposes. In those cases, each is listed separately and they are designated as "B" (bibliographic) or "T" (terminology). For the purpose of describing “Language”, “T” shall be used. In all other cases there is only one ISO 639-2 code. Multiple codes assigned to the same language are to be considered synonyms.

official_name (0..n)

SNM.ON The official name section N If “Official Name” has been specified in “Substance_Name_Type” this section is mandatory. For any other name type, the section is present as not mandatory.

Official_name_type

ON.1.CV The type of the official name shall be specified based on a controlled vocabulary.

CV [Source]

Y text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: INN

Official_name_status

ON.2.CV The status of the official name shall be specified based on a controlled vocabulary. EXAMPLE: current, proposed.

CV [Status]

Y text 250

Official_name_status_change_date

ON.3 The change date of the status of the official name shall be specified in line with the ISO 8601 date format, which shall be only entered when name is changed. EXAMPLE: 2011-06-01

ISO 8601 date format

N alphanumeric

10 ISO 8601 advises numeric representation of dates and times on an internationally agreed basis. It represents elements from the largest to the smallest element: e.g. year-month-day YYYY-MM-DD

official_name_domain (1..n)

ON.DOM Y If “Official Name” has been specified in “Substance Name Type” this section is mandatory. Each “Official Name” shall have at least one “Official Name Domain”.

Official_name_domain

DOM.1.CV The domain of the name shall be provided based on a controlled vocabulary.

CV [Domain]

Y Text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: Human Pharmaceutical

official_name_jurisdiction (1..n)

ON.JUR The jurisdiction of the official name section

Y If “Official Name” has been specified in “Substance Name Type” this section is mandatory. Each “Official Name” shall have at least one “Official Name Jurisdiction”.

Official_name_jurisdiction

JUR.1.CV The jurisdiction of the official name shall be provided based on ISO 3166-1 alpha-2 codes with two exceptions: EL (not GR) is used to represent Greece, and UK (not GB) is used to represent the United Kingdom. For the European Union EU shall be used.

CV [Country Code]

Y Text 3

reference_source (1..n)

SNM.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be

Y


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CV Reference

Mandatory

Type Field Length

Business Rules

specified.

Public_domain

RS.1 It shall be specified if the reference source information is public or not. Yes or No values apply.

Yes /No

Y Boolean

Reference_source_type

RS.2.CV The type of the reference source shall be specified based on a controlled vocabulary. EXAMPLE: INN

CV [Source]

Y text 250

Reference_source_class

RS.3.CV The class of the reference source shall be specified based on a controlled vocabulary. EXAMPLE: Regulatory submission

CV [Source Class]

Y text 250

Reference_source_id

RS.4 The code or number referring to the reference source shall be specified.

N/A N alphanumeric

12

Reference_source_citation

RS.5 The textual description of the reference source within the literature or regulatory document shall be described. EXAMPLE:

N/A N text 2500


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CV Reference

Mandatory

Type Field Length

Business Rules

Ph.E. 7.1, p.34 Literature reference: Encycl. 3: 429 (1792)

substance_code (0..n)

COM.SC The substance code section This section describes the specific code(s) within one or more available code system(s) that apply to a substance.

N

Code SC.1 The specific code (the value) with regard to a referenced code system shall be provided. NOTE: InChI is not considered a code and shall be specified within the structure description.

N/A Y alphanumeric

500

Code_system

SC.2.CV The code system shall be specified based on a controlled vocabulary.

CV [Code System]

Y

Text 250

Code_system_id

SC.3.CV The identifier for the code system shall be provided based on a controlled vocabulary.

CV [Code System]

N alphanumeric

12

Code_sy SC.4.CV The status of the code system CV Y text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

stem_status

shall be specified based on a controlled vocabulary. EXAMPLE: current, proposed.

[Status]

Code_system_change_date

SC.5 The change date of the code system shall be specified in line with the ISO 8601 date format, where applicable. EXAMPLE: 2011-06-01


N alphanumeric

10 This applies only when the code is changed, so it is not applicable for initial submission. ISO 8601 advises numeric representation of dates and times on an internationally agreed basis. It represents elements from the largest to the smallest element: e.g. year-month-day YYYY-MM-DD

Comment

SC.6 Any comment can be provided in this field, if necessary.

N Text 4000


SC.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be

Y


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CV Reference

Mandatory

Type Field Length

Business Rules

specified.

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


RS.5 The textual description of the reference source within the literature or regulatory document shall be described. EXAMPLE:

N/A N text 2500


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CV Reference

Mandatory

Type Field Length

Business Rules

Ph.E. 7.1, p.34 Literature reference: Encycl. 3: 429 (1792)

version (1..n)

COM.VER The version section This section shall provide information on the version of the substance.

Y Where no “Version Number” and “Effective Date” have been assigned by an authority source, the version number shall be set as 0 with the date set as the date of initial submission of the substance.

Version_number

VER.1 The number of the version of the SSI shall be provided.

N/A Y numeric

4

Effective_date

VER.2 The date when the SSI was effective shall be provided in line with the ISO 8601 date format. This shall be defined when the SSI is generated or modified.


N alphanumeric


Change_made

VER.3 The description of the updates or changes of the SSI shall be specified.

N/A

N text 4000


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CV Reference

Mandatory

Type Field Length

Business Rules

The field will be left empty when first insert of substance.

reference_information (1..1)

COM.RI The reference information section This section is used to provide details about: - substance classification - target - gene from which proteins are derived - substance relationship

Y

Comment

RI.1 Any comment can be provided in this field, if necessary.

N Text 4000

substance_classification (1..n)

RI.SCLF The substance classification

Y One or more “Substance Classifications” shall be specified.

Domain SCLF.1.CV The domain of the substance classification shall be provided based on a controlled vocabulary. EXAMPLE: Human Pharmaceuticals

CV [Domain]

Y text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

Substance_Classification

SCLF.2.CV Type of substance based on a controlled vocabulary. EXAMPLE: Single, Mixture

CV [Substance Class]

Y Text 250 The information provided in this field shall be automatically populated based on the information provided in the Substance_Classification field (COM.2.CV).

Substance_classification_type

SCLF.3.CV The type of the substance shall be provided based on a controlled vocabulary. NOTE: When Substance_Classification=mixture and the substances that are forming the mixture are of the same class, the class of those substances shall be specified in this field. EXAMPLE: two chemicals forming the mixture, specified_classification_type = chemical If the substances that are forming the mixture are of a different class, the value ‘mixture’ shall be specified in this field.

CV [Substance Type] [Specified substance Type]

Y Text 250 When Substance_Classification= Single or mixture, the [Substance Type] CV applies. When Substance_Classification=Specified substance the [Specified Substance Type] CV applies.


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CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: One polymer combined in a protein, Specified_classification_type =mixture

Substance_classification_code

SCLF.4 The code of the classification type where applicable shall be specified based on a controlled vocabulary.

N alphanumeric

250

subtype (1..n)

SCLF.ST The subtype section Y

Substance_class_subtype

ST.1.CV The sub-type of the classification shall be described based on a controlled vocabulary. EXAMPLE: Vaccine, Herbal, Multiple Substances

CV [Substance subtype]

Y Text 250


SCLF.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y


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CV Reference

Mandatory

Type Field Length

Business Rules

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


RS.5 The textual description of the reference source within the literature or regulatory document shall be described. EXAMPLE: Ph.E. 7.1, p.34 Literature reference:

N/A N text 2500


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CV Reference

Mandatory

Type Field Length

Business Rules

Encycl. 3: 429 (1792)

substance_relationship (0..n)

RI.REL The substance relationship This section shall provide information related to relationship of a substance, where this is applicable.

N

Relationship

REL.1.CV The relationship of a substance shall be defined based on a controlled vocabulary. NOTE: Target and gene elements are not to be specified in this section. EXAMPLE: transporter, metabolic enzyme

CV [relationship type]

Y Text 250

Interaction_type

REL.2.CV The type of interaction shall be specified based on a controlled vocabulary, where applicable. EXAMPLE: covalent

CV [Interaction Type]

N Text 250

Substance_id

REL.3 The substance identifier, for which the relationship is specified, shall be described.

CV [Substance Name]

N Alphanumeric

12


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CV Reference

Mandatory

Type Field Length

Business Rules

NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

Substance_name

REL.4 The substance name shall be specified.

CV [Substance Name]

Y text 4000 Mandatory when there is a “substance relationship”

Amount_type

REL.5.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250

amount (0..1)

REL.AMT The amount section N

Quantity Operator

AMT.1.CV CV [Quantity

N text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

Operator]

Low_limit_numerator_value

AMT.2 The lower limit value of the substance shall be specified, where available.

N Numeric

10

Low_limit_numerator_unit

AMT.3.CV The lower limit unit of the substance shall be specified, where available.

CV [Unit of Measure]

N alphanumeric

250

Low_limit_numerator_unit_prefix

AMT.4.CV The prefix of the lower limit unit of the substance shall be specified, where available.

CV [Unit Prefix]

N alphanumeric

250

Low_limit_denominator_value


N Numeric

10

Low_limit_ denominator _unit



N alphanumeric

250

Low_limit_ denominator_unit_prefix


CV [Unit Prefix]

N alphanumeric

250

High_limi AMT.8 The higher limit value of the N Nume 10


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CV Reference

Mandatory

Type Field Length

Business Rules

t_numerator_value

substance shall be specified, where available.

ric

High_limit_numerator_unit

AMT.9.CV The higher limit unit of the substance shall be specified, where available.


N alphanumeric

250

High_limit_numerator_unit_prefix

AMT.10.CV The prefix of the higher limit unit of the substance shall be specified, where available.

CV [Unit Prefix]

N alphanumeric

250

High_limit_denominator_value

AMT.11 The higher limit value of the substance shall be specified, where available.

N Numeric

10

High_limit_ denominator _unit



N alphanumeric

250

High_limit_ denominator_unit_prefix


CV [Unit Prefix]

N alphanumeric

250

Average

AMT.14 The average amount or single value of the substance shall be specified.

N Numeric

10


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CV Reference

Mandatory

Type Field Length

Business Rules

Prefix AMT.15.CV The prefix of the average unit of the substance shall be specified, where available.

CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV The applicable unit for the average shall be specified based on a controlled vocabulary.


N alphanumeric

250

Non_numeric_value

AMT.17 The non numeric value shall be specified when a numeric value it is not applicable. EXAMPLE: Short, High (temperature)

N alphanumeric

250


REL.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean


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CV Reference

Mandatory

Type Field Length

Business Rules



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


RS.5 The textual description of the reference source within the literature or regulatory document shall be described. EXAMPLE: Ph.E. 7.1, p.34 Literature reference: Encycl. 3: 429 (1792)

N/A N text 2500

gene (0..n)

RI.GN The gene section This section shall provide a

N This section does not apply when Substance_classification_type is


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CV Reference

Mandatory

Type Field Length

Business Rules

description of the gene in relation to a substance, where applicable. The gene section refers only to gene that is the origin of the substance (protein).

equal to chemical, Specified Substance Group 1, Specified Substance Group 2 and Specified substance group 3.

Gene_sequence_origin

GN.1.CV The common name for the organism from which the final gene sequence originated shall be specified based on a controlled vocabulary. NOTE: it applies primarily to proteins.

CV [Organism Name]

N Text 4000

Gene_id GN.2 The identifier of the gene shall be provided based on a controlled vocabulary. E.g.: YP_299723.1

CV [Gene Name]

N alphanumeric

12

Gene_name

GN.3 The complete name given for a gene shall be provided based on a controlled vocabulary. E.g.: hIL-10 gene

CV [Gene Name]

Y Text 4000

reference_ GN.RS The reference source section Y


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CV Reference

Mandatory

Type Field Length

Business Rules

source (1..n)

This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


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CV Reference

Mandatory

Type Field Length

Business Rules



N/A N text 2500

Gene_element (0..n)

RI.GE The gene element section N

Gene_element_type

GE.1.CV The type of the gene element shall be specified based on a controlled vocabulary. EXAMPLE: enhancer, promoter, silencer, terminator

CV [Gene Element Type]

Y Text 250

Gene_element_id

GE.2 The unique identifier for the gene element shall be specified based on a controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID”

CV [Substance Name]

N Alphanumeric

12


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CV Reference

Mandatory

Type Field Length

Business Rules

shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

Gene_element_name

GE.3 The specific gene element name shall be described based on a controlled vocabulary.

CV [Substance Name]

Y Text 4000


GE.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean

Reference_source

RS.2.CV The type of the reference source shall be specified based

CV

Y text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

_type on a controlled vocabulary. EXAMPLE: INN

[Source]



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Target (0..n)

RI.TRG The target section This section shall provide information on the target substance.

N This section does not apply when Substance_classification_type is equal to Specified Substance Group 1, Specified Substance


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CV Reference

Mandatory

Type Field Length

Business Rules

It refers for genes to the target of the protein expressed by that gene. For all the other substances type it refers to the substrate of the substance. EXAMPLE: enzyme, protein/channel, receptor

Group 2 and Specified substance group 3.

Target_gene_id

TRG.1 The identifier of the target gene shall be provided.

CV [Target Gene]

N alphanumeric

12

Target_gene_name

TRG.2 The target gene name shall be specified based on a controlled vocabulary. EXAMPLE: single substance, an enzyme type

CV [Target Gene]

Y Text 4000

Interaction_type

TRG.3.CV The type of interaction shall be specified based on a controlled vocabulary. EXAMPLE: Inhibition

CV [Target interaction type]

Y text 250

Target_o TRG.4.CV The type of target organism CV N Text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

rganism_type

shall be specified based on a controlled vocabulary. EXAMPLE: human, viral

[Organism type]

Target_type

TRG.5.CV The target type shall be specified based on a controlled vocabulary. EXAMPLE: enzyme, receptor, membrane

CV [Target type]

N Text 250


TRG.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250


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CV Reference

Mandatory

Type Field Length

Business Rules



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Structure (0..n)

SING.STR The structure section The structure of the substance shall be described, where applicable

N The structure section is mandatory when Substance_classification_type= chemical, protein, polymer and nucleic acid.

Structural_represe

STR.1.CV The type of the structural representation shall be

CV

Y Text 250


EMA/721630/2011 Page 43/485



CV Reference

Mandatory

Type Field Length

Business Rules

ntation_type

described based on a controlled vocabulary. EXAMPLE: InChI, mol file

[Structural Representation Type]

Structural_representation

STR.2 The structural representation shall be provided. This shall contain only textual and not graphical information. When we enter more than one structural representation, the whole section is repeated (includes stereochemistry, optical activity etc) E.g. for an InChI code this field is populated with the InChI representation.

N/A Y Alphanumeric

4000

Structural_representation_attachment

STR.3 A copy of the structural representation shall be provided.

N .jpeg

Stereochemistry

STR.4.CV The stereochemistry of the substance shall be described based on a controlled vocabulary.

CV [Stereochemistry]

Y Text 250


EMA/721630/2011 Page 44/485



CV Reference

Mandatory

Type Field Length

Business Rules

Optical_activity

STR.5.CV The optical activity shall be described based on a controlled vocabulary. EXAMPLE: (+), (-), (+/-)

CV [optical activity]

Y CV 250

Molecular_formula

STR.6 The molecular formula shall be provided. The molecular formula shall be specified with all the characters in capital letters.

N/A N Text 2000

Isotope (0..n)

STR.ISO The isotope section The isotope shall be described in this section, where applicable.

N

Nuclide_id

ISO.1 The identifier for each nuclide shall be provided based on a controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV.

CV [Substance Name]

N alphanumeric

12


EMA/721630/2011 Page 45/485



CV Reference

Mandatory

Type Field Length

Business Rules

In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

Nuclide_name

ISO.2 The name for the nuclide shall be provided.

CV [Substance Name]

Y Text 4000

Substitution_type

ISO.3.CV The type of substitution shall be described using a controlled vocabulary. Substitution refers to the relationship between the nuclide and the rest of the substance EXAMPLE: specific; non-specific; unknown

CV [Substitution Type]

Y Text 250

Chemical (0..1)

SING.CHM The chemical substance section This section further defines the identifying characteristics of a chemical substance.

The section is mandatory if Substance_type_cv= Chemical


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CV Reference

Mandatory

Type Field Length

Business Rules

Stoichiometric

CHM.1 The stoichiometric characteristics shall be specified based on a controlled vocabulary.

Yes/ No

Y Boolean

Comment

CHM.2 Any comment can be provided in this field, if necessary.

N/A N 4000


CHM.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250


RS.3.CV The class of the reference source shall be specified based on a controlled vocabulary.

CV [Source

Y text 250


EMA/721630/2011 Page 47/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: Regulatory submission

Class]

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

non_stoichiometric (1..1)

CHM.NS This section provides the non-stoichiometric characteristics of the chemical substance.

N

This section is mandatory when Stochiometric value= no

Number_of_moieties

NS.1 The number of moieties specified shall be provided. Non-stoichiometric chemical substances shall have at least two moieties.

N/A

Y Numeric

4 The numeric value shall be always ≥ 2 The value is automatically calculated.


EMA/721630/2011 Page 48/485



CV Reference

Mandatory

Type Field Length

Business Rules

Each moiety shall be represented by a chemical structure.

Moiety (2..n)

NS.MOT The moiety section shall be provided. The moiety section serves for the description of both the moiety and the other fragment constituting the substance. EXAMPLE: Abacavir Sulphate Abacavir and sulfate shall be described separately based on this section characteristic.

Y The section is repeatable. The number of available section is = to the value given in Number_of_moieties.

Moiety_Role

MOT.1.CV The role of the moiety shall be described based on a controlled vocabulary. EXAMPLE: antigen, linker, conjugate

CV [Role]

Y text 250

Moiety_name

MOT.2 The name of the moiety shall be provided.

CV [Substance

Y Text 4000


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CV Reference

Mandatory

Type Field Length

Business Rules

If the substance name is not present in the Controlled Vocabulary, the moiety name shall be described as a free text.

Name]

Moiety_id

MOT.3 The unique identifier assigned to the substance representing the moiety based on controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N Alphanumeric

12

Amount_type

MOT.4.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250

amount

MOT.AMT The amount section N


EMA/721630/2011 Page 50/485



CV Reference

Mandatory

Type Field Length

Business Rules

(0..1) Quantity

Operator AMT.1.CV CV

[Quantity Operator]

N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

Low_limit_

AMT.7.CV The prefix of the lower limit unit of the substance shall be

CV

N alphanumer

250


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CV Reference

Mandatory

Type Field Length

Business Rules

denominator_unit_prefix

specified, where available.

[Unit Prefix] ic

High_limit_numerator_value


N Numeric

10




N alphanumeric

250


AMT.10.CV

The prefix of the higher limit unit of the substance shall be specified, where available.

CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV

The higher limit unit of the substance shall be specified, where available.


N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250


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CV Reference

Mandatory

Type Field Length

Business Rules

Average


N Numeric

10

Prefix AMT.15.CV

The prefix of the average unit of the substance shall be specified, where available.

CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV

The applicable unit for the average shall be specified based on a controlled vocabulary.


N alphanumeric

250

Non_numeric_value


N alphanumeric

250

Property (0..n)

NS.PROP The property section The characteristics of the property shall be described.

N

Property_type

PROP.1.CV The type of property shall be specified based on a controlled vocabulary. EXAMPLE: physical, chemical,

CV [Property Type]

Y Text 250


EMA/721630/2011 Page 53/485



CV Reference

Mandatory

Type Field Length

Business Rules

enzymatic, immunological

Property_name

PROP.2.CV The name of property shall be specified based on a Controlled Vocabulary.

CV [Parameter]

Y Text 250

Substance_id

PROP.3 The identifier of the substance related to a defining property shall be described where applicable and based on controlled vocabulary. EXAMPLE: solubility in Water, Water ID shall be specified NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N Alphanumeric

12

Substance_name

PROP.4 The name of the substance related to a defining property

CV

N Text 4000


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CV Reference

Mandatory

Type Field Length

Business Rules

shall be described where applicable. EXAMPLE: solubility in Water, Water shall be specified

[Substance Name]

Amount_type

PROP.5.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250

Amount (1..1)

PROP.AMT The amount section Y

Quantity Operator

AMT.1.CV CV [Quantity Operator]

N text 250



N Numeric

10




N alphanumeric

250

Low_limit_numer


CV

N alphanumer

250


EMA/721630/2011 Page 55/485



CV Reference

Mandatory

Type Field Length

Business Rules

ator_unit_prefix


[Unit Prefix] ic



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 56/485



CV Reference

Mandatory

Type Field Length

Business Rules



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value

AMT.17 The non numeric value shall be specified when a numeric value it is not applicable.

N alphanumeric

250


EMA/721630/2011 Page 57/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: Short, High (temperature)


EMA/721630/2011 Page 58/485

4.3.2. SSI for Proteins

For substances that can be classified as proteins, the following data elements shall be specified:



CV Reference

Mandatory

Type Field Length

Business Rules

substance

SUB

Language


CV [Language]

Y text 3 Note: ISO 639-2 is the alpha-3 code in Codes for the representation of names of languages-- Part 2. There are 21 languages that have alternative codes for bibliographic or terminology purposes. In those cases, each is listed separately and they are designated as "B" (bibliographic) or "T" (terminology). For the purpose of describing “Language”, “T” shall be used. In all other cases there is only one ISO 639-2 code. Multiple codes assigned to the same


EMA/721630/2011 Page 59/485



CV Reference

Mandatory

Type Field Length

Business Rules

language are to be considered synonyms.

Substance_id


CV [Substance Name]

N Alphanumeric

12


COM.2.CV Type of substance based on a controlled vocabulary. EXAMPLE: Single, Mixture


Y Text 250


COM.SNM The substance name section This section contains the set of elements for the description of

Y


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CV Reference

Mandatory

Type Field Length

Business Rules

the name of the substance. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

Substance_name


Y Text 4000

Substance_name_type



Y text 250

Language

SNM.3.CV The language used to provide the structure substance information shall be specified according to ISO 639-2 alpha-3 codes. EXAMPLE: eng – English deu (T) - German

CV [Language]



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CV Reference

Mandatory

Type Field Length

Business Rules




Official_name_type

ON.1.CV The type of the official name shall be specified based on a controlled vocabulary. EXAMPLE: INN

CV [Source]

Y text 250


ON.2.CV The status of the official name shall be specified based on a controlled vocabulary. EXAMPLE: current, proposed

CV [Status]

Y text 250


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CV Reference

Mandatory

Type Field Length

Business Rules




N alphanumeric





DOM.1.CV The domain of the name shall be provided based on a controlled vocabulary. EXAMPLE: Human Pharmaceutical

CV [Domain]

Y Text 250



Y If “Official Name” has been specified in “Substance Name Type” this section is mandatory. Each “Official Name” shall have


EMA/721630/2011 Page 63/485



CV Reference

Mandatory

Type Field Length

Business Rules

at least one “Official Name Jurisdiction”.



CV [Country Code]

Y Text 3


SNM.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean

Referenc RS.2.CV The type of the reference CV Y text 250


EMA/721630/2011 Page 64/485



CV Reference

Mandatory

Type Field Length

Business Rules

e_source_type

source shall be specified based on a controlled vocabulary. EXAMPLE: INN

[Source]



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

substance_code

COM.SC The substance code section This section describes the specific code(s) within one or

N


EMA/721630/2011 Page 65/485



CV Reference

Mandatory

Type Field Length

Business Rules

(0..n) more available code system(s) that apply to a substance.


N/A Y alphanumeric

500

Code_system


CV [Code System]

Y

Text 250

Code_system_id


CV [Code System]

N alphanumeric

12

Code_system_status

SC.4.CV The status of the code system shall be specified based on a controlled vocabulary. EXAMPLE: current, proposed.

CV [Status]

Y text 250

Code_system_change_dat

SC.5 The change date of the code system shall be specified in line with the ISO 8601 date format,


N alphanumeric

10 This applies only when the code is changed, so it is not


EMA/721630/2011 Page 66/485



CV Reference

Mandatory

Type Field Length

Business Rules

e where applicable. EXAMPLE: 2011-06-01

applicable for initial submission. ISO 8601 advises numeric representation of dates and times on an internationally agreed basis. It represents elements from the largest to the smallest element: e.g. year-month-day YYYY-MM-DD

Comment


N Text 4000


SC.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean



EMA/721630/2011 Page 67/485



CV Reference

Mandatory

Type Field Length

Business Rules

e_source_type


[Source]



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

version (1..n)

COM.VER The version section This section shall provide information on the version of

Y Where no “Version Number” and “Effective Date” have been assigned by an authority


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CV Reference

Mandatory

Type Field Length

Business Rules

the substance. source, the version number shall be set as 0 with the date set as the date of initial submission of the substance.

Version_number


N/A Y numeric

4

Effective_date



N alphanumeric


Change_made

VER.3 The description of the updates or changes of the SSI shall be specified. The field will be left empty when first insert of substance.

N/A

N text 4000


COM.RI The reference information section This section is used to provide details about:

Y


EMA/721630/2011 Page 69/485



CV Reference

Mandatory

Type Field Length

Business Rules

- substance classification - target - gene from which proteins are derived - substance relationship

Comment


N Text 4000





CV [Domain]

Y text 250






EMA/721630/2011 Page 70/485



CV Reference

Mandatory

Type Field Length

Business Rules


SCLF.3.CV The type of the substance shall be provided based on a controlled vocabulary. NOTE: When Substance_Classification=mixture and the substances that are forming the mixture are of the same class, the class of those substances shall be specified in this field. EXAMPLE: two chemicals forming the mixture, specified_classification_type = chemical If the substances that are forming the mixture are of a different class, the value ‘mixture’ shall be specified in this field. EXAMPLE: One polymer combined in a protein, Specified_classification_type =mixture



Substance_classification_c

SCLF.4 The code of the classification type where applicable shall be specified based on a controlled

N alphanumeric

250


EMA/721630/2011 Page 71/485



CV Reference

Mandatory

Type Field Length

Business Rules

ode vocabulary.

subtype (1..n)





Y Text 250



Y

Public_domain


Yes /No

Y Boolean


RS.2.CV The type of the reference source shall be specified based on a controlled vocabulary.

CV [Source]

Y text 250


EMA/721630/2011 Page 72/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: INN



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500



N


EMA/721630/2011 Page 73/485



CV Reference

Mandatory

Type Field Length

Business Rules

Relationship



Y Text 250

Interaction_type



N Text 250

Substance_id

REL.3 The substance identifier, for which the relationship is specified, shall be described. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 74/485



CV Reference

Mandatory

Type Field Length

Business Rules

“Substance ID” e. g. for the initial submission of the substance this data element is not required.

Substance_name


CV [Substance Name]


Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10



CV [Unit of

N alphanumeric

250


EMA/721630/2011 Page 75/485



CV Reference

Mandatory

Type Field Length

Business Rules

Measure]



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


EMA/721630/2011 Page 76/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250


EMA/721630/2011 Page 77/485



CV Reference

Mandatory

Type Field Length

Business Rules

Non_numeric_value


N alphanumeric

250



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250

Reference_source

RS.3.CV The class of the reference source shall be specified based

CV

Y text 250


EMA/721630/2011 Page 78/485



CV Reference

Mandatory

Type Field Length

Business Rules

_class on a controlled vocabulary. EXAMPLE: Regulatory submission

[Source Class]

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

gene (0..n)

RI.GN The gene section This section shall provide a description of the gene in relation to a substance, where applicable. The gene section refers only to gene that is the origin of the substance (protein).

N This section does not apply when Substance_classification_type is equal to chemical, Specified Substance Group 1, Specified Substance Group 2 and Specified substance group 3.


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CV Reference

Mandatory

Type Field Length

Business Rules



CV [Organism Name]

N Text 4000


CV [Gene Name]

N alphanumeric

12

Gene_name


CV [Gene Name]

Y Text 4000


GN.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y


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CV Reference

Mandatory

Type Field Length

Business Rules

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500


EMA/721630/2011 Page 81/485



CV Reference

Mandatory

Type Field Length

Business Rules

Encycl. 3: 429 (1792)

Gene_element (0..n)


Gene_element_type



Y Text 250

Gene_element_id

GE.2 The unique identifier for the gene element shall be specified based on a controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N Alphanumeric

12


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CV Reference

Mandatory

Type Field Length

Business Rules

Gene_element_name


CV [Substance Name]

Y Text 4000



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


EMA/721630/2011 Page 83/485



CV Reference

Mandatory

Type Field Length

Business Rules


Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Target (0..n)

RI.TRG The target section This section shall provide information on the target substance. It refers for genes to the target of the protein expressed by that gene. For all the other substances type it refers to the substrate of the substance.

N This section does not apply when Substance_classification_type is equal to Specified Substance Group 1, Specified Substance Group 2 and Specified substance group 3.


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CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: enzyme, protein/channel, receptor

Target_gene_id


CV [Target Gene]

N

alphanumeric

12

Target_gene_name


CV [Target Gene]

Y Text 4000

Interaction_type



Y text 250

Target_organism_type

TRG.4.CV The type of target organism shall be specified based on a controlled vocabulary. EXAMPLE: human, viral

CV [Organism type]

N Text 250

Target_type

TRG.5.CV The target type shall be specified based on a controlled vocabulary.

CV [Target type]

N Text 250


EMA/721630/2011 Page 85/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: enzyme, receptor, membrane



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


EMA/721630/2011 Page 86/485



CV Reference

Mandatory

Type Field Length

Business Rules

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Structure (0..n)



Structural_representation_type

STR.1.CV The type of the structural representation shall be described based on a controlled vocabulary. EXAMPLE: InChI, mol file

CV [Structural Representation Type]

Y Text 250


STR.2 The structural representation shall be provided. This shall contain only textual

N/A Y Alphanumeric

4000


EMA/721630/2011 Page 87/485



CV Reference

Mandatory

Type Field Length

Business Rules

and not graphical information. When we enter more than one structural representation, the whole section is repeated (includes stereochemistry, optical activity etc) E.g. for an InChI code this field is populated with the InChI representation.



N .jpeg

Stereochemistry



Y Text 250

Optical_activity



Y CV 250

Molecula STR.6 The molecular formula shall be N/A N Text 2000


EMA/721630/2011 Page 88/485



CV Reference

Mandatory

Type Field Length

Business Rules

r_formula

provided. The molecular formula shall be specified with all the characters in capital letters.

Isotope (0..n)


N

Nuclide_id

ISO.1 The identifier for each nuclide shall be provided based on a controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N alphanumeric

12

Nuclide_ ISO.2 The name for the nuclide shall CV Y Text 4000


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CV Reference

Mandatory

Type Field Length

Business Rules

name be provided.

[Substance Name]

Substitution_type



Y Text 250

Protein (0..1)

SING.PRO The protein section The identifying characteristics of the protein shall be specified in this section.

The section is mandatory if Substance_type_cv= Protein

Sequence_type

PRO.1.CV The type of the protein sequence shall be specified based on a controlled vocabulary. EXAMPLE: complete; Partial protein descriptive elements will only be used

CV [Sequence Type]

Y Text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

when a complete or partial amino acid sequence is available or derivable from a nucleic acid sequence.

Number_of_subunits

PRO.2 The number of subunit constituting the protein shall be described. NOTE: If not specified in the reference source, the assumption is that there is 1 subunit.

N/A Y Numeric

4 The value is automatically calculated.

Disulfide_linkage

PRO.3 The position of the disulfide bonds in the protein shall be described. Each disulfidelinkage shall be specified followed by a comma and space (not-repeatable field). The position of the disulfide bonds in the protein shall be described in increasing order of subunit number and position within subunit followed by the abbreviation of the aminoacids involved.

N/A Y Alphanumeric

2500


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CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: - “Cys1_10-Cys2_16” refers to a disulfide linkage between the residue of cysteine in the position 10 and 16 respectively of the first and second subunit. If disulfide linkage are not present, the value N/A shall be specified.

Comment

PRO.4 Any comment can be provided in this field, if necessary.

N/A N Text 4000

protein_subunit (1..n)

PRO.PSU The protein subunit section This section refers to the description of each constituting the protein. The section is repeatable for each diverse subunit of the protein.

Y

Subunit PSU.1 The numeric value that relates back to the subunit shall be specified in order of decreasing length.

N/A Y Numeric

4


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CV Reference

Mandatory

Type Field Length

Business Rules

Sequences of the same length will be ordered by molecular weight. Subunits that have identical sequences will be repeated and have sequential subscripts. EXAMPLE: 1,2,3,..

Sequence

PSU.2 Sequences shall be described using the standard single letter amino acid code. Transcribed proteins will always be described using the translated sequence.

N/A Y Text 4000

Length PSU.3 The number of amino acid residues linked through peptide bonds shall be specified.

N/A Y Alphanumeric

100

N_terminal_modification

PSU.4.CV The modification at the n-terminal of the protein shall be provided based on a controlled vocabulary.

CV [Modification]

Y Text 250

N_terminal_modification_id

PSU.5 The unique identifier assigned to the modification at the N-

CV [Modification]

N Alphanumeric

12 If N_terminal_modification value is not equal to unknown or not applicable, the


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CV Reference

Mandatory

Type Field Length

Business Rules

terminal of the protein based on a Controlled vocabulary.

N_terminal_modification_id field is mandatory.

C_terminal_modification

PSU.6.CV The modification at the c-terminal of the protein shall be provided based on a controlled vocabulary.

CV [Modification]

Y Text 250

C_terminal_modification_id

PSU.7 The unique identifier assigned to the modification at the C-terminal of the protein based on a Controlled vocabulary.

CV [Modification]

N Alphanumeric

12 If C_terminal_modification value is not equal to unknown or not applicable, the C_terminal_modification_id field is mandatory.

Glycosylation (0..n)

PRO.GLY The glycosilation section Details on the glycosilation shall be provided. The section is repeatable to allow the description of each glycosilation present in a protein.

N This section applies if the protein is glycosylated. The value of Glycosylation_type cannot be null. In case of no glycosilation the user must specify the value= Not applicable from the [Glycosylation Type] CV.

Glycosylation_type

GLY.1.CV The type of the glycosilation shall be specified based on a controlled vocabulary. EXAMPLE: human

CV [Glycosylation Type]

Y Text 250

N_glycos GLY.3 The site of n-glycosylation shall N/A N Alpha 4000 If Glycosylation_type = Not


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CV Reference

Mandatory

Type Field Length

Business Rules

ylation be described according to the protein sequence. The extent and type of the modification at a given site is not captured. The convention to be used is as follow: “3 Aminoacid code letter+subunit number”_”position of aminoacid” EXAMPLE: asparagine “Asn1_34”

numeric

applicable, this field is not applicable.

O_glycosylation

GLY.4 The site of the o-glycosylation shall be described. The convention to be used is as follow: “3 Aminoacid code letter+subunit number”_”position of aminoacid” EXAMPLE: serine “Ser2_34”

N/A N Alphanumeric

4000 If Glycosylation_type = Not applicable, this field is not applicable.

C_glycosylation

GLY.5 The site of the c-glycosylation shall be described.

N/A N Alphanumeric



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CV Reference

Mandatory

Type Field Length

Business Rules

The convention to be used is as follow: “3 Aminoacid code letter+subunit number”_”position of aminoacid” EXAMPLE: tryptophan “Trp2_45”

Modification (0..n)

PRO.MOD The modification section The modification details shall be specified.

N This section apply to: -Nucleic Acid -Protein -Polymer -Structurally Diverse Substances -Mixture This section shall be repeatable to describe each modification occurred on each residue modified.

Modification_type

MOD.1.CV The type of the modification shall be provided based on a controlled vocabulary. EXAMPLE: Structural

CV [Modification Type]

Y Text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

Residue_modified

MOD.2.CV The name of the residue modified shall be described based on controlled vocabulary. NOTE: For virus or bacteria the value residue modified is = not applicable;

CV [Nucleotide Bases] OR [Aminoacid] OR [Substance Name]

Y Text 4000 If Substance_classification_type= protein, the CV [Amino acid] applies; If Substance_classification_type= nucleic acid, the CV [Nucleotide Bases] applies; If Substance_classification_type= polymer, the CV [Substance Name] applies. If Substance_classification_type= Structurally Diverse Substance or Mixture, the value residue modified is= not applicable

Residue_site

MOD.3 The position of specific residue undergone to modifications shall be described. Each residue shall be specified followed by a comma and space.

N Text 2000


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CV Reference

Mandatory

Type Field Length

Business Rules

For protein and nucleic acid, the number of the subunit followed by the number of the residue modified shall be specified. The underscore “_” shall be used as separator. EXAMPLE: 1_10 refers to the 10th residue on the 1st subunit Or A1_10

physical_modification (0..n)

MOD.PM The physical modification section

N This section shall only apply if Modification_type= Physical

Role PM.1.CV The role of the physical modification shall be provided based on a controlled vocabulary. EXAMPLE: inactivation, activation

CV [Modification]

Y Text 250

Number_of_para

PM.2 The number of parameter that is going to be described as

No N Numeric



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CV Reference

Mandatory

Type Field Length

Business Rules

meters result of the modification shall be provided.

Parameter (0..n)

PM.PARA The parameter section N The repeatability of this section is strictly related to the Value of the “Number_of_ Parameter” field. The section shall be repeated as many time as specified in the ‘number_of_parameters’ field.

Parameter

PARA.1.CV The parameter shall be described based on controlled vocabulary. EXAMPLE: time, temperature, pressure

CV [Parameter]

Y Text 250

Amount_type

PARA.2.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250

amount (0..1)

PARA.AMT The amount section N

Quantity Operator

AMT.1.CV CV [Quantity

N text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

Operator]



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

High_lim AMT.8 The higher limit value of the N Nume 10


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CV Reference

Mandatory

Type Field Length

Business Rules

it_numerator_value


ric




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


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CV Reference

Mandatory

Type Field Length

Business Rules

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

structural_modification (0..n)

MOD.SM The structural modification section

N This section shall apply if Modification_type= Structural This section is repeatable.

Structural_modification_type

SM.1.CV The type of the structural modification shall be described based on a controlled vocabulary

CV [Modification]

Y Text 250

Moiety (0..n)

SM.MOT The moiety section This section describes the

N


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CV Reference

Mandatory

Type Field Length

Business Rules

moiety affected by the modification where applicable.

Moiety_Role


CV [Role]

Y text 250

Moiety_name

MOT.2 The name of the moiety shall be provided. If the substance name is not present in the Controlled Vocabulary, the moiety name shall be described as a free text.

CV [Substance Name]

Y Text 4000

Moiety_id

MOT.3 The unique identifier assigned to the substance representing the moiety based on controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV.

CV [Substance Name]

N Alphanumeric

12


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CV Reference

Mandatory

Type Field Length

Business Rules

In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250

Low_limit_numer


CV

N alphanumer

250


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CV Reference

Mandatory

Type Field Length

Business Rules

ator_unit_prefix


[Unit Prefix] ic



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250


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CV Reference

Mandatory

Type Field Length

Business Rules



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


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CV Reference

Mandatory

Type Field Length

Business Rules


molecular_fragment (0..n)

SM.MFRAG The molecular fragment section. This section describes the molecular fragment affected by the modification where applicable.

N

Role MFRAG.1.CV

The role of the molecular fragment shall be described based on a controlled vocabulary.

CV [Role]

Y Text 250

Molecular_fragment_id

MFRAG.2 The unique identifier for molecular fragment shall be provided.

CV [Substance Name]

N Alphanumeric

12

Molecular_fragment_name

MFRAG.3 The name for molecular fragment shall be specified.

CV [Substance Name]

Y Text 4000

Amount_type

MFRAG.4.CV

The type of the amount of the substance shall be specified

CV

N Text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

using a controlled vocabulary.

[Amount Type]

amount (0..1)

MFRAG.AMT

The amount section N

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10

Low_limit_ denomin


CV [Unit of

N alphanumeric

250


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CV Reference

Mandatory

Type Field Length

Business Rules

ator _unit

Measure]



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


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CV Reference

Mandatory

Type Field Length

Business Rules


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

agent_modification (0..n)

MOD.AM The modification agent section. This section described the agent that caused the modification.

N


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CV Reference

Mandatory

Type Field Length

Business Rules

Agent_modification_type

AM.1.CV The type of the agent used for the modification shall be specified based on a controlled vocabulary. EXAMPLE: chemical, enzymatic

CV [Agent Modification Type]

Y text 250

Role AM.2.CV The role of the modification agent shall be specified based on a controlled vocabulary.

CV [Modification]

Y Text 250

Modification_agent

AM.3 The name of modifying agent shall be specified based on a controlled vocabulary.

CV [Substance Name]

Y Text 4000

Modification_agent_id

AM.4 The unique identifier of modifying agent shall be provided. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the

CV [Substance Name]

N Alphanumeric

12


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CV Reference

Mandatory

Type Field Length

Business Rules

initial submission of the substance this data element is not required.

Modification_process

AM.5.CV The modification process shall be specified based on a controlled vocabulary. EXAMPLE: UV irradiation

CV [Modification Process]

N Text

250

Amount_type

AM.6.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250

amount (0..1)

AM.AMT The amount section N

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250


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CV Reference

Mandatory

Type Field Length

Business Rules



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

High_lim AMT.10.C The prefix of the higher limit CV N alpha 250


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CV Reference

Mandatory

Type Field Length

Business Rules

it_numerator_unit_prefix

V unit of the substance shall be specified, where available.

[Unit Prefix]

numeric



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250


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CV Reference

Mandatory

Type Field Length

Business Rules

Non_numeric_value


N alphanumeric

250

molecular_weight (0..n)

PRO.MWT The molecular weight section N The section is mandatory if Substance_classification_type= protein, polymer or nucleic acid

Molecular_weight_method

MWT.1.CV The method used to measure the molecular weight shall be specified based on a controlled vocabulary. EXAMPLE: sds_page

CV [Method of Measure]

Y text 250

Molecular_weight_type

MWT.2.CV The type of the molecular weight shall be specified based on a controlled vocabulary.

CV [Molecular Weight Type]

Y Text 250

Amount_type

MWT.3.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250

Amount

MW.AMT The amount section Y


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CV Reference

Mandatory

Type Field Length

Business Rules

(1..1) Quantity


[Quantity Operator]

N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

Low_limit_


CV

N alphanumer

250


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CV Reference

Mandatory

Type Field Length

Business Rules



[Unit Prefix] ic



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250


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CV Reference

Mandatory

Type Field Length

Business Rules

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

Property (0..n)

PRO.PROP The property section The characteristics of the property shall be described.

N

Property_type

PROP.1.CV

The type of property shall be specified based on a controlled vocabulary. EXAMPLE: physical, chemical,

CV [Property Type]

Y Text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

enzymatic, immunological

Property_name

PROP.2.CV

The name of property shall be specified based on a Controlled Vocabulary.

CV [Parameter]

Y Text 250

Substance_id


CV [Substance Name]

N Alphanumeric

12

Substance_name

PROP.4 The name of the substance related to a defining property

CV

N Text 4000


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CV Reference

Mandatory

Type Field Length

Business Rules

shall be described where applicable. EXAMPLE: solubility in Water, Water shall be specified

[Substance Name]

Amount_type

PROP.5.CV

The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250

amount (1..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250


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CV Reference

Mandatory

Type Field Length

Business Rules

_prefix



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



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CV Reference

Mandatory

Type Field Length

Business Rules

t_denominator_value


ric


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


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CV Reference

Mandatory

Type Field Length

Business Rules



PRO.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


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CV Reference

Mandatory

Type Field Length

Business Rules

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

4.3.3. SSI for nucleic acids

For substances, which can be classified as nucleic acid the SSI the following data elements shall be specified:



CV Reference Mandatory

Type Field Length

Business Rules


EMA/721630/2011 Page 124/485




Type Field Length

Business Rules

substance

SUB

Language


CV [Language]

Y text 3 Note: ISO 639-2 is the alpha-3 code in Codes for the representation of names of languages-- Part 2. There are 21 languages that have alternative codes for bibliographic or terminology purposes. In those cases, each is listed separately and they are designated as "B" (bibliographic) or "T" (terminology). For the purpose of describing “Language”, “T” shall be used. In all other cases there is only one ISO 639-2 code. Multiple codes assigned to the same language are to be considered synonyms.

Substance_id

COM.1 The substance identifier shall be described based on a controlled vocabulary.

CV [Substance Name]

N Alphanumeric

12


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Type Field Length

Business Rules





Y Text 250



Y

Substance_name


Y Text 4000


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Type Field Length

Business Rules

Substance_name_type



Y text 250

Language SNM.3.CV The language used to provide the structure substance information shall be specified according to ISO 639-2 alpha-3 codes. EXAMPLE: eng – English deu (T) - German

CV [Language]



SNM.ON The official name section N If “Official Name” has been specified in “Substance_Name_Type” this section is mandatory.


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Type Field Length

Business Rules

For any other name type, the section is present as not mandatory.

Official_name_type


CV [Source]

Y text 250


ON.2.CV The status of the code system shall be specified based on a controlled vocabulary. EXAMPLE: current, proposed.

CV [Status]

Y text 250




N alphanumeric



ON.DOM Y If “Official Name” has been specified in “Substance Name Type” this section is mandatory. Each “Official Name” shall have


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Type Field Length

Business Rules

at least one “Official Name Domain”.



CV [Domain]

Y Text 250






CV [Country Code]

Y Text 3

reference_source

SNM.RS The reference source section This section describes the

Y


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Type Field Length

Business Rules

(1..n)

reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


RS.5 The textual description of the reference source within the literature or regulatory document shall be described.

N/A N text 2500


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Type Field Length

Business Rules

EXAMPLE: Ph.E. 7.1, p.34 Literature reference: Encycl. 3: 429 (1792)



N


N/A Y alphanumeric

500

Code_system


CV [Code System]

Y

Text 250

Code_system_id


CV [Code System]

N alphanumeric

12

Code_system_stat

SC.4.CV The status of the code system shall be specified based on a

CV

Y text 250


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Type Field Length

Business Rules

us controlled vocabulary. EXAMPLE: current, proposed.

[Status]




N alphanumeric


Comment SC.6 Any comment can be provided in this field, if necessary.

N Text 4000



Y

Public_domain

RS.1 It shall be specified if the reference source information is

Yes /No

Y Boolean


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Type Field Length

Business Rules

public or not. Yes or No values apply.



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

version

COM.VER The version section

Y Where no “Version Number”


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Type Field Length

Business Rules

(1..n) This section shall provide information on the version of the substance.

and “Effective Date” have been assigned by an authority source, the version number shall be set as 0 with the date set as the date of initial submission of the substance.

Version_number


N/A Y numeric

4

Effective_date



N alphanumeric


Change_made


N/A

N text 4000


COM.RI The reference information section This section is used to provide details about: - substance classification

Y


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Type Field Length

Business Rules

- target - gene from which proteins are derived - substance relationship

Comment RI.1 Any comment can be provided in this field, if necessary.

N Text 4000





CV [Domain]

Y text 250





Substance_classification_ty

SCLF.3.CV The type of the substance shall be provided based on a controlled vocabulary.

CV [Substance Type]

Y Text 250 When Substance_Classification= Single or mixture, the


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Type Field Length

Business Rules

pe NOTE: When Substance_Classification=mixture and the substances that are forming the mixture are of the same class, the class of those substances shall be specified in this field. EXAMPLE: two chemicals forming the mixture, specified_classification_type = chemical If the substances that are forming the mixture are of a different class, the value ‘mixture’ shall be specified in this field. EXAMPLE: One polymer combined in a protein, Specified_classification_type =mixture

[Specified substance Type]

[Substance Type] CV applies. When Substance_Classification=Specified substance the [Specified Substance Type] CV applies.



N alphanumeric

250

subtype (1..n)



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Type Field Length

Business Rules




Y Text 250



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


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Type Field Length

Business Rules

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500



N

Relationship



Y Text 250


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Type Field Length

Business Rules

Interaction_type



N Text 250

Substance_id

REL.3 The substance identifier, for which the relationship is specified, shall be described. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N Alphanumeric

12

Substance_name


CV [Substance Name]


Amount_type


CV [Amount Type]

N Text 250


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Type Field Length

Business Rules

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

Low_limit_


CV

N alphanume

250


EMA/721630/2011 Page 140/485




Type Field Length

Business Rules



[Unit Prefix] ric



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


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Type Field Length

Business Rules

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250


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Type Field Length

Business Rules

EXAMPLE: INN



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

gene (0..n)

RI.GN The gene section This section shall provide a description of the gene in relation to a substance, where applicable. The gene section refers only to gene that is the origin of the



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Type Field Length

Business Rules

substance (protein).



CV [Organism Name]

N Text 4000


CV [Gene Name]

N alphanumeric

12

Gene_name


CV [Gene Name]

Y Text 4000



Y


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Type Field Length

Business Rules

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500


EMA/721630/2011 Page 145/485




Type Field Length

Business Rules

Gene_element (0..n)


Gene_element_type



Y Text 250

Gene_element_id


CV [Substance Name]

N Alphanumeric

12

Gene_element_name


CV [Substance Name]

Y Text 4000


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Type Field Length

Business Rules



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


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Type Field Length

Business Rules



N/A N text 2500

Target (0..n)

RI.TRG The target section This section shall provide information on the target substance. It refers for genes to the target of the protein expressed by that gene. For all the other substances type it refers to the substrate of the substance. EXAMPLE: enzyme, protein/channel, receptor


Target_gene_id


CV [Target Gene]

N alphanumeric

12

Target_gene_nam

TRG.2 The target gene name shall be specified based on a controlled

CV

Y Text 4000


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Type Field Length

Business Rules

e vocabulary. EXAMPLE: single substance, an enzyme type

[Target Gene]

Interaction_type



Y text 250



CV [Organism type]

N Text 250

Target_type


CV [Target type]

N Text 250



Y

Public_domain

RS.1 It shall be specified if the reference source information is

Yes /No

Y Boolean


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Type Field Length

Business Rules

public or not. Yes or No values apply.



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Structure

SING.STR The structure section

N The structure section is mandatory when


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Type Field Length

Business Rules

(0..n) The structure of the substance shall be described, where applicable

Substance_classification_type= chemical, protein, polymer and nucleic acid.


STR.1.CV The type of the structural representation shall be described based on a controlled vocabulary. EXAMPLE: InChI , mol file


Y Text 250



N/A Y Alphanumeric

4000



N .jpeg


EMA/721630/2011 Page 151/485




Type Field Length

Business Rules

Stereochemistry



Y Text 250

Optical_activity



Y CV 250

Molecular_formula


N/A N Text 2000

Isotope (0..n)


N

Nuclide_id

ISO.1 The identifier for each nuclide shall be provided based on a controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the

CV [Substance Name]

N alphanumeric

12


EMA/721630/2011 Page 152/485




Type Field Length

Business Rules

Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

Nuclide_name


CV [Substance Name]

Y Text 4000

Substitution_type



Y Text 250

nucleic_acid (0..1)

SING.NA This section provides a description of the identifying characteristics of a nucleic acid.

The section is mandatory if Substance_type_cv= Nucleic Acid

Sequence_type

NA.1.CV The type of the sequence shall be specified based on a controlled vocabulary.

CV [Sequence Type]

Y Text 250


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Type Field Length

Business Rules

NOTE: complete, partial protein descriptive elements will only be used when a complete or partial amino acid sequence is available or derivable from a nucleic acid sequence.

Number_of_subunits

NA.2 The number of linear sequences of nucleotides linked through phosphodiesteric bonds shall be described. NOTE: If not specified in the reference source, the assumption is that there is 1 subunit.

N/A Y Numeric


Area_of_hybridisation

NA.3.CV The area of hydbridization shall be described if applicable. The number associated with the subunit followed by the number associated to the residue shall be specified in increasing order. The underscore “_” shall be used as separator as follow: “Subunit_number Residue”. EXAMPLE: 1_10 refers to the 10th residue on the 1st subunit

N/A N alphanumeric

250


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Type Field Length

Business Rules

Or A1_10, A1_11 Each residue shall be specified followed by a comma and space.

Comment NA.4 Any comment can be provided in this field, if necessary.

N Text 4000

nucleic_acid_subunit (1..n)

NA.NASU The nucleic acid subunit This section describes the nucleic acid subunits.

Y This section is repeatable for each subunit.

Subunit NASU.1 The numeric value that relates back to subunit shall be specified in order of decreasing length. Sequences of the same length will be ordered by molecular weight. Subunits that have identical sequences will be repeated and have sequential subscripts. EXAMPLE: 1,2,3,..

N/A Y Numeric

4

Sequence NASU.2 The nucleotide sequence shall be specified.

N/A Y Alphanumeric

4000


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Type Field Length

Business Rules

Length NASU.3 The number of nucleotide residues linked through phosphate esters shall be specified.

N/A N Alphanumeric

100

Five_prime

NASU.4.CV

The nucleotide present at the 5’ terminal shall be specified based on a controlled vocabulary. NOTE: If not specified in the available reference source this value shall be derived from the nucleic acid sequence.

CV: [Nucleotide Bases]

Y Text 250

Three_prime

NASU.5.CV

The nucleotide present at the 3’ terminal shall be specified based on a controlled vocabulary. NOTE: If not specified in the available reference source this value shall be derived from the nucleic acid sequence.

CV [Nucleotide Bases]

Y Text 250

Modification (0..n)

NA.MOD The modification section The modification details shall be specified.

N This section apply to: -Nucleic Acid -Protein -Polymer -Structurally Diverse Substances -Mixture


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Type Field Length

Business Rules

This section shall be repeatable to describe each modification occurred on each residue modified.

Modification_type



Y Text 250

Residue_modified



Y Text 4000 If Substance_classification_type= protein, the CV [Amino acid] applies; If Substance_classification_type= nucleic acid, the CV [Nucleotide Bases] applies; If Substance_classification_type= polymer, the CV [Substance Name] applies. If Substance_classification_type= Structurally Diverse Substance or Mixture, the value residue


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Type Field Length

Business Rules

modified is= not applicable

Residue_site

MOD.3 The position of specific residue undergone to modifications shall be described. Each residue shall be specified followed by a comma and space. For protein and nucleic acid, the number of the subunit followed by the number of the residue modified shall be specified. The underscore “_” shall be used as separator. EXAMPLE: 1_10 refers to the 10th residue on the 1st subunit Or A1_10

N Text 2000


MOD.PM The physical modification section N This section shall only apply if Modification_type= Physical

Role PM.1.CV The role of the physical modification shall be provided based on a controlled

CV [Modification]

Y Text 250


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Type Field Length

Business Rules

vocabulary. EXAMPLE: inactivation, activation

Number_of_parameters

PM.2 The number of parameter that is going to be described as result of the modification shall be provided.

No N Numeric


Parameter (0..n)


Parameter

PARA.1.CV

The parameter shall be described based on controlled vocabulary. EXAMPLE: time, temperature, pressure

CV [Parameter]

Y Text 250

Amount_type

PARA.2.CV


CV [Amount Type]

N Text 250

amount



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Type Field Length

Business Rules

(0..1) Quantity


[Quantity Operator]

N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



EMA/721630/2011 Page 160/485




Type Field Length

Business Rules

t_numerator_value


ric




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 161/485




Type Field Length

Business Rules

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250






CV [Modification]

Y Text 250

Moiety (0..n)

SM.MOT The moiety section This section describes the moiety affected by the modification where applicable.

N

Moiety_Role

MOT.1.CV The role of the moiety shall be described based on a controlled vocabulary. EXAMPLE: antigen, linker,

CV [Role]

Y text 250


EMA/721630/2011 Page 162/485




Type Field Length

Business Rules

conjugate

Moiety_name


CV [Substance Name]

Y Text 4000

Moiety_id MOT.3 The unique identifier assigned to the substance representing the moiety based on controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N Alphanumeric

12

Amount_type


CV [Amount Type]

N Text 250


EMA/721630/2011 Page 163/485




Type Field Length

Business Rules

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

Low_limit_ denominator_unit_


CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 164/485




Type Field Length

Business Rules

prefix



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV

The prefix of the average unit of the substance shall be specified,

CV

N alphanumeric

250


EMA/721630/2011 Page 165/485




Type Field Length

Business Rules

where available.

[Unit Prefix]

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


SM.MFRAG

The molecular fragment section. This section describes the molecular fragment affected by the modification where applicable.

N

Role MFRAG.1.CV


CV [Role]

Y Text 250


MFRAG.2 The unique identifier for molecular fragment shall be provided. NOTE: If a unique “Substance ID”

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 166/485




Type Field Length

Business Rules

(EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.



CV [Substance Name]

Y Text 4000

Amount_type

MFRAG.4.CV


CV [Amount Type]

N Text 250

amount (0..1)

MFRAG.AMT


Quantity Operator


N text 250



N Numeric

10


EMA/721630/2011 Page 167/485




Type Field Length

Business Rules




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

High_limit_numerator_unit_

AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 168/485




Type Field Length

Business Rules

prefix



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


EMA/721630/2011 Page 169/485




Type Field Length

Business Rules



N




Y text 250


CV [Modification]

Y Text 250

Modification_agent


CV [Substance Name]

Y Text 4000


AM.4 The unique identifier of modifying agent shall be provided. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 170/485




Type Field Length

Business Rules

Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.




N Text

250

Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10

Low_limit_numerat

AMT.3.CV The lower limit unit of the substance shall be specified,

CV

N alphanumeric

250


EMA/721630/2011 Page 171/485




Type Field Length

Business Rules

or_unit where available.

[Unit of Measure]



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250

High_limi AMT.11 The higher limit value of the N Numer 10


EMA/721630/2011 Page 172/485




Type Field Length

Business Rules

t_denominator_value


ic


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

Property NA.PROP The property section N


EMA/721630/2011 Page 173/485




Type Field Length

Business Rules

(0..n)

The characteristics of the property shall be described.

Property_type

PROP.1.CV

The type of property shall be specified based on a controlled vocabulary. EXAMPLE: physical, chemical, enzymatic, immunological

CV [Property Type]

Y Text 250

Property_name

PROP.2.CV


CV [Parameter]

Y Text 250

Substance_id


CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 174/485




Type Field Length

Business Rules

Substance_name

PROP.4 The name of the substance related to a defining property shall be described where applicable. EXAMPLE: solubility in Water, Water shall be specified

CV [Substance Name]

N Text 4000

Amount_type

PROP.5.CV


CV [Amount Type]

N Text 250

Amount (1..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 175/485




Type Field Length

Business Rules



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10

High_limit_

AMT.12.CV


CV

N alphanum

250


EMA/721630/2011 Page 176/485




Type Field Length

Business Rules

denominator _unit

[Unit of Measure]

eric


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


NA.MWT The molecular weight section N The section is mandatory if Substance_classification_type= protein, polymer or nucleic acid


MWT.1.CV The method used to measure the molecular weight shall be specified based on a controlled vocabulary.

CV [Method of

Y text 250


EMA/721630/2011 Page 177/485




Type Field Length

Business Rules

EXAMPLE: sds_page

Measure]




Y Text 250

Amount_type


CV [Amount Type]

N Text 250

Amount (1..1)

MWT.AMT The amount section Y

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250

Low_limit_numerat

AMT.4.CV The prefix of the lower limit unit of the substance shall be specified, where

CV

N alphanum

250


EMA/721630/2011 Page 178/485




Type Field Length

Business Rules

or_unit_prefix

available.

[Unit Prefix] eric



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


EMA/721630/2011 Page 179/485




Type Field Length

Business Rules


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


NA.RS The reference source section This section describes the reference source information.

Y


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Type Field Length

Business Rules

For each “Substance Name” a “Reference Source” shall be specified.

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500


EMA/721630/2011 Page 181/485




Type Field Length

Business Rules


EMA/721630/2011 Page 182/485

4.3.4. SSI for Polymers

For substances that can be classified as polymers, the following data elements shall be specified:



CV Reference

Mandatory

Type Field Length

Business Rules

substance SUB

Language


CV [Language]


Substance_id

COM.1 The substance identifier shall be described based on a controlled vocabulary. NOTE:

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 183/485



CV Reference

Mandatory

Type Field Length

Business Rules

If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.




Y Text 250



Y

Substance_name


Y Text 4000


EMA/721630/2011 Page 184/485



CV Reference

Mandatory

Type Field Length

Business Rules

Substance_name_type



Y text 250

Language


CV [Language]


official_name

SNM.ON The official name section N If “Official Name” has been specified in “Substance_Name_Type” this


EMA/721630/2011 Page 185/485



CV Reference

Mandatory

Type Field Length

Business Rules

(0..n) section is mandatory. For any other name type, the section is present as not mandatory.

Official_name_type


CV [Source]

Y text 250



CV [Status]

Y text 250




N alphanumeric



ON.DOM Y If “Official Name” has been specified in “Substance Name Type” this section is mandatory. Each “Official Name” shall have


EMA/721630/2011 Page 186/485



CV Reference

Mandatory

Type Field Length

Business Rules

at least one “Official Name Domain”.



CV [Domain]

Y Text 250






CV [Country Code]

Y Text 3


SNM.RS The reference source section This section describes the reference source information.

Y


EMA/721630/2011 Page 187/485



CV Reference

Mandatory

Type Field Length

Business Rules


Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500


EMA/721630/2011 Page 188/485



CV Reference

Mandatory

Type Field Length

Business Rules

Encycl. 3: 429 (1792)



N


N/A Y alphanumeric

500

Code_system


CV [Code System]

Y

Text 250

Code_system_id


CV [Code System]

N alphanumeric

12

Code_system_status


CV [Status]

Y text 250


EMA/721630/2011 Page 189/485



CV Reference

Mandatory

Type Field Length

Business Rules




N alphanumeric


Comment


N Text 4000



Y

Public_domain


Yes /No

Y Boolean


EMA/721630/2011 Page 190/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

version (1..n)


Y Where no “Version Number” and “Effective Date” have been assigned by an authority source, the version number


EMA/721630/2011 Page 191/485



CV Reference

Mandatory

Type Field Length

Business Rules

shall be set as 0 with the date set as the date of initial submission of the substance.

Version_number


N/A Y numeric

4

Effective_date



N alphanumeric


Change_made


N/A

N text 4000



Y


EMA/721630/2011 Page 192/485



CV Reference

Mandatory

Type Field Length

Business Rules

Comment


N Text 4000





CV [Domain]

Y text 250






SCLF.3.CV The type of the substance shall be provided based on a controlled vocabulary. NOTE: When Substance_Classification=mixture and the substances that are forming the mixture are of the same class, the class of those substances shall




EMA/721630/2011 Page 193/485



CV Reference

Mandatory

Type Field Length

Business Rules

be specified in this field. EXAMPLE: two chemicals forming the mixture, specified_classification_type = chemical If the substances that are forming the mixture are of a different class, the value ‘mixture’ shall be specified in this field. EXAMPLE: One polymer combined in a protein, Specified_classification_type =mixture



N alphanumeric

250

subtype (1..n)





Y Text 250

reference_source

SCLF.RS The reference source section

Y


EMA/721630/2011 Page 194/485



CV Reference

Mandatory

Type Field Length

Business Rules

(1..n)


Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


RS.5 The textual description of the reference source within the literature or regulatory document shall be described.

N/A N text 2500


EMA/721630/2011 Page 195/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: Ph.E. 7.1, p.34 Literature reference: Encycl. 3: 429 (1792)



N

Relationship



Y Text 250

Interaction_type



N Text 250

Substance_id

REL.3 The substance identifier, for which the relationship is specified, shall be described.

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 196/485



CV Reference

Mandatory

Type Field Length

Business Rules


Substance_name


CV [Substance Name]


Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250

Low_limit_numer

AMT.2 The lower limit value of the substance shall be specified, where

N Numeric

10


EMA/721630/2011 Page 197/485



CV Reference

Mandatory

Type Field Length

Business Rules

ator_value

available.




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10



CV [Unit of

N alphanumeric

250


EMA/721630/2011 Page 198/485



CV Reference

Mandatory

Type Field Length

Business Rules

Measure]



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250

Non_nu AMT.17 The non numeric value shall be N alpha 250


EMA/721630/2011 Page 199/485



CV Reference

Mandatory

Type Field Length

Business Rules

meric_value

specified when a numeric value it is not applicable. EXAMPLE: Short, High (temperature)

numeric



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


EMA/721630/2011 Page 200/485



CV Reference

Mandatory

Type Field Length

Business Rules

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

gene (0..n)





CV [Organism Name]

N Text 4000


EMA/721630/2011 Page 201/485



CV Reference

Mandatory

Type Field Length

Business Rules


CV [Gene Name]

N alphanumeric

12

Gene_name


CV [Gene Name]

Y Text 4000



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250

Reference_source

RS.3.CV The class of the reference source shall be specified based on a

CV

Y text 250


EMA/721630/2011 Page 202/485



CV Reference

Mandatory

Type Field Length

Business Rules

_class controlled vocabulary. EXAMPLE: Regulatory submission

[Source Class]

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Gene_element (0..n)


Gene_element_type



Y Text 250

Gene_element_id

GE.2 The unique identifier for the gene element shall be specified based on a controlled vocabulary.

CV [Substance

N Alphanumeric

12


EMA/721630/2011 Page 203/485



CV Reference

Mandatory

Type Field Length

Business Rules


Name]

Gene_element_name


CV [Substance Name]

Y Text 4000



Y

Public_domain


Yes /No

Y Boolean

Reference_source

RS.2.CV The type of the reference source shall be specified based on a

CV

Y text 250


EMA/721630/2011 Page 204/485



CV Reference

Mandatory

Type Field Length

Business Rules

_type controlled vocabulary. EXAMPLE: INN

[Source]



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Target (0..n)

RI.TRG The target section This section shall provide information on the target substance. It refers for genes to the target of the protein expressed by that gene. For all the other substances type it



EMA/721630/2011 Page 205/485



CV Reference

Mandatory

Type Field Length

Business Rules

refers to the substrate of the substance. EXAMPLE: enzyme, protein/channel, receptor

Target_gene_id


CV [Target Gene]

N alphanumeric

12

Target_gene_name


CV [Target Gene]

Y Text 4000

Interaction_type



Y text 250



CV [Organism type]

N Text 250

Target_type


CV [Target

N Text 250


EMA/721630/2011 Page 206/485



CV Reference

Mandatory

Type Field Length

Business Rules


type]



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12

Referenc RS.5 The textual description of the N/A N text 2500


EMA/721630/2011 Page 207/485



CV Reference

Mandatory

Type Field Length

Business Rules

e_source_citation

reference source within the literature or regulatory document shall be described. EXAMPLE: Ph.E. 7.1, p.34 Literature reference: Encycl. 3: 429 (1792)

Structure (0..n)






Y Text 250



N/A Y Alphanumeric

4000


EMA/721630/2011 Page 208/485



CV Reference

Mandatory

Type Field Length

Business Rules



N .jpeg

Stereochemistry



Y Text 250

Optical_activity



Y CV 250

Molecular_formula


N/A N Text 2000

Isotope (0..n)


N

Nuclide_id

ISO.1 The identifier for each nuclide shall be provided based on a controlled

CV

N alphanume

12


EMA/721630/2011 Page 209/485



CV Reference

Mandatory

Type Field Length

Business Rules

vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

[Substance Name]

ric

Nuclide_name


CV [Substance Name]

Y Text 4000

Substitution_type



Y Text 250

polymer (0..1)

SING.POLY The polymer section The characteristics the uniquely

N The section is mandatory if Substance_type_cv = polymer


EMA/721630/2011 Page 210/485



CV Reference

Mandatory

Type Field Length

Business Rules

define a polymer shall be specified in this section.

Polymer_class

POLY.1.CV The class of polymer shall be described based on a controlled vocabulary. EXAMPLE: homopolymer, copolymer

CV [Polymer Class]

Y Text 250

Polymer_geometry

POLY.2.CV The geometry of the polymer shall be described based on a controlled vocabulary. EXAMPLE: linear, branched, cross linked, network, dendritic, star, comb, brush

CV [Geometry]

Y Text 250

Copolymer_sequence_type

POLY.3.CV The type of copolymer of the polymer sequence shall be described based on a controlled vocabulary. EXAMPLE: random, alternating, block, graft, Statistical

CV [Copolymer Sequence Type]

Y Text 250

Comment

POLY.4 Any comment can be provided in this field, if necessary.

N/A N Text 4000

monomer_description

POLY.MDESC The description of the monomer section.

N


EMA/721630/2011 Page 211/485



CV Reference

Mandatory

Type Field Length

Business Rules

(0..n) Number_

of_monomers

MDESC.1 The number of diverse monomers that constitutes the polymer shall be specified.

N/A Y Numeric


monomer (0..n)

MDESC.MON The monomer section. This section is repeatable for each monomer of the polymer.

Y

Monomer_id

MON.1 The unique identifier assigned to the monomer based on controlled vocabulary.

CV [Substance Name]

N Alphanumeric

12 In the absence of a unique “Substance ID” e.g. for the initial submission of the substance this data element shall not be populated. If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified accordingly.

Monomer_name

MON.2.CV The name of the monomer shall be provided.

CV [Substance Name]

Y Text 4000

Amount_type

MON.3.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250


EMA/721630/2011 Page 212/485



CV Reference

Mandatory

Type Field Length

Business Rules

amount (0..1)

MON.AMT The amount section N

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

Low_limi AMT.7.CV The prefix of the lower limit unit of CV N alpha 250


EMA/721630/2011 Page 213/485



CV Reference

Mandatory

Type Field Length

Business Rules

t_ denominator_unit_prefix

the substance shall be specified, where available.

[Unit Prefix]

numeric



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average AMT.14 The average amount or single value N Nume 10


EMA/721630/2011 Page 214/485



CV Reference

Mandatory

Type Field Length

Business Rules

of the substance shall be specified.

ric


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

structural_repeat (0..n)

POLY.SR The structural repeat section N This section is mandatory if Number_of_monomers is >1

Number_of_structural_repeat_units

SR.1 The number of diverse repeated units represented in the structure of the polymer shall be specified. The number of time that the monomer is repeated in the polymer. EXAMPLE: PEG 40 is 40

N/A

Y Numeric



EMA/721630/2011 Page 215/485



CV Reference

Mandatory

Type Field Length

Business Rules

structural_repeat_unit (1..n)

SR.SRU Y

Orientation_of_polymerization

SRU.1.CV The orientation of the polymerization shall be described based on a controlled vocabulary. EXAMPLE: head-tail, head-head, random

CV [Orientation]

Y Text 250

Structural_repeat_unit

SRU.2 The letter that relates back to the structure of the unit shall be specified in order of decreasing molecular weight. EXAMPLE: a,b,c,...

N/A N Text 250

Amount_type

SRU.3.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250

amount (1..1)

SRU.AMT The amount section N

Quantity Operator


N text 10


EMA/721630/2011 Page 216/485



CV Reference

Mandatory

Type Field Length

Business Rules



N Numeric

250




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

High_limi AMT.9.CV The higher limit unit of the CV N alpha 250


EMA/721630/2011 Page 217/485



CV Reference

Mandatory

Type Field Length

Business Rules

t_numerator_unit


[Unit of Measure]

numeric



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250


CV [Unit of

N alphanumeric

250


EMA/721630/2011 Page 218/485



CV Reference

Mandatory

Type Field Length

Business Rules

Measure]

Non_numeric_value


N alphanumeric

250

degree_polymerization (1..1)

SRU.DOP The degree of the polymerization section.

Y

Degree_of_polymerization

DOP.1.CV The type of the degree of polymerization shall be described.

CV [Degree of Polymerization]

Y Text 250

Amount_type

DOP.2.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250

amount (0..1)

DOP.AMT The amount section N

Quantity Operator


N text 250


EMA/721630/2011 Page 219/485



CV Reference

Mandatory

Type Field Length

Business Rules



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10

High_limi AMT.9.CV The higher limit unit of the CV N alpha 250


EMA/721630/2011 Page 220/485



CV Reference

Mandatory

Type Field Length

Business Rules

t_numerator_unit


[Unit of Measure]

numeric



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250


CV [Unit of

N alphanumeric

250


EMA/721630/2011 Page 221/485



CV Reference

Mandatory

Type Field Length

Business Rules

Measure]

Non_numeric_value


N alphanumeric

250


POLY.MWT The molecular weight section N The section is mandatory if Substance_classification_type= protein, polymer or nucleic acid




Y text 250




Y Text 250

Amount_type


CV [Amount Type]

N Text 250

Amount (1..1)

MWT.AMT The amount section Y


EMA/721630/2011 Page 222/485



CV Reference

Mandatory

Type Field Length

Business Rules

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 223/485



CV Reference

Mandatory

Type Field Length

Business Rules



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV The prefix of the average unit of the substance shall be specified, where

CV

N alphanume

250


EMA/721630/2011 Page 224/485



CV Reference

Mandatory

Type Field Length

Business Rules

available.

[Unit Prefix]

ric



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

Property (0..n)

POLY.PROP The property section The characteristics of the property shall be described.

N

Property_type

PROP.1.CV The type of property shall be specified based on a controlled vocabulary. EXAMPLE: physical, chemical, enzymatic, immunological

CV [Property Type]

Y Text 250

Property_name


CV [Parameter]

Y Text 250

Substance_id

PROP.3 The identifier of the substance related to a defining property shall

CV

N Alphanume

12


EMA/721630/2011 Page 225/485



CV Reference

Mandatory

Type Field Length

Business Rules

be described where applicable and based on controlled vocabulary. EXAMPLE: solubility in Water, Water ID shall be specified NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

[Substance Name]

ric

Substance_name


CV [Substance Name]

N Text 4000

Amount_type


CV [Amount Type]

N Text 250

amount (1..1)



EMA/721630/2011 Page 226/485



CV Reference

Mandatory

Type Field Length

Business Rules

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 227/485



CV Reference

Mandatory

Type Field Length

Business Rules



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV The prefix of the average unit of the substance shall be specified, where

CV

N alphanume

250


EMA/721630/2011 Page 228/485



CV Reference

Mandatory

Type Field Length

Business Rules

available.

[Unit Prefix]

ric



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

Modification (0..n)

POLY.MOD The modification section The modification details shall be specified.

N This section apply to: -Nucleic Acid -Protein -Polymer -Structurally Diverse Substances -Mixture This section shall be repeatable to describe each modification occurred on each residue modified.

Modification_type



Y Text 250


EMA/721630/2011 Page 229/485



CV Reference

Mandatory

Type Field Length

Business Rules

Residue_modified



Y Text 4000 If Substance_classification_type= protein, the CV [Amino acid] applies; If Substance_classification_type= nucleic acid, the CV [Nucleotide Bases] applies; If Substance_classification_type= polymer, the CV [Substance Name] applies. If Substance_classification_type= Structurally Diverse Substance or Mixture, the value residue modified is= not applicable

Residue_site

MOD.3 The position of specific residue undergone to modifications shall be described. Each residue shall be specified followed by a comma and space. For protein and nucleic acid, the number of the subunit followed by the number of the residue modified

N Text 2000


EMA/721630/2011 Page 230/485



CV Reference

Mandatory

Type Field Length

Business Rules

shall be specified. The underscore “_” shall be used as separator. EXAMPLE: 1_10 refers to the 10th residue on the 1st subunit Or A1_10


MOD.PM The physical modification section N This section shall only apply if Modification_type= Physical


CV [Modification]

Y Text 250



No N Numeric


Parameter (0..n)

PM.PARA The parameter section N The repeatability of this section is strictly related to the Value of the “Number_of_ Parameter” field. The section shall be repeated as many time as specified in the


EMA/721630/2011 Page 231/485



CV Reference

Mandatory

Type Field Length

Business Rules

‘number_of_parameters’ field.

Parameter


CV [Parameter]

Y Text 250

Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250

Low_limit_numer

AMT.4.CV The prefix of the lower limit unit of the substance shall be specified,

CV

N alphanumer

250


EMA/721630/2011 Page 232/485



CV Reference

Mandatory

Type Field Length

Business Rules

ator_unit_prefix

where available.

[Unit Prefix]

ic



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

High_limit_denominator_val


N Numeric

10


EMA/721630/2011 Page 233/485



CV Reference

Mandatory

Type Field Length

Business Rules

ue




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

structural_modification

MOD.SM The structural modification section N This section shall apply if Modification_type= Structural


EMA/721630/2011 Page 234/485



CV Reference

Mandatory

Type Field Length

Business Rules

(0..n)

This section is repeatable.



CV [Modification]

Y Text 250

Moiety (0..n)


N

Moiety_Role


CV [Role]

Y text 250

Moiety_name


CV [Substance Name]

Y Text 4000

Moiety_id

MOT.3 The unique identifier assigned to the substance representing the moiety based on controlled vocabulary. NOTE:

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 235/485



CV Reference

Mandatory

Type Field Length

Business Rules

If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250


EMA/721630/2011 Page 236/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



EMA/721630/2011 Page 237/485



CV Reference

Mandatory

Type Field Length

Business Rules

t_denominator_value


ric




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

molecular_ SM.MFRAG The molecular fragment section. N


EMA/721630/2011 Page 238/485



CV Reference

Mandatory

Type Field Length

Business Rules

fragment (0..n)

This section describes the molecular fragment affected by the modification where applicable.

Role MFRAG.1.CV The role of the molecular fragment shall be described based on a controlled vocabulary.

CV [Role]

Y Text 250


MFRAG.2 The unique identifier for molecular fragment shall be provided. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N Alphanumeric

12



CV [Substance Name]

Y Text 4000

Amount_type

MFRAG.4.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount

N Text 250


EMA/721630/2011 Page 239/485



CV Reference

Mandatory

Type Field Length

Business Rules

Type]

amount (0..1)

MFRAG.AMT The amount section N

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


EMA/721630/2011 Page 240/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 241/485



CV Reference

Mandatory

Type Field Length

Business Rules

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250

Non_numeric_value


N alphanumeric

250



N




Y text 250


CV [Modificatio

Y Text 250


EMA/721630/2011 Page 242/485



CV Reference

Mandatory

Type Field Length

Business Rules

n]

Modification_agent


CV [Substance Name]

Y Text 4000


AM.4 The unique identifier of modifying agent shall be provided. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N Alphanumeric

12




N Text

250

Amount_type


CV [Amount Type]

N Text 250


EMA/721630/2011 Page 243/485



CV Reference

Mandatory

Type Field Length

Business Rules

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

Low_limit_

AMT.7.CV The prefix of the lower limit unit of the substance shall be specified,

CV

N alphanume

250


EMA/721630/2011 Page 244/485



CV Reference

Mandatory

Type Field Length

Business Rules


where available.

[Unit Prefix]

ric



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


EMA/721630/2011 Page 245/485



CV Reference

Mandatory

Type Field Length

Business Rules


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

source_material (0..n)

POLY.SRCM The source material section The source material shall be specified in this section.

N

Source_material_class

SRCM.1.CV The classification of the source material shall be specified based on controlled vocabulary. EXAMPLE: organic, inorganic

CV [Source Material Cass]

Y text 250 The source material class values allow the display of different Source_material_type value as specified below.

Source_material_type

SRCM.2.CV The type of the source material shall be specified based on controlled vocabulary. For vaccines this section refers to

CV organism type]

Y text 250 If Source material class= inorganic, the [Inorganic Material Type] CV applies If Source material class =


EMA/721630/2011 Page 246/485



CV Reference

Mandatory

Type Field Length

Business Rules

the class of infectious agent. EXAMPLE: bacterium, human, mammal, fungus, virus, plant

Or [Inorganic Material Type]

organic, CV organism type] applies

Source_material_state

SRCM.3.CV The state of the source material shall be specified based on controlled vocabulary. EXAMPLE: live, activated, inactivated, attenuated, conjugated, live (attenuated).

CV [Source material state]

Y text 250

Organism_id

SRCM.4 The unique identifier associated with the source material parent organism shall be specified.

CV [Organism Name]

N Alphanumeric

12

Organism_name

SRCM.5 The organism accepted Latin name shall be provided based on the binomial Latin nomenclature. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

CV [Organism Name]

Y text 4000

Developmental_stage

SRCM.6.CV The developmental stage shall be defined based on a controlled vocabulary. EXAMPLE: foetus, infant, juvenile, adult, senescent, leafing, pre-flowering, flowering, fruiting

CV [Developmental Stage]

N text 250


EMA/721630/2011 Page 247/485



CV Reference

Mandatory

Type Field Length

Business Rules

Part (0..n)

SRCM.PT The part section is required to be provided where applicable.

N

Part PT.1.CV The portion of an organism with a definable anatomical location shall be described based on a controlled vocabulary.

CV [Plant Part] Or [Organism Part]

Y Text 250 If Source_material_type= human or mammalian the [organism part] CV applies; If Source_material_type= plant, [Plant Part] CV applies

Part_location

PT.2.CV The anatomical location shall be specified based on a controlled vocabulary. EXAMPLE: Stomach, shoulder

CV [Location]

Y Text 250 Applicable only if Source_material_type= human or mammalian

Fraction (0..n)

SRCM.FRCT The fraction section. Fraction of the part if applicable

N

Material_type

FRCT.1.CV The material type shall be specified based on a controlled vocabulary. EXAMPLE: cell, polysaccharide

CV [Material Type]

Y Text 250

Fraction FRCT.2.CV The fraction shall be specified based on a controlled vocabulary. The fractions of fractions are

CV [Fraction]

N Text 250


EMA/721630/2011 Page 248/485



CV Reference

Mandatory

Type Field Length

Business Rules

allowed.

organism (0..n)

SRCM.ORG The organism section The organism shall be defined based on specific elements defined in this section. This section describes the organism which the substance derived from. For vaccines, the parent organism shall be specified based on these section elements. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

N

Kingdom ORG.1.CV The kingdom of an organism shall be specified based on a controlled vocabulary.

CV [Kingdom]

N Text 250

Phylum ORG.2.CV The phylum of an organism shall be specified based on a controlled vocabulary.

CV [Phylum]

N Text 250

Class ORG.3.CV The class of an organism shall be specified based on a controlled vocabulary.

CV [Class]

N Text 250


EMA/721630/2011 Page 249/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: Mammalia, maxillopoda, Sauropsida

Order ORG.4.CV The order of an organism shall be specified based on a controlled vocabulary. EXAMPLE: Primate

CV [Order]

N Text 250

Family ORG.5.CV The family of an organism shall be specified based on a controlled vocabulary. EXAMPLE: Homidae

CV [Family]

N Text 250

Genus ORG.6.CV The genus of an organism shall be specified based on a controlled vocabulary. Refers to the Latin epithet of the genus of the plant/animal; it is present in names for genera, species and infraspecies EXAMPLE: Tanacetum

CV [Genus]

Y Text 250

Species ORG.7.CV The species of an organism shall be specified based on a controlled vocabulary. Refers to the Latin epithet of the species of the plant/animal; it is

CV [Species]

Y Text 250


EMA/721630/2011 Page 250/485



CV Reference

Mandatory

Type Field Length

Business Rules

present in names for species and infraspecies EXAMPLE: Parthenium

Species_parenthetical_author

ORG.8 The parenthetical author of an organism species shall be specified. Refers to the first author, who published the plant/animal name (of any rank). EXAMPLE: (L.)

N/A N Text 2000

Species_parenthetical_author_year

ORG.9 The parenthetical author year of an organism species an organism shall be specified. Refers to the year in which the first author published the plant/animal name (of any rank). For vaccines names, it refers to the year of isolation. EXAMPLE: 2010/2011

N/A N alphanumeric

10

Species_primary_author

ORG.10 The primary author of an organism species shall be specified. Refers to the first author, who published the plant/animal name (of any rank) EXAMPLE: Sch.Bip

N/A N Text 2000


EMA/721630/2011 Page 251/485



CV Reference

Mandatory

Type Field Length

Business Rules

Species_primary_author_year

ORG.11 The primary author year of an organism species shall be specified. Refers to the year in which the first author published the plant/animal name (of any rank)

N/A N alphanumeric

10

Hybrid_species_maternal_organism_id

ORG.12 The identifier of the maternal species constituting the hybrid organism shall be specified based on a controlled vocabulary.

CV [Species]

N Alphanumeric

12

Hybrid_species_paternal_organism_id

ORG.13 The identifier of the paternal species constituting the hybrid organism shall be specified based on a controlled vocabulary.

CV [Species]

N Alphanumeric

12

Hybrid_type

ORG.14 The hybrid type of an organism shall be defined.

Yes/No

N Boolean

Infraspecfic_type

ORG.15.CV The infraspecific type of an organism shall be specified based on a controlled vocabulary.

CV [Infraspecific Type]

N Text 250

Infraspec_descripti

ORG.16 The infraspecific description of an organism shall be specified based on a controlled vocabulary. For Influenza Vaccine, the infraspecifc description shall contain

N/A

N Text 4000


EMA/721630/2011 Page 252/485



CV Reference

Mandatory

Type Field Length

Business Rules

the syntax of the antigen in line with the WHO convention. EXAMPLE: A/BRISBANE/59/2007(H1N1)

Infraspecific_parenthetical_author

ORG.17 The infraspecific parenthetical author of an organism shall be specified. Refers to the first author, who published the infraspecific plant/animal name (of any rank)

N/A N Text 2000

Infraspecific_parenthetical_author_year

ORG.18 The infraspecific parenthetical author year of an organism shall be specified. Refers to the year in which the first author published the infraspecific plant/animal name (of any rank)

N/A N alphanumeric

10

Infraspecific_primary_author

ORG.19 The infraspecific primary author of an organism shall be specified. Refers to the first author, who published the infraspecific plant/animal name (of any infraspecific rank)

N/A N Text 2000

Infraspecific_primary_auth

ORG.20 The infraspecific primary author year of an organism shall be specified.

N/A N alphanumeric

10


EMA/721630/2011 Page 253/485



CV Reference

Mandatory

Type Field Length

Business Rules

or_year Refers to the year in which the first author published the infraspecific plant/animal name (of any infraspecific rank)


POLY.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


EMA/721630/2011 Page 254/485



CV Reference

Mandatory

Type Field Length

Business Rules

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500


EMA/721630/2011 Page 255/485


EMA/721630/2011 Page 256/485

4.3.5. SSI for Structurally Diverse Substances

For substances that can be classified as structurally diverse, the following data elements shall be specified:



CV Reference

Mandatory

Type Field Length

Business Rules

substance

SUB

Language


CV [Language]

Y text 3 Note: ISO 639-2 is the alpha-3 code in Codes for the representation of names of languages-- Part 2. There are 21 languages that have alternative codes for bibliographic or terminology purposes. In those cases, each is listed separately and they are designated as "B" (bibliographic) or "T" (terminology). For the purpose of describing “Language”, “T” shall be used. In all other cases there is only one ISO 639-2 code. Multiple codes assigned to the same language are to be considered


EMA/721630/2011 Page 257/485



CV Reference

Mandatory

Type Field Length

Business Rules

synonyms.

Substance_id


CV [Substance Name]

N Alphanumeric

12




Y Text 250


COM.SNM The substance name section This section contains the set of elements for the description of the name of the substance.

Y


EMA/721630/2011 Page 258/485



CV Reference

Mandatory

Type Field Length

Business Rules

The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

Substance_name


Y Text 4000

Substance_name_type



Y text 250

Language


CV [Language]



EMA/721630/2011 Page 259/485



CV Reference

Mandatory

Type Field Length

Business Rules




Official_name_type


CV [Source]

Y text 250



CV [Status]

Y text 250


EMA/721630/2011 Page 260/485



CV Reference

Mandatory

Type Field Length

Business Rules




N alphanumeric






CV [Domain]

Y Text 250





EMA/721630/2011 Page 261/485



CV Reference

Mandatory

Type Field Length

Business Rules




CV [Country Code]

Y Text 3



Y

Public_domain


Yes /No

Y Boolean



EMA/721630/2011 Page 262/485



CV Reference

Mandatory

Type Field Length

Business Rules

e_source_type


[Source]



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

substance_code


N


EMA/721630/2011 Page 263/485



CV Reference

Mandatory

Type Field Length

Business Rules



N/A Y alphanumeric

500

Code_system


CV [Code System]

Y

Text 250

Code_system_id


CV [Code System]

N alphanumeric

12

Code_system_status


CV [Status]

Y text 250

Code_system_change_da



N alphanumeric



EMA/721630/2011 Page 264/485



CV Reference

Mandatory

Type Field Length

Business Rules

te where applicable. EXAMPLE: 2011-06-01


Comment


N Text 4000



Y

Public_domain


Yes /No

Y Boolean



EMA/721630/2011 Page 265/485



CV Reference

Mandatory

Type Field Length

Business Rules

e_source_type


[Source]



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

version (1..n)


Y Where no “Version Number” and “Effective Date” have been assigned by an authority


EMA/721630/2011 Page 266/485



CV Reference

Mandatory

Type Field Length

Business Rules

the substance. source, the version number shall be set as 0 with the date set as the date of initial submission of the substance.

Version_number


N/A Y numeric

4

Effective_date



N alphanumeric


Change_made


N/A

N text 4000



Y


EMA/721630/2011 Page 267/485



CV Reference

Mandatory

Type Field Length

Business Rules


Comment


N Text 4000

substance classification (1..n)




CV [Domain]

Y text 250






EMA/721630/2011 Page 268/485



CV Reference

Mandatory

Type Field Length

Business Rules







N alphanumeric

250


EMA/721630/2011 Page 269/485



CV Reference

Mandatory

Type Field Length

Business Rules

ode vocabulary.

subtype (1..n)





Y Text 250



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250


EMA/721630/2011 Page 270/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: INN



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500



N


EMA/721630/2011 Page 271/485



CV Reference

Mandatory

Type Field Length

Business Rules

Relationship



Y Text 250

Interaction_type



N Text 250

Substance_id


CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 272/485



CV Reference

Mandatory

Type Field Length

Business Rules


Substance_name


CV [Substance Name]


Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10



CV [Unit of

N alphanumeric

250


EMA/721630/2011 Page 273/485



CV Reference

Mandatory

Type Field Length

Business Rules

Measure]



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


EMA/721630/2011 Page 274/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250


EMA/721630/2011 Page 275/485



CV Reference

Mandatory

Type Field Length

Business Rules

Non_numeric_value


N alphanumeric

250



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250

Reference_source


CV

Y text 250


EMA/721630/2011 Page 276/485



CV Reference

Mandatory

Type Field Length

Business Rules


[Source Class]

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

gene (0..n)




EMA/721630/2011 Page 277/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Organism Name]

N Text 2000


CV [Gene Name]

N alphanumeric

12

Gene_name


CV [Gene Name]

Y Text 4000



Y


EMA/721630/2011 Page 278/485



CV Reference

Mandatory

Type Field Length

Business Rules

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500


EMA/721630/2011 Page 279/485



CV Reference

Mandatory

Type Field Length

Business Rules

Encycl. 3: 429 (1792)

Gene_element (0..n)


Gene_element_type



Y Text 250

Gene_element_id


CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 280/485



CV Reference

Mandatory

Type Field Length

Business Rules

Gene_element_name


CV [Substance Name]

Y Text 4000



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


EMA/721630/2011 Page 281/485



CV Reference

Mandatory

Type Field Length

Business Rules


Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Target (0..n)




EMA/721630/2011 Page 282/485



CV Reference

Mandatory

Type Field Length

Business Rules


Target_gene_id


CV [Target Gene]

N alphanumeric

12

Target_gene_name


CV [Target Gene]

Y Text 4000

Interaction_type



Y text 250



CV [Organism type]

N Text 250

Target_type


CV [Target type]

N Text 250


EMA/721630/2011 Page 283/485



CV Reference

Mandatory

Type Field Length

Business Rules




Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Referenc RS.4 The code or number referring N/A N alpha 12


EMA/721630/2011 Page 284/485



CV Reference

Mandatory

Type Field Length

Business Rules

e_source_id

to the reference source shall be specified.

numeric



N/A N text 2500

Structure (0..n)






Y Text 250


STR.2 The structural representation shall be provided. This shall contain only textual and not graphical information.

N/A Y Alphanumeric

4000


EMA/721630/2011 Page 285/485



CV Reference

Mandatory

Type Field Length

Business Rules

When we enter more than one structural representation, the whole section is repeated (includes stereochemistry, optical activity etc) E.g. for an InChI code this field is populated with the InChI representation.



N .jpeg

Stereochemistry



Y Text 250

Optical_activity



Y CV 250

Molecular_formul

STR.6 The molecular formula shall be provided.

N/A N Text 2000


EMA/721630/2011 Page 286/485



CV Reference

Mandatory

Type Field Length

Business Rules

a The molecular formula shall be specified with all the characters in capital letters.

Isotope (0..n)


N

Nuclide_id

ISO.1 The identifier for each nuclide shall be provided based on a controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N alphanumeric

12

Nuclide_name


CV

Y Text 4000


EMA/721630/2011 Page 287/485



CV Reference

Mandatory

Type Field Length

Business Rules

[Substance Name]

Substitution_type



Y Text 250

structurally_Diverse_Substance (0..1)

SING.SD The structurally diverse substance section The identifying characteristics of the structurally diverse substances shall be specified.

Comment

SD.1 Any comment can be provided in this field, if necessary.

Modification (0..n)

SD.MOD The modification section The modification details shall be specified.

N This section apply to: -Nucleic Acid -Protein -Polymer -Structurally Diverse Substances


EMA/721630/2011 Page 288/485



CV Reference

Mandatory

Type Field Length

Business Rules

-Mixture This section shall be repeatable to describe each modification occurred on each residue modified.

Modification_type



Y Text 250

Residue_modified



Y Text 4000 If Substance_classification_type= protein, the CV [Aminoacid] applies; If Substance_classification_type= nucleic acid, the CV [Nucleotide Bases] applies; If Substance_classification_type= polymer, the CV [Substance Name] applies.


EMA/721630/2011 Page 289/485



CV Reference

Mandatory

Type Field Length

Business Rules

If Substance_classification_type= Structurally Diverse Substance or Mixture, the value residue modified is= not applicable

Residue_site

MOD.3 The position of specific residue undergone to modifications shall be described. Each residue shall be specified followed by a comma and space. For protein and nucleic acid, the number of the subunit followed by the number of the residue modified shall be specified. The underscore “_” shall be used as separator. EXAMPLE: 1_10 refers to the 10th residue on the 1st subunit Or A1_10

N Text 2000

physical_ MOD.PM The physical modification N This section shall only apply if


EMA/721630/2011 Page 290/485



CV Reference

Mandatory

Type Field Length

Business Rules

modification (0..n)

section Modification_type= Physical


CV [Modification]

Y Text 250



No N Numeric


Parameter (0..n)


Parameter

PARA.1.CV The parameter shall be described based on controlled vocabulary. EXAMPLE: time, temperature,

CV [Parameter]

Y Text 250


EMA/721630/2011 Page 291/485



CV Reference

Mandatory

Type Field Length

Business Rules

pressure

Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Low_limit_denomi

AMT.5 The lower limit value of the substance shall be specified,

N Numeric

10


EMA/721630/2011 Page 292/485



CV Reference

Mandatory

Type Field Length

Business Rules

nator_value

where available.




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


EMA/721630/2011 Page 293/485



CV Reference

Mandatory

Type Field Length

Business Rules


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


EMA/721630/2011 Page 294/485



CV Reference

Mandatory

Type Field Length

Business Rules






CV [Modification]

Y Text 250

Moiety (0..n)


N

Moiety_Role


CV [Role]

Y text 250

Moiety_name

MOT.2 The name of the moiety shall be provided. If the substance name is not present in the Controlled Vocabulary, the moiety name

CV [Substance Name]

Y Text 4000


EMA/721630/2011 Page 295/485



CV Reference

Mandatory

Type Field Length

Business Rules

shall be described as a free text.

Moiety_id


CV [Substance Name]

N Alphanumeric

12

Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity AMT.1.CV CV N text 250


EMA/721630/2011 Page 296/485



CV Reference

Mandatory

Type Field Length

Business Rules

Operator [Quantity Operator]



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 297/485



CV Reference

Mandatory

Type Field Length

Business Rules



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


EMA/721630/2011 Page 298/485



CV Reference

Mandatory

Type Field Length

Business Rules

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250



N

Role MFRAG.1.CV


CV [Role]

Y Text 250


EMA/721630/2011 Page 299/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Substance Name]

N Alphanumeric

12



CV [Substance Name]

Y Text 4000

Amount_type

MFRAG.4.CV


CV [Amount Type]

N Text 250

amount

MFRAG.AMT



EMA/721630/2011 Page 300/485



CV Reference

Mandatory

Type Field Length

Business Rules

(0..1)

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

Low_limit_


CV

N alphanume

250


EMA/721630/2011 Page 301/485



CV Reference

Mandatory

Type Field Length

Business Rules



[Unit Prefix] ric



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 302/485



CV Reference

Mandatory

Type Field Length

Business Rules

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250



N


AM.1.CV The type of the agent used for the modification shall be specified based on a controlled vocabulary.

CV [Agent Modification

Y text 250


EMA/721630/2011 Page 303/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: chemical, enzymatic

Type]


CV [Modification]

Y Text 250

Modification_agent


CV [Substance Name]

Y Text 4000



CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 304/485



CV Reference

Mandatory

Type Field Length

Business Rules




N Text

250

Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 305/485



CV Reference

Mandatory

Type Field Length

Business Rules

_prefix



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



EMA/721630/2011 Page 306/485



CV Reference

Mandatory

Type Field Length

Business Rules

t_denominator_value


ric


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


EMA/721630/2011 Page 307/485



CV Reference

Mandatory

Type Field Length

Business Rules


Property (0..n)

SD.PROP The property section The characteristics of the property shall be described.

N

Property_type

PROP.1.CV

The type of property shall be specified based on a controlled vocabulary. EXAMPLE: physical, chemical, enzymatic, immunological

CV [Property Type]

Y Text 250

Property_name

PROP.2.CV


CV [Parameter]

Y Text 250

Substance_id

PROP.3 The identifier of the substance related to a defining property shall be described where applicable and based on controlled vocabulary. EXAMPLE: solubility in Water, Water ID shall be specified NOTE: If a unique “Substance ID”

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 308/485



CV Reference

Mandatory

Type Field Length

Business Rules

(EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

Substance_name


CV [Substance Name]

N Text 4000

Amount_type

PROP.5.CV


CV [Amount Type]

N Text 250

amount (1..1)


Quantity Operator

AMT.1.CV CV

N text 250


EMA/721630/2011 Page 309/485



CV Reference

Mandatory

Type Field Length

Business Rules

[Quantity Operator]



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 310/485



CV Reference

Mandatory

Type Field Length

Business Rules



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


EMA/721630/2011 Page 311/485



CV Reference

Mandatory

Type Field Length

Business Rules

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


SD.SRCM The source material section The source material shall be specified in this section.

N

Source_material_class

SRCM.1.CV

The classification of the source material shall be specified based on controlled vocabulary. EXAMPLE: organic, inorganic

CV [Source Material Cass]

Y text 250 The source material class values allow the display of different Source_material_type value as specified below.

Source_material

SRCM.2.CV

The type of the source material shall be specified based on

CV

Y text 250 If Source material class= inorganic, the [Inorganic


EMA/721630/2011 Page 312/485



CV Reference

Mandatory

Type Field Length

Business Rules

_type controlled vocabulary. For vaccines this section refers to the class of infectious agent. EXAMPLE: bacterium, human, mammal, fungus, virus, plant

organism type] Or [Inorganic Material Type]

Material Type] CV applies If Source material class = organic, CV organism type] applies


SRCM.3.CV

The state of the source material shall be specified based on controlled vocabulary. EXAMPLE: live, activated, inactivated, attenuated, conjugated, live (attenuated).


Y text 250

Organism _id


CV [Organism Name]

N Alphanumeric

12

Organism_name

SRCM.5 The organism accepted Latin name shall be provided based on the binomial Latin nomenclature. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

CV [Organism Name]

Y text 4000


EMA/721630/2011 Page 313/485



CV Reference

Mandatory

Type Field Length

Business Rules

Developmental_stage

SRCM.6.CV

The developmental stage shall be defined based on a controlled vocabulary. EXAMPLE: foetus, infant, juvenile, adult, senescent, leafing, pre-flowering, flowering, fruiting


N text 250

Part (0..n)


N




Part_location

PT.2.CV The anatomical location shall be specified based on a controlled vocabulary. EXAMPLE: Stomach, shoulder

CV [Location]

Y Text 250 Applicable only if Source_material_type= human or mammalian

Fraction

SRCM.FRCT

The fraction section.

N


EMA/721630/2011 Page 314/485



CV Reference

Mandatory

Type Field Length

Business Rules

(0..n) Fraction of the part if applicable

Material_type


CV [Material Type]

Y Text 250

Fraction FRCT.2.CV The fraction shall be specified based on a controlled vocabulary. The fractions of fractions are allowed.

CV [Fraction]

N Text 250

organism (0..n)

SRCM.ORG

The organism section The organism shall be defined based on specific elements defined in this section. This section describes the organism which the substance derived from. For vaccines, the parent organism shall be specified based on these section elements. The latest version of the

N


EMA/721630/2011 Page 315/485



CV Reference

Mandatory

Type Field Length

Business Rules

Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.


CV [Kingdom]

N Text 250


CV [Phylum]

N Text 250

Class ORG.3.CV The class of an organism shall be specified based on a controlled vocabulary. EXAMPLE: Mammalia, maxillopoda, Sauropsida

CV [Class]

N Text 250

Order ORG.4.CV The order of an organism shall be specified based on a controlled vocabulary. EXAMPLE: Primate

CV [Order]

N Text 250


CV [Family]

N Text 250


EMA/721630/2011 Page 316/485



CV Reference

Mandatory

Type Field Length

Business Rules


CV [Genus]

Y Text 250

Species ORG.7.CV The species of an organism shall be specified based on a controlled vocabulary. Refers to the Latin epithet of the species of the plant/animal; it is present in names for species and infraspecies EXAMPLE: Parthenium

CV [Species]

Y Text 250


ORG.8 The parenthetical author of an organism species shall be specified. Refers to the first author, who published the plant/animal name (of any rank).

N/A N Text 2000


EMA/721630/2011 Page 317/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: (L.)



N/A N alphanumeric

10


ORG.10 The primary author of an organism species shall be specified. Refers to the first author, who published the plant/animal name (of any rank) EXAMPLE: Sch.Bip

N/A N Text 2000


ORG.11 The primary author year of an organism species shall be specified.

N/A N alphanumeric

10


EMA/721630/2011 Page 318/485



CV Reference

Mandatory

Type Field Length

Business Rules

Refers to the year in which the first author published the plant/animal name (of any rank)



CV [Species]

N Alphanumeric

12



CV [Species]

N Alphanumeric

12

Hybrid_type

ORG.14 The hybrid type of an organism shall be defined.

Yes/No

N Boolean

Infraspecfic_type

ORG.15.CV

The infraspecific type of an organism shall be specified based on a controlled vocabulary.


N Text 250

Infraspec_descripti

ORG.16 The infraspecific description of an organism shall be specified based on a controlled vocabulary.

N/A

N Text 4000


EMA/721630/2011 Page 319/485



CV Reference

Mandatory

Type Field Length

Business Rules

For Influenza Vaccine, the infraspecifc description shall contain the syntax of the antigen in line with the WHO convention. EXAMPLE: A/BRISBANE/59/2007(H1N1)



N/A N Text 2000



N/A N alphanumeric

10

Infraspecific_prim

ORG.19 The infraspecific primary author of an organism shall be

N/A N Text 2000


EMA/721630/2011 Page 320/485



CV Reference

Mandatory

Type Field Length

Business Rules

ary_author

specified. Refers to the first author, who published the infraspecific plant/animal name (of any infraspecific rank)

Infraspecific_primary_author_year

ORG.20 The infraspecific primary author year of an organism shall be specified. Refers to the year in which the first author published the infraspecific plant/animal name (of any infraspecific rank)

N/A N alphanumeric

10

glycosylation (0..n)

SD.GLY The glycosilation section Details on the glycosilation shall be provided. The section is repeatable to allow the description of each glycosilation present in a protein.

N This section applies if the protein is glycosylated. The value of Glycosylation_type cannot be null. In case of no glycosilation the user must specify the value= Not applicable from the [Glycosylation Type] CV.

Glycosylation_type

GLY.1.CV The type of the glycosilation shall be specified based on a controlled vocabulary.

CV [Glycosylation

Y Text 250


EMA/721630/2011 Page 321/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: human

Type]

N_glycosylation

GLY.2 The site of n-glycosylation shall be described according to the protein sequence. The extent and type of the modification at a given site is not captured. The convention to be used is as follow: “3 Aminoacid code letter+subunit number”_”position of aminoacid” EXAMPLE: asparagine “Asn1_34”

N/A N Alphanumeric


O_glycosylation

GLY.3 The site of the o-glycosylation shall be described. The convention to be used is as follow: “3 Aminoacid code letter+subunit number”_”position of aminoacid”

N/A N Alphanumeric



EMA/721630/2011 Page 322/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: serine “Ser2_34”

C_glycosylation

GLY.4 The site of the c-glycosylation shall be described. The convention to be used is as follow: “3 Aminoacid code letter+subunit number”_”position of aminoacid” EXAMPLE: tryptophan “Trp2_45”

N/A N Alphanumeric



SD.MWT The molecular weight section N The section is mandatory if Substance_classification_type= protein, polymer or nucleic acid




Y text 250




Y Text 250


EMA/721630/2011 Page 323/485



CV Reference

Mandatory

Type Field Length

Business Rules

Amount_type


CV [Amount Type]

N Text 250

amount (1..1)

MW.AMT The amount section Y

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


EMA/721630/2011 Page 324/485



CV Reference

Mandatory

Type Field Length

Business Rules




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10

High_limit_ denomin

AMT.12.CV


CV [Unit of

N alphanumeric

250


EMA/721630/2011 Page 325/485



CV Reference

Mandatory

Type Field Length

Business Rules

ator _unit

Measure]


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

reference_source

SD.RS The reference source section This section describes the

Y


EMA/721630/2011 Page 326/485



CV Reference

Mandatory

Type Field Length

Business Rules

(1..n) reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12

Reference_source

RS.5 The textual description of the reference source within the

N/A N text 2500


EMA/721630/2011 Page 327/485



CV Reference

Mandatory

Type Field Length

Business Rules

_citation literature or regulatory document shall be described. EXAMPLE: Ph.E. 7.1, p.34 Literature reference: Encycl. 3: 429 (1792)


EMA/721630/2011 Page 328/485

4.3.6. SSI for Mixtures

For substances that can be classified as a mixture substance, the following data elements shall be specified:



CV Reference

Mandatory

Type Field Length

Business Rules

substance

SUB

Language


CV [Language]

Y text 3 Note: ISO 639-2 is the alpha-3 code in Codes for the representation of names of languages-- Part 2. There are 21 languages that have alternative codes for bibliographic or terminology purposes. In those cases, each is listed separately and they are designated as "B" (bibliographic) or "T" (terminology). For the purpose of describing “Language”, “T” shall be used. In all other cases there is only one ISO 639-2 code. Multiple codes assigned to the same language are to be considered


EMA/721630/2011 Page 329/485



CV Reference

Mandatory

Type Field Length

Business Rules

synonyms.

Substance_id


CV [Substance Name]

N Alphanumeric

12




Y Text 250


COM.SNM The substance name section This section contains the set of elements for the description of the name of the substance.

Y


EMA/721630/2011 Page 330/485



CV Reference

Mandatory

Type Field Length

Business Rules

The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

Substance_name


Y Text 4000

Substance_name_type



Y text 250

Language


CV [Language]



EMA/721630/2011 Page 331/485



CV Reference

Mandatory

Type Field Length

Business Rules




Official_name_type


CV [Source]

Y text 250



CV [Status]

Y text 250


EMA/721630/2011 Page 332/485



CV Reference

Mandatory

Type Field Length

Business Rules




N alphanumeric






CV [Domain]

Y Text 250





EMA/721630/2011 Page 333/485



CV Reference

Mandatory

Type Field Length

Business Rules




CV [Country Code]

Y Text 3



Y

Public_domain


Yes /No

Y Boolean



EMA/721630/2011 Page 334/485



CV Reference

Mandatory

Type Field Length

Business Rules

e_source_type


[Source]



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

substance_code


N


EMA/721630/2011 Page 335/485



CV Reference

Mandatory

Type Field Length

Business Rules



N/A Y alphanumeric

500

Code_system


CV [Code System]

Y

Text 250

Code_system_id


CV [Code System]

N alphanumeric

12

Code_system_status


CV [Status]

Y text 250

Code_system_change_dat



N alphanumeric



EMA/721630/2011 Page 336/485



CV Reference

Mandatory

Type Field Length

Business Rules

e where applicable. EXAMPLE: 2011-06-01


Comment


N Text 4000



Y

Public_domain


Yes /No

Y Boolean



EMA/721630/2011 Page 337/485



CV Reference

Mandatory

Type Field Length

Business Rules

e_source_type


[Source]



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

version (1..n)


Y Where no “Version Number” and “Effective Date” have been assigned by an authority source,


EMA/721630/2011 Page 338/485



CV Reference

Mandatory

Type Field Length

Business Rules

the substance. the version number shall be set as 0 with the date set as the date of initial submission of the substance.

Version_number


N/A Y numeric

4

Effective_date



N alphanumeric


Change_made


N/A

N text 4000



Y


EMA/721630/2011 Page 339/485



CV Reference

Mandatory

Type Field Length

Business Rules


Comment


N Text 4000





CV [Domain]

Y text 250






EMA/721630/2011 Page 340/485



CV Reference

Mandatory

Type Field Length

Business Rules







N alphanumeric

250


EMA/721630/2011 Page 341/485



CV Reference

Mandatory

Type Field Length

Business Rules

ode vocabulary.

subtype (1..n)





Y Text 250



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250


EMA/721630/2011 Page 342/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: INN



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500



N


EMA/721630/2011 Page 343/485



CV Reference

Mandatory

Type Field Length

Business Rules

Relationship



Y Text 250

Interaction_type



N Text 250

Substance_id


CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 344/485



CV Reference

Mandatory

Type Field Length

Business Rules


Substance_name


CV [Substance Name]


Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10



CV [Unit of

N alphanumeric

250


EMA/721630/2011 Page 345/485



CV Reference

Mandatory

Type Field Length

Business Rules

Measure]



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


EMA/721630/2011 Page 346/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250


EMA/721630/2011 Page 347/485



CV Reference

Mandatory

Type Field Length

Business Rules

Non_numeric_value


N alphanumeric

250



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250

Reference_source


CV

Y text 250


EMA/721630/2011 Page 348/485



CV Reference

Mandatory

Type Field Length

Business Rules


[Source Class]

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

gene (0..n)




EMA/721630/2011 Page 349/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Organism Name]

N Text 2000


CV [Gene Name]

N alphanumeric

12

Gene_name


CV [Gene Name]

Y Text 4000



Y


EMA/721630/2011 Page 350/485



CV Reference

Mandatory

Type Field Length

Business Rules

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500


EMA/721630/2011 Page 351/485



CV Reference

Mandatory

Type Field Length

Business Rules

Encycl. 3: 429 (1792)

Gene_element (0..n)


Gene_element_type



Y Text 250

Gene_element_id


CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 352/485



CV Reference

Mandatory

Type Field Length

Business Rules

Gene_element_name


CV [Substance Name]

Y Text 4000



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


EMA/721630/2011 Page 353/485



CV Reference

Mandatory

Type Field Length

Business Rules


Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Target (0..n)




EMA/721630/2011 Page 354/485



CV Reference

Mandatory

Type Field Length

Business Rules


Target_gene_id


CV [Target Gene]

N alphanumeric

12

Target_gene_name


CV [Target Gene]

Y Text 4000

Interaction_type



Y text 250



CV [Organism type]

N Text 250

Target_type


CV [Target type]

N Text 250


EMA/721630/2011 Page 355/485



CV Reference

Mandatory

Type Field Length

Business Rules




Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Referenc RS.4 The code or number referring to N/A N alpha 12


EMA/721630/2011 Page 356/485



CV Reference

Mandatory

Type Field Length

Business Rules

e_source_id

the reference source shall be specified.

numeric



N/A N text 2500

mixture_substance (0..1)

EXT.MIXT The mixture substance section The identifying characteristics for a mixture substance shall be described.

The section is mandatory if Substance_type_cv = Mixture

Mixture_type

MIXT.1.CV The type of the mixture shall be specified based on a controlled vocabulary. EXAMPLE: one of, all of, any of

CV [Mixture Type]

Y Text 250


MIXT.SRCM

The source material section The source material shall be specified in this section.

N

Source_ SRCM.1.C The classification of the source CV Y text 250


EMA/721630/2011 Page 357/485



CV Reference

Mandatory

Type Field Length

Business Rules

material_class

V material shall be specified based on controlled vocabulary. EXAMPLE: organic, inorganic

[Source Material Cass]

The source material class values allow the display of different Source_material_type value as specified below.

Source_material_type

SRCM.2.CV

The type of the source material shall be specified based on controlled vocabulary. For vaccines this section refers to the class of infectious agent. EXAMPLE: bacterium, human, mammal, fungus, virus, plant

CV organism type] Or [Inorganic Material Type]

Y text 250 If Source material class= inorganic, the [Inorganic Material Type] CV applies If Source material class = organic, CV organism type] applies


SRCM.3.CV

The state of the source material shall be specified based on controlled vocabulary. EXAMPLE: live, activated, inactivated, attenuated, conjugated, live (attenuated).


Y text 250

Organism _id


CV [Organism Name]

N Alphanumeric

12

Organism_name

SRCM.5 The organism accepted Latin name shall be provided based on the binomial Latin

CV [Organism

Y text 4000


EMA/721630/2011 Page 358/485



CV Reference

Mandatory

Type Field Length

Business Rules

nomenclature. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

Name]

Developmental_stage

SRCM.6.CV

The developmental stage shall be defined based on a controlled vocabulary. EXAMPLE: foetus, infant, juvenile, adult, senescent, leafing, pre-flowering, flowering, fruiting


N text 250

Part (0..n)


N




Part_loca PT.2.CV The anatomical location shall be CV Y Text 250 Applicable only if


EMA/721630/2011 Page 359/485



CV Reference

Mandatory

Type Field Length

Business Rules

tion specified based on a controlled vocabulary. EXAMPLE: Stomach, shoulder

[Location]

Source_material_type= human or mammalian

Fraction (0..n)

SRCM.FRCT

The fraction section. Fraction of the part if applicable

N

Material_type


CV [Material Type]

Y Text 250

Fraction FRCT.2.CV The fraction shall be specified based on a controlled vocabulary. The fractions of fractions are allowed.

CV [Fraction]

N Text 250

organism (0..n)

SRCM.ORG

The organism section The organism shall be defined based on specific elements defined in this section. This section describes the organism which the substance

N


EMA/721630/2011 Page 360/485



CV Reference

Mandatory

Type Field Length

Business Rules

derived from. For vaccines, the parent organism shall be specified based on these section elements. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.


CV [Kingdom]

N Text 250


CV [Phylum]

N Text 250

Class ORG.3.CV The class of an organism shall be specified based on a controlled vocabulary. EXAMPLE: Mammalia, maxillopoda, Sauropsida

CV [Class]

N Text 250

Order ORG.4.CV The order of an organism shall be specified based on a controlled vocabulary.

CV [Order]

N Text 250


EMA/721630/2011 Page 361/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: Primate


CV [Family]

N Text 250


CV [Genus]

Y Text 250

Species ORG.7.CV The species of an organism shall be specified based on a controlled vocabulary. Refers to the Latin epithet of the species of the plant/animal; it is present in names for species and infraspecies

CV [Species]

Y Text 250


EMA/721630/2011 Page 362/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: Parthenium


ORG.8 The parenthetical author of an organism species shall be specified. Refers to the first author, who published the plant/animal name (of any rank). EXAMPLE: (L.)

N/A N Text 2000



N/A N alphanumeric

10


ORG.10 The primary author of an organism species shall be specified. Refers to the first author, who

N/A N Text 2000


EMA/721630/2011 Page 363/485



CV Reference

Mandatory

Type Field Length

Business Rules

published the plant/animal name (of any rank) EXAMPLE: Sch.Bip


ORG.11 The primary author year of an organism species shall be specified. Refers to the year in which the first author published the plant/animal name (of any rank)

N/A N alphanumeric

10



CV [Species]

Y Alphanumeric

12



CV [Species]

N Alphanumeric

12

Hybrid_type

ORG.14 The hybrid type of an organism shall be defined. EXAMPLE: yes/no

Yes/No

N Boolean


EMA/721630/2011 Page 364/485



CV Reference

Mandatory

Type Field Length

Business Rules

Infraspeific_type

ORG.15.CV

The infraspecific type of an organism shall be specified based on a controlled vocabulary.


N Text 250

Infraspec_descript

ORG.16 The infraspecific description of an organism shall be specified based on a controlled vocabulary. For Influenza Vaccine, the infraspecifc description shall contain the syntax of the antigen in line with the WHO convention. EXAMPLE: A/BRISBANE/59/2007(H1N1)

N/A

N Text 4000



N/A N Text 2000


EMA/721630/2011 Page 365/485



CV Reference

Mandatory

Type Field Length

Business Rules



N/A N alphanumeric

10

Infraspecific_primary_author

ORG.19 The infraspecific primary author of an organism shall be specified. Refers to the first author, who published the infraspecific plant/animal name (of any infraspecific rank)

N/A N Text 2000

Infraspecific_primary_author_year

ORG.20 The infraspecific primary author year of an organism shall be specified. Refers to the year in which the first author published the infraspecific plant/animal name (of any infraspecific rank)

N/A N alphanumeric

10

Modification

MIXT.MOD

The modification section

N This section apply to:


EMA/721630/2011 Page 366/485



CV Reference

Mandatory

Type Field Length

Business Rules

(0..n)

The modification details shall be specified.

-Nucleic Acid -Protein -Polymer -Structurally Diverse Substances -Mixture This section shall be repeatable to describe each modification occurred on each residue modified.

Modification type



Y Text 250

Residue modified


CV [Nucleotide Bases] OR [Amino acid] OR [Substance

Y Text 4000 If Substance_classification_type= protein, the CV [Amino acid] applies; If Substance_classification_type= nucleic acid, the CV [Nucleotide Bases] applies;


EMA/721630/2011 Page 367/485



CV Reference

Mandatory

Type Field Length

Business Rules

Name] If Substance_classification_type= polymer, the CV [Substance Name] applies. If Substance_classification_type= Structurally Diverse Substance or Mixture, the value residue modified is= not applicable

Residue_site

MOD.3 The position of specific residue undergone to modifications shall be described. Each residue shall be specified followed by a comma and space. For protein and nucleic acid, the number of the subunit followed by the number of the residue modified shall be specified. The underscore “_” shall be used as separator. EXAMPLE: 1_10 refers to the 10th residue on the 1st subunit Or

N Text 2000


EMA/721630/2011 Page 368/485



CV Reference

Mandatory

Type Field Length

Business Rules

A1_10


MOD.PM The physical modification section

N This section shall only apply if Modification type= Physical


CV [Modification]

Y Text 250



No N Numeric


Parameter (0..n)



EMA/721630/2011 Page 369/485



CV Reference

Mandatory

Type Field Length

Business Rules

Parameter


CV [Parameter]

Y Text 250

Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250

Low_limi AMT.4.CV The prefix of the lower limit unit CV N alpha 250


EMA/721630/2011 Page 370/485



CV Reference

Mandatory

Type Field Length

Business Rules

t_numerator_unit_prefix

of the substance shall be specified, where available.

[Unit Prefix]

numeric



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 371/485



CV Reference

Mandatory

Type Field Length

Business Rules



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


EMA/721630/2011 Page 372/485



CV Reference

Mandatory

Type Field Length

Business Rules




N This section shall apply if Modification type= Structural This section is repeatable.



CV [Modification]

Y Text 250

Moiety (0..n)


N

Moiety_Role


CV [Role]

Y text 250

Moiety_name

MOT.2 The name of the moiety shall be provided.

CV [Substance

Y Text 4000


EMA/721630/2011 Page 373/485



CV Reference

Mandatory

Type Field Length

Business Rules

If the substance name is not present in the Controlled Vocabulary, the moiety name shall be described as a free text.

Name]

Moiety_id


CV [Substance Name]

N Alphanumeric

12

Amount_type


CV [Amount Type]

N Text 250

amount



EMA/721630/2011 Page 374/485



CV Reference

Mandatory

Type Field Length

Business Rules

(0..1) Quantity


[Quantity Operator]

N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

Low_limit_


CV

N alphanume

250


EMA/721630/2011 Page 375/485



CV Reference

Mandatory

Type Field Length

Business Rules



[Unit Prefix] ric



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 376/485



CV Reference

Mandatory

Type Field Length

Business Rules

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

molecular fragment (0..n)


N

Role MFRAG.1.CV


CV [Role]

Y Text 250


EMA/721630/2011 Page 377/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Substance Name]

N Alphanumeric

12



CV [Substance Name]

Y Text 4000

Amount_type

MFRAG.4.CV


CV [Amount Type]

N Text 250

amount

MFRAG.AMT



EMA/721630/2011 Page 378/485



CV Reference

Mandatory

Type Field Length

Business Rules

(0..1) Quantity


[Quantity Operator]

N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250

Low_limit_


CV

N alphanume

250


EMA/721630/2011 Page 379/485



CV Reference

Mandatory

Type Field Length

Business Rules



[Unit Prefix] ric



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 380/485



CV Reference

Mandatory

Type Field Length

Business Rules

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250



N




Y text 250


EMA/721630/2011 Page 381/485



CV Reference

Mandatory

Type Field Length

Business Rules


CV [Modification]

Y Text 250

Modification_agent


CV [Substance Name]

Y Text 4000



CV [Substance Name]

N Alphanumeric

12

Modification_proce

AM.5.CV The modification process shall be specified based on a

CV

N Text

250


EMA/721630/2011 Page 382/485



CV Reference

Mandatory

Type Field Length

Business Rules

ss controlled vocabulary. EXAMPLE: UV irradiation

[Modification Process]

Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 383/485



CV Reference

Mandatory

Type Field Length

Business Rules



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250

High_limit_denominator_val


N Numeric

10


EMA/721630/2011 Page 384/485



CV Reference

Mandatory

Type Field Length

Business Rules

ue


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


EMA/721630/2011 Page 385/485



CV Reference

Mandatory

Type Field Length

Business Rules

mixture_constituent (2..n)

MIXT.MXCON

The mixture constituent section The substance constituting the mixture shall be described.

Y The section is mandatory if Substance_type_cv= Mixture

Constituent_id

MXCON.1 The unique identifier assigned to the constituent based on controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

CV [Substance Name]

N Alphanumeric

12

Constituent_name

MXCON.2 The name of the constituent of the mixture shall be described.

CV [Substance Name]

Y Text 4000

Constituent_requirement

MXCON.3.CV

The requirement of the constituent shall be described based on a controlled

CV [Requirement

N Text 250


EMA/721630/2011 Page 386/485



CV Reference

Mandatory

Type Field Length

Business Rules

vocabulary. EXAMPLE: may be present

]


EMA/721630/2011 Page 387/485

4.3.7. SSI for Specified Substance Group 1

For Specified Substance Group 1, the SSI shall be described based on the following data elements:



CV Reference

Mandatory

Type Field Length

Business Rules

specified_substance_group1

SPCFD.GP1 The specified substance group 1 section The identifying characteristics for the specified substance group 1 shall be specified.

The section is mandatory if Substance_type_cv= Specified_substance_group1




Y Text 250

Language


CV [Language]

Y text 3 Note: ISO 639-2 is the alpha-3 code in Codes for the representation of names of languages-- Part 2. There are 21 languages that have alternative codes for bibliographic or terminology purposes. In those cases, each is listed separately and they are designated as "B" (bibliographic) or "T" (terminology). For the purpose of describing “Language”, “T” shall be used.


EMA/721630/2011 Page 388/485



CV Reference

Mandatory

Type Field Length

Business Rules

In all other cases there is only one ISO 639-2 code. Multiple codes assigned to the same language are to be considered synonyms.

Specified_substance_group1_id

GP1.1 The unique identifier assigned to the specified substance group1 shall be specified. NOTE: If a unique “Specified Substance ID” (EVCODE) has been assigned by the EMA, this “Specified Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Specified Substance ID” e. g. for the initial submission of the substance this data element is not required.

N Alphanumeric

12 In the absence of a unique “Specified Substance ID” e.g. for the initial submission of the specified substance this data element shall not be populated. The ID of the substance will be automatically assigned by the system once the message will be processed.

Specified_substance_group1_name

GP1.2 The name of the specified substance group 1 shall be provided in this field. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

N/A Y Text 4000

substance_name

COM.SNM The substance name section

Y


EMA/721630/2011 Page 389/485



CV Reference

Mandatory

Type Field Length

Business Rules

(1..n)

This section contains the set of elements for the description of the name of the substance. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

Substance_name


Y Text 4000

Substance_name_type



Y text 250

Language


CV [Language]



EMA/721630/2011 Page 390/485



CV Reference

Mandatory

Type Field Length

Business Rules




Official_name_type


CV [Source]

Y text 250



CV [Status]

Y text 250

Official_name_status_chan

ON.3 The change date of the status of the official name shall be specified in line with the ISO 8601 date format, which


N alphanumeric

10 ISO 8601 advises numeric representation of dates and times on an internationally


EMA/721630/2011 Page 391/485



CV Reference

Mandatory

Type Field Length

Business Rules

ge_date shall be only entered when name is changed. EXAMPLE: 2011-06-01

agreed basis. It represents elements from the largest to the smallest element: e.g. year-month-day YYYY-MM-DD





CV [Domain]

Y Text 250




Official_name_juri

JUR.1.CV The jurisdiction of the official name shall be provided based on ISO 3166-

CV

Y Text 3


EMA/721630/2011 Page 392/485



CV Reference

Mandatory

Type Field Length

Business Rules

sdiction 1 alpha-2 codes with two exceptions: EL (not GR) is used to represent Greece, and UK (not GB) is used to represent the United Kingdom. For the European Union EU shall be used.

[Country Code]



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


EMA/721630/2011 Page 393/485



CV Reference

Mandatory

Type Field Length

Business Rules

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500



N


N/A Y alphanumeric

500

Code_system


CV [Code System]

Y

Text 250


EMA/721630/2011 Page 394/485



CV Reference

Mandatory

Type Field Length

Business Rules

Code_system_id


CV [Code System]

N alphanumeric

12

Code_system_status


CV [Status]

Y text 250




N alphanumeric


Comment


N Text 4000


SC.RS The reference source section This section describes the reference source information.

Y


EMA/721630/2011 Page 395/485



CV Reference

Mandatory

Type Field Length

Business Rules


Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


EMA/721630/2011 Page 396/485



CV Reference

Mandatory

Type Field Length

Business Rules



N/A N text 2500

version (1..n)



Version_number


N/A Y numeric

4

Effective_date



N alphanumeric



EMA/721630/2011 Page 397/485



CV Reference

Mandatory

Type Field Length

Business Rules

Change_made


N/A

N text 4000



Y

Comment


N Text 4000





CV [Domain]

Y text 250


EMA/721630/2011 Page 398/485



CV Reference

Mandatory

Type Field Length

Business Rules










EMA/721630/2011 Page 399/485



CV Reference

Mandatory

Type Field Length

Business Rules



N alphanumeric

250

subtype (1..n)





Y Text 250



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250


EMA/721630/2011 Page 400/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500



N

Relationship

REL.1.CV The relationship of a substance shall be defined based on a controlled vocabulary. NOTE: Target and gene elements are not to be specified in this section.


Y Text 250


EMA/721630/2011 Page 401/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: transporter, metabolic enzyme

Interaction_type



N Text 250

Substance_id


CV [Substance Name]

N Alphanumeric

12

Substance_name


CV [Substance Name]


Amount_type


CV [Amount Type]

N Text 250


EMA/721630/2011 Page 402/485



CV Reference

Mandatory

Type Field Length

Business Rules

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



EMA/721630/2011 Page 403/485



CV Reference

Mandatory

Type Field Length

Business Rules



[Unit Prefix]

numeric



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



EMA/721630/2011 Page 404/485



CV Reference

Mandatory

Type Field Length

Business Rules


ric


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250

Non_numeric_value


N alphanumeric

250



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250


EMA/721630/2011 Page 405/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: INN



CV [Source Class]

N text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

gene (0..n)




EMA/721630/2011 Page 406/485



CV Reference

Mandatory

Type Field Length

Business Rules



CV [Organism Name]

N Text 2000


CV [Gene Name]

N alphanumeric

12

Gene_name


CV [Gene Name]

Y Text 4000



Y

Public_domain


Yes /No

Y Boolean

Reference_source

RS.2.CV The type of the reference source shall be specified based on a controlled

CV

Y text 250


EMA/721630/2011 Page 407/485



CV Reference

Mandatory

Type Field Length

Business Rules

_type vocabulary. EXAMPLE: INN

[Source]



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Gene_element (0..n)


Gene_element_type

GE.1.CV The type of the gene element shall be specified based on a controlled vocabulary.

CV [Gene Element

Y Text 250


EMA/721630/2011 Page 408/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: enhancer, promoter, silencer, terminator

Type]

Gene_element_id


CV [Substance Name]

N Alphanumeric

12

Gene_element_name


CV [Substance Name]

Y Text 4000



Y

Public_domain

RS.1 It shall be specified if the reference source information is public or not.

Yes /No

Y Boolean


EMA/721630/2011 Page 409/485



CV Reference

Mandatory

Type Field Length

Business Rules

Yes or No values apply.



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Target (0..n)

RI.TRG The target section This section shall provide information on the target substance.

N This section does not apply when Substance_classification_type is equal to Specified Substance


EMA/721630/2011 Page 410/485



CV Reference

Mandatory

Type Field Length

Business Rules

It refers for genes to the target of the protein expressed by that gene. For all the other substances type it refers to the substrate of the substance. EXAMPLE: enzyme, protein/channel, receptor

Group 1, Specified Substance Group 2 and Specified substance group 3.

Target_gene_id


CV [Target Gene]

N alphanumeric

12

Target_gene_name


CV [Target Gene]

Y Text 4000

Interaction_type



Y text 250



CV [Organism type]

N Text 250


EMA/721630/2011 Page 411/485



CV Reference

Mandatory

Type Field Length

Business Rules

Target_type


CV [Target type]

N Text 250



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


EMA/721630/2011 Page 412/485



CV Reference

Mandatory

Type Field Length

Business Rules

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

constituent (1..n)

GP1.CON The constituent section The identifying characteristics of the constituent of the specified substance group 1 shall be specified. The section is repeatable to allow the description of: - the parent ID(s) of the specified substance group 1 that is always referring to Substance ID(s) - All the components of substances such as impurities, degradent, metabolite, active markers and solvent used in herbal preparations. NOTE: the constituent section shall be repeatable to describe multiple substances where each of the applicable parent IDs shall be

Y The section is mandatory if Substance_type_cv= Specified_substance_group1 It is mandatory to specify at least one constituent section with role = parent ID;


EMA/721630/2011 Page 413/485



CV Reference

Mandatory

Type Field Length

Business Rules

provided.

Substance_id

CON.1 The unique identifier assigned to the substance that constitutes the specified substance group 1 shall be defined based on controlled vocabulary. For herbals, the constituents refers to herbal markers or the herbal substance (s) which is present in the herbal preparation (e.g. Sennosides A; Senna Acutifolia et Senna Angustifolia leaf tincture) For vaccines, the constituents refer to adjuvant (s). For multiple substances, the constituent refers to the substances complexed together to form the final multiple substance (e.g. Insulin human and protamine are constituents of the Insulin Isophane) NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 414/485



CV Reference

Mandatory

Type Field Length

Business Rules

submission of the substance this data element is not required.

Substance_name

CON.2 The name of the substance which is the constituent of the specified substance group 1 shall be described.

CV [Substance Name]

Y Text 4000

Substance_role

CON.3.CV The role of the substance in the specified substance shall be described based on a controlled vocabulary. An impurity component is not described in the Specified Substance Group 1. The parent ID of a specified substance group 1 shall always be specified. EXAMPLE: active marker, component, degradent, metabolite, active moiety

CV [Constituent Role]

Y Text 250 The constituent section shall be present as mandatory with a role=Parent ID

Amount_type

CON.4.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250

amount (0..1)

CON.AMT The amount section N


EMA/721630/2011 Page 415/485



CV Reference

Mandatory

Type Field Length

Business Rules

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



EMA/721630/2011 Page 416/485



CV Reference

Mandatory

Type Field Length

Business Rules

t_numerator_value


ric




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit

N alphanumeric

250


EMA/721630/2011 Page 417/485



CV Reference

Mandatory

Type Field Length

Business Rules

Prefix]



N alphanumeric

250

Non_numeric_value


N alphanumeric

250

Property (0..n)

GP1.PROP The property section The characteristics of the property shall be described.

N

Property_type

PROP.1.CV The type of property shall be specified based on a controlled vocabulary. EXAMPLE: physical, chemical, enzymatic, immunological

CV [Property Type]

Y Text 250

Property_name


CV [Parameter]

Y Text 250

Substance_id

PROP.3 The identifier of the substance related to a defining property shall be described where applicable and based on controlled vocabulary.

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 418/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: solubility in Water, Water ID shall be specified NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

Substance_name


CV [Substance Name]

N Text 4000

Amount_type


CV [Amount Type]

N Text 250

amount (1..1)


Quantity Operator

AMT.1.CV CV

N text 250


EMA/721630/2011 Page 419/485



CV Reference

Mandatory

Type Field Length

Business Rules

[Quantity Operator]



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10


EMA/721630/2011 Page 420/485



CV Reference

Mandatory

Type Field Length

Business Rules




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV The applicable unit for the average shall be specified based on a

CV

N alphanume

250


EMA/721630/2011 Page 421/485



CV Reference

Mandatory

Type Field Length

Business Rules

controlled vocabulary.

[Unit of Measure]

ric

Non_numeric_value


N alphanumeric

250

physical_form (0..n)

GP1.PF The physical form section The characteristics of the physical form of the specified substance shall be described. It is required to provide the physical form information when applicable.

N

Physical_state

PF.1.CV The physical form shall be specified based on a controlled vocabulary. EXAMPLE: solid, liquid

CV [Physical state]

Y Text 250 If a physical_form of the specified substance is applicable, the “physical_state” should be specified.

Physical_form_type

PF.2.CV The physical form type shall be specified based on a controlled vocabulary. EXAMPLE: crystaline, amorphous, tincture, dry, extract

CV [Physical Form]

Y Text 250

Amount_type

PF.3.CV The type of the amount of the substance shall be specified using a controlled vocabulary.

CV [Amount Type]

N Text 250


EMA/721630/2011 Page 422/485



CV Reference

Mandatory

Type Field Length

Business Rules

amount (0..1)

PF.AMT The amount section N

Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



EMA/721630/2011 Page 423/485



CV Reference

Mandatory

Type Field Length

Business Rules



[Unit Prefix]

numeric



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



EMA/721630/2011 Page 424/485



CV Reference

Mandatory

Type Field Length

Business Rules


ric


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


GP1.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250


EMA/721630/2011 Page 425/485



CV Reference

Mandatory

Type Field Length

Business Rules

EXAMPLE: INN



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500


EMA/721630/2011 Page 426/485




Ref Code Data Element Description and Notes CV Reference

Mandatory

Type Field Length

Business Rules


SPCFD.GP2

The specified substance group 2 section The identifying characteristics for the specified substance group 2 shall be specified.





Y Text 250

Language


CV [Language]

Y text 3 Note: ISO 639-2 is the alpha-3 code in Codes for the representation of names of languages-- Part 2. There are 21 languages that have alternative codes for bibliographic or terminology purposes. In those cases, each is listed separately and they are designated as "B" (bibliographic) or "T" (terminology). For the purpose of describing “Language”, “T” shall be


EMA/721630/2011 Page 427/485



Mandatory

Type Field Length

Business Rules

used. In all other cases there is only one ISO 639-2 code. Multiple codes assigned to the same language are to be considered synonyms.



N Alphanumeric

12


GP2.2 The name of the specified substance group 2 shall be described. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

N/A Y Text 4000


EMA/721630/2011 Page 428/485



Mandatory

Type Field Length

Business Rules

Parent_substance_id

GP2.3 The unique identifier assigned to the substance that is the parent of the specified substance shall be provided based on controlled vocabulary. The ID of the parent for the specified substance group 1 may refer to either a substance ID or a specified substance group 1 ID. NOTE: If a unique “ID” (EVCODE) has been assigned by the EMA, this “ID” shall be specified based on the Substance Name CV. In the absence of a unique “ID” e. g. for the initial submission of specified substance and parent substance, the name of the parent substance shall be specified.

CV [Substance Name]

Y Alphanumeric

4000


COM.SNM The substance name section This section contains the set of elements for the description of the name of the substance. The latest version of the Naming Conventions document (Ref. Doc.:

Y


EMA/721630/2011 Page 429/485



Mandatory

Type Field Length

Business Rules

EMA/720247/2011) shall be followed.

Substance_name


Y Text 4000

Substance_name_type



Y text 250

Language


CV [Language]

Y text 3 Note: ISO 639-2 is the alpha-3 code in Codes for the representation of names of languages-- Part 2. There are 21 languages that have alternative codes for bibliographic or terminology purposes. In those cases, each is listed separately and they are designated as "B" (bibliographic) or "T" (terminology). For the purpose of describing “Language”, “T” shall be used. In all other cases there is


EMA/721630/2011 Page 430/485



Mandatory

Type Field Length

Business Rules

only one ISO 639-2 code. Multiple codes assigned to the same language are to be considered synonyms.



Official_name_type


CV [Source]

Y text 250



CV [Status]

Y text 250


ON.3 The change date of the status of the official name shall be specified in line with the ISO 8601 date format, which shall be only entered when name is changed.


N alphanumeric

10 ISO 8601 advises numeric representation of dates and times on an internationally agreed basis.


EMA/721630/2011 Page 431/485



Mandatory

Type Field Length

Business Rules

EXAMPLE: 2011-06-01

It represents elements from the largest to the smallest element: e.g. year-month-day YYYY-MM-DD





CV [Domain]

Y Text 250




Official_name_juri

JUR.1.CV The jurisdiction of the official name shall be provided based on ISO 3166-1

CV

Y Text 3


EMA/721630/2011 Page 432/485



Mandatory

Type Field Length

Business Rules

sdiction alpha-2 codes with two exceptions: EL (not GR) is used to represent Greece, and UK (not GB) is used to represent the United Kingdom. For the European Union EU shall be used.

[Country Code]



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


EMA/721630/2011 Page 433/485



Mandatory

Type Field Length

Business Rules

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500



N


N/A Y alphanumeric

500

Code_system


CV

Y

Text 250


EMA/721630/2011 Page 434/485



Mandatory

Type Field Length

Business Rules

[Code System]

Code_system_id


CV [Code System]

N alphanumeric

12

Code_system_status


CV [Status]

Y text 250




N alphanumeric


Commen SC.6 Any comment can be provided in this N Text 4000


EMA/721630/2011 Page 435/485



Mandatory

Type Field Length

Business Rules

t field, if necessary.



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


EMA/721630/2011 Page 436/485



Mandatory

Type Field Length

Business Rules



N/A N text 2500

version (1..n)



Version_number


N/A Y numeric

4

Effective_date



N alphanumeric

10 ISO 8601 advises numeric representation of dates and times on an internationally agreed basis. It represents elements from the largest to the smallest


EMA/721630/2011 Page 437/485



Mandatory

Type Field Length

Business Rules

element: e.g. year-month-day YYYY-MM-DD

Change_made


N/A

N text 4000



Y

Comment


N Text 4000





CV [Domain]

Y text 250


EMA/721630/2011 Page 438/485



Mandatory

Type Field Length

Business Rules






SCLF.3.CV The type of the substance shall be provided based on a controlled vocabulary. NOTE: When Substance_Classification=mixture and the substances that are forming the mixture are of the same class, the class of those substances shall be specified in this field. EXAMPLE: two chemicals forming the mixture, specified_classification_type = chemical If the substances that are forming the mixture are of a different class, the value ‘mixture’ shall be specified in this field. EXAMPLE: One polymer combined in a




EMA/721630/2011 Page 439/485



Mandatory

Type Field Length

Business Rules

protein, Specified_classification_type =mixture



N alphanumeric

250

subtype (1..n)





Y Text 250



Y

Public_domain


Yes /No

Y Boolean

Reference_source

RS.2.CV The type of the reference source shall be specified based on a controlled

CV

Y text 250


EMA/721630/2011 Page 440/485



Mandatory

Type Field Length

Business Rules

_type vocabulary. EXAMPLE: INN

[Source]



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500



N

Relationship

REL.1.CV The relationship of a substance shall be defined based on a controlled

CV

Y Text 250


EMA/721630/2011 Page 441/485



Mandatory

Type Field Length

Business Rules

vocabulary. NOTE: Target and gene elements are not to be specified in this section. EXAMPLE: transporter, metabolic enzyme

[relationship type]

Interaction_type



N Text 250

Substance_id


CV [Substance Name]

N Alphanumeric

12

Substance_name


CV



EMA/721630/2011 Page 442/485



Mandatory

Type Field Length

Business Rules

[Substance Name]

Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250

Low_limit_denominator_val


N Numeric

10


EMA/721630/2011 Page 443/485



Mandatory

Type Field Length

Business Rules

ue




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10

High_limit_


CV

N alphanume

250


EMA/721630/2011 Page 444/485



Mandatory

Type Field Length

Business Rules

denominator _unit

[Unit of Measure]

ric



CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10


CV [Unit Prefix]

N alphanumeric

250



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


REL.RS The reference source section This section describes the reference source information. For each “Substance Name” a

Y


EMA/721630/2011 Page 445/485



Mandatory

Type Field Length

Business Rules

“Reference Source” shall be specified.

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500


EMA/721630/2011 Page 446/485



Mandatory

Type Field Length

Business Rules

gene (0..n)





CV [Organism Name]

N Text 2000


CV [Gene Name]

N alphanumeric

12

Gene_name


CV [Gene Name]

Y Text 4000

reference_source

GN.RS The reference source section This section describes the reference

Y


EMA/721630/2011 Page 447/485



Mandatory

Type Field Length

Business Rules

(1..n) source information. For each “Substance Name” a “Reference Source” shall be specified.

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


RS.5 The textual description of the reference source within the literature or regulatory document shall be described. EXAMPLE: Ph.E. 7.1, p.34

N/A N text 2500


EMA/721630/2011 Page 448/485



Mandatory

Type Field Length

Business Rules

Literature reference: Encycl. 3: 429 (1792)

Gene_element (0..n)


Gene_element_type



Y Text 250

Gene_element_id


CV [Substance Name]

N Alphanumeric

12

Gene_element_na

GE.3 The specific gene element name shall be described based on a controlled

CV

Y Text 4000


EMA/721630/2011 Page 449/485



Mandatory

Type Field Length

Business Rules

me vocabulary.

[Substance Name]



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


EMA/721630/2011 Page 450/485



Mandatory

Type Field Length

Business Rules



N/A N text 2500

Target (0..n)

RI.TRG The target section This section shall provide information on the target substance. It refers for genes to the target of the protein expressed by that gene. For all the other substances type it refers to the substrate of the substance. EXAMPLE: enzyme, protein/channel, receptor


Target_gene_id


CV [Target Gene]

N alphanumeric

12

Target_gene_name

TRG.2 The target gene name shall be specified based on a controlled vocabulary.

CV [Target

Y Text 4000


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Mandatory

Type Field Length

Business Rules

EXAMPLE: single substance, an enzyme type

Gene]

Interaction_type



Y text 250



CV [Organism type]

N Text 250

Target_type


CV [Target type]

N Text 250



Y

Public_domain


Yes /No

Y Boolean


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Mandatory

Type Field Length

Business Rules



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Manufacturing (1..1)

GP2.MANU The manufacturing section The main characteristics in relation to the manufacturing of the substance shall be specified.

Y The section is mandatory if Substance_type_cv= Specified_substance_group2


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Mandatory

Type Field Length

Business Rules

Manufacturer_id

MANU.1 The unique code used to track manufacturers shall be provided.

N/A Y Alphanumeric

12

Manufacturer_name

MANU.2.CV

The name of the manufacturer of the specified substance shall be provided.

CV [Manufacturer Name]

Y Text 2000

Manufacturing_type

MANU.3.CV

The type of the manufacturer shall be provided based on a controlled vocabulary.

CV [Manufacturing Type]

Y Text 250

Production_method_type

MANU.4.CV

The type of the production method shall be provided based on a controlled vocabulary. EXAMPLE: synthetic, extractive, semisynthetic, biosynthetic, etc

CV [Production Method] Or [Herbal Production Method]

Y Text 250 When Substance_class_subtype= Herbal, the [Herbal Production Method] CV applies. For all the other subtype, [Production Method] CV applies.

Production_system_type

MANU.5.CV

The type of the production system shall be provided based on a controlled vocabulary. EXAMPLE: cell line, animal, tissue, egg

CV [Production System Type]

Y Text 250

Production_syste

MANU.6.CV

The production system description shall be provided when available.

CV

N Text 250


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Mandatory

Type Field Length

Business Rules

m EXAMPLE: cho cell, goat, bovine lungs The production system does not apply to Herbals.

[Production System]


MANU.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


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Mandatory

Type Field Length

Business Rules

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500





Mandatory

Type Field Length

Business Rules


SPCFD.GP3

The specified substance group 3 section The identifying characteristics of the specified substance group 3 shall be provided.



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Mandatory

Type Field Length

Business Rules




Y Text 250

Language

SUB.LANG

The language used to provide the structure substance information shall be specified according to ISO 639-2 alpha-3 codes. EXAMPLE: eng – English deu (T) - German

CV [Language]



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Mandatory

Type Field Length

Business Rules



N Alphanumeric

12


GP3.2 The name of the specified substance group 3 shall be described. The latest version of the Naming Conventions document (Ref. Doc.: EMA/720247/2011) shall be followed.

N/A

Y Text 4000

Parent_substance_id

GP3.3 The unique identifier assigned to the substance that is the parent of the specified substance shall be provided based on controlled vocabulary. The ID of the parent for the specified substance group 3 may refer to either a substance ID or specified substance

CV [Substance Name]

Y Alphanumeric

4000


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Mandatory

Type Field Length

Business Rules

group 1 ID. NOTE: If a unique “ID” (EVCODE) has been assigned by the EMA, this “ID” shall be specified based on the Substance Name CV. In the absence of a unique “ID” e. g. for the initial submission of specified substance and parent substance, the name of the parent substance shall be specified.



Y

Substance_name


Y Text 4000

Substance_name_type

SNM.2.CV The type of the name shall be specified based on a controlled vocabulary.

CV [Substance

Y text 250


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Mandatory

Type Field Length

Business Rules

EXAMPLE: Official name, Code

Name Type]

Language


CV [Language]


official_name

SNM.ON The official name section N If “Official Name” has been specified in “Substance_Name_Type” this


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Mandatory

Type Field Length

Business Rules

(0..n) section is mandatory. For any other name type, the section is present as not mandatory.

Official_name_type


CV [Source]

Y text 250



CV [Status]

Y text 250




N alphanumeric


official_name_domai

ON.DOM Y If “Official Name” has been specified in “Substance Name


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Mandatory

Type Field Length

Business Rules

n (1..n)

Type” this section is mandatory. Each “Official Name” shall have at least one “Official Name Domain”.



CV [Domain]

Y Text 250






CV [Country Code]

Y Text 3


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Mandatory

Type Field Length

Business Rules



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


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Mandatory

Type Field Length

Business Rules



N/A N text 2500



N


N/A Y alphanumeric

500

Code_system


CV [Code System]

Y

Text 250

Code_sys SC.3.CV The identifier for the code system shall CV N alpha 12


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Mandatory

Type Field Length

Business Rules

tem_id be provided based on a controlled vocabulary.

[Code System]

numeric

Code_system_status


CV [Status]

Y text 250




N alphanumeric


Comment


N Text 4000

reference_ SC.RS The reference source section Y


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Mandatory

Type Field Length

Business Rules

source (1..n)


Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


EMA/721630/2011 Page 466/485



Mandatory

Type Field Length

Business Rules



N/A N text 2500

version (1..n)



Version_number


N/A Y numeric

4

Effective_date



N alphanumeric

10 ISO 8601 advises numeric representation of dates and times on an internationally agreed basis. It represents elements from


EMA/721630/2011 Page 467/485



Mandatory

Type Field Length

Business Rules

the largest to the smallest element: e.g. year-month-day YYYY-MM-DD

Change_made


N/A

N text 4000



Y

Comment


N Text 4000




Domain SCLF.1.CV

The domain of the substance classification shall be provided based on a controlled vocabulary.

CV [Domain]

Y text 250


EMA/721630/2011 Page 468/485



Mandatory

Type Field Length

Business Rules

EXAMPLE: Human Pharmaceuticals


SCLF.2.CV

Type of substance based on a controlled vocabulary. EXAMPLE: Single, Mixture




SCLF.3.CV

The type of the substance shall be provided based on a controlled vocabulary. NOTE: When Substance_Classification=mixture and the substances that are forming the mixture are of the same class, the class of those substances shall be specified in this field. EXAMPLE: two chemicals forming the mixture, specified_classification_type = chemical If the substances that are forming the mixture are of a different class, the value ‘mixture’ shall be specified in this field.




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Mandatory

Type Field Length

Business Rules

EXAMPLE: One polymer combined in a protein, Specified_classification_type =mixture



N alphanumeric

250

subtype (1..n)





Y Text 250



Y

Public_domain


Yes /No

Y Boolean


EMA/721630/2011 Page 470/485



Mandatory

Type Field Length

Business Rules



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

substance_relationship

RI.REL The substance relationship This section shall provide information related to relationship of a substance,

N


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Mandatory

Type Field Length

Business Rules

(0..n)

where this is applicable.

Relationship



Y Text 250

Interaction_type



N Text 250

Substance_id

REL.3 The substance identifier, for which the relationship is specified, shall be described. NOTE: If a unique “Substance ID” (EVCODE) has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 472/485



Mandatory

Type Field Length

Business Rules

required.

Substance_name


CV [Substance Name]


Amount_type


CV [Amount Type]

N Text 250

amount (0..1)


Quantity Operator


N text 250



N Numeric

10




N alphanumeric

250

Low_limi AMT.4.CV The prefix of the lower limit unit of the CV N alpha 250


EMA/721630/2011 Page 473/485



Mandatory

Type Field Length

Business Rules

t_numerator_unit_prefix


[Unit Prefix]

numeric



N Numeric

10




N alphanumeric

250



CV [Unit Prefix]

N alphanumeric

250



N Numeric

10




N alphanumeric

250


AMT.10.CV


CV [Unit Prefix]

N alphanumeric

250


EMA/721630/2011 Page 474/485



Mandatory

Type Field Length

Business Rules



N Numeric

10


AMT.12.CV



N alphanumeric

250


AMT.13.CV


CV [Unit Prefix]

N alphanumeric

250

Average


N Numeric

10

Prefix AMT.15.CV


CV [Unit Prefix]

N alphanumeric

250

Unit AMT.16.CV



N alphanumeric

250

Non_numeric_value


N alphanumeric

250


EMA/721630/2011 Page 475/485



Mandatory

Type Field Length

Business Rules



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


EMA/721630/2011 Page 476/485



Mandatory

Type Field Length

Business Rules



N/A N text 2500

gene (0..n)





CV [Organism Name]

N Text 2000


CV [Gene Name]

N alphanumeric

12


EMA/721630/2011 Page 477/485



Mandatory

Type Field Length

Business Rules

Gene_name


CV [Gene Name]

Y Text 4000



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250


EMA/721630/2011 Page 478/485



Mandatory

Type Field Length

Business Rules

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Gene_element (0..n)


Gene_element_type



Y Text 250

Gene_element_id

GE.2 The unique identifier for the gene element shall be specified based on a controlled vocabulary. NOTE: If a unique “Substance ID” (EVCODE)

CV [Substance Name]

N Alphanumeric

12


EMA/721630/2011 Page 479/485



Mandatory

Type Field Length

Business Rules

has been assigned by the EMA, this “Substance ID” shall be specified based on the Substance Name CV. In the absence of a unique “Substance ID” e. g. for the initial submission of the substance this data element is not required.

Gene_element_name


CV [Substance Name]

Y Text 4000



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250


EMA/721630/2011 Page 480/485



Mandatory

Type Field Length

Business Rules

EXAMPLE: INN



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12



N/A N text 2500

Target (0..n)

RI.TRG The target section This section shall provide information on the target substance. It refers for genes to the target of the protein expressed by that gene. For all the other substances type it refers



EMA/721630/2011 Page 481/485



Mandatory

Type Field Length

Business Rules

to the substrate of the substance. EXAMPLE: enzyme, protein/channel, receptor

Target_gene_id


CV [Target Gene]

N alphanumeric

12

Target_gene_name


CV [Target Gene]

Y Text 4000

Interaction_type



Y text 250



CV [Organism type]

N Text 250

Target_type


CV [Target

N Text 250


EMA/721630/2011 Page 482/485



Mandatory

Type Field Length

Business Rules

EXAMPLE: enzyme, receptor, membrane type]



Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


EMA/721630/2011 Page 483/485



Mandatory

Type Field Length

Business Rules



N/A N text 2500

Grade (1..1)

GP3.GRD The grade section The characteristics of the grade of the substance shall be specified.

Y The section is mandatory if Substance_type_cv= Specified_substance_group3

Grade_type

GRD.1.CV The type of the grade shall be provided based on a controlled vocabulary.

CV [Grade Type]

Y Text

250

Grade_name

GRD.2 The name of the grade as specified in the monograph shall be provided. EXAMPLE: purified water, water for injection, Insulin Human Injection

N/A Y Text 4000

Grade_reference_source

GRD.3 The specific reference to a monograph source shall be provided. EXAMPLE: For Insulin zinc injectable suspension (crystalline) monograph. Ph. Eu. Ed 7th

N/A

Y Text

4000


EMA/721630/2011 Page 484/485



Mandatory

Type Field Length

Business Rules

2011 (7.2)


GRD.RS The reference source section This section describes the reference source information. For each “Substance Name” a “Reference Source” shall be specified.

Y

Public_domain


Yes /No

Y Boolean



CV [Source]

Y text 250



CV [Source Class]

Y text 250

Reference_source_id


N/A N alphanumeric

12


EMA/721630/2011 Page 485/485



Mandatory

Type Field Length

Business Rules



N/A N text 2500

Documents

Detailed guidance on the electronic submission of ... · 9/1/2011 · Detailed guidance on the electronic submission of information on medicinal products for human use by marketing