1

ICH Consensus Guideline 

Released for Consultation on 10 May 2005, 

at Step 2 of the ICH Process 

 

Data Elements and Standards for Drug 

Dictionaries 

M5 

Recommended for Adoption 

at Step 2 of the ICH Process 

on 10 May 2005 

by the ICH Steering Committee 

This guideline has been developed by the appropriate ICH Expert 

Working Group and is subject to consultation in accordance with the 

ICH process. 

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) 

current thinking on this topic. It does not create or confer any rights for or on any person and does not 

operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the 

requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, 

contact the FDA staff responsible for implementing this guidance. If you cannot identify the 

appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 

For questions regarding this draft document contact (CDER) Randy Levin at 301-827-7784 

or (CBER) Ann Schwartz at 301-827-3070. 
 3

Table of Content 

1. INTRODUCTION............................................................................................................ 4 

1.1 Objectives of the Guideline ................................................................................. 4 

1.2 Background.............................................................................................................. 5 

1.3 Scope of the Guideline.......................................................................................... 5 

2. GUIDELINE..................................................................................................................... 6 

2.1 Medicinal Product and Term Identifiers ......................................................... 6 

2.1.1 Medicinal Product Identifier (MedID)..................................................... 6 

2.1.2 Pharmaceutical Product Identifier (PhPID) .......................................... 7 

2.1.3 Controlled Vocabulary Term Identifier (TermID)................................ 7 

2.2 Controlled Vocabulary .......................................................................................... 8 

2.2.1 Background.................................................................................................... 8 

2.2.2 Active Ingredients Controlled Vocabulary............................................ 8 

2.2.3 Pharmaceutical Dose Form Controlled Vocabulary........................ 10 

2.2.4 Routes of Administration Controlled Vocabulary............................ 11 

2.2.5 Units and Measurements Controlled Vocabulary............................ 12 

2.3 Data Elements....................................................................................................... 13 

2.3.1 Medicinal Product Identifier.................................................................... 15 

2.3.2 Medicinal Product Administrative Section......................................... 15 

2.3.3 Marketing Authorization Holder/Manufacturer/Distributor 

Section 17 

2.3.4 Marketing Authorization Section........................................................... 18 

2.3.5 Pharmaceutical Product Section ........................................................... 20 

2.3.6 Active Ingredient(s) Section..................................................................... 21 

2.3.7 Pharmaceutical Dose Form Section ..................................................... 24 

2.3.8 Route of Administration Section ........................................................... 25 

2.3.9 Maintenance Section................................................................................. 25 

3. GLOSSARY.................................................................................................................... 27 

4. REFERENCES ............................................................................................................. 29 
 4

Data Elements and Standards for Drug 

Dictionaries 

1. INTRODUCTION 

1.1 Objectives of the Guideline 

It is desirable for regulators and pharmaceutical industry to engage in an 

intensive information exchange during the drug development phase, the drug 

evaluation and approval phase and the post-authorization phase. The 

standardization of medicinal product information is regarded as one of the key 

elements of this information flow. 

However, regulators in the ICH regions and observer countries have established 

their own procedures and applications with standards that differ in data format, 

content, language and applied terminology (e.g. terminology used for active 

ingredients, routes of administration, pharmaceutical dose forms). 

Due to the lack of a common and harmonized approach, both regulators and 

pharmaceutical industry are confronted with the following issues: 

- No possibility to exchange medicinal product information between 

regulators and industry in a structured and efficient way; 

- Difficulties in ensuring data consistency and in evaluating and comparing 

medicinal product-related information across the ICH regions due to the 

lack of harmonized definitions of terminologies and data sets. This 

currently impairs pharmacovigilance activities in particular; 

- For the pharmaceutical industry, major administrative burdens and 

duplication of efforts requiring substantial human and financial 

resources to comply with and handle different regional requirements. 

- Lack of consistency in the use of terminology in the health care 

community. 

The objectives of this guideline are to address the issues outlined above by 

developing harmonized standards that build on the processes currently 

established in the three ICH regions and the observer countries and to support 

the population of existing systems/applications with fully reliable regulatory 

medicinal product information. More specifically, the objectives focus on the 

development of: 

- ‘Unique identifiers’ at the level of 

 Medicinal products: Medicinal Product Identifiers (MedIDs) 

 Pharmaceutical products: Pharmaceutical Product Identifiers 

(PhPIDs) 

 The controlled vocabulary: Terminology Identifiers (TermIDs) 

- ‘Controlled vocabulary’ as a standard for the electronic transmission of 

core sets of medicinal product information related to the following 

terminologies: 
 5

 Active ingredients 

 Pharmaceutical dose forms 

 Routes of administration 

 Units and measurements 

- ‘Data elements’ for the electronic transmission of core sets of medicinal 

product information based on the following data set: 

 Proprietary medicinal product name 

 Active ingredient(s) 

 Pharmaceutical dose form(s) 

 Strength of the active ingredient(s) 

 Route(s) of administration 

 Marketing authorization holder 

 Marketing authorization number 

 Country of authorization 

The ‘Data elements’ have been developed for the electronic transmission 

of MedIDs and the related core medicinal product information. 

This guideline does not cover the establishment and maintenance of a drug 

dictionary. 

1.2 Background 

The lack of internationally harmonized standards related to core sets of 

medicinal product information and medicinal product terminology is hindering 

the scientific evaluation and comparison of product data as well as healthcare. 

This applies in particular to the area of pharmacovigilance, where the exchange 

and management of medicinal product information in expedited and periodic 

adverse reaction reports at the international level is a key aspect of ensuring 

drug safety. 

This document provides guidance on the harmonized standards that are being 

proposed by the ICH M5 EWG to facilitate the exchange and practical use of 

medicinal product data by regulators and pharmaceutical industry. 

1.3 Scope of the Guideline 

This guideline refers to approved medicinal products. Homeopathic medicinal 

products and investigational medicinal products are excluded from this 

guideline. 

 
 6

2. GUIDELINE 

2.1 Medicinal Product and Term Identifiers 

2.1.1 Medicinal Product Identifier (MedID) 

Definition: 

 An identifier assigned to a medicinal product by the regulator of the 

country/territory of authorization. 

General Conventions: 

 The regulators in the regions and observer countries have various 

processes established to identify individual medicinal products. 

Because medicinal product information is exchanged 

internationally, worldwide unique medicinal product identifiers 

(MedIDs) are desirable. 

Regulators intend to assign MedIDs as follows: 

 At the ‘medicinal product level’, which means that a 

specific medicinal product has only one identifier for 

different pack sizes. 

For example, the medicinal product ‘TRADENAME X’ has 

the same MedID related to two different presentations; a 

pack size of 50 tablets and a pack size of 100 tablets. 

or 

 At ‘medicinal product package level’, which means that 

for each package presentation of the medicinal product a 

different MedID is assigned. 

For example, the medicinal product ‘TRADENAME Y’ has 

two different MedIDs for each of the two different 

presentations available: a MedID for the pack size of 50 

tablets and a MedID for the pack size of 100 tablets. 

Methodology:

 The world-wide unique MedID is constructed as follows: 

 Prefix of the country code of that region followed by 

 The regionally-assigned identifier followed by 

 An error detection code 

The regionally-assigned identifier refers to the medicinal product 

level or to the medicinal product package level. As a general rule, 

the MedID should accompany the exchange of the medicinal 

product information. 
 7

Examples: 

 EU-EU/1/2342323/001-K 

FR-123456-X 

JP-123456789-Y 

US-0123456789-Z 

 CA-2323232-V 

2.1.2 Pharmaceutical Product Identifier (PhPID) 

Definition: 

 An identifier assigned at the level of the pharmaceutical product 

based on the active ingredient(s), the strength(s) of the ingredient(s) 

and the pharmaceutical dose form. 

Methodology: 

 PhPIDs represent the pharmaceutical product at four levels as 

defined as follows: 

- PhPID4 = Ingredient(s) - Strength(s) - Strength unit(s) - 

 Pharmaceutical Dose Form 

- PhPID3 = Ingredient(s) - Pharmaceutical Dose Form 

- PhPID2 = Ingredient(s) - Strength(s) - Strength unit(s) 

- PhPID1 = Ingredient(s) 

Each PhPID is a unique, non-semantic, alphanumeric code and is 

derived from the ICH M5 data elements, but is not part of these 

data elements. 

Examples:

Medicinal products with the same active ingredients, strengths and 

pharmaceutical dose form share a common PhPID4. 

Medicinal products with the same active ingredients and 

pharmaceutical dose form share a common PhPID3. 

Medicinal products with the same active ingredients and strengths 

share a common PhPID2. 

Medicinal products with the same active ingredients share a 

common PhPID1. 

2.1.3 Controlled Vocabulary Term Identifier (TermID) 

Definition: 

 An identifier assigned at the level of each term of the controlled 

vocabulary (active ingredients, pharmaceutical dose forms, routes of 

administrations and units and measurements). 

Methodology: 

 The TermID is a unique, non-semantic, alphanumeric code assigned 

for each term of the controlled vocabulary. 
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2.2 Controlled Vocabulary 

2.2.1 Background 

Different regulatory standard terminologies are in place in the ICH regions and 

observer countries, which makes it difficult to exchange this information at the 

international level. These terminology differences complicate specifically 

activities in the area of pharmacovigilance and healthcare and the management 

of medicinal product information. 

To address the identified terminology differences, the ICH M5 EWG is developing 

controlled vocabularies for active ingredient(s), pharmaceutical dose form(s), 

route(s) of administrations and unit(s) and measurement(s) using the following 

methodology: 

- Preparing an inventory of the different regulatory standard terminologies 

including those defined in the ICH E2B(M) guideline (version 4.4.1 

includes the Post Step 4 corrections agreed by the Steering Committee on 

5 February 2001); 

- Analyzing definitions for the different regulatory standard terminologies; 

- Developing a controlled vocabulary that supports good terminological 

practice; 

- Defining mapping procedures to determine unique terms and related 

synonym terms on the basis of the regional definitions in place; 

- Mapping the individual terms; 

- Assigning unique TermIDs. 

The Active Ingredients Controlled Vocabulary, the Pharmaceutical Dose Forms 

Controlled Vocabulary, the Routes of Administration Controlled Vocabulary and 

the Units and Measurements Controlled Vocabulary will be made available on 

the ICH website. 

2.2.2 Active Ingredients Controlled Vocabulary 

Scope: 

The Active Ingredients Controlled Vocabulary includes active ingredient 

terms related to approved medicinal products. Excluded are active 

ingredients related to homeopathic medicinal products and investigational 

medicinal products. 

Definitions: 

An active ingredient is defined as a substance that alone or in combination 

with one or more other ingredients produces the intended activity of a 

medicinal product. 

A substance is any matter and can be of human, animal, vegetable or 

chemical (natural, semi-synthetic or synthetic) origin. 

An active moiety is the portion of the active ingredient that is responsible 

for the effect. 
 9

Methodology: 

A comprehensive list of active ingredient terms has been collected based on 

the standard terminologies currently used by the EMEA, FDA, MHLW and 

Health Canada. 

The active ingredient terms are limited to English language terms, with the 

exception of herbal active ingredients, for which the Latin language terms 

and/or Japanese language terms are also included. 

Within the list, the indication of the provenance of the term (i.e. its source) is 

also included. 

An active ingredient TermID will be assigned to each unique term. 

The following approach will be used for the mapping: 

- Chemical Abstract Service Number (CAS Number) 

- Reference Source for each active ingredient name (e.g. USAN, INN, 

JAN) that is linked to the chemical structure by the organizations 

- Chemical name (e.g. following the IUPAC nomenclature) 

Mapping of synonyms will be performed on the level of both the active moiety 

and the active ingredient where applicable. 

Herbal substances will be mapped on the following principles: 

- Botanical scientific name according to the Latin binomial system 

(genus + species) 

- The author (e.g., Linnaeus, abbreviated L.) if known, 

- The plant parts (if known) and 

- The process (when applicable, and if known) 

Herbal preparations will be mapped on the basis of the standardized 

treatments (for instance extraction, distillation, expression, fractionation, 

purification, concentration or fermentation) as described in the official 

Pharmacopoeias of the three regions. For extractions, the solvent will also be 

specified. 

For vaccine antigens the mapping of active substances will be based on the 

following principles: 

- Conformity with the pharmacopoeia monograph terminology for 

vaccine antigens in the regions; 

- For non-pharmacopoeia active substances, according to the formal 

Latin/Greek name and/or the disease being protected against. 

 

For bacteria and viruses, the strain serotype or other appropriate subspecies the designation will also be mapped with the name of each antigen, if 

relevant. 

In addition, the nature of any cellular system(s) used for production, and if 

relevant the use of recombinant DNA technology (including the use of the 

expression ‘produced in XXX cells <by recombinant DNA technology>) will be 

mapped, following the pattern set by the following examples: 

- ‘produced in human diploid (MRC-5) cells’ 

- ‘produced in Escherichia coli cells by recombinant DNA technology’ 

- ‘produced in chick-embryo cells’ 
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The inclusion of a mention of the production process in vaccine active 

substance names will be mapped at the level of the following terms: 

- ‘live, attenuated’ (in the case of vaccines containing living microorganisms) 

- ‘inactivated’ (in the case of vaccines containing killed microorganisms). 

2.2.3 Pharmaceutical Dose Form Controlled Vocabulary 

Scope: 

The Pharmaceutical Dose Form Controlled Vocabulary includes 

pharmaceutical dose form terms of standard terminologies in use by the 

regulators in the ICH regions and observer countries. 

Definitions: 

A Dose Form is defined as the physical manifestation [“entity”] that 

contains the active and/or inactive ingredients that deliver a dose of the 

medicinal product. The key defining characteristics of the Dose Form 

can be the state of matter, delivery method, release characteristics, and 

the administration site or route for which the product is formulated. 

A Pharmaceutical Dose Form is the form in which a pharmaceutical 

product is presented in the medicinal product package as supplied by the 

marketing authorization holder/manufacturer/distributor. 

Methodology:

A comprehensive list of Dose Form terms has been collected, which 

includes: 

- European Pharmacopoeia Standard terms 

- United States Pharmacopeia (USP) terms 

- Japanese Pharmacopoeia terms 

- MHLW terms 

- Health Canada terms 

Within the list, the indication of the provenance of the term (i.e. its 

source) will also be included. 

Tasks to be undertaken include: 

- A term identifier will be allocated to each term (entry) in the list, 

enabling linkage with original dose form lists. 

- Each term will initially be identified as a “dose form concept”, 

pending identification of synonymy. 

- Synonymous terms will be identified and “annotated” e.g. “otic 

drops” and “ear drops”. 

- Terms that do not fit (for example, device terms) will be identified 

and annotated, as will be all terms that do not fit within the 

agreed definition (for example, dose forms that describe aspects of 

medication such as strength or shape or indication). 

- Each of the “dose form concepts” will be analyzed against the 

agreed defining characteristics to create a logical description 

pattern. This pattern will assist in the identification of 

unrecognized synonymy and hence will ensure that the resulting 
 11

Dose Form concepts are unique and unambiguous. A description 

logic will enable concepts to be defined by the pattern or “graph” of 

their relationships with other concepts. 

- Having analyzed all the “dose form concepts”, any concepts found 

to be sharing an identical “set” of characteristics will again be 

reviewed; additional “distinguishing” characteristics will be added 

as appropriate. 

The dose form description applies to only one concept at a time. 

Therefore, items that are marketed as packs containing more than one 

medicinal product will not themselves have a “combination dose form”, 

but each medicinal product within them will have a dose form 

description. This will avoid terms such as “pessary + cream” or “powder 

+ solvent”. 

2.2.4 Routes of Administration Controlled Vocabulary 

Scope: 

The Routes of Administration Controlled Vocabulary includes routes of 

administration terms of standard terminologies in use by the regulators 

in the ICH regions and observer countries and defined in the ICH E2B(M) 

guideline (version 4.4.1 includes the Post Step 4 corrections agreed by 

the Steering Committee on 5 February 2001). 

Definitions: 

The Route of Administration indicates the part of the body through or 

into which, or the way in which, the medicinal product is intended to be 

introduced. 

In some cases a medicinal product can be intended for more than one 

route and/or method of administration. 

Methodology: 

A comprehensive list of Route of Administration terms has been collected 

and includes: 

- European Pharmacopoeia Standard terms; 

- United States Pharmacopeia (USP) terms; 

- Health Canada terms; 

- MHLW terms; 

- ICH E2B(M) Routes of Administration List 

Each term is given an identifier, a description and relationships to other 

terms within the terminology. 

Tasks undertaken include: 

- A term identifier is allocated to each term (entry) in the list, 

enabling linkage with the original route of administration term 

lists. 

- Within the list there is an indication of the provenance of the term 

(i.e. its source). A formal definition from the source vocabulary is 

included, where necessary. 

Synonymous terms are identified and “annotated” e.g. ocular use and 

ophthalmic use. 

- The route of administration terms are mapped on the basis of the 

same or the equivalent meaning for route of administration 
 12

purposes e.g. ocular, ophthalmic. In specific cases the regional 

definitions were crosschecked to clarify the meaning. 

- An adjective is used to describe the route of administration where 

a suitable adjective is available, e.g. inhalational not inhalation. 

- The descriptor 'use' is generally not supported unless it adds a 

specific meaning e.g. ‘oral’ was used instead of ‘oral use’. 

- Where a prefix and a main word in the terms are concatenated, 

the concatenated word is hyphenated only if the ending of the 

prefix and the beginning of the next word were both vowels (a, e, i, 

o, u). 

- Where a suitable ICH E2B(M) route of administration term exists, 

this is used as the basis for the official ICH M5 Route of 

Administration Controlled Vocabulary term. Where a suitable ICH 

E2B(M) route of administration term is not available to represent 

the route concept, a new term is added to the vocabulary. In either 

case, the above procedures are applied. 

- The Routes of Administration Controlled Vocabulary presents the 

corresponding terms (translations) applicable in the different 

regions and in the E2B(M) list as follows: 

o MedID: e.g. 001 

o ICH M5 Route of Administration Term e.g. Auricular (OTIC) 

o Regional Standard Terms: 

 EU e.g. Auricular Use 

 FDA e.g. Auricular (OTIC) 

 MHLW e.g. Otological Agent 

 Health Canada e.g. OTIC 

 E2B(M) e.g. Auricular (OTIC) 

- Where, within one region, two or more terms (e.g. a current term 

and a historic non-current term) refer to the same route of 

administration, these terms were specified in sequence and 

separated by the symbol "/". The preferred or current term is 

specified as the first term, e.g. ocular use/ophthalmic use for EU 

or unknown/unassigned for the US. 

- A draft translation for the ICH M5 Routes of Administration 

Controlled Vocabulary in Japanese has been included. 

2.2.5 Units and Measurements Controlled Vocabulary 

Scope: 

The Units and Measurements Controlled Vocabulary includes units and 

measurements in use by the regulators in the ICH regions and observer 

countries and defined in the ICH E2B(M) guideline (version 4.4.1 

includes the Post Step 4 corrections agreed by the Steering Committee on 

5 February 2001). 

 General Conventions: 

The International System of Units (SI) and the Units and Measurements 

as described in the E2B(M) guideline, (version 4.4.1 includes the Post 

Step 4 corrections agreed by the Steering Committee on 5 February 2001) 

are followed in the ICH regions and observer countries. Additional, region 

specific units are in use specifically regarding biological and 

microbiological units. 
 13

Methodology: 

A comprehensive list of Units and Measurements has been collected and 

includes: 

- International System of Units (SI) 

- Units and Measurements as described in the E2B(M) 

guideline1

- Region specific units and measurements (CA, EU, JP, US) 

Each unit and measurement is given an identifier, a description, a 

symbol and relationships to other terms within the terminology. 

Tasks undertaken include: 

- A term identifier is allocated to each unit and measurement (entry) 

in the list, enabling linkage with the original unit and 

measurement entries in the lists. 

- Within the list there is an indication of the provenance of the term 

(i.e. its source) and a formal definition from the source vocabulary 

is included, where appropriate. 

- Synonymous entries are identified and “annotated” e.g. %(v/v) and 

(v/v)%. 

- The mapping of Units and Measurements is based on the 

International System of Units (SI) and its abbreviations and 

definitions. The definitions of the SI base units refer to the NIST 

Special Publication 330 (SP 330). 

- Lower case has been used for the term description. 

- Exponents of symbols are not expressed in superscript format; e.g. 

the symbol ‘m2’ has been used for square meters. 

- Some important and widely used units outside the International 

System have been added with regard to biological and 

microbiological units. Descriptions of these units and their 

abbreviations were added as appropriate. 

2.3 Data Elements 

This chapter describes the data elements for the electronic transmission of a core 

set of medicinal product information. 

The data elements as presented in this guideline refer to the consolidated core data 

sets of medicinal products as defined in the scope of this guideline, chapter 1.3. 

These data elements are based on the regional standards already established by 

these regulators to support the local data collection process and do not replace or 

supersede the regional standards or legal requirements for data collection between 

the regulators and pharmaceutical companies. 

As a result, a medicinal product is characterized in the frame of this guideline as 

follows: 

 A Medicinal Product has: 

o One and only one MedID 

o One and only one Medicinal Product Name 

 

1 Version 4.4.1 includes the Post Step 4 corrections agreed by the Steering Committee on 5 February 2001 
 14

o One and only one Marketing Authorization Holder 

o One and only one Marketing Authorization (number) 

o One or more Pharmaceutical Products 

 A Pharmaceutical Product has 

o One or more Active Ingredients with a specific strength (the same 

active ingredient with a different strength is considered a different 

pharmaceutical product) 

o One and only one Pharmaceutical Dose Form

o One or more possible Routes of Administration

In order to facilitate the understanding of the relationship of the data elements described in this 

chapter, a conceptual model is included as follows:

Figure 1 - Conceptual Model of the ICH M5 MedID and Data Element Set

This conceptual model does not define the actual message specifications for the 

exchange format of MedIDs and the related ICH M5 data elements. 

The figure provides the relationship between the ICH M5 data elements and the 

MedID. 

 All data elements are grouped as elements or attributes within a section. 

 A section defines a concept which is further described by its data elements or 

attributes. 

 The data elements are flagged as Mandatory2 (M:) or Optional (O:). 

 

2 The use of ‘Mandatory’ in the remainder of this document refers to technical and not legal requirements.
 15

 The data elements for which the entry is strictly controlled by a list of values 

(e.g. ISO Country Code 3166) or by the ICH M5 Controlled Vocabulary are in 

italics. 

There are relationships between entities, with a specific cardinality. 

 The relationship with cardinality 1..1 means that, for example, a 

Pharmaceutical Product has precisely one pharmaceutical dose form. 

 The relationship with cardinality 1..n means that, for example, a 

Pharmaceutical Product has one or more Active Ingredients. 

Each section and each element of the ICH M5 data element set is described in the 

following paragraphs. 

As a general principle, it should be noted that depending on regional laws and 

regulations a formal marketing authorization might not be required for certain 

categories of medicinal products (e.g. certain OTC drugs, ‘grandfather’ drugs). For 

these medicinal products the same principles apply as for ‘authorised’ medicinal 

products. 

2.3.1 Medicinal Product Identifier 

2.3.1.1 Medicinal Product Identifier (MedID)

User Guidance: 

The MedID as defined in chapter 2.1.1 of the medicinal product and as 

presented in the ICH M5 data element set should be provided in this 

field.

As a general rule, the MedID should be maintained in any reType: 

Mandatory

Example:

FR-123456-X 

EU-EU/1/2342323/001-K 

JP-123456789-Y 

US-0123456789-Z 

CA-2323232-V 

2.3.2 Medicinal Product Administrative Section 

2.3.2.1 Medicinal Product Name

Definition: 

The name assigned to a medicinal product as approved by the 

regulator of the country of authorization. 

User Guidance: 

The naming of a medicinal product differs in the ICH regions and 

observer countries. 

The full and complete medicinal product name as approved by the 

regulator of the country or territory of authorization and as 
 16

appearing on the package of the medicinal product, the container or 

the package insert should be provided in this field.

For medicinal products which do not require prior marketing 

authorization under regional law, the full and complete medicinal 

product name as appearing on the package of the medicinal product, 

the container or the package insert should be provided in this field.

Synonyms: 

Proprietary Medicinal Product Name (ICH E2B(M)) 

Name of the Medicinal Product 

Product Name 

Type: 

Mandatory

Examples: 

Lithium Carbonate liq. Paediatric Company D 

ABC Tabs 500 Company B 

Vinblastine Sulphate Injection Solution 10mg/ml 

Tri-Product C Forte 

Product X Oral Gel 

BRANDX 100 U/ml Concentrate for solution for infusion-Intravenous 

use Vial (glass) 5 ml (100 U/ml) 1 vial 

2.3.2.2 Medicinal Product Short Name 

Definition: 

The medicinal product name without the trademark or the name of 

the marketing authorization holder or any other descriptor (e.g. 

strength, dosage form, user group, route of administration). 

User Guidance: 

The name assigned to a medicinal product as approved by the 

regulator of the country or territory of authorization, without the 

trademark or the name of the marketing authorization holder or any 

other descriptor should be provided in this field. 

For medicinal products which do not require prior marketing 

authorization under regional law, the medicinal product name 

without the trademark or the name of the manufacturer/distributor 

or any other descriptor should be provided in this field. 

Synonyms: 

Trade Name 

Brand Name 

Scientific Name 

Common Name 

Invented Name 

Type: 

Optional 

Example: 

Lithium Carbonate 

ABC 

Vinblastine Sulphate 

Tri-Product C 

Product X 
 17

BRANDX 

2.3.3 Marketing Authorization Holder/Manufacturer/Distributor 

Section

Definitions: 

Marketing Authorization Holder (MAH)

Natural or legal person in possession of the marketing authorization or 

license for a medicinal product within a given country/territory. 

Manufacturer (MF) 

Natural or legal person in possession of a license for manufacturing a 

medicinal product within a given country/territory. 

Distributor

Natural or legal person in possession of a license covering the 

procuring, holding, supplying or exporting of medicinal products, apart 

from supplying medicinal products to the public. 

Such activities are carried out with manufacturers or their 

depositories, importers, other wholesale distributors or with 

pharmacists and persons authorized or entitled to supply medicinal 

products to the public within a given country/territory.

2.3.3.1 Name of the Marketing Authorization Holder or 

Manufacturer or Distributor 

User Guidance: 

The full and complete name of the marketing authorization holder of an 

authorized medicinal product as appearing on the package of a 

medicinal product, the container or the package insert should be 

provided in this field. 

For medicinal products which do not require prior marketing 

authorization under regional law, the full and complete name of the 

manufacturer/distributor, as appearing on the package, the container 

or the package insert, should be provided in this field.

Type: 

Mandatory

2.3.3.2 Marketing Authorization Holder or Manufacturer or 

Distributor Identifier 

User Guidance: 

The identifier assigned by a regulator of a region or observer country to 

a marketing authorization holder for authorized medicinal products, or 

to the manufacturer/distributor for medicinal products that do not 

require prior marketing authorization, should be provided in this field. 

Type: 
 18

Optional

 

2.3.3.3 Country of the Marketing Authorization Holder or 

Manufacturer or Distributor

User Guidance: 

The two letter ISO 3166 country code of the country in which the 

marketing authorization holder is located should be provided in this 

field. 

For medicinal products that do not require prior marketing 

authorization under regional law, the two letter ISO 3166 country code 

of the country in which the manufacturer/distributor is located should 

Type: 

Mandatory

2.3.4 Marketing Authorization Section 

Definitions: 

The marketing authorization information of the medicinal product as 

granted by the regulator in the respective territory/country should be 

provided. 

For medicinal products that do not require prior marketing 

authorization under regional law, the section should be completed as 

specified. 

2.3.4.1 Marketing Authorization Number

Definition: 

The marketing authorization number of the medicinal product as 

granted by the regulator in the respective territory/country. 

User Guidance:

The marketing authorization number of the medicinal product as 

granted by the regulator in the respective territory/country should be 

provided. 

For medicinal products that do not require prior marketing 

authorization under regional law, a unique identifier should be 

Synonyms: 

Authorization Number 

License Number 

Identifier

Type: 

Mandatory 

2.3.4.2 Marketing Authorization Country 

Definition: 

The marketing authorization country refers to the country/territory 

in which the marketing authorization was granted by the regulator of 
 19

this country/territory. 

User Guidance:

The medicinal product authorization country for the medicinal 

product should be provided as a two letter country code (ISO 3166). 

For medicinal products in the United States and Japan the country 

code will be set as default to US or JP. For centrally authorized 

medicinal products in the European Union, the country code will be 

set to EU. 

For medicinal products that do not require prior marketing 

authorization under regional law, the country of marketing should be 

specified in this field. 

Synonyms: 

Authorization Country 

License Country

Type: 

Mandatory

2.3.4.3 Marketing Authorization Date

Definition: 

The date on which the marketing authorization was granted by the 

regulator of the respective country/territory. 

User Guidance:

The date on which the authorization for the medicinal product was 

granted by the regulator should be provided in this field. A complete 

date consisting of day, month and year should be specified. 

For medicinal products that do not require prior marketing 

authorization under regional law, a default date will be provided by the 

regulator of the region in this field. 

Synonyms: 

Authorization Date 

License Date

Type: 

 Mandatory

2.3.4.4 Marketing Authorization Withdrawal Date

Definition: 

The date on which the authorization for the medicinal product was 

withdrawn/revoked by the regulator of the country/territory or by the 

marketing authorization holder/manufacturer/distributor, depending 

on the regulatory requirements in the region or observer countries. 

User Guidance:

The date on which the authorization for the medicinal product was 

withdrawn/revoked by the regulator of the respective 

country/territory or by the marketing authorization 

holder/manufacturer/distributor should be provided in this field. A 

complete date consisting of day, month and year should be specified. 
 20

For medicinal products that do not require prior marketing 

authorization under regional law, this field is not applicable. 

This information should be provided if applicable. 

Synonyms: 

Withdrawal Date 

License Withdrawal Date 

Revocation Date 

Type: 

 Optional 

2.3.5 Pharmaceutical Product Section 

Definition: 

The pharmaceutical product section reflects the active ingredient(s), 

strength(s), pharmaceutical/dosage form(s) and routes of 

administration(s) that constitute a medicinal product. 

A medicinal product can consist of one or several pharmaceutical 

products, given to (or taken by) a patient with a therapeutic or 

User Guidance: 

The Pharmaceutical Product Section is repeatable to allow for the entry 

of each pharmaceutical product that constitutes the medicinal product. 

The exact composition at the level of the active ingredient(s), the 

strength of the ingredient(s), the pharmaceutical dose form and the 

route(s) of administration should be provided for each pharmaceutical 

product. 

The majority of medicinal products contain only one pharmaceutical 

Examples: 

Product A 

consists of one pharmaceutical product as follows: 

Pharmaceutical Product: 

Active Ingredient: Acetaminophen 

Strength of the Active Ingredient: 500 mg 

Pharmaceutical/Dosage Form: Tablet 

Route of Administration: Oral Use
 21

Product Z ® 

consists of two tablets with different composition as follows: 

 White tablet with Estradiol 2mg 

 Pink tablet with Estradiol 2mg and Levonorgestrel 0.075mg 

Pharmaceutical Product 1: 

Active Ingredient: Estradiol 

Strength of the Active Ingredient: 2 mg 

Pharmaceutical/Dosage Form: Tablet 

Route of Administration: Oral Use 

Pharmaceutical Product 2: 

Active Ingredient: Estradiol 

Strength of the Active Ingredient: 2 mg 

Active Ingredient: Levonorgestrel 

Strength of the Active Ingredient: 0.075mg 

Pharmaceutical/Dosage Form: Tablet 

Route of Administration: Oral Use 

Product Combi ®3

consists of two pharmaceutical products as follows: 

Pharmaceutical Product 1: 

Active Ingredient: Clotrimazole 

Strength of the Active Ingredient: 500 mg 

Pharmaceutical/Dosage Form: Pessary 

Route of Administration: Vaginal Use 

Pharmaceutical Product 2: 

Active Ingredient: Clotrimazole 

Strength of the Active Ingredient: 2% w/w 

Pharmaceutical/Dosage Form: Cream 

Route of Administration: Cutaneous Use

2.3.6 Active Ingredient(s) Section 

User Guidance: 

The active ingredient section is a repeatable section. 

If a pharmaceutical product contains more than one active ingredient, 

the section should be repeated for each active ingredient. 

Type: 

 Mandatory 

2.3.6.1 Active Ingredient Term

User Guidance: 

The active ingredient as reflected in the medicinal product labeling 

should be provided as a standard term in line with the ICH M5 Active 

 

3

 This type of medicinal product is not available in Japan. 
 22

Ingredients Controlled Vocabulary in this field.

Type: 

 Mandatory

2.3.6.2 Active Ingredient TermID

User Guidance: 

The ICH M5 Active Ingredients Controlled Vocabulary TermID for the 

active ingredient term should be provided in this field. 

Type: 

 Mandatory

2.3.6.3 Strength Section

Definition: 

The content of the active ingredient expressed quantitatively per 

dosage unit, per unit of volume or per unit of weight, according to 

the pharmaceutical dose form.

User Guidance: 

This section includes the strength of the active ingredient. 

Synonyms: 

Concentration, Unit dose 

Type: 

 Mandatory 

Example: 

Solid forms: 

 the strength is defined as the amount of active ingredient per 

unit dose; 

Liquid ready-to-use preparations: 

 the strength is identical to the concentration; 

Powder for reconstitution, powder for oral solution, etc.: 

 as a general principle, the strength is identical to the 

concentration after reconstitution to the volume recommended.

2.3.6.3.1 Strength Type 

Definition: 

Descriptor that specifies the strength type of the active ingredient of a medicinal 

product.

User Guidance: 

For some medicinal products, the exact dose strength cannot be 

indicated and is therefore expressed as a concentration range or as ‘not 

greater than’ or as ‘not less than’ a particular value. 

The following four descriptors are available to express the strength of 

an active ingredient:

Equal: 

 The dose strength is indicated as a unique value in the ‘Strength 

Value 1’ field. 
 23

Range: 

 If the strength is expressed as a range, the minimum value and the 

 maximum value of the dose strength are indicated in the ‘Strength 

 Value 1’ field and in the ‘Strength Value 2’ field. 

Not greater than: 

 If the dose strength is expressed as “not greater than”, the 

maximum dose strength is indicated in the ‘Strength Value 1’ field. 

Not less than: 

 If the dose strength is expressed as “not less than”, the minimum 

dose strength is indicated in the ‘Strength Value 1’ field. 

If the dose strength is expressed as a range where both an upper and 

lower value are designated, and only one value can be provided, the 

strength value should be specified in the field ‘Strength Value 1’.

Type: 

 Mandatory 

2.3.6.3.2 Strength Value 1 

User Guidance: 

The numeric value of the dose strength of the active ingredient as 

specified in the medicinal product labeling should be indicated in this 

field. For numeric values with decimal fractions, a full stop should be 

used. 

If the strength is expressed as a range, the minimum value of the dose 

strength should be specified in the field ‘Strength Value 1’.

If the dose strength is expressed as a range where both an upper and 

lower value is designated, and only one value can be provided, the 

Type: 

 Mandatory 

2.3.6.3.3 Strength Value 2 

User Guidance: 

The numeric value of the dose strength of the active ingredient as 

specified in the medicinal product labeling should be indicated in this 

field. For numerical values with decimal fractions, a full stop should be 

used. 

If the strength is expressed as a range, the maximum value of the dose 

Type: 

 Optional 

2.3.6.3.4 Strength Unit Term 

User Guidance: 

The strength unit symbol should be specified as the corresponding 

descriptor of the ICH M5 Units and Measurements Controlled 

Vocabulary. 

Type: 
 24

Mandatory

2.3.6.3.5 Strength Unit TermID 

User Guidance: 

The Unit and Measurement Controlled Vocabulary TermID of the 

corresponding unit and measurement term should be provided in this 

Type: 

Mandatory

2.3.6.3.6 Strength Description 

User Guidance: 

 This free text field can be used to describe a concentration range for 

some medicinal products where the exact dose strength cannot be 

structured in the Strength Section.

Type: 

Optional 

2.3.7 Pharmaceutical Dose Form Section 

User Guidance: 

This section refers to the pharmaceutical dose form. Each 

pharmaceutical product can have only one pharmaceutical dose form. 

Therefore, this section is not repeatable. 

2.3.7.1 Pharmaceutical Dose Form Term

User Guidance: 

The pharmaceutical dose form as reflected in the medicinal product 

labeling should be provided as standard term in line with the ICH M5 

Pharmaceutical Dose Form Controlled Vocabulary in this field. 

Synonyms: 

Pharmaceutical Form E2B(M) 

Dosage Form E2B(M)

Type: 

Mandatory 

2.3.7.2 Pharmaceutical Dose Form TermID

User Guidance: 

The ICH M5 Pharmaceutical Dose Form Controlled Vocabulary TermID 

of the corresponding pharmaceutical dose form term should be 

provided in this field. 

Type: 

Mandatory 
 25

2.3.8 Route of Administration Section 

User Guidance: 

This section refers to the route(s) of administration of the 

pharmaceutical product. The route of administration section is a 

repeatable section. 

2.3.8.1 Route(s) of Administration Term

User Guidance: 

The route of administration as reflected in the medicinal product 

labeling should be provided as standard term in line with the ICH M5 

Route of Administrations Controlled Vocabulary in this field.

Type: 

Mandatory 

2.3.8.2 Route of Administration TermID

User Guidance: 

The ICH M5 Routes of Administration Controlled Vocabulary TermID of the 

corresponding pharmaceutical dose form term should be provided in this field. 

Type: 

Mandatory 

2.3.9 Maintenance Section 

User Guidance: 

This section contains information related to the maintenance of 

MedIDs and the medicinal product information as specified in the ICH 

M5 data element set. 

2.3.9.1 Maintenance Operator

Definition: 

The maintenance operator: 

 Refers to the ICH M5 data element set for a specific medicinal 

product and to the MedID assigned by the regulator for that 

product 

 Specifies the operation type regarding the ICH M5 data element 

set and the MedID for a specific medicinal product. 

Three types of maintenance operators are available:

 New 

 This operator applies for the initial transmission of the MedID 

and the related ICH M5 data elements for a specific medicinal 

 product. 

 Update 

 This operator applies for the transmission of the MedID and the 

 related ICH M5 data elements for a specific medicinal product,

 when previously transmitted information needs to be updated. 

 Nullify 
 26

 This operator applies for the transmission of the MedID and the 

 related ICH M5 data elements for a specific medicinal product, 

 when previously transmitted information needs to be nullified.

User Guidance: 

 As a general principle, the complete information available for a 

medicinal product in line with the ICH M5 data element set 

should be provided for any maintenance operator i.e. New, 

Update and Nullify. 

 The maintenance operator ‘New’ should be used in line with the 

assignment of the MedID. Every time a new MedID is assigned 

by a regulator in a country/territory the full information of the 

medicinal product with the corresponding MedID and the 

complete ICH M5 data element set should be transmitted with 

the maintenance operator set to New. 

In this case the status of the MedID and the complete ICH M5 

data element set is ‘Current’. 

 The maintenance operator ‘Update’ should be used any time 

any information related to the ICH M5 data element set needs to 

be updated for an existing MedID. 

In this case the status of the most recently transmitted ICH M5 

data element set for the MedID is ‘Current’. 

The status of the previous ICH M5 data element set(s) is 

‘Replaced’. 

 The maintenance operator ‘Nullify’ should be used if an existing 

MedID and any of the related ICH M5 data elements are void or 

erroneous and need to be deleted. 

 In particular the maintenance operator ‘Nullify’ should be used 

if a MedID previously reported is wrong. 

The status of the MedID and the ICH M5 data element set is ‘Nullified’ Type: 

Mandatory

2.3.9.2 Operation Date

Definition: 

The date at which the maintenance operation is effective. 

User Guidance: 

The operation date should be specified for any transmission of a 

MedID and the related ICH M5 data element set including the 

applicable maintenance operator. 

Based on the maintenance operator and the operation date, the 

status of each MedID and the related ICH M5 data element set can 

be maintained i.e. entries can be flagged as ‘Current’, ‘Replaced’ or 

Type: 

Mandatory

2.3.9.3 Operation Comments

User Guidance: 
 27

Comments on the maintenance operator can be provided, e.g. the 

reason for an update or a nullification of a MedID and the ICH M5 

data element set. 

Type: 

Optional 

3. GLOSSARY 

This glossary defines the way in which certain terms are used for the purpose of 

the guideline and for which no specific definition has been provided within the 

guideline itself. 

In addition this glossary provides an overview of acronyms used throughout the 

document. 

Glossary of Terms 

Medicinal Product Package 

Definition: 

 Delivery unit of a medicinal product in an outer container. 

Synonyms: 

 Package presentation

Country or Territory 

Definition: 

A country or territory is defined as geographical, political or 

economic area. 

Acronyms

CA 

 Canada 

CAS 

 Chemical Abstract Service Number 

EMEA 

 European Medicines Agency, EU 

EU 

 European Union 

FDA 

 Food and Drug Administration, US 

HL7 

 Health Level 7 

ICH 

 International Conference on Harmonisation of Technical Requirements 

for Registration of Pharmaceuticals for Human Use 
 28

ICH M5 EWG 

 International Conference on Harmonization of Technical Requirements 

for Registration of Pharmaceuticals for Human Use M5 Data Elements 

and Standards for Drug Dictionaries Expert Working Group 

ICH E2B (M) 

 International Conference on Harmonization of Technical Requirements 

for Registration of Pharmaceuticals for Human Use E2B(M): Clinical 

Data Management: Data Elements for Transmission of Individual Case 

Safety Reports 

INN 

 International Non-proprietary Name 

ISO 

 International Organization for Standardization 

IUPAC 

 International Union of Pure and Applied Chemistry 

JAN 

 Japanese Accepted Name 

JP 

 Japan 

MAH 

 Marketing Authorization Holder 

MedID 

 Medicinal Product Identifier 

MF 

 Manufacturer 

MHLW 

 Ministry of Health, Labour and Welfare, Japan 

NDC 

 National Drug Code 

NIST 

 National Institute of Standards and Technology 

OTC 

 Over the Counter 

PhPID 

 Pharmaceutical Product Identifier 

SI 

 International System of Units 

TermID 

 Terminology Identifier of the ICH M5 controlled Vocabulary 

US 

 United States 

USAN 

 United States Adopted Name 

USP 

 United States Pharmacopoeia 
 29

4. REFERENCES 

 

Canada

The Food and Drugs Act and Regulations and related Health Canada 

Guidelines: 

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.html 

: 

The Natural Health Product Regulations and related Health Canada 

Guidelines: 

http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/index_e.html

European Union

Directive 2001/83/EC of the European Parliament and of the Council of 6 

November 2001 on the Community code relating to medicinal products for 

human use (Official Journal L 311, 28/11/2001 p. 67 - 128) 

http://pharmacos.eudra.org/F2/eudralex/vol1/DIR_2001_83/DIR_2001_83_EN.pdf

Directive 2004/24/EC of the European Parliament and of the Council of 

31 March 2004 amending, as regards traditional herbal medicinal 

products, Directive 2001/83/EC on the Community code relating to 

medicinal products for human use (Official Journal L 136, 30/4/2004, p. 

85 - 90).

http://pharmacos.eudra.org/F2/eudralex/vol1/DIR_2004_24/DIR_2004_24_EN.pdf 

Consolidated Directive 2001/83/EC of the European Parliament and of 

the Council of 6 November 2001 on the Community code relating to 

medicinal products for human use as amended by Directive 2002/98/EC, 

Directive 2004/24/EC and Directive 2004/27/EC) 

http://pharmacos.eudra.org/F2/eudralex/vol1/CONSOL_2004/Human%20Code.pdf

Notice to Applicants Volume 2 A, Medicinal Products for Human Use, 

Version 2 - December 2004 

http://pharmacos.eudra.org/F2/eudralex/vol-2/home.htm

A Guideline on Summary of Product Characteristics, December 1999, 

(Doc. Ref. Notice to Applicants, Final – revision 0) 

http://pharmacos.eudra.org/F2/eudralex/vol-2/C/SPCGuidRev0-Dec99.pdf

Guideline on Pharmaceutical Aspects of the Product Information for 

Human Vaccines, 26 November 2003 (Doc. Ref. 

EMEA/CPMP/BWP/2758/02) 

http://www.emea.eu.int/pdfs/human/bwp/275802en.pdf

Guideline on the Acceptability of Invented Names for Human Medicinal 

Products Processed through the Centralized Procedure, London, 14 

September 2004 (Doc. Ref. CPMP/328/98, Revision 4) 

http://www.emea.eu.int/pdfs/human/regaffair/032898r4en.pdf
 30

Guideline on the Chemistry of new Active Substances, 17 December 2003 

(Doc. Ref. CPMP/QWP/130/96 Rev. 1) 

http://www.emea.eu.int/pdfs/human/qwp/013096en.pdf

Standard Terms: Dosage Forms, Routes of Administration and Containers, 

EDQM, Fifth Edition, December 2004, Version 5.0.0 

http://st.pheur.org/entry.htm

EudraVigilance Medicinal Product Dictionary (EVMPD) Version 2.0 

Technical Specifications, 9 November 2004 (Doc. Ref. 

EMEA/140190/2004) 

http://eudravigilance.emea.eu.int/human/docs/EVMPD%20Technical%2

0Specifications.pdf

 

EudraVigilance Medicinal Product Dictionary (EVMPD) Version 2.0 

Message and Acknowledgement Specifications, 8 December 2004 (Doc. 

Ref. EMEA/178966/2004) 

http://eudravigilance.emea.eu.int/human/docs/EVMPD%20Message%20

and%20%20Acknowledgement%20Description.pdf

EudraVigilance (EV) Access simple Database Version 2.0 8 November 2004 

(Doc. Ref: EMEA/140327/2004) 

http://eudravigilance.emea.eu.int/human/docs/EV%20Access%20Simple

%20Database%202.0%20-%20Tables%20Documentation.pdf

EudraVigilance (EV) Access Simple Database Version 2.0 Forms 

Documentation, 31 January 2005, (Doc. Ref: EMEA/35416/2005) 

http://eudravigilance.emea.eu.int/human/docs/EVAccessSimple%20Dat

abase_v20_Formsdocumentation.pdf

EudraVigilance (EV) Access Simple Database Version 2.0 Step by Step 

Guide 

8 December 2004, (Doc. Ref: EMEA/191986/2004) 

http://eudravigilance.emea.eu.int/human/docs/EV%20Access%20Simple

%20Database%202.0%20-%20Step%20by%20Step%20Guide.pdF 

Japan

Japanese Pharmacopoeia, Fourteenth Edition, Part 1, General Rules For 

Preparation 

http://jpdb.nihs.go.jp/jp14e/14data/General_Rules_for_Prepart1.pdf

United States

Guidance for Industry Providing Regulatory Submissions in Electronic 

Format — Content of Labeling 

http://www.fda.gov/cder/regulatory/guidance

Release Notes for SPL Schema PORR_MT050020 (3.20.05) 

FDA SPL Schema for Implementation

http://www.fda.gov/oc/datacouncil/spl.html

CaCore 2.0 Technical Guide, National Cancer Institute, Center for 

Bioinformatics, U.S. Department of Health and Human Services 

ftp://ftp1.nci.nih.gov/pub/cacore/caCORE2.0_Tech_Guide.pdf

A guide to RXNorm, United States National Library of Medicine, National 
 31

Institute of Health

http://www.nlm.nih.gov/research/umls/rxnorm_guide.pdf