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This draft guidance, when finalized, will represent the Food and Drug  Administration's (FDA's)  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.  
1
   
 
Topic Reference:  Data  Elements  and Standards for Drug Dictionaries  
Version:           2.0  
Dated:    10 May 2005  
 
 
Comments to be sent  to the Rapporteur:  
Name:    Dr. Sabine Brosch   
Address:   European  Medicines Agency (EMEA)  
  7 Westferry Circus, Canary Wharf 
  London E14 4HB UK 
Fax   + 44 (0) 207 418 8668  
 
 
Circulation list: 
ICH Coordinators 
ICH Secretariat 
Experts: 
 
  Dr. Sabine Bosch, Mr. Fabrizio Abbinante, .............   EU 
  Mr.  Hans Georg Wagner..........................................   EU 
  Mr.  Barry  Hammond, Dr. Cor Jol, Mrs.  Raj Long ....   EFPIA  
  Dr. Gaby Danan,  Dr. Isabelle de  Zegher..................   EFPIA  
  Ms. Chie Kojima,  Mr. Masahiko Yokota...................   MHLW  
  Mr.  Keiji Sawamukai, Mr. Manabu Inoue,  Mr. Jiro Shimada   JPMA  
  Dr. Randy Levin, Dr.  Ann Schwartz,  Dr. Roger Goetsch   FDA 
  Mr. Kostas Kidos,  Dr. William Gregory ....................   PhRMA 
  Ms. Heather Sutcliffe  ...................................................Health Canada 
  Dr. Marie  Lindquist, Ms. Jessica Nilsson ................   WHO 
 
 
2
  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  

3
   
 
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:  
4
    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.  
 
   
 
 
  
 
5
  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.    
 
6
   
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.  
 
 
7
   
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.   
 
8
  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  sub
species  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 

 
9
  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 micro
organisms)  
-  inactivated  (in  the  case  of  vaccines  containing  killed  micro
organisms).  
 
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 
10 
 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  
11 
 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.  
 
12 
 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  
13 
 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.  
14 
   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  re-
Type:    
  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  
15 
 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 

16 
   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:   
17 
   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 
18 
 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.  
19 
  
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  
20 
   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.  
21 
 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.  
22 
 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:    
23 
   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  
24 
 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  
25 
   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: 
26 
   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  
27 
 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 
 
28 
  
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/vol
1/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/vol
1/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/vol
1/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  
  
29 
 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 
30 
 Institute of Health  
http://www.nlm.nih.gov/research/umls/rxnorm_guide.pdf  
 
 
31