IDMP Wiki

ISO 11239

ISO 11239 IDMP Standard lists regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.

The ISO 11239 standard identifies for example injection solution, injection suspension, infusion solution (or a less granular regional term linked to these.

Differences in granularity between regional terminologies
Many of the concepts covered in ISO 11239 are already described in various regions using their own sets of terminologies, which are usually not harmonised with those of other regions. This is often because of different levels of granularity between regions, which means that one-to-one mapping between those regions’ terms is not possible. For example, if the terms used in region A have a relatively low level of granularity compared to the terms used in region B, one term from region A will often map to several terms from region B. Indeed, the purpose of ISO 11239 is to allow for the development of a single set of controlled vocabularies that can be used by all regions to communicate with each other, and to which all regions can map their own regional terms.

The figure gives an example of how terms from Europe, the US and Japan might map to a list of central terms.

In this example:

  •  central terms distinguish between injection and infusion products but not between lyophilised and non-lyophilised powders;
  • Europe distinguishes between injection and infusion products but not between lyophilised and non-lyophilised powders (i.e. the same as the central terms);
  • the US distinguishes between lyophilised and non-lyophilised powders but not between injection and infusion products;
  • Japan uses a single term to describe all injection and infusion products.

As a result, with respect to the central terms there is one-to-one mapping for each European term, there is one-to-two mapping for each US term, and there is one-to-many mapping for the Japanese term.

 

iso 11239 mapping terms

iso-11239-mapping-terms

ISO 11239 Screen from the IDMP Term Browser® for “capsule”:

Synonym and Abbreviations:

Kapsel
Kapsula
Kapsulė
Kapsulë
Капсула
Капсули

Synonym Details:

Term Lang Role Code Type Source
Capsule EN PT 12100 SYN EDQM
Capsule EN PT C25158 PHF FDA
Capsule EN PT PHF00005MIG PHF EMA
Kapsel ET ST 12100 SYN EDQM
Kapsula SR ST 12100 SYN EDQM
Kapsulė LT ST 12100 SYN EDQM
Kapsulë SQ ST 12100 SYN EDQM
Капсула KK ST 12100 SYN EDQM
Капсули UK ST 12100 SYN EDQM

Other Properties:

Type Code Descr
Contributing Source EDQM FDA EMA
Semantic Type SYN PHF PAC PRE

 

IDMP Wiki

ISO 11240

ISO 11240 – Units of Measurement

What ISO 11240 does:

  • specifies rules for the usage of units of measurement for IDMP
  • specifies requirements for traceability to metrological standards
  • establish reference code system for units
  • provide structures and rules for mapping between different unit vocabularies and language translations
  • linking to existing systems, dictionaries, and repositories

Strength of a medicinal product based on ISO 11240

In the case of strength given on a per dose basis, additional information on the characteristics of the countable dose item
may be required when comparing to strengths of other products.

EXAMPLE 1 Expression “per dose”: Total amount of substance per total amount of solution (200 mg of substance
contained in 10 ml of solution), total mass of ingredient contained in one single dose (500 mg of substance contained in
one tablet). Note that the description of the component (substance, solution, tablet) is not part of the unit of measurement.

EXAMPLE 2 Expression as intensive quantity: Mass concentration 20 mg/ml, activity content 5,000 IU/g.

EXAMPLE 3 Using the unit symbol “U”
The unit “U” of enzymatic activity was defined in 1964 by the International Union of Biochemistry as the
catalytic activity that catalyses the transformation of 1 µmol of the substrate per minute. Typical biological
enzyme activities are in the range of 1 U to 100 U. This unit of measurement can also be expressed explicitly
as “µmol/min”, where enzymatic activity is the property being addressed. Still, some arbitrariness is involved in
the definition of “standard conditions” (e.g. temperature, pH).

This unit denoted by the symbol “U” is not an arbitrary unit. In order to ensure traceability and avoid ambiguities,
it is important to discriminate this meaning against the frequently encountered usage of the same symbol “U”
for other (arbitrary) units. This is especially required to ensure unique meaning of codes used for information
exchange. “U” is assigned to enzymatic activity in the UCUM code system. However, the following description
uses the symbol “U” for a completely unrelated concept. Here “U” stands for an arbitrary unit that is defined
based on a “bioassay”:

e.g. Concentration 5 000 U/ml solution for injection.

Mapping between different unit vocabularies and language translations

ISO 11240 mapping table

ISO 11240 mapping table

IDMP Wiki

ISO 11615

ISO 11615 establishes definitions and concepts required for the detailed description and unique identification of medicinal products.

The scope of ISO 11615

ISO 11615 describes data elements and regulated medicinal product information during their entire life cycle (development, authorisation, post-marketing and renewal or withdrawal from the market) and is composed of several ISO Standards.
Taken together all ISO IDMP standards (EN ISO 11615/DTS 20443, EN ISO 11616/DTS 20451, EN ISO 11238/DTS 19844, EN ISO 11239/DTS 20440 and EN ISO 11240) define, characterize and uniquely identify regulated medicinal products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable.
Furthermore, to support successful information exchange in relation to the unique identification and characterization of medicinal products, the use of HL7 Common Product Model and Structured Product Labeling (SPL) messaging aspects is also described.
In addition, reference to the use of other normative IDMP and messaging standards for Medicinal Product information is included in this Technical Specification in order to support successful related information exchange.

Information for an authorized medicinal product

ISO 11615 describes the main concepts modelled to identify a medicinal product.

ISO 11615 model

ISO 11615 model

 

ISO Standards included in ISO 11615

The following normative standards are essential components for successful implementation of the exchange of IDMP data elements:

  • EN ISO 11615:2012, Health Informatics -Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information
  • EN ISO11616:2012, Health informatics – Identification of Medicinal Products – Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
  • EN ISO 11238:2012, Health informatics — Identification of Medicinal Products — Data elements and structures for the unique identification and exchange of regulated information on substances
  • EN ISO 11239:2012, Health Informatics — Identification of Medicinal Products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
  • EN ISO 11240:2012, Health informatics — Identification of Medicinal Products — Data elements and structures for the unique identification and exchange of units of measurement

 

IDMP Wiki

ISO 11616

ISO 11616 International Standard “Health informatics — Identification of Medicinal Products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information”.

ISO 11616 is intended to assist pharmaceutical companies, medicines regulatory authorities and all other interested parties in implementing systems and constructing transmittable messages pertaining to pharmaceutical product identification.

Pharmaceutical Product Identification in ISO 11616

The following principles for the unique identification of a pharmaceutical product shall apply in different strata and levels

ISO 11616 Mode Overview

ISO 11616 Model Overview

Pharmaceutical Product Identification (PhPID) shall be based on the following subset of elements that describe the pharmaceutical product (See also Figure above):

  • active substance(s)/specified substance(s);
  • strength(s), strength units (units of measurement and/or unit of presentation);
  • reference strengths;
  • administrable dose form;
  • medical device, when it is a component of a medicinal product.
  • adjuvant, when it is a component of a pharmaceutical product

Representation of pharmaceutical products in IDMP

Pharmaceutical identifiers and elements shall represent pharmaceutical products as represented in a medicinal product per the authorization by a regulatory authority.

PhPID Active Substance Identification:

  • PhPID_SUB_L1 → Substance(s) Term
  • PhPID_ SUB _L2 → Substance Term(s) + Strength + Reference Strength
  • PhPID_ SUB _L3 → Substance Term(s) + Administrable Dose Form
  • PhPID_ SUB _L4 → Substance(s) Term+ Strength + Reference Strength + Administrable Dose Form

 

IDMP Wiki

Pharmacovigilance Implementing Measures

The Pharmacovigilance Implementing Measures, is the new pharmacovigilance legislation which came into effect in 2012. It introduced a range of new responsibilities for regulators and the pharmaceutical industry in the European Union (EU) concerning the Identification of Medicinal Products (IDMP).

The activities introduced with the pharmacovigilance legislation fall into four main areas:

  • Collection of key information on medicines
  • Analysis and understanding of data and information
  • Regulatory action to safeguard public health
  • Communicating with stakeholders

Data submission for authorised medicines

The legislation requires marketing-authorisation holders to submit structured electronic information to the Agency on medicines authorised in the European Union (EU) and European Economic Area (EEA).

This will ensure that the pharmacovigilance systems for the Agency, national competent authorities and industry are driven by accurate, complete and reliable information on medicines, substances and organisations.

Article 26(2) of the Pharmacovigilance Implementing Measures

26(2) For the purpose of paragraph 1 national competent authorities, marketing authorisation holders and the Agency may also apply the following  formats and standards:
(a) EN ISO 27953-2:2011 Health Informatics, Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011);
(b) EN ISO 11615:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique  identification and exchange of regulated medicinal product information’ (ISO/FDIS 11615:2012);
(c) EN ISO 11616:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard ‘Data elements and structures for unique identification and exchange of regulated pharmaceutical product information’ (ISO/FDIS 11616:2012);
(d) EN ISO 11238:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique  identification and exchange of regulated information on substances’ (ISO/FDIS 11238:2012);
(e) EN ISO 11239:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique  identification and exchange of regulated information on pharmaceutical dose forms, units of presentation and routes of administration’ (ISO/FDIS 11239:2012);
(f) EN ISO 11240:2012, Health Informatics, Identification of Medicinal Products (IDMP) standard, ‘Data elements and structures for unique identification and exchange of units of measurement’ (ISO/FDIS 11240:2012)

Article 40 of the Pharmacovigilance Implementing Measures
Transitional provisions
1. The obligation on the part of marketing authorisation holders, national competent authorities and the Agency to use the terminology provided for in Article 26(2) shall apply from 1 July 2016.