IDMP Wiki

IDMP

IDMP Definition of Identification of Medicinal Products

IDMP defines the data elements and structures for the unique identification and exchange of medicinal products´ information.

Download here for free the “What is IDMP” PDF File

Iso IDMP Standards at a glance

IDMP Standards - What is IDMP?

ISO IDMP Standards

The set of fife ISO international standards has been developed by the ISO in response to a worldwide demand for internationally harmonised specifications for identification and description of medicinal products.

Article 40 of the new pharmacovigilance implementing measures legislation mandated the EMA to use the ISO IDMP standard latest by July 2016.

IDMP provides the basis for the unique identification of medicinal products, which facilitates the activities of medicines regulatory agencies worldwide by jurisdiction for a variety of regulatory activities (development, registration and life cycle management of medicinal products, pharmacovigilance, and risk management). They can also be applied to Investigational Medicinal Products.

Messaging specifications are included as an integral part of the IDMP Standards. They describe and protect the integrity of the interactions for the submission of regulated medicinal product information in the context of the unique product identification; they include acknowledgement of receipt including the validation of transmitted information. Health Level Seven (HL7) Message Exchange are normative within the IDMP Standards.

IDMP Standards are completed with Implementation Guides which are currently in development (2015), as well as with Technical Specifications (TS) 16791 (provides guidance for the identification of medicinal products by using intenational supply chain Standards, securing traceability, safe supply chain and other market requirements) and Technical Requirements (TR) 14872 (Requirements for the implementation of the Standards for the identification of medicinal products for the exchange of regulated medicinal product Information), the latter being in development.

Implications for Marketing Authorisation Holders (MAHs)

In order to submit the data all branches of a company should share a common language, from pharmacovigilance to product supply to comply with the controlled vocabulary dedicated.
The structured substance information, and controlled vocabularies for pharmaceutical dose forms, units of presentation, routes of administration, and packaging will be challenging to integrate.
Furthermore the terminology needs to be aligned throughout the company.

You will find more details here

IDMP Wiki

ISO 11238

Regulated information on substances (ISO 11238)
ISO 11238 defines substances by their main, general characteristics and Specified Substances (which are more granular, specific descriptions of a substance, e.g. including manufaturing information, purity, grade). Substances can have different roles in medicinal products (e.g. active, adjuvant). They are identified via their molecular weight, structure and their unique Identification Number (ID).

Synonym and Abbreviations for Amlodipin (as example):
(RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorphenyl)-6-methyl-1,4-dihydropyridin-3,5-dicarbonsäure-3-ethylester-5-methylester (IUPAC)
3-Ethyl 5-methyl (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate (WHO)
AMLODIPIINI
Amlodipin (ABDATA-SK)
Amlodipin (ABDATA-SK;ASK;INN.L25.D)
AMLODIPINA
AMLODIPINĂ
AMLODIPINAS
Amlodipine (BAN1999;DCF;INN.L25.E;INN.L25.F)
Amlodipino (INN.L25.S)
AMLODIPĪNS
Amlodipinum (INN.L25.L)
AMLODYPINA
ΑΜΛΟΔΙΠΊΝΗ
ΑΜΛΟΔΙΠΊΝΗΣ
АМЛОДИПИН

Synonym Details:

Term Lang Role Code Type Source
(RS)-2-[(2-Aminoethoxy)methyl]-4-(2-chlorphenyl)-6-methyl-1,4-dihydropyridin-3,5-dicarbonsäure-3-ethylester-5-methylester N/A SY 1134301 SUB ABDATA
3-Ethyl 5-methyl (+/-)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate N/A SY 1134301 SUB ABDATA
AMLODIPIINI FI ST SUB05467MIG SUB EMA
Amlodipin DE ST C08CA01 ATC WHO
Amlodipin N/A PT 1134301 SUB ABDATA
Amlodipin DA ST SUB05467MIG SUB EMA
Amlodipin HR ST SUB05467MIG SUB EMA
Amlodipin HU ST SUB05467MIG SUB EMA
Amlodipin SK ST SUB05467MIG SUB EMA
Amlodipin SL ST SUB05467MIG SUB EMA
AMLODIPINA ES ST SUB05467MIG SUB EMA
AMLODIPINA IT ST SUB05467MIG SUB EMA
AMLODIPINĂ RO ST SUB05467MIG SUB EMA
AMLODIPINAS LT ST SUB05467MIG SUB EMA
Amlodipine N/A PT SUB05467MIG SUB EMA
Amlodipine FR ST SUB05467MIG SUB EMA
Amlodipine N/A SY 1134301 SUB ABDATA
Amlodipine EN PT 1J444QC288 SUB FDA
Amlodipine EN PT C08CA01 ATC WHO
Amlodipino N/A SY 1134301 SUB ABDATA
Amlodipino ES ST SUB05467MIG SUB EMA
AMLODIPĪNS LV ST SUB05467MIG SUB EMA
Amlodipinum CS ST SUB05467MIG SUB EMA
Amlodipinum LA ST SUB05467MIG SUB EMA
Amlodipinum N/A SY 1134301 SUB ABDATA
AMLODYPINA PL ST SUB05467MIG SUB EMA
ΑΜΛΟΔΙΠΊΝΗ EL ST SUB05467MIG SUB EMA
ΑΜΛΟΔΙΠΊΝΗΣ EL ST SUB05467MIG SUB EMA
АМЛОДИПИН BG ST SUB05467MIG SUB EMA

Other Properties:

Type Code Descr
ATC C08CA01 Calcium channel blockers
Selective calcium channel blockers with mainly vascular effects
Dihydropyridine derivatives
Amlodipine
Contributing Source ABDATA WHO FDA FDB EMA
Semantic Type SUB ATC
CAS-Registry Number 88150-42-9
Molecular formula C20H25ClN2O5
Molecular weight 408,88

Synonym and Abbreviations:
Amlodipin benzolsulfonat (1:1)
Amlodipine besilate (BAN1999;BP)
Amlodipine besylate (USAN;USP)
Amlodipini besilas

Weblinks:
Visit the IDMP Term Browser® with ISO 11238 data on Amlodipine Besilate in idmp1 (access restricted to registered users of the IDMP Term Browser®)

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