top of page

Implementation of ISO standards for the identification of medicinal products (IDMP) in Europe


Following the publication of version 2.0 in February 2021, the content of sections 2. Chapters and 3. Considerations were amended to include information relevant to the publication of version 2.1 of the EU Implementation Guide (IG) documents. Released on 24-June-2021.



The International Organisation for Standardisation (ISO) Identification of Medicinal Products (IDMP) standards specify the use of standardised definitions for the identification and description of medicinal products for human use. The purpose of these standards is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, by providing a common product ’language’ for stakeholders to use in their interactions.


The use of ISO IDMP standards is required in accordance with Articles 25 and 26 of Commission Implementing Regulation (EU) No 520/2012. These provisions mandate member states (MSs), marketing authorisation holders (MAHs) and the European Medicines Agency (EMA) to use ISO IDMP standards for the exchange and communication of information on medicinal products.


The EU IG Version 2.1 is composed of the following chapters available on the 'Substances and products data management services'


See the updated chapters in the below link

  • Chapter 2: Data elements for the electronic submission of information on medicinal products for human use

  • Chapter 3: Process for the electronic submission of medicinal products information

  • Chapter 8 – Practical examples

  • Annex to EU IG Chapter 8 – Practical examples

11 views0 comments

Opmerkingen


bottom of page