The Europe Introduction - EU Implementation Guide has been prepared by the European Medicines Agency (EMA) upon consultation with different stakeholders (representatives of marketing authorisation holders and sponsors, national competent authorities, industry associations, international public organisations and software vendors) through the SPOR Task Force (SPOR TF) and the EU Telematics governance.
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.
To pursue the implementation of the ISO IDMP standards, EMA has established services to support the management of master data including:
These services are together referred to as 'SPOR' throughout this guidance (Substance, Product, Organisation and Referentials Management Services).
Within the context of Product Management Service (PMS), implementation of the ISO IDMP standards is governed by the following specifications:
- ISO IDMP Implementation Guides (Technical Specifications): define the technical details on how to implement the standards, such as specific fields, their formats, and business rules describing their use;
- HL7 messaging specifications: define the messages that will be used to exchange IDMP information, which are based on HL7 (Health Level Seven) standards; EU Implementation Guide (EU IG): provides guidance on the interpretation of data fields specifically for the EU regulatory environment as well as guidance on the processes for submitting and updating data.
Download EU Implementation Guide
Download Chapter 2
Download Chapter 8 (Practical Examples)
Download Chapter 8 Annex I: Complete representation
Interested in learning more? Contact us today to find out how we can help with your global regulatory needs.