Europe – Chapter 2 : Implementation of ISO standards for the identification of medicinal products in Europe

Chapter 2: Initial submission of medicinal products

This document provides detailed guidance on the data elements and associated business rules for the initial submission of medicinal products authorised for human use to the Product Management Services (PMS) only in accordance with the International Organisation for Standardisation (ISO), Identification of Medicinal Products (IDMP).

While in the EU IG version 1 Chapter 2 – Initial submission describes the business rules, data fields and specification for the creation of a new medicinal product in the context of an Initial Marketing Authorisation, EU IG version 2 will provide additional information on the specific stakeholder responsible for the completion and validation of each independent data field as well as the timing and processes for completion of medicinal product information.

In the EU IG version 1 where data fields and business rules are currently under discussion, and therefore they may be subject to modifications as a result of the further development of the EU IG, these are marked with a Note.

ISO IDMP standards specify the use of standardised definitions for the identification and description of medicinal products for human use.

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