Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe

On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management services: Chapter 8 – Practical examples.

This document provides detailed guidance on the interpretation of IDMP standards in the European regulatory framework with the provision of practical examples aiming to complement the understanding and narrative of EU IG Chapter 2 – Data elements for the electronic submission of information on medicinal products for human use.

This chapter on practical examples is expected to be a living document with additional examples or corrections being included as the experience of the European Medicines Regulatory network and marketing authorization holders with IDMP standards increases.

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