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Detailed GuideMHRA

Reference medicinal products (RMPs)

There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.

First published: Dec 31, 2020Last updated: Mar 11, 2025Changes: 3

Latest change: Updated to remove: “1. Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14” from document Reference Medicinal Products (RMPs)

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