Legal News

MHRA issues new guidance on medicine risk minimisation measures

Published on: 17 April 2025
Published by LNB News

LNB News 17/04/2025

Document Information

Issue Date: 17 April 2025

Published Date: 17 April 2025

Jurisdiction(s): England, Northern Ireland, Scotland and Wales

Article summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on 16 April 2025 detailing requirements for risk minimisation measures for medicines. The guidance outlines how Marketing Authorisation Holders must implement both routine and additional risk minimisation measures, including patient guidance, controlled access programmes, and pregnancy prevention programmes. It explains MHRA's decision-making process for requiring additional measures and specifies that all materials must be MHRA-approved before distribution. The guidance aims to ensure safe medicine use through clear protocols for healthcare professionals and patients.

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