# Risk minimisation measures for medicines

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/4321e983-3cfb-47bf-84fb-d7601c77e744
Type: Guidance
Published: April 15, 2025
Updated: June 9, 2025

> Guidance for healthcare professionals on risk minimisation options for medicines.

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## Content

Risk minimisation measures are put in place to facilitate the safe and effective use of medicines by healthcare professionals, patients and their carers or guardians. It is a requirement for Marketing Authorisation Holders (MAHs) to implement routine risk minimisation measures, such as the legal status of a medicine (for example prescription-only), pack size of a medicine, and a Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for every medicine. These measures are standard requirements to address safety concerns once a product is on the market. But for certain medicines, additional risk minimisation measures are required for their safe and effective use.

## Attachments

- [Risk minimisation measures for medicines](/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines)