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March 5, 2026
Approximately 5 minutes
Guidance on Risk Minimisation Measures for Medicines in the UK
Guidance on Risk Minimisation Measures for Medicines in the UK
1. Publication Details
Updated 9 June 2025. Published by Medicines and Healthcare products Regulatory Agency. Licensed under Open Government Licence v3.0. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines
2. Purpose of Risk Minimisation Measures
This guidance is aimed at healthcare professionals on risk minimisation measures for medicines. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines Risk minimisation measures facilitate the safe and effective use of medicines by healthcare professionals, patients, and their carers or guardians. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines Marketing Authorisation Holders (MAHs) must implement routine risk minimisation measures, such as the legal status of a medicine (e.g., prescription-only), pack size, Summary of Product Characteristics (SmPC), and Patient Information Leaflet (PIL). These address safety concerns post-market. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines Additional risk minimisation measures are required for certain medicines to reduce or prevent adverse events, mitigate severity or impact, support informed treatment decisions, enable treatment monitoring, prevent medication errors, and ensure appropriate administration. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines Measures cannot be used for commercial promotion. They should be available in various formats for accessibility by healthcare professionals and patients, and include information on reporting adverse events to the Yellow Card scheme where possible. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines
3. Decisions on Risk Minimisation Measures
The MHRA may require MAHs to produce measures as a condition for product licensing or following safety reviews. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines Before requiring additional measures, the MHRA assesses impact on patients and caregivers, unintended consequences (e.g., raising off-label use awareness), and implementation feasibility in the healthcare system. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines MHRA reviews and agrees materials before distribution; patients and healthcare professionals may be consulted on drafts. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines MAHs may independently implement materials to support safe use, without MHRA review. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines
4. Examples of Risk Minimisation Measures
4.1 Patient Guidance
Guidance for patients taking or planning to take a medicine, providing benefits, risks, adverse event actions, correct administration, and treatment steps (e.g., blood tests). May signpost to external support organisations. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines Formats: brochures, leaflets, checklists, patient cards. Accessible online or in print; clear, accessible, patient-friendly language; easy-read formats where possible. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines
4.2 Healthcare Professional Guidance
Guidance on medicines with complex considerations, prescribing/dispensing requirements, or patient care. Includes contraindications, warnings, patient selection, pre-treatment requirements (e.g., blood tests), administration instructions, treatment management, monitoring, and patient information advice. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines Formats: brochures, leaflets, posters, checklists. Accessible online or in print; clear and actionable. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines
4.3 Patient Cards
Provided to patients to highlight key messages: adverse event risks, actions if adverse event occurs, contraindications (e.g., health conditions, pregnancy), correct intake instructions. Not a substitute for PIL (included in every pack); encourages reading PIL. Aids informed decisions. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines Can be carried (e.g., wallet-sized) to inform healthcare professionals, caregivers, or public in emergencies about medicine and reactions. Distributed by professionals, as packaging inserts, or extra packaging parts; extras for pharmacists when splitting packs. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines
4.4 Other Educational Tools
Educational tools/programmes for professionals or patients to raise awareness or provide training, in audio, video, web, or in-person formats. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines
4.5 Controlled Access Programmes
Ensure medicine use is limited to specific situations or patient groups to minimise significant risks with public health or individual impact, beyond routine controls. For medicines with high risks for non-qualifying patients but significant benefits for qualifying ones (e.g., failed other treatments). https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines Involves strict procedures: patient testing for criteria, risk understanding documentation, registries, follow-up, pharmacy registration. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines
4.6 Controlled Distribution System
Traces product through distribution to patient to prevent misuse/abuse, ensuring no loss in chain. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines
4.7 Pregnancy Prevention Programmes
For medicines with known/potential teratogenic effects. Ensures pregnancy exclusion in women of childbearing potential before start, and minimises pregnancy risk during/after therapy. Combines education with prescribing/dispensing requirements; may include Risk Acknowledgement/Awareness Forms signed by patients. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines MHRA requires only after risk/benefit consideration, including negative impacts; decided with Commission on Human Medicines consultation. https://www.gov.uk/government/publications/risk-minimisation-measures-for-medicines/risk-minimisation-measures-for-medicines
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