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UK MHRA Guidance: Risk Minimisation Measures for Medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on "Risk Minimisation Measures (RMMs) for medicines" in the UK. These measures are essential tools used to ensure that the benefits of medicines continue to outweigh their risks during their use in the general population. Published in April 2025, this guidance sets out the principles, responsibilities, and real-world examples of RMMs to support safer medicine use in the UK.


Risk Minimisation Measures (RMMs) are regulatory strategies or activities designed to reduce the likelihood or impact of adverse drug reactions (ADRs) or medication errors. These measures complement routine pharmacovigilance and aim to ensure that patients and healthcare professionals use medicines safely and effectively.


There are two main types:

  • Routine RMMs – such as product labelling, patient information leaflets (PILs), and Summary of Product Characteristics (SmPCs).

  • Additional RMMs (aRMMs) – required when routine measures alone are not enough to manage a known risk.


RMMs aim to:

  1. Prevent or reduce adverse outcomes (e.g., severe side effects, medication errors).

  2. Educate stakeholders about specific risks and safe use conditions.

  3. Monitor outcomes through targeted data collection (e.g., registries, surveys).

RMMs are tailored to address risks that cannot be adequately managed by standard product information alone.


The MHRA decides whether additional risk minimisation measures are necessary on a case-by-case basis, as part of the benefit-risk assessment during marketing authorisation or when new safety data emerges post-authorisation.

Factors influencing this decision include:

  • The seriousness and frequency of the risk.

  • The patient population exposed.

  • The potential for off-label use or misuse.

  • Whether effective communication and education can reduce harm.


When aRMMs are required, the Marketing Authorisation Holder (MAH) must develop, implement, and monitor them in collaboration with the MHRA. MHRA also reviews their effectiveness and may request adjustments if outcomes do not align with safety goals. This is typically done through effectiveness evaluations, audits, and pharmacovigilance inspections.


Examples of Risk Minimisation Measures

1. Educational Materials

  • Healthcare professionals: Prescriber checklists, e-learning modules, or safety alerts.

  • Patients: Illustrated leaflets, video guides, or mobile app reminders.Example: Awarfarin app that tracks INR levels and dosage schedules.

2. Controlled Access Programs

  • Prescription restrictions: Limited to specialists (e.g., oncologists for chemotherapy drugs).

  • Patient registries: Mandatory enrollment for drugs with long-term risks (e.g., biologics).

3. Pregnancy Prevention Programs (PPPs)

  • Contraception requirements: For teratogenic drugs (e.g., isotretinoin).

  • Negative pregnancy tests: Mandatory before dispensing.

4. Direct Healthcare Professional Communications (DHPCs)

  • Letters or emails: Alerting HCPs about new risks or usage restrictions.

5. Additional Monitoring

  • Enhanced pharmacovigilance: Regular safety updates to the MHRA.

  • Surveys: Collecting real-world data on side effects or adherence.

6. Packaging Changes

  • Dosing aids: Pre-filled syringes or blister packs with day-of-week labels.

  • Safety features: Tamper-evident seals or color-coded caps.

RMMs bridge the gap between clinical trial data and real-world use, ensuring patients receive the full benefits of medicines while minimizing avoidable harm. The MHRA’s 2025 updates emphasize digital tools (e.g., apps, telehealth integrations) to improve accessibility and adherence.




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