Belgium
The Federal Agency for Medicines and Health Products (FAMHP, Belgium) has published an updated version of its guidelines for Additional Risk Minimisation Activities (version 08/2026).
The updated guidelines are available in Dutch and French and all changes have been highlighted in blue for ease of reference.
Key updates include:
- New recommendations promoting the use of joint RMA materials for generic, biosimilar and hybrid products that require the same additional risk minimisation measures.
- Guidance aimed at reducing the use of MAH logos in RMA materials.
- Additional examples of acceptable RMA materials.
- Expanded recommendations on the design, content and implementation of patient alert cards, aligned with the latest GVP Module XVI Rev.3 guidance.
- Further clarification regarding the availability and distribution of patient alert cards.
Source: Risicobeheerprogramma en risicobeperkende activiteiten | FAGG