by In2Pharma | Aug 20, 2026 | News
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...
by In2Pharma | Jun 21, 2022 | News
The Netherlands On March 30, 2022, the Dutch Health Authorities (MEB) updated the local policy regarding aRMM which is applicable for new and updated materials. No changes are required for aRMM that are already approved by MEB nor for ongoing procedures. The most...
by In2Pharma | Oct 25, 2021 | News
Luxembourg The Luxembourg national competent authority Division de la Pharmacie et des Médicaments de la Direction de la Santé has published 2 new documents. Instructions for marketing authorization holders for preparation and submission of additional risk...
by In2Pharma | Jun 22, 2021 | News
The Netherlands The Medicines Evaluation Board (MEB) has amended its policy regarding the national implementation of ‘additional Risk Minimization Measures’ (aRMM) (MEB 45). This is still a draft version. The main changes are: 1. Clarification of the...
