by In2Pharma | Sep 19, 2025 | News
The Netherlands The Medicines Evaluation Board (MEB/CBG) has published an updated version of the policy document MEB45 (National implementation of additional risk minimisation measures) – version July 2025. Key changes include: – For digital materials, such as...
by In2Pharma | Feb 26, 2021 | News
Belgium Circular No. 635 (4 May 2018) details the approval procedure for risk minimisation activities (RMA). Certain paragraphs of this circular could be misinterpreted and specific situations were not considered. Therefore, the FAMHP provided more...
by In2Pharma | May 23, 2018 | News
FAMHP Following the amendment to Article 65quater of the Royal Decree of 14 December 2006, the procedure for approval of risk minimisation activities (RMA) has been adapted. This article was amended to adapt the deadlines for the evaluation and approval of RMAs....
