When must an ending or interruption in the marketing of medical and in vitro diagnostic devices be notified? The European Commission recently published a decision tree to support the economic operators concerned.

The medicinal product Fibclot 1.5 g is temporarily unavailable from 9 October 2025 until 31 January 2027. The task force Unavailability of the FAMHP makes recommendations to physician specialists and hospital pharmacists.

During its March 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended an update to the vaccine’s product information to reflect that serious side effects, such as aseptic meningitis, have also been observed in healthy young adults.

As of 1 January 2026, sponsors will not be charged a fee for the Clinical Trial Regulation safety assessment and ethics committee assessment when a clinical trial application must be resubmitted due to technical issues in the Clinical Trials Information System, provided that these issues occurred after validation.

The FAMHP is launching a new dashboard with up-to-date figures on clinical trials in Belgium. With this initiative, the agency aims to increase transparency and further support the clinical research sector.

From 1 April 2026, Rybelsus tablets (oral semaglutide) will be replaced by a new formulation that offers improved bioavailability. Both formulations will temporarily coexist on the market, which may lead to confusion and a risk of overdose.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine GNT0004 for the treatment of Duchenne Muscular Dystrophy. The public consultation will take place from March 9th to April 8th 2026.

The FAMHP is launching HemoVigilance, a new online application for reporting serious adverse reactions related to the donation or transfusion of blood and blood components. The application also allows users to report any serious adverse incidents that have an impact on the quality and safety of labile blood components to the FAMHP.