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.
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Unavailability of Fibclot 1.5 g powder and solvent for injection/infusion: recommendations for physician specialists and hospital pharmacists
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.
PRAC March 2026: warning about the known risk of aseptic meningitis after administration of the Ixchiq vaccine
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.
CTIS technical issues: no fee for resubmission of clinical trial applications
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 dashboard with up-to-date figures and statistics for clinical trials
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.
Rybelsus – Reminder: risk of medication errors due to the introduction of a new formulation
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.
Give your opinion on a genetically modified medicine against Duchenne Muscular Dystrophy
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.
Launch of the new online application HemoVigilance
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.
PRAC February 2026 – PRAC recommends the withdrawal of medicines containing levamisole
During its February 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended the withdrawal of medicines containing levamisole from the EU market. These medicinal products are not marketed in Belgium, but are included in the World Health Organisation list of essential medicines.
Give your opinion on a genetically modified medicine against Stargardt Disease
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine AAVB-039 for the treatment of Stargardt Disease. The public consultation will take place from February 28th to March 30th 2026.