News FAMHP

The use of the PLM Portal web-based electronic application form for human variations is now recommended and an eCTD validation report for Belgium as Reference Member State (RMS) is required.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine AB-1002 for the treatment of congestive heart failure. The public consultation will take place from 16 July to 15 August 2025.

The successful ‘benzodiazepine withdrawal programme’ project was made permanent on 21 March 2025. Certain outpatients who chronically take benzodiazepines or Z-drugs can take part in the programme. This programme is based on the officinal preparation of capsules following a doctor's prescription.

Some medicines can cause (serious) skin reactions when you are being exposed to UV light from the sun or an artificial light source. The FAMHP wants to inform you about this issue.

Distributors of medical devices are legally required to register with the Federal Agency for Medicines and Health Products (FAMHP). Between 2022 and 2024, the FAMHP inspection services conducted a thematic action in order to verify that. Thanks to this action, nearly four hundred distributors were registered on the FAMHP web portal.

Due to a delay in production, the availability of Visudyne, a medicine used in ophthalmology, has been limited since 9 December 2024. This situation is expected to continue until at least the end of April 2026. The experts of the FAMHP’s Unavailability Task Force are making the following recommendations to (hospital) pharmacists and medical specialists.

The Federal Agency for Medicines and Health Products appeared before the Belgian House of Representatives on Tuesday 17 June 2025, as part of the hearing on the case of the sperm donor carrying the TP53 gene mutation.

Advice following reports of unplanned pregnancies related to GLP-1 receptor agonists. An investigation by the EMA is currently ongoing.

During its June 2025 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION). Furthermore, the PRAC is reviewing the known risk of encephalitis (inflammation of the brain) with two varicella (chickenpox) vaccines, Varilrix and Varivax, following a report of a fatal outcome after vaccination with Varilrix.

After a fertility centre contacted the Federal Agency for Medicines and Health Products, it emerged that its dossier on the sperm donor carrying the TP53 gene mutation was incomplete, as two additional children were reported. FAMHP inspectors immediately visited the centre for an inspection. The procedure is still underway. The FAMHP considers that the fact that the centre is communicating these elements only now, despite previous information and questions, is very serious.