News FAMHP

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.

The FAMHP has set up an internal crisis unit in response to news of a specific donor carrying a potentially carcinogenic TP53 gene mutation, and the fact that the limit of six women per donor has been exceeded.

The FAMHP now publishes a list of medical devices and in vitro diagnostic medical devices notified under Article 10bis of regulations (EU) 2017/745 and 2017/746, introduced by the regulation (EU) 2024/1860. In other words, medical devices that are temporarily (interruption) or permanently (discontinuation) absent from the Belgian market and whose unavailability could result in serious harm or a risk of serious harm to patients or public health.

From 1 June 2025, the Federal Agency for Medicines and Health Products (FAMHP) will introduce a new contact form for firms that have questions around their files of variations and renewals for medicinal products for human use.

Healthcare institutions often develop their own software to support patient care. This software has to comply with the legal requirements and obligations described below.