News FAMHP

The European Medicines Agency publishes the second European Sales and Use of Antimicrobials for Veterinary Medicine report and launches a new platform to improve monitoring of data on the use of antimicrobials in animals. The report shows a slight increase in antimicrobial sales, an increase of 5 % in 2024 compared to 2023.

The European press has published information about a Danish sperm donor who carries a rare genetic mutation (TP53). Many European countries have been affected by this. In Belgium, this case has received extensive media coverage since May 2025, and several parliamentary hearings have taken place in which the FAGG responded to questions from federal parliamentarians.

The FAMHP is looking for GPs and gynaecologists willing to take part in a survey on educational material designed to reduce the risk of thromboembolic events associated with combined hormonal contraceptives.

From 11 December 2025, a new Royal Decree will come in force that fundamentally changes the rules on parallel distribution and parallel import of medicinal products for human use in Belgium. The decree simplifies administrative steps and provides more transparency.

From 28 May 2026, it will be mandatory to use the first four modules of the European Database on Medical Devices.

Medication errors have occurred with injectable forms of GLP-1 analogues and dual GIP/GLP-1 analogues. Below are a few reminders for a proper use of these medicines.

Ever more healthcare institutions are developing their own digital tools. This obviously raises some questions: what about regulations and patient safety? Therefore, the FAMHP is organising a study day on in-house software. Please mark your calendar for 10 March 2026.

As of 28 May 2026, it will be mandatory to use the first four modules of the European database on medical devices. This follows a decision published by the European Commission.

The medical devices HeartSine samaritan PAD models SAM 350P/360P/450P/500P, as well as the HeartSine samaritan Pad-Pak and Paediatric-Pak units, are subject to two safety actions due to potential malfunctions or failures of certain defibrillators and accessories.

On Tuesday 18 November 2025, the Federal Agency for Medicines and Health Products (FAMHP) once again appeared before the House of Representatives regarding the sperm donor case involving a sperm donor who carried a TP53 gene mutation and the failure to comply with the legal limit of six women per donor.