News FAMHP

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.

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.

As every year, the World Antimicrobial Resistance Awareness Week (18-24 November 2025) is raising awareness of the need to take action in the face of this public health challenge. The FAMHP is also actively working on this challenge.

"Act now: protect our present, secure our future” is the motto of the World Antimicrobial Awareness Week (WAAW) that promotes rational antibiotic use, starting today. The slogan highlights the need for sustained action against antimicrobial resistance, a threat to human, animal and environmental health. Belgium has managed to reduce both antibiotic use in animals and resistance to some of these molecules. Building on those encouraging results, we continue our endeavours for safe use of antibiotics, in order to preserve them for future generations.

During its November 2025 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency agreed on a communication to healthcare professionals on injectable tranexamic acid medicines, with regards to serious adverse reactions when inadvertently given intrathecally.

The FAMHP is publishing the audit report ‘Inspection, biovigilance and external communication with fertility centres’ in the wake of the sperm donor case.