News FAMHP

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.

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 participating in a webinar organised by the European Medicines Agency specifically for Belgium to support non-commercial sponsors involved in the new Clinical Trials Regulation 536/2014.

During the end-of-year period, the FAMHP will be closed from Thursday 25 December 2025 to Thursday 1 January 2026. Deadlines have been set for the submission of different types of dossiers.

The ‘Commission Santé et Égalité des Chances/Commissie voor Gezondheid en Gelijke Kansen’ once again addressed donor matters at its meeting on 4 November 2025, including a presentation and explanation of the Federal Internal Audit report and the reading guide for the FAMHP inspection reports.

By reporting suspected side effects, you help to make medicines safer for everyone. That is the core message of the #MedSafetyWeek campaign, which is celebrating its 10th anniversary this year. To mark this anniversary, the FAMHP is publishing statistics on side effect reporting in Belgium over the last ten years.

Several respiratory syncytial virus immunisation agents are available in Belgium. It is essential not to confuse them: each one is intended for a different target group.

Following the award of a new public contract, BNP Paribas Fortis will take over the federal government’s public bank accounts from bpost during the weekend of 13 and14 December 2025.