"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.
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PRAC November 2025 – The PRAC agreed on a communication to healthcare professionals on injectable tranexamic acid medicines
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.
Case on donor issues – Publication of the audit report
The FAMHP is publishing the audit report ‘Inspection, biovigilance and external communication with fertility centres’ in the wake of the sperm donor case.
Non-commercial sponsors involved in the new Clinical Trials Regulation – sign up for the EMA-webinar
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.
Deadlines for the submission of dossiers during the end-of-year period
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.
Commission meeting on donor issues – 4 November 2025
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.
MedSafetyWeek: the FAMHP looks back on ten years of side effect reporting
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.
RSV immunisation: choosing the right product
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.
BNP Paribas Fortis will take over the federal government’s public bank accounts
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.
PRAC September 2025 – The PRAC started a review of medicines containing levamisole and adopted DHPCs for medicines containing caspofungin and for the medicines Crysvita, Remsima and Tegretol
During its September 2025 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency started a review of medicines containing levamisole, authorised in four countries of the European Union to treat infections caused by parasitic worms in adults and children. This medicinal product is not marketed in Belgium, but it is included in the World Health Organization’s list of essential medicines. Additionally, the PRAC adopted DHPCs for medicines containing caspofungin, as well as for the medicines Crysvita (burosumab), Remsima (infliximab) and Tegretol (carbamazepine).