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.
News FAMHP
There are 953 result(s) found based on your search criteria
1-10 from 953 result(s)
Case on donor issues – Commission on Health and Equal Opportunity of 18 November 2025
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.
Antimicrobial resistance: a challenge for our health
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.
18-24 November 2025: World Antimicrobial Awareness Week (WAAW) for rational antibiotics use
"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.
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.