During its January 2025 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) started a review of medicines containing semaglutide following concerns regarding an increased risk of non-arteritic anterior ischemic optic neuropathy (NAION).
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Operation Shield V: Belgian authorities seize 349 386 pills and tablets in action against counterfeit medicines, doping and food supplements
Customs, the Federal Police, the Federal Agency for Medicines and Health Products (FAMHP), the Federal Agency for the Safety of the Food Chain (FASFC) and anti-doping organisations (NADO Flanders, ONAD Fédération Wallonie-Bruxelles, ONADO Brussels) took part in operation SHIELD V, coordinated by Europol. This operation ran from April to November 2024 and targeted counterfeit medicines, doping and food supplements.
Vaccine againts epizootic haemorrhagic disease virus: second authorisation for use in Belgium
On 29 January 2025, the FAMHP authorises the use of the immunological veterinary medicinal product Syvac EH Marker (suspension for injection from the company Laboratorios SYVA, S.A.U.) intended for cattle.
FAMHP unveils its strategic plan 2025-2027
The Federal Agency for Medicines and Health Products (FAMHP) is proud to present its new strategic plan for the years 2025-2027.
Royal Decree of 17 December 2024 on the prevention and control of antimicrobial resistance in animals: assigning of AB farm status to certain breeders
Breeders of pigs, broiler chickens, laying hens or veal calves will receive an AB status determined by their first Sanitel-Med benchmarking report of 2025. Depending on the status – green, yellow or red – the breeder may be obliged to take certain measures.
Updated guidelines for the labelling and packaging of medicinal products for human use
Marketing authorisation holders of a medicinal product for human use are required to follow certain guidelines for the labelling and packaging of medicinal products. These guidelines have recently been updated.
Availability of medical devices on the EU market: manufacturers, authorised representatives, importers and distributors, your opinion is important for us
Upon request by the European Commission, a survey intended for economic operators is ongoing to monitor and analyse the availability of medical devices on the EU market in the context of the implementation of European Regulations 2017/745 (MDR) and 2017/746 (IVDR). This survey aims to identify obstacles that could affect availability of devices and/or impair the conformity assessment process, pointing to potential solutions.
Evaluation of European regulations on medical devices: the European Commission launches a public consultation
The European Commission has launched a public consultation to assess Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) on medical devices and in vitro diagnostic medical devices. The aim of this initiative is to gather stakeholders' opinions on the effectiveness of the current regulations and to identify any shortcomings.
Obligation for manufacturers to notify interruptions or discontinuations in the supply of medical devices and in vitro diagnostic medical devices
From 10 January 2025, manufacturers will have to report interruptions or discontinuations in the supply of medical devices and in vitro diagnostic medical devices placed on the European Union market for which it is reasonably foreseeable that such absence from the European market could endanger patient or public health in one or more countries.
Vet-AM Sales: a new tool for declaring sales figures of antibiotics for veterinary use
On 1 January 2025, the FAMHP is launching the online application Vet-AM Sales for the declaration of sales figures of antibiotics for veterinary use in Belgium. Vet-AM Sales will be integrated into the PharmaStatus application.