News

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.

PRAC January 2025: EMA started a review of medicines containing semaglutide following concerns regarding an increased risk of non-arteritic anterior ischemic optic neuropathy

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).

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.

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.