News FAMHP

The European Medicines Regulatory Network (EMRN), of which the FAMHP is part, has been designated as WHO Listed Authority by the World Health Organisation.

Following a control in ten tobacco shops in the Mouscron area, the FAMHP is warning against the purchase of non-compliant/illegal products that may present a health risk.

From 1 January 2024 to 30 June 2024, Belgium chaired the Council of the European Union, the body in which the 27 member states set the political direction and priorities of the European Union. During this period, the FAMHP organised over 20 events and meetings to promote cooperation and dialogue among member states and with European institutions. In addition, the FAMHP provided expertise to many important European initiatives. Time for a recap.

Total sales of antibiotics for animals in Belgium fell sharply in 2023: 21.7% compared to 2022, with a cumulative reduction of 62.4% compared to 2011 (reference year). Overall, the results of antibiotic resistance monitoring in food-producing animals are favourable. New initiatives are needed to support all stakeholders in their efforts to use antibiotics in a reduced, careful and rational way, to ensure the sustainable use of antibiotics in the future.

Although 2023 saw an increase in notifications regarding temporary unavailability of medicines, the agency once again demonstrated its effectiveness in ensuring the most efficient possible management of medicine stocks, as in the case of thrombolytics. The FAMHP also played its part in protecting public health by increasing the number of investigations into illegal medicines and devices by 30 %, and of inspections of pharmacies open to the public by over 40 %.

Some medicines may cause (severe) skin reactions if the skin is exposed to UV light (from the sun or from an artificial source). The FAMHP is drawing attention to the different types of light sensitivity, which common medicines present an increased risk, the reports it has received, and a number of precautionary measures.

Bavarian Nordic, the company that holds the marketing authorisation for Rabipur (Powder and solvent for solution for injection in pre-filled syringe - Rabies virus (inactivated, strain Flury LEP)) has notified the FAMHP that the medicinal product will be unavailable until 31 August 2024 due to a delay in the release of the final product. The Federal Agency for Medicines and Health Products (FAMHP) convened a task force with experts in order to find solutions.

CT CURE, the European Union’s joint action, will conduct the training session titled ‘Emergency Preparedness through Platform Trials in the European Union - European Economic Area’ on September 5th and 6th in Brussels. The training is designed specifically for assessors of clinical trial applications from Medical Research Ethics Committees and National Competent Authorities.

During its May 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU).

All ongoing clinical trials in the EU must have transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. The FAMHP is hosting a webinar for all stakeholders on 13 June 2024.