News FAMHP

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.

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.

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.

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.

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.

In 2019, the FAMHP published recommendations for the use of paclitaxel-coated balloons and paclitaxel-eluting stents. The European Commission recently published a scientific advice from an expert panel. The expert panel's advice contains no new elements that change the previous recommendations.

The European Medicines Agency has launched the European Shortages Monitoring Platform. For reporting at European level, marketing authorisation holders can now report shortages for centrally authorised medicines to the European Medicines Agency through this platform. For reporting at national level, PharmaStatus remains the reference in Belgium for reporting medicine shortages.

Sanofi Belgium has decided to stop marketing Depakine 300 mg/5 ml syrup as of 28 April 28 2025. However, Depakine's other oral liquid formulation, the 300 mg/ml oral solution, will remain available in Belgium. As this drink is more concentrated than the syrup and dosed with a different device, patients, healthcare professionals and parents need to be informed and prepared to avoid potential medication errors.

In Belgium, any authorisation for the opening, merger, transfer, temporary and permanent closure of a pharmacy open to the public must be registered in the FAMHP's register of pharmacies. In addition, any change, such as a different pharmacist in charge, an additional cadastral plot or the acquisition of a pharmacy, must be reported to the FAMHP. From now on, the FAMHP's new online application can be used for this purpose.

From Wednesday 11 December 2024, PharmaStatus, the online application that collects information about the availability of medicines in Belgium, has adopted a fresh look. The Federal Agency for Medicines and Health Products (FAMHP) has integrated new functionalities and updated the interface of the application.