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.
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European Medicines Agency launches platform for a better monitoring of medicine shortages
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.
Flash VIG-news : Marketing stop of Depakine (sodium valproate) 300 mg/5 ml syrup - beware of medication errors
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.
Applications for revisions to the register of pharmacies can from now on be done online
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.
PharmaStatus had adopted a fresh look
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.
Publication of a guidance for the implementation of a self-checking system related to the installation and maintenance of medical devices used in the diagnosis and treatment of sleep apnea syndrome outside the hospital
Pursuant to the Royal Decree of 24 October 2024, the FAMHP has approved a guide explaining in detail all the aspects that actors in the service and technical home assistance (STHA) sector must take into account to correctly set up a self-checking system. This guide includes a set of obligations.
Notification procedure for advertising of medicinal products for veterinary use to the public
On 1 January 2025, the Royal Decree of 22 September 2024 on advertising of medicinal products for veterinary use will come into force. That Decree describes the mandatory notification procedure prior to the distribution of any advertisement for a medicinal product for veterinary use to the general public.
Register for the Seventh Vigilance Day
On 12th December 2024, the Vigilance Division of the FAMHP will organise the seventh edition of Vigilance Day. This year, we are opting for a webinar.
Significant increase in the number of Belgians who have registered their will to make a donation of human body material in 2023
The Orgadon annual report provides quantitative data on the donation of human body material in Belgium since 2020. In 2023, the number of declarations of explicit consent increased considerably, while the number of declarations of opposition showed a slight increase.
Limited availability of intravenous infusion fluids: recommendations for physicians (specialists) and (hospital) pharmacists
The Federal Agency for Medicines and Health Products (FAMHP) was notified on 15 October 2024, by the company Baxter of the limited availability of certain infusion fluids for intravenous (IV) administration until 31 December 2024. Indeed, Baxter's largest manufacturing facility in North Cove (North Carolina, United States of America) was severely affected by Hurricane Helene.