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.
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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.
Important call to clinical trial sponsors: transfer clinical trials to the CTR as soon as possible
From 31 January 2025, only the Clinical Trials Regulation (EU) 536/2014 and its delegated acts will apply, as stipulated in Article 98 of the regulation. The FAMHP calls on sponsors to transfer clinical trials to Regulation 536/2014 as soon as possible.
Deadlines for the submission of dossiers during the end-of-year period
During the end-of-year period, the FAMHP will be closed from Wednesday 25 December 2024 to Wednesday 1 January 2025. Deadlines have been set for the submission of different types of dossiers.
The FAMHP once again takes part in the global campaign for safer use of medicines
Today sees the start of the ninth edition of #MedSafetyWeek, a global campaign running from 4 to 10 November 2024, bringing together 107 organisations from 94 countries. This year's theme is the importance of using medicines correctly in order to prevent adverse effects and to report them if they occur.
PRAC October 2024 – The EMA started safety review of medicines containing finasteride and dutasteride
During its October 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency started safety review of medicines containing finasteride and dutasteride, to assess data related to suicidal thoughts and behaviours. Furthermore the PRAC formulated new safety information intended to healthcare professionals (DHPC) regarding a risk of medication errors due to change of dosing syringe for Keppra oral solution 150ml 100mg (levetiracetam)/1ml (with dosing syringe of 3 ml).
Import of medicinal products by wholesalers in case of special needs: publication of notification forms
On 1 November 2024, the new Article 105/1 came into force. Wholesalers will be allowed to distribute medicinal products that are not authorised in Belgium in our country if they meet a special need in Belgium due to a critical unavailability. The notification forms are now available.