Progress report on the Recovery plan for the supervision of fertility centres: actions completed and measures currently in progress

In order to guarantee a high standard of safety and quality in gamete donations in Belgium and to strengthen the supervision of fertility centres in the long term, the Federal Agency for Medicines and Health Products (FAMHP) has drawn up a plan setting out structural improvement measures. This plan was presented to Parliament in April 2026.

Jascayd

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Jascayd

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Tepkinly

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Quota exceedances: the FAMHP continues its efforts and increases transparency

Following the press articles published today concerning a new case of quota exceedance involving a foreign gamete donor, as well as the publication of the relevant information on its website, the Federal Agency for Medicines and Health Products (FAMHP) wishes to clarify the situation. The FAMHP emphasises that the identification and publication of new quota exceedances form part of the Agency’s ongoing work and reflect its commitment to transparency towards citizens.

Guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies

Belgium offers a synchronised submission procedure for combined studies involving medicinal products and medical devices and/or in vitro diagnostic devices. This Belgian approach aligns the timelines of both submission procedures, making it easier and more efficient for sponsors to submit their applications.

Registration of antibiotics in VAMREG: e-learning for veterinarians

Since 1 July 2026, the use of antibiotics in all horses and aquaculture fish (intended for food production) must be recorded in the VAMREG application. The FAMHP and AMCRA are offering an e-learning course to support veterinarians with a medicinal products depot and active in these sectors in their use of this new application. A question-and-answer session is also planned.
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