News FAMHP

A new guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies is now available.

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.

The Federal Agency for Medicines and Health Products (FAMHP) is pleased to invite you to celebrate 50 years of pharmacovigilance in Belgium.

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.

Applicants and marketing authorisation holders can now use the new version (1.28.0.0) of the Marketing Authorisation Application Form for national, mutual recognition and decentralised procedures.

On 27 July 2026, Implementing Regulation (EU) 2026/1810 was published concerning the update of the list of essential substances for food-producing horses. This Regulation entered into force on the day following its publication and amends Implementing Regulation (EU) 2025/901 and Regulation (EC) No 1950/2006.

Since January 2022 veterinarians have the obligation to use a new model for veterinary prescriptions. This new model is being introduced in several stages. Since 1 July 2026, the animal species must be specified on the prescription, in addition to the identification of the animal or group of animals to be treated.

During its July 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata.

Following the recent publication of the WOREL guideline on a multimodal approach to sleep disorders and insomnia, the FAMHP wants to remind patients and healthcare professionals of the importance of the rational use of benzodiazepines and related medicines.

The document concerning the approval date for variations, renewals and notifications has recently been updated. The changes include a clearer distinction between the revision date and the approval date in the product information for medicinal products for human use.