News FAMHP

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.

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

Due to supply issues, Azactam 1 g and Azactam 2 g powder for solution for injection/infusion are currently only available in very limited quantities on the Belgian market. The available stock is not sufficient to meet patients’ needs during the expected period of shortage. Production is not expected to resume before July 2027. The FAMHP's task force on Unavailability issues recommendations.

European legislative initiatives such as the Biotech Act, the MDR/IVDR revision, the Critical Medicines Act, the new European pharmaceutical legislation and measures relating to online health information will have a significant impact on all stakeholders. The FAMHP provides an update on the current situation.

On 1 July 2026 VAMREG is officially launched. This new FAMHP application facilitates data collection on the volume of sales, and the use and the supply of antibiotics for animals used in animals in Belgium.

The FAMHP launches BioVigilance, a new online application for reporting serious adverse events and reactions related to reproductive and non-reproductive substances of human origin (SoHO) intended for human application.

During its June 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency completed its review of a safety signal for valproate and related substances and recommended New safety information for healthcare professionals regarding the chikungunya vaccine Ixchiq.