As of 1 January 2026, there are a number of important changes to the registration of antibiotic use in animals that are necessary to comply with European regulations, namely Regulation 2019/6 on veterinary medicinal products and Delegated Regulation 2021/578, and the pending amendments to the Royal Decree of 21 July 2016.
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Conformity check of veterinary prescriptions models temporarily not a priority
As not all veterinarians yet have prescriptions in line with the new legislation, the FAMHP has issued a circular asking its inspection services to no longer give priority to checking the conformity of these model prescriptions.
Deadline for the registration of sales volumes of veterinary medicinal products
Marketing authorisation holders must submit the 2024 sales volumes of veterinary medicinal products to the UPD by 28 February 2025.
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.
Vaccine against epizootic haemorrhagic disease virus: authorisation for use in Belgium
The FAMHP authorises the use of the immunological veterinary medicinal product Hepizovac (suspension for injection from the company CZ Vaccines S.A.U.) intended for cattle.
Reminder - Deadline for registration of annual sales volume data for veterinary medicinal products
Marketing authorisation holders have until 29 February 2024 to submit annual sales volume data for veterinary medicinal products for 2023.
Deadline for registration of annual sales volume data for veterinary medical products
Marketing authorisation holders have until the end of February 2024 to submit annual sales volume data for veterinary medical products for 2023.
COVID-19: electronic files submission
Following the recommendations of the Belgian National Security Council regarding the coronavirus epidemic, the FAMHP encourages employees to work more from home. Therefore, we ask all our partners to submit their files to us electronically as much as possible.
Soumission électronique des dossiers d’AMM des médicaments à usage vétérinaire : nouvelle version du checker
A partir du 1er juillet 2013, la nouvelle guideline « vNeeS » et les nouvelles règles de validation entreront en vigueur pour les dossiers d’autorisation de mise sur le marché (AMM) des médicaments à usage vétérinaire. Le « checker » correspondant utilisé pour la validation technique de ces dossiers a fait l’objet d’un « release » de maintenance (v 2.2.a) pour en tenir compte.
Medicines for veterinary use: new QRD (Quality Review of Documents)
Within the European Medicines Agency, the Coordination group for Mutual Recognition and Decentralized Procedures – veterinary medicines (CMDv), and the "Quality Review of Documents "(QRD) Working Group reviewed at the end of 2012 the templates for the Summary of Product Characteristics (SPC), package leaflet and labelling of veterinary medicines. The "QRD" templates Version 8 are now available.