Belgium | Royal Decree of 1 September 2024 Completes Implementation of Regulation (EU) 2019/6 on Veterinary Medicinal products
- 25/09/2024
- News
The Belgian Official Journal (Belgisch Staatsblad / Moniteur belge) published today a Royal Decree of 1 September 2024 on veterinary medicinal products (Koninklijk Besluit van 1 september 2024 betreffende diergeneesmiddelen / Arrêté royal du 1er septembre 2024 sur les médicaments vétérinaires – the RD). The RD completes the implementation of Regulation (EU) 2019/6 and of the Law of 5 May 2022 on veterinary medicinal products.
The RD governs:
- the granting, amendment, suspension and revocation of national marketing authorisations, manufacturing authorisations, and wholesale distribution authorisations for veterinary medicinal products (Articles 2-6, 8-9 and 11-16, RD);
- the procedure for inclusion in the list of qualified persons responsible for manufacturing and batch release (Article 7, RD);
- the required qualifications of the responsible person for wholesale distributors (Article 10, RD);
- the formalities to be fulfilled by veterinarians who use medicines outside the terms of the marketing authorisation pursuant to Articles 112-114 of Regulation (EU) 2019/6 and the notification of the importation of these medicines from third countries (Article 17, RD); and
- the distribution and changing of the packaging or presentation of veterinary medicines by the person authorised to dispense veterinary medicines to the public (i.e., the pharmacist) and the person authorised to provide veterinary medicinal products to the person responsible for the animals (i.e., the veterinarian) with a view to dispensing small quantities of medicine (Article 18, RD).
The RD repeals part 2 (“Medicinal products for veterinary use”) of the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use (the RD of 14 December 2006) and removes the reference to veterinary medicines from the title of that Royal Decree. Accordingly, the scope of the RD of 14 December 2006 will now be limited to medicines for human use.
The RD will enter into force on 5 October 2024.
Attached is a copy of the RD and the related opinion of the Council of State dated 22 May 2024.
