Belgium | Royal Decree of 22 September 2024 on Advertising of Veterinary Medicinal Products Is Published
- 07/10/2024
- News
The Belgian Official Journal (Belgisch Staatsblad / Moniteur belge) publishes today a Royal Decree of 22 September 2024 on advertising of veterinary medicinal products (Koninklijk Besluit van 22 september 2024 betreffende reclame voor diergeneesmiddelen / Arrêté royal du 22 septembre 2024 concernant la publicité des médicaments vétérinaires – the RD). The RD implements Articles 47/1 through 47/5 of the Law of 5 May 2022 on veterinary medicinal products which, in turn, implement Articles 119 through 122 of Regulation (EU) 2019/6.
The RD governs:
- the requirement to keep (i) a copy of any advertisement of veterinary medicinal products subject to veterinary prescription that is addressed to veterinarians and/or pharmacists; and (ii) a register containing details of any such advertisements (Articles 2 and 3, RD);
- the procedure of prior notification to the Federal Agency for Medicines and Health Products (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten / Agence fédérale des médicaments et des produits de santé – FAMHP) of advertisements to the general public of non-prescription veterinary medicinal products and the requirement to maintain a register containing details of any such advertisements (Articles 4-6, RD);
- the requirement to keep a register containing details of any advertisements to veterinarians and/or pharmacists of non-prescription veterinary medicinal products (Article 7, RD);
- the conditions under which samples of veterinary medicinal products can be supplied to veterinarians having a medicine depot (Articles 8-10, RD); and
- the requirement for marketing authorisation holders (or the wholesaler designated by them to carry out their advertising activities) to keep a register of all premiums and benefits promised, offered or supplied to veterinarians or pharmacists (Article 11, RD).
The RD repeals (i) the Royal Decree of 9 July 1984 on information and advertising of medicinal products; and (ii) the Royal Decree of 11 July 2003 laying down the conditions under which medicinal products for veterinary use may be supplied in the form of samples (Articles 18 and 19, RD).
The RD will enter into force on 1 January 2025. Advertisements addressed to the general public that have already been distributed on 1 January 2025 will have to be notified to the FAHMP no later than three months after the entry into force of the RD in accordance with Article 5, §2, RD.
The RD marks another step in the implementation of Regulation (EU) 2019/6 in Belgium (see also, Van Bael & Bellis Life Sciences News and Insights of 25 September 2024).
Attached is a copy of the RD and the related opinion of the Council of State dated 6 May 2024.
