Belgium - Entry into Force of New Law Governing Veterinary Medicinal Products

• 24/05/2022
• Articles

The Law of 5 May 2022 regarding veterinary medicinal products (the Law – see, attachment) entered into force on 21 May 2022, subject to limited exceptions in relation to the identification code on the immediate and outer packagings. The Law both complements and implements Regulation (EU) 2019/6 on veterinary medicinal products which started to apply on 28 January 2022 (see, Van Bael & Bellis Life Sciences News and Insights of 10 January 2019; see also, Van Bael & Bellis Life Sciences News and Insights of 10 September 2021).
 
The Law regulates a set of important issues, including clinical trials with veterinary medicinal products; product requirements such as packaging, labelling, and summary of product characteristics (SmPC); marketing authorisations; post marketing authorisation measures, including the requirement to collect data regarding the sales volumes and use of antimicrobial medicines; pharmacovigilance; the manufacturing, preparation, importation and exportation of veterinary medicinal products; wholesale and retail trade, including sales at a distance; parallel trade; veterinary medicinal products prepared in a pharmacy in accordance with a magistral or an officinal formula; inspection, supervision and criminal penalties; and administrative settlements.
 
As a result of the Law, the Law of 25 March 1964 governing medicines will no longer apply to veterinary medicinal products and is for that reason made subject to a lot of modifications. The stated objective of the Law was to create two distinct sets of rules and to have veterinary products covered exclusively by the Law and its implementing Royal Decrees. However, the Law of 28 August 1991 regarding the exercising of the veterinary profession (the Veterinary Profession Law or VP Law) continues to apply and contains several rules that affect veterinary medicines. Additionally, the Law does not address a range of topics for which a separate set of rules was considered to be necessary, while there was no time left to complete the legislative process for that set (as noted, Regulation (EU) 2019/6 has already become applicable on 28 January 2022).
 
This is why a separate statute, currently scheduled to be submitted as a bill to the federal Parliament in the fall of 2022, will regulate the following matters: 

• Additional indications on the SmPC of homeopathic veterinary medicines;
• Additional obligations for wholesalers engaging in the parallel trade of veterinary medicines for reasons of public or animal health;
• Authorisations for making preparations;
• Substantive requirements for prescriptions;
• Processing of personal data contained in inspection files;
• Advertising for veterinary medicines;
• Rights and obligations of veterinarians with regard to veterinary medicines (Articles 9 to 12 of the VP Law) – It is unclear whether the future law will also tackle Article 17, VP Law which covers pricing issues as well as benefits and reductions given for the benefit of veterinarians.