Belgium - Committees for Borderline Products for Human and Veterinary Use Replace Mixed Committee
- 20/08/2024
- News
On 19 August 2024, the Belgian Official Journal published a Royal Decree of 16 July 2024 determining the composition, tasks and functioning of the Committee for Borderline Products for Human Use and the Committee for Borderline Products for Veterinary Use and implementing Articles 12/1 and 12/2 of the Law of 20 July 2006 on the establishment and functioning of the Federal Agency for Medicines and Health Products (FAMHP) (Koninklijk Besluit van 16 juli 2024 tot vaststelling van de samenstelling, de opdrachten en de werking van de Commissie voor Borderline producten voor menselijk gebruik en de Commissie voor Borderline producten voor diergeneeskundig gebruik en tot uitvoering van de artikelen 12/1 en 12/2 van de Wet van 20 juli 2006 betreffende de oprichting en de werking van het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/Arrêté royal du 16 juillet 2024 fixant la composition, les missions et le fonctionnement de la Commission pour les produits borderline à usage humain et de la Commission pour les produits borderline à usage vétérinaire, et portant exécution des articles 12/1 et 12/2 de la Loi du 20 juillet 2006 relative à la création et au fonctionnement de l'Agence fédérale des médicaments et des produits de santé – the RD).
The RD repeals the so-called “Mixed Committee”, which is tasked with issuing opinions on the legal status of borderline products, i.e., products of which it is not clear whether they qualify as a medicine, medical device, food supplement, cosmetic, nutrient or daily consumer good. The Mixed Committee, which is established within the FAMHP and comprises two Chambers (one for products for products for human use and one for products for veterinary use), is replaced by a Committee for Borderline Products for Human Use and a Committee for Borderline Products for Veterinary Use (the Committees). Just as the Mixed Committee, the Committees will be composed of representatives of (i) the FAMHP; (ii) the Federal Public Service (FPS) Health, Food Chain Safety and Environment (both DG Animals, Plants and Food and DG Environment); (iii) the FPS Economy, SMEs, and Energy; and (iv) the Federal Agency for the Safety of the Food Chain.
Persons responsible for placing a product on the market, any of the above-listed authorities and third parties can each request a decision on the status of a specific borderline product and seek an opinion of the relevant Committee. The RD regulates the applicable procedures (see, Articles 11 and 12, RD) which, if the request does not emanate from the person responsible for placing the product on the market, ensure that the latter is being informed of the request and given the opportunity to submit written observations. Requests for decisions on the status of a borderline product should include, under penalty of inadmissibility, the following information:
- a reasoned analysis by the applicant of the status of the product, with a proposed status;
- all available scientific and technical data to support the analysis referred to in point (i) and the proposed status;
- the posology, composition, dosage and action of the product, as applicable (to the extent known by the applicant if the latter is not the person responsible for placing the product on the market); and
- the proposed use or application of the product and the general presentation of the product (to the extent known by the applicant if the latter is not the person responsible for placing the product on the market).
Attached is a copy of the RD, which will enter into force on 29 August 2024. Requests submitted prior to 29 August 2024 will be handled in accordance with the procedures of the RD.
