2024/0243/BE
EC/EFTA
BE Belgien
  • C00P - PHARMAZEUTIKA, KOSMETIKA
2024-08-05
2024-05-30

Bydureon, Ozempic, Rybelsus, Trulicity, Victoza.

Decision to extend the export of medicinal products belonging to GLP-1 analogues which are subject to anauthorisation including the indication of type 2 diabetes mellitus intended for the Belgian market subject to priorauthorisation

The prepared draft extends an authorisation obligation for the export of a specific medicinal productintended for the Belgian market in the event of unavailability, under the conditions laid down by the Royal Decree of18 January 2023 implementing Article 12f(2) of the Law of 25 March 1964 on medicinal products, Article 4, § 1, § 2(1) and § 3(1). Prior authorisation for a certain period (i.e. the duration of the notified planned period of unavailability), in particular until 28/02/2025.