Circular 547 for the attention of the Marketing Authorisation (MA) Holders of medicines

Circular 547 of the Federal Agency for Medicines and Health Products (FAMHP) reminds MA holders of medicines of the obligation to notify the FAMHP the date when they are placed on the market or are withdrawn. Circular 547 provides guidance on how data on the status of marketing in Belgium of medicines authorized by the European Commission (centralized procedure for obtaining an MA) must be communicated to the AFMPS.

MA holders of medicines must notify the AFMPS the date when marketed. The temporary or permanent cessation of marketing must also be notified no later than two months before the cessation of marketing.

This communication is mandatory for all medicinal products (aArticle 6, paragraph 1e of the Law of 25 March 1964 on medicines).
Nevertheless, FAMHP notes that all the information on drugs approved by the European Commission (centralized procedure for obtaining an MA) is not provided.

The FAMHP requests all MA holders of these drugs to report if they are available or not on the Belgian market on 1 September 2009.

Circular 547  (Hum - Vet - Operating procedure) provides guidance on how the data on the status of marketing in Belgium of medicines authorized by the European Commission (centralized procedure for obtaining an MA) must be communicated to the AFMPS.

 

Last updated on
31/07/2009