Unavailability

Under the provisions of Article 6, §1st sexies, second subparagraph of the law of 25/03/1964 (French version) on medicinal products and Articles 113, § 3 and 238, § 3 of the RD of 14/12/2006 (French version) (part 1 - part 2) on medicinal products for human and veterinary use, the marketing authorization or registration holders of a medicinal product have the legal obligation to communicate to the FAMHP any information concerning a temporary or a permanent cessation of marketing of this medicinal product.
If this withdrawal may cause a problem for public health, the FAMHP releases this information on its website.

Circular 577 (PDF, 700.17 Kb) of 15/02/2011 reminds readers of these legal obligations to MA or registration holders of a medicinal product for human and veterinary use and the practical measures on how to inform the FAMHP on the marketing status of the authorized medicinal products.

The MA or registration holder who expects that the unavailability of the medicinal product may last for 14 days or more, must inform the FAMHP about it at the latest within 7 days of the start of the unavailability.

Any temporary unavailability must be communicated to the FAMHP via the mailbox: supply-problems@fagg-afmps.be by completing the notification template (XLS, 42.5 Kb) of the temporary unavailability of a medicinal product.

The end of the unavailability must also be reported to the same address.

In case of a permanent cessation of marketing, this information must be communicated to the mailbox: commercialisation@fagg-afmps.be.

As for the MA granted by the Belgian authorities, this information is also taken into account for the enforcement of article 6 §1st of the law of 25/03/1964 (French version) (sunset clause).

List of unavailable medicinal products:

Link to unavailability of medicinal products