Commercialisation/ Unavailability

Notification procedure

Holders of a marketing authorisation (MA), a registration, an authorisation for parallel import or a temporary authorisation for use and parallel distributors are legally required to report any information regarding:

  • the marketing (start of commercialisation);
  • the permanent discontinuation of marketing (stop of commercialisation);
  • the temporary discontinuation of marketing (temporary unavailability and interruption of commercialisation)

of medicines to the FAMHP via PharmaStatus.

 

Please refer to the frequently asked questions and the PharmaStatus manual for more information.

 

  1. Reporting of commercialisation

The marketing authorisation holder or parallel distributor reports the commercialisation of a medicine as soon as the effective commercialisation date is known. To ensure the commercialisation status information is up to date, it is essential to report commercialisation at least fifteen business days before the effective commercialisation date.

 

  1. Reporting permanent discontinuation of commercialisation

The marketing authorisation holder or parallel distributor reports the permanent discontinuation of commercialisation at least six months before the effective date of discontinuation.

 

Please note

The provisions of Article 6 section 1 of the Law of 25 March 1964 (Sunset clause) continue to apply to MAs/registrations of medicines granted by the Belgian government.

 

  1. Reporting temporary unavailability and interruption of commercialisation

If the marketing authorisation holder or parallel distributor expects that not all orders can be fulfilled in full within three working days, this must be reported to the FAMHP as soon as possible and no later than the start of the unavailability period.

 

Please note

A temporary unavailability is a temporary problem where the marketing authorisation holder or parallel distributor makes the medicine available again in the short term. An unavailability period of more than one year can no longer be considered temporary. In this case, the more correct course of action is to report an interruption of commercialisation.

 

  1. Reporting the end date of temporary unavailability and interruption of commercialisation

The marketing authorisation holder or parallel distributor reports the end date as soon as the medicine is available again.

 

Legal framework

  • Article 6, section 1e, paragraphs one and two of the Law of 25 March 1964 on medicines.
  • Articles 113, section 3, and 238, section 3, of the Royal Decree of 14 December 2006, part 1 and part 2 on medicines for human and veterinary use.
  • Articles 2, 4 and 5 of the Law of 20 December 2019 amending various laws concerning shortages of medicines.

 

Publication

If certain medicines are no longer available in Belgium, temporarily or permanently, this may cause a public health issue. The FAMHP publishes relevant information for healthcare professionals and patients on the webpage Availability of medicines and on PharmaStatus.

 

The various lists are also available at the links below.

 

 

Last updated on 25/03/2022