Sunset clause

According to article  6 §1section 3 of the law of 25th March 1964 (French version) about medicines, marketing authorisation or registration of a medicine expires if the medicine has not effectively been marketed within three years of receiving approval. This is the so-called « sunset clause ». This is also valid for a medicine that is (has been) sold but will not be marketed for 3 consecutive years.

The term « marketing » includes being freely available to other commercial operators than the authorisation holder, such as distributors and pharmacists.

Not covered by this clause are medicines that have received authorisation for parallel import or authorisation for temporary use, or medicines authorised via the centralised procedure. 

The conditions of the sunset clause apply to marketing authorisation in the « global » sense, i.e. for different doses, pharmaceutical forms, methods of administration and different presentations of the same medicine. This implies that, once one of the presentations of the same medicine has been marketed, the 3-year period no longer counts for the other presentations of the same medicine and the marketing authorisation of all the presentations is upheld.

In order to apply this clause correctly all holders of a marketing authorisation or a registration were asked to advise FAMHP if their medicine(s) was (were) marketed or not as of 1st April 207 (ref. circular 481 (PDF, 97.05 Kb)). In April 2010 the marketing authorisation of medicines that have not been marketed will be revoked.

In accordance with article 6 §1 sexies of the law on medicines the holder of a marketing authorisation for any medicine has to advise the date when it will be marketed. This is also required if marketing is temporarily or permanently stopped and should be advised at the latest 2 months before marketing is sopped..

Holders of marketing authorisation for medicines are requested to advise FAMHP about changes in marketing at the following e-mail address:

fagg-afmps.sunsetclause@fagg-afmps.be

The following data should be given: the name of the medicine, the marketing authorisation number, the holder of the marketing authorisation, the type of change in the marketing, the date of the change and the packaging concerned. If one packaging is withdrawn from the market, but other packaging of the same medicine is still being marketed, this must be clearly indicated.