According to article 6 §1 section 3 of the law of 25th March 1964 (French version) about medicinal products, marketing authorisation or registration of a medicinal product expires if the medicinal product has not effectively been marketed within three years of receiving approval. This is the so-called « sunset clause ». This is also valid for a medicinal product 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.
The provision of the sunset clause to medicinal products for which marketing authorisation has been granted by the European Commission (centralized procedure) is the responsibility of the European Commission.
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, the FAMHP set the date to be considered as a starting point for the “period of 3 years of unavailability on the market” in the following cases:
1. MA or registration not followed by effective marketing
1.1. MA or registration approved for the first time before 1 April 2007.
Date of commencement of the "period of 3 years of unavailability on the market" = 1 April 2007. All marketing authorisation holders or registration holders have been invited to advise FAMHP if their medicinal product(s) was (were) marketed on the Belgian market or not as of 1 April 2007 (see Circular 481 (French version)). In April 2010 the marketing authorisation of medicinal products that have not been marketed will be revoked.
1.2. MA or registration approved for the first time since 1 April 2007.
Date of commencement of the "period of 3 years of unavailability on the market" = first date of approval of marketing authorisation or registration.
2. The medicinal product has been marketed but no longer available on the market for three consecutive years.
2.1. Medicinal product unavailable on the market on 1 April 2007.
Date of commencement of the "period of 3 years of unavailability on the market" = 1 April 2007 (see 1.1.)
2.2 Medicinal product no more available on the market after 1 April 2007.
Date of commencement of the "period of 3 years of unavailability on the market" = date of notification to stop marketing.
In exceptional circumstances and for reasons of public health, a derogation from the provisions of the sunset clause may be granted by the Minister or his delegate.
The document “Application of measures relating to the sunset clause in Belgium for medicinal products authorized at the national level” reminds the reader of the basic rules of the sunset clause and provides all information about derogation.
In accordance with article 6 §1 sexies of the law on medicinal products, the holder of a marketing authorisation for any medicinal product 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 stopped.
Holders of marketing authorisation for medicines are requested to advise FAMHP about changes in marketing via https://pharmastatut.be