Expiration of marketing authorisations and registrations (sunset clause)

The revision of the Directive on human medicines (Directives of the European Parliament an of the Council 2004/27/EC, 2004/28/EC) introduced a so-called Sunset clause article, which was added to the Medicines Act (395/87), section 29, subsection 1, paragraph 3. According to this regulation, the marketing authorisation and registration will expire, if the holders have not introduced the product to market within three years of the granting of the marketing authorisation and registration, or the product has been removed from the market continuously for three years.

This amendment of the Medicines Act (395/87), Section 29 came into force on 7 November 2005. The legal effects of the regulation to the marketing authorisations and registrations of medicinal products came into effect on 7 November 2008.

List of expired marketing authorisations and registrations

By the 15th day of each month, Fimea publishes on its website a list of marketing authorisations and registrations that have expired pursuant to section 29, subsection 1, paragraph 3 of the Medicines Act (395/87). This means that the preparations in question have not been introduced to marked by the 7th day of that month, or an exemption has not been applied for by the deadline. When a marketing authorisation or registration of a medicinal product expires, the holder is notified in writing

Fimea’s task as a Reference Member State (RMS)

For expiring preparations where Fimea acts as an RMS, Fimea will complete the officially started (i.e. where the procedure is on-going) RMS tasks. Fimea will not act as an RMS for expiring preparations whose applications have been submitted to Fimea but whose procedure has not yet been initiated, nor will Fimea process such applications (Type I and II variations and renewals). Such marketing authorisations will expire pursuant to Medicines Act (395/87) section 29, subsection 1. Fimea will take care of the RMS change process for expired products once Fimea is informed of the future RMS.                     

After a marketing authorisation or registration has expired, the holder of the marketing authorisation or registration may submit a written request to Fimea for a refund of the handling fee for procedures that were not started. The request must identify the submitted application and the date and amount of the paid handling fee. The request must also contain the requester’s address and banking information (organisations operating in the EU area must state the bank account in the IBAN format and the SWIFT code of the bank).