Initial effects of the Sunset clause on the marketing authorisations and registrations of medicinal products

The reform of the European pharmaceutical Directives in 2004 introduced the Sunset clause, under which a marketing authorisation or registration lapses i.e. ceases to be valid if the product has not been placed on the market within three years of the granting of the marketing authorisation or registration, or if the product has been absent from the market for a period of three consecutive years (the Sunset clause has been implemented into section 29 of the Medicines Act (395/87). The aim and intention of enacting the Sunset clause was to ensure that medicinal products with marketing authorisation or registration are placed on the market in the authorising Member State and thus become available to patients.

The legal effects of the Act commenced on 7 November 2008, on which date 250 marketing authorisations lapsed. Another 441 marketing authorisations at risk of lapsing were withdrawn by the relevant marketing authorisation holder before 7 November 2008. Most of the lapsed and withdrawn marketing authorisations concerned generic medicinal products, while of the 261 registrations of homeopathic preparations at risk of lapsing, 173 came to lapse. The lapsing of the aforementioned marketing authorisations and registrations will have no effect on medical or veterinary care in Finland, as the products concerned were not available on the Finnish market.

Section 29 of the Medicines Act will in future ensure that the administration of marketing authorisations and registrations targets precisely those medicinal products intended for the Finnish market and Finnish patients. The National Agency for Medicines will publish a monthly bulletin on the marketing authorisations and registrations that have lapsed.

Read more:
List of lapsed marketing authorisations and registrations (pdf)
Lapsing of marketing authorisations and registrations (Sunset clause)

For further information, please contact:
Professor Pekka Kurki, Head of Section, tel. +358 (0)9 4733 4225
Consulting Legal Advisor Risto Salmi, tel. +358 (0)9 4733 4220

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