Pharma Regulatory: The Effects of the Sunset Clause as of 7 November 2008
- Finland
- 09/09/2008
- Roschier, Attorneys Ltd. - Finland
The National Agency for Medicines (“NAM”) has published on its website a list of marketing authorizations and registrations for pharmaceutical products which are under the threat of lapsing as of 7 November 2008 when the so-called “Sunset Clause” will for the first time have legal effect. The Sunset Clause was introduced in Finland in November 2005 in connection with the implementation of Directive 2004/27/EC. According to the implementing provisions of the Medicines Act, a marketing authorization will be cancelled if the pharmaceutical product in question is not launched on the Finnish market within a period of three years from the date on which the marketing authorization was granted, or if a product is not marketed within three consecutive years. The NAM has announced that no corresponding list will be published of marketing authorizations lapsing after 7 November 2008 and that ensuring the validity of marketing authorizations is the duty of the pharmaceutical company in question. Marketing authorization holders will be notified in writing once the registration has lapsed and this information will also be available at NAM’s website.
