Lapsing of marketing authorisations and registrations (Sunset clause)
The reform of European pharmaceutical legislation (Directives 2004/27/EC, 2004/28/EC of the European Parliament and of the Council) introduced the “sunset clause” subsequently transposed into the national legislation in section 29(1) of the Medicines Act (395/87). Under the said provision, 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 amended section 29 of the Medicines Act (395/87) entered into force on 7 November 2005. The provision has legal effect on marketing authorisations and registrations of medicinal products as of 7 November 2008.
List of marketing authorisations and registrations at risk of lapsing
The National Agency for Medicines published on 15 August 2008 on its website a list of those marketing authorisations and registrations that will lapse pursuant to section 29(1)(3) of the Medicines Act (395/87) unless the said products are placed on the market by 7 November 2008 or for which no waiver has been sought by the deadline. The said list will be published only on 15 August 2008. Ensuring the validity of marketing authorisations and registrations thereafter is the duty of the relevant holders. Written notification of lapsing will be provided to the holders of marketing authorisations and registrations. In addition, the National Agency for Medicines will maintain on its website lists on those marketing authorisations and registrations which have lapsed.
The final list of marketing authorisations and registrations that have ceased to be valid has been published on the National Agency for Medicines website on 14 November 2008. The holders of marketing authorisations and registrations will also be provided written notification of the lapsing.
For reasons relating to the health of humans or animals or for other particular reasons, the National Agency for Medicines may upon application from the holder of the marketing authorisation or registration decide that the marketing authorisation or registration shall not cease to be valid pursuant to subsection 1, paragraph 3. Application to continue the validity of a marketing authorisation or registration shall be submitted to the National Agency for Medicines by the relevant holder no later than three (3) months prior to the expiry of the three-year time limit (section 29, Medicines Act 395/87).
By virtue of the above, the National Agency for Medicines has issued waivers to vaccines and parentherally administered hospital products, for example.
Reference state duties of the National Agency for Medicines and the legal effect of section 29 (1) of the Medicines Act as of 8 November 2008
Furthermore, the National Agency for Medicines issues the following statement concerning products for which marketing authorisation or registration ceases to be valid on 8 November 2008:
(1) the National Agency for Medicines will not assume a new reference state duty in respect of the said products (Finland requested to serve as a reference state in a mutual recognition procedure);
(2) the National Agency for Medicines will not, in its capacity as a reference state, initiate the review of applications (type I and II variations and renewals) received in respect of the said products that remain unprocessed to date (process not yet started);
(3) the National Agency for Medicines will complete the reference state duties that have been officially initiated in a mutual recognition procedure by 13 June 2008 (process started). In spite of this, the marketing authorisations in question will lapse as provided in section 29(1) of the Medicines Act.
Fees paid to the National Agency for Medicines
In cases (1) and (2) referred to above, the holder of a marketing authorisation or registration may apply for reimbursement of the processing fees by filing a written application with the National Agency for Medicines after the lapsing of the marketing authorisation or registration. The previously filed application, the amount of the processing fee paid and the date of payment must be indicated in the application, along with the applicant’s address and bank details. (Those operating in the EU area must designate their account in IBAN format and provide the SWIFT code of their bank).
For further information, please contact:
Consulting Legal Advisor Risto Salmi, tel. +358 (0)9 4733 4220
Original medicinal products: Procedure Manager Marja Helenius, tel. +358 (0)9 4733 4235
Generic medicinal products: Procedure Manager Leena Pietilä, tel. +358 (0)9 4733 4436
Veterinary medicinal products: Procedure Manager Heidi Mustalammi, tel. +358 (0)9 4733 4286
firstname.lastname@nam.fi
Updated 16.9.2009