Sunset clause for medicinal products in Norway

"Sunset clause" is a common term for the provision which could lead to the cessation of the validity of the marketing authorisation of a medicinal product.

In accordance with Article 14 nr 4-6 of Regulation 726/2004, as well as Article 24 nr 4-6 of Directive 2001/83, the marketing authorisation of a medicinal product shall cease to be valid if either of the following conditions applies:

·         the medicinal product is not placed on the market within three years of the authorisation being granted or,

·         a medicinal product previously placed on the market is no longer actually present on the market for three consecutive years.

In Norway, the legal framework for sunset clause was not implemented in national law until January 2010. Sunset clause is governed by the Regulation on medicinal products section 8-4, which harmonises with Article 24 nr 4-6 of the Directive.

Marketing authorisations approved by either mutual recognition procedure, decentralised procedure or national procedure may therefore be invalidated by the Norwegian Medicines Agency (NMA) in January 2013, should either conditions of the sunset clause apply. The same also applies for marketing authorizations for parallel imported medicinal products.

Products approved in by centralized procedure are governed by the European Medicines Agency (EMA), and in such cases NMA follows the decisions from the Commission.

In exceptional circumstances and on public health grounds the NMA may grant exemptions for the invalidation. Such exemptions must be duly justified.

The NMA has stated that it will notify the MA-holders of products which may be affected by sunset clause, and that no MAs will be invalidated without the holder being notified in advance.