Sunset clause in EU Marketing authorization

Sunset clause

Sunset clause is a provision leading to the cessation of the validity of the marketing authorization if:

• The medicinal product is not placed on the market within three years of the authorisation being granted or,
• Where a medicinal product previously placed on the market is no longer actually present on the market for three consecutive years.

The marketing authorisation of a medicinal product will remain valid if at least one presentation/pack size of the existing product presentations is placed on the market in the Community (in at least one Member State) including Iceland, Norway and Liechtenstein.The marketing authorization of a centrally authorised medicinal product includes the initial marketing authorisation and all variations (e.g. additional presentations) and extensions (e.g. new strengths, new pharmaceutical forms) authorized for this specific medicinal product.

Reference: Article 14(11) of Regulation (EC) No 726/2004