Sunset clause exemption

Fimea may, upon application by the marketing authorisation holder, or in cases related to human or veterinary health, decide that a marketing authorisation or registration will not expire after the set period of three years. The marketing authorisation or registration holder must submit to Fimea an application for extending the period of validity of the marketing authorisation or registration at least three months before the three-year set period expires (Medicines Act 395/87, section 29).

Based on the grounds above, Fimea has granted exemptions for e.g. vaccines or parenteral preparations administered in hospitals.

An application for the sunset clause exemption has to be submitted no later than three months before the authorisation or registration expires.