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). Exemption applications must be submitted to Fimea same way as all other marketing authorisation applications. Applications that arrive only via email, will not be handled.

Based on the grounds above, Fimea has granted exemptions for e.g. vaccines or parenteral preparations administered in hospitals. When Finland has acted as the Reference Member State (RMS) an exemption is granted for the product without further justifications.

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

Instructions for the submission of the application