Exemption may be granted for a product that is subject to a marketing authorisation or a registered product if the product is critical to the Finnish pharmaceutical service and its availability would otherwise be interrupted.
According to the sunset clause, a marketing authorisation and registration shall lapse if their holders have not marketed the product within three years of the granting of ...
An exemption is applied for separate application form Application Form for an or by a free-form application that should be delivered to Fimea by email kirjaamo[at]fimea.fi
Sunset clause exemption: The marketing authorisation or registration holder shall submit to Fimea an application for the extension of the marketing authorisation or registration before the expiry of the three-year period. Sunset clause exemption is applied for by means of an application for a Sunset clause exemption.
For justified reasons, Fimea may grant a sunset clause or a batch exemption from the terms of a marketing authorisation or registration if there would otherwise be a shortage of availability of a product that is critical to the Finnish pharmaceutical service (Fimea’s administrative regulation ”Applying for and maintaining a marketing authorisation and registration for a medicinal product”).
Only a product with a valid marketing authorisation or registration may be granted the permit. Otherwise, an exceptional permit procedure shall be used.
Sunset clause: The marketing authorisation expires on the basis of section 29 of the Medicines Act (395/87) if their holders have not marketed the product within three years of the granting of the marketing authorisation or registration, or the marketing has been continuously interrupted for three years.