Exceptional permits for medicinal products

Sunset clause exceptional permit: The marketing authorisation or registration holder shall submit to Fimea an application for the extension of the marketing authorisation or registration at least three months before the expiry of the three-year period. An exceptional permit is applied for by means of an application for a Sunset clause exceptional permit.

There is no separate application form for other exceptional permits, but the permit is applied for with a free-form application, which can be sent to Fimea by e-mail: kirjaamo[at]fimea.fi.

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.