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Responsible for the service Finnish Medicines Agency Fimea

Exceptional permits for medicinal products

  • Permit or other obligation
  • Nationwide
  • Public service

An exceptional permit 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 the marketing authorisation or registration or if the marketing has been continuously interrupted for three years. Upon application by the holder of a marketing authorisation or registration, it may be decided that the marketing authorisation or registration will not expire after a period of 3 years.

Do the following

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.

To whom and on what terms

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.

A fee is charged for the service.


Deadline

Sunset clause: at least three months before the three-year deadline.

Processing time

Sunset clause: 30 days Other exceptional permits: 14 days

Period of validity

Temporary or valid until further notice.

Basic information

The service is provided byFimea
Responsible for the serviceFimea
Area Whole Finland
Available languagesFinnish, Swedish, English
Text edited by: Finnish Medicines Agency Fimea
Updated: 5/3/2021