Exemption

Exemption

If justified, Fimea may grant a batch-specific exemption from the conditions of a marketing authorisation or registration, if a medicinal product is critical for the Finnish pharmaceutical services and its availability would otherwise be jeopardised (Fimea regulation 04/2019, Applying for and maintaining a marketing authorisation for a medicinal product). The exemption can only be granted for a preparation that has a valid marketing authorisation or registration. Otherwise, the special permit procedure must be followed.

An exemption is not granted for

  • a preparation that is not critical for the Finnish pharmaceutical services (for example if equivalent or otherwise suitable products are available for the indication).
  • purely financial reasons.
  • case where the problem is not an actual availability problem

Application for an exemption

An exemption is applied for separate application form Application Form for an Exemption (hum, vet) (pdf) or by a free-form application that should be delivered to Fimea by email [email protected].

Application Form for an Exemption (hum, vet) (pdf)

Ask more: [email protected]

The marketing authorisation holder must usually supply to Fimea at least the following information:

  • A description of the problem and the requested exemption for the marketing authorisation.
  • Justifications for the criticality of the preparation for Finland’s pharmaceutical services.
  • An estimate of the duration of non-availability and the sales data of the preparation for e.g. the last 6 or 12 months.
  • Information about the lot that the exemption applies to (lot number, expiry date, number of packages)
  • If necessary, mock-ups of packages that are in a foreign language

  • Power of attorney if the application is submitted by someone other than the marketing authorisation holder or the contact person previously notified to Fimea by the marketing authorisation holder.

If all details are not known at the time of application, it can be agreed that some information can be submitted later, after the exemption has been granted.

Processing of the exemption application

The processing time of an exemption application is 14 days, but the intention is to process the applications as fast as possible. If necessary, Fimea may ask for further clarifications from the marketing authorisation holder. An exemption application can either be approved or rejected. However, if the criteria for an exemption are not met, the applicant is usually requested to cancel their exemption application.

Exemption decision

The decision on an exemption is given only in Finnish to speed up processing. If the marketing authorisation holder requires a translation of the decision, they must procure the translation themselves.

Fimea publishes information of the granted exemptions on the webpage starting 1.5.2020. The information is available in Finnish and Swedish.

Ask more

Sirpa Lohi, tel. +358 29 522 3382

Anu Ollikainen, tel. +358 29 522 3417

Maria Pirinen, tel. +358 29 522 3038

Anu Pusa, tel. +358 29 522 3432

Anniina Ritvanen, tel. +358 29 522 3450

Nina Ruso, tel. +358 29 522 3400

Veera Vähärautio, tel. +358 29 522 3565

Hanna Varakas tel. +358 29 522 3328

E-mail address format: [email protected]