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 02/2013, 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
There is no separate form for an exemption. An exemption is applied for by a free-form application that should be delivered to Fimea by email. 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
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.
An exemption can also be granted for having a centralised preparation on the market simultaneously with two different compositions, two different trade names or in the packages of two different marketing authorisation holders, since it is not possible to apply for such a simultaneous market availability in the centralised procedure. In these cases, the application must be accompanied with a document stating that the variation is approved in the centralised procedure.
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. The decision on an exemption is published only in Finnish to speed up processing. If the marketing authorisation holder requires a translation of the decision, they must procure the translation themselves.