Applications for a special permit are processed within 30 days in line with the Medicines Decree. However, applications for expedited processing are processed as soon as possible. The time required for any further clarifications is not included in the processing time. The party releasing the product for consumption must inform the user of the medicinal product of the processing time.
The fees are based on the Decree of the Ministry of Social Affairs and Health on Fees Chargeable by the Finnish Medicines Agency.
Fimea informs the applicant of the outcome of the application and sends requests for further clarification primarily by secure email or by phone, when necessary.
Fimea sends a written decision on the special permit to the party releasing the medicinal product for consumption (applicant). The decision is not sent to the prescriber or the patient.
The original special permit application need not be sent to Fimea by post if it was submitted to Fimea by secure e-mail. This applies to both expedited and normal special permit applications. Fimea recommends that the releasing parties (applicants) store the original application forms.
Frequently asked questions concerning secure mail
(For more detailed instructions for using the secure mail service, click on the question mark symbol in the secure mail service).