How to apply for a special permit
How to apply for a special permit
The legislation concerning special permits can be found from the Medicines Decree (693/1987) as currently amended.
Completing the special permit application form
The special permit application (at the bottom of the page) may be completed electronically, but the original application form shall be submitted to the party releasing the product for consumption (the applicant). Fimea advices the releasing parties to retain the original application forms.
The releasing party shall ensure that all sections of the application form have been duly completed and check the product information and the availability of the product before the application is submitted to Fimea. Where necessary, the releasing party shall complete up-to-date product information in the special permit application.
In the ‘Party supplying the product’ section of the special permit application, enter the contact details:
- official name of the party releasing the product for consumption
- fax number (if in use)
The bottom section of the special permit application is reserved for the authorities’ markings.
Submitting the special permit application
Special permit applications (complete with potential appendices and contact details), as well as responses to requests for further clarification, can be sent
- by Fimea’s secure e-mail to email@example.com
- if necessary, by fax to +358 29 522 3006
- to the mailing address:
Finnish Medicines Agency Fimea
PO Box 55
FI-00034 FIMEA, Finland
Fimea will not log into other service providers’ secure mail services for the receipt of applications. Additionally, it must be observed that applications that contain personal data may not be submitted by regular e-mail for data security reasons.
Special permit applications with expedited processing and responses to requests for further clarification shall be primarily submitted by Fimea’s secure e-mail.
Special permit applications with normal processing are currently also received by Fimea’s secure e-mail. The application can still be sent as a letter as well.
When naming the secure e-mail massage, be sure to indicate in the message heading whether the special permit application is for expedited or normal processing. Any further clarifications will slow down the processing of the application.
- Normal special permit application
- Urgent special permit application
- Further clarification / normal special permit application
- Further clarification / urgent special permit application
Additionally, include the name of the medicinal product and the official name of the party releasing the product for consumption in the message heading. Example: Normal special permit application / Medicinal product / Official name of the party releasing the product for consumption
Each special permit application must be submitted as a separate single pdf-file. If the same secure e-mail message includes several special permit applications, be sure to name the medicinal products in the message heading.
The original special permit application need not be sent to Fimea by post if it was submitted to Fimea by secure e-mail (or fax). This applies to both urgent and normal special permit applications. Fimea encourages the releasing parties (applicants) to save the original application forms.
The party releasing the product for consumption must have traceable information for the past five years specifying when and on whose order prescription medicinal products have been supplied from a pharmacy with special permits and temporary special permits (section 57 of the Medicines Act and Fimea Administrative Regulation on the supply of medicines 2/2016).
The user of the medicinal product and the individual preparing the application must note that they cannot by themselves submit the application to Fimea, but instead it shall always be submitted by the party releasing the product for consumption (pharmacy, subsidiary pharmacy, hospital pharmacy, medicinal product wholesaler, pharmaceutical plant).
Frequently asked questions concerning secure mail
(See more detailed instructions for using the secure mail service by clicking on the question mark symbol in the secure mail service.
Special permit decision, processing times and prices
Efforts will be made to process urgent special permit applications (€40) as rapidly as possible. For normal special permit applications (€20), the statutory 30-day processing time applies. The time spend for any further clarifications will not be included in 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.
The party releasing the product for consumption should inform the user of the processing time. Contacting Fimea by phone to inquire about your application during its processing will cause backlogging in the processing of permits, for which reason we ask that you avoid making such inquiries.
Fimea will notify the endorsement of an urgent application and any requests for further clarifications based on the contact details indicated by the releasing party either by phone or secure e-mail or, where necessary, by fax.
The releasing party should note that Fimea continues to send the written special permit decision on applications with normal processing by regular mail even if the application was submitted by secure e-mail or by fax.