Applying for a special permit – Information for the releasing party
The party releasing the medicinal product into consumption is the applicant for a special permit (a pharmacy, hospital pharmacy, pharmaceutical wholesaler, medicinal product manufacturer). The user of the medicinal product and the physician who completed the application must take into account that they cannot send the form to Fimea themselves.
Responsibility of the party releasing the product for consumption
The releasing party is responsible for ensuring the appropriateness of the application when submitting the application to Fimea. The releasing party must ensure that all sections of the application form have been duly completed and check the product information and the availability of the medicinal product before submitting the application to Fimea. Where necessary, the releasing party must complete up-to-date product information in the special permit application based on the information provided by the pharmaceutical wholesaler, for example.
In the section “Kulutukseen luovuttaja” on the application, add the official name and contact details of the party releasing the product for consumption.
See also Fimea’s guidance letter to pharmacies on applying for a patient-specific special permit and supplying a medicinal product requiring a special permit based on an electronic prescription as of 1 January 2024 (in Finnish).
When a medicinal product is released for consumption under a special permit for compassionate use, the releasing party is required, for its part, to ensure that the user of the product is provided with sufficient information on the safe and correct use of the medicinal product concerned, along with storage and other relevant instructions.
The party releasing the product for consumption must have traceable information for the past five years specifying when and with whose prescription medicinal products have been supplied from a pharmacy under special permits and fixed-term special permits (Section 57a of the Medicines Act and Fimea Administrative Regulation on the supply of medicines 2/2016).
Applying for a special permit and contact details
Submit the application for a special permit (and possible attachments) as well responses to a request for further clarification:
- By Fimea’s secure e-mail to [email protected]
- By post to: Finnish Medicines Agency Fimea, Special permits, PO Box 55 FI-00034 FIMEA, Finland
Applications for expedited processing and responses to requests for further clarification are submitted by Fimea’s secure e-mail.
Currently, applications for normal processing can also be sent by Fimea’s secure e-mail. The application can also be sent by post.
Fimea will not log into other service providers’ secure mail services for the receipt of applications. Please note that applications containing personal data may not be submitted by regular e-mail for data security reasons.
The title of a secure email
When using secure email, be sure to indicate in the message title whether you are applying for expedited or normal processing of the special permit application. Appropriate titles speed up the processing.
- Normal special permit application or Expedited special permit application
- Further clarification/normal special permit application or Further clarification/expedited 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.
Form
Special permit application form (pdf) (in Finnish)
Instructions for filling the special permit application form (pdf) (in Finnish)