Applying for a special permit – Information for the releasing party
Instructions for the use of the electronic services (in Finnish)
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.
If a special permit application has been prepared electronically in the ERKKA service, the person releasing the medicine for consumption can only apply for a special permit through the ERKKA service. If digitalised application is not possible for some reason, you can apply for a special permit using the old form. Switching to e-services is recommended as soon as possible. Pharmacy representatives can log in to ERKKA directly through their pharmacy systems using a server certificate. If the application has been prepared in writing (manually or mechanically completed Fimea special permit application form), it is not possible to apply for a special permit electronically through ERKKA.
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. The information on the party releasing the product for consumption are updated in the electronic service from Fimea’s pharmacy register to ERKKA, so the party releasing the product for consumption must ensure that their contact information is up to date.
See also Fimea’s guidance letter to pharmacies (pdf, in Finnish) 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.
A copy of the prescription no longer needs to be attached to the special permit application submitted to Fimea. This applies to all prescriptions issued for human and veterinary medicine (including pro auctore). Fimea may still request a copy of the prescription or additional information related to the prescription in individual cases.
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
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
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)