How to apply for a special permit

How to apply for a special permit

Applying for special permission for compassionate use

Legislation concerning the compassionate use of medicinal products is based on the Medicines Decree (693/1987, 1184/2002 and 868/2005).

Completing the Compassionate Use application form

The form may be completed electronically, but the party releasing the product for consumption must submit a paper copy complete with the necessary annexes to the Finnish Medicines Agency at the following address:

Fimea
Compassionate Use
PO Box 55
FI-00034 FIMEA

The Releasing Party section of the special permit application must include contact details

  • official name of the applicant
  • phone
  • e-mail
  • fax number (if in use)

Urgent applications for special permits (including appendices and contact details), as well as responses to requests for further clarification, can be sent

When using secure mail, the express permit application must be named: Express permit – name of medicinal product

Most common questions about secure mail
(See more detailed instructions for using the secure mail service by selecting the question mark symbol in the secure mail service.)

Please note: The original application forms for urgently processed special permit applications will not be submitted to Fimea.

Fimea encourages the releasing parties (applicants) to save the original application forms. An applicant must have documentation from the past five years specifying when and on whose order prescription medicinal products have been delivered from the pharmacy with special permits and temporary special permits (section 57 of the Medicines Act and Fimea Administrative Regulation on the delivery of medicines 2/2016).

The form comprises one page.

At the bottom of the page, there is an area for official use only.

Instructions for electronic form completion

MS Word file
This electronic form can be completed using Word 6.0 or a newer version. To move between the fields, use the TAB key or click on the field with the mouse.
To tick or untick a box, click on it with the mouse.

PDF file
This electronic form is opened with Acrobat Reader, a free software programme available at the Adobe website. The form can be completed electronically, much like the Word file, and then printed on paper. The free version of Adobe Acrobat allows you to save an unchanged copy of the form. If the form has been changed (completed), it can only be saved using the commercial version of Adobe Acrobat.

Forms

Information on products available for compassionate use