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 Fimea at the following address:
PO Box 55
Urgent applications for special permits (including appendices and contact details), as well as any supplementary information requested, can be initially sent
- by fax to +358 29 522 3006, or
- by e-mail via Fimea’s secure mail service to firstname.lastname@example.org.
(Instructions for using the secure mail service can be found under the question mark symbol in the service.)
Please note: Applications for special permits must be accompanied by contact details: fax number and/or telephone number. Original copies of applications for special permits, including appendices, must also always be sent by post to Fimea.
The form may also be printed and completed on paper, preferably using a typewriter. If the form is completed by hand, clearly legible handwriting should be used.
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.
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.