Applying for special permit
Applying for a special permit
To apply for a special permit for compassionate use, the veterinarian is required to fill in a form and either send or, in urgent cases, fax it to the selected wholesaler or pharmacy. The original application should be sent by mail to the selected wholesaler or pharmacy, even if it has already been submitted urgently by fax. The form is available here. Answers to frequently asked questions on how to fill in the form and apply for the permit can be found here.
Special permits can also be applied for specific patients, particularly when medication is needed to treat a chronic condition (such as diabetes, pancreatic insufficiency) or in cases where a veterinarian is not allowed to release the medicine (e.g. medicines mainly affecting the CNS). In such a case, the veterinarian fills in the application and writes a prescription, if required, and the customer takes these to the pharmacy of their choice.
If the product requiring a special permit for compassionate use is entirely new and no special permit has been granted for it in Finland previously, the application should also include the package leaflet for the product in question, a summary of product characteristics, or another document providing product information. The need for a new special-permit product must be thoroughly substantiated, backed up with the relevant literature references. In the case of a new immunological product requiring a special permit, we recommend contacting Fimea by telephone or e-mail before submitting an application.
As a rule, a special permit is granted for the quantity indicated in the prescription, but for no more than one year’s treatment. A permit to release a medicinal product for consumption is valid for one year from the date of the decision. Certain conditions will be included in the decision, such as withdrawal periods for food-producing animals and user safety warnings. As a rule, pharmacological information, such as contraindications or adverse reactions, is no longer recorded under conditions for use; instead, the veterinarian applying for the special permit is responsible for studying the pharmacological information.