B Questions and answers regarding the technical aspects of permit application
Veterinary / Special permits for compassionate use / FAQ / B Questions and answers regarding the technical aspects of permit application
No. If each clinic has a separate physical location, you need to apply for separate permits. This is because it will be more difficult to monitor the use of medicines if the permit covers several areas. In addition, the Medicines Decree 693/1987 clearly states that a special permit may be granted to an individual animal or group of animals. A special permit may not therefore be granted for use in several locations.
Vets practising at the same clinic can use a medicinal product for which one vet has obtained a special permit. The vet who signed the permit application is responsible for the correct use and storage of the product at the clinic.
No appendices are required, with the exception of the first-time permit application for a product in Finland (appendices required include a summary of product characteristics or package leaflet, and, depending on the case, literature references or publications) and a permit requiring a prescription for an individual patient (the client will provide the pharmacy with both the prescription and the application).
The party releasing the product for consumption (pharmaceutical wholesaler or pharmacy to which the permit is granted) is entitled to release the product specified in the decision for consumption for a period of one year from the date indicated in the decision.
No. You will only need to fill in one application, but Fimea will issue a separate decision for each strength. A separate fee will be charged for each decision (EUR 20/EUR 40 for an express permit).
When applying for a first-time special permit for a vaccine, other medicine with an immunological effect or an allergen, Fimea requires sufficient information on the quality and/or manufacture of such preparations in addition to the summary of product characteristics. The wholesaler/pharmacy will provide the necessary documents to Fimea for assessment. Depending on the preparation, an assessment may take 2–4 weeks. We recommend that applicants contact Fimea either by telephone or in an electronic format before submitting an application for a vaccine.
Depending on the case, the process to grant a permit for a new product requiring a special permit may be very short or can take months. The duration of the process depends on the severity of the demand, the availability of substituting products, and the feasibility of a risk to benefit assessment. If there is an acute need for a medicinal product, it is advisable to contact Fimea's Veterinary Officers by telephone.