Special permits for compassionate use
The Finnish Medicines Agency Fimea may grant a permit for the release for consumption of a veterinary medicinal product in individual cases where the product either has no marketing authorisation in Finland or has a marketing authorisation but has not been placed on the market, if no other means are available to treat an individual animal or group of animals, or if an available treatment would not yield the desired result.
An application for a special permit may be submitted by veterinarians or Bachelors of Veterinary Medicine, when serving as a locum veterinarian. The veterinarian to whom a permit is granted is responsible for the use of the medicine.
The permit to release the medicine for consumption is granted to the pharmaceutical wholesaler or pharmacy through which the application was received. When a medicinal product is released for consumption under a special permit for compassionate use, the releasing party is under an obligation to ensure that the user is provided with sufficient information on the safe and correct use of the product and on its appropriate storage and other relevant issues. When considering the use of a medicinal product requiring a special permit as an individual treatment solution, the veterinarian should check the product information and, if necessary, obtain more information on the product in question. A special permit for compassionate use is valid for one year from the grant date.
The information required for special permit applications is specified in Section 10 of the Medicines Decree. The grounds provided for the use of the medicinal product should indicate that this is an exceptional case where other treatment is unavailable or fails to produce the desired outcome. It is recommended that the previous pharmacotherapies used without an adequate outcome be listed, and an explanation be provided as to why a product or pharmaceutical form for which marketing authorisation has been granted is not an option.
Because limited information is available on the safety and efficacy of medicines requiring a special permit, any suspected adverse reactions should be reported to the Finnish Medicines Agency Fimea. Products requiring a special permit and for which no marketing authorisation has been granted may not be advertised or marketed.