A Questions and answers on how to fill in the form

Products for which special permits have been granted are listed here. The list shows pharmaceutical wholesalers /pharmacies that have previously released the product in question for consumption.  In most cases this is the fastest way to access the product. However, an application for a special-permit product may be submitted to any pharmacy or pharmaceutical wholesaler. If a special permit has not yet been granted for the product, it is advisable to contact the wholesaler in advance.

As here. The pharmaceutical wholesaler or pharmacy releasing the product for consumption can help you with this section.

The permit is granted for a quantity needed for one year's treatment at most. If a prescription is attached to the application, the quantities indicated in the two should match.

When veterinarians apply for pro auctore use of the product, or for resale to their patients, the place or region where the medicinal product will be used should be indicated. If the medicinal product will be used at a clinic, the name of the clinic should be indicated. The general principle is to submit one application per place of use. This principles stems from the Medicines Decree 693/1987, according to which a special permit may be granted for the treatment of an individual animal or group of animals. If the permit is for a specific patient, indicate the name and address of the customer, and e.g. the patient's name.

A general description of the therapeutic indication is required (e.g. cases of serious infection combined with resistance to primary anti-microbial drugs) but some concrete examples should also be given (two or three will suffice). If a product for which marketing authorisation has been granted is available for the therapeutic indication in question, attention should be paid to detailing the indications for which the authorised product is not suitable.

The general principle is to itemise each animal species on which the medicinal product will be used, with the exception of wild animals (hedgehog, squirrel etc.) and birds.

The Finnish Medicines Agency (Fimea) may grant a special permit for the use of a medicinal product for special reasons, if authorised products will not yield the desired result. The person prescribing the medicine is required to explain the special medical reasons for which the medicinal product is needed. Fimea makes its decisions in accordance with the Medicines Act 395/1987 (Section 21 f) and the Medicines Decree 693/1987 (Section 10 b and c). The so-called cascade rule on the use of medicines reflects the same principle.

If the therapeutic indication and the target species match the marketing authorisation, presentation of grounds is not required.

Apply for a special permit for the medicinal product which is used in the ex tempore manufacture. In other words, apply for a permit for a commercial product using its trade name.

The pharmacy releasing the ex tempore manufactured medicine for consumption can help you fill in the “Medicinal product details” section.

As the amount, indicate the amount of the commercial product used in the ex tempore preparation of the prescribed medicinal product.

Bachelors of Veterinary Medicine licensed to serve as locum veterinarians should indicate their title after their signature, for instance, “locum municipal veterinarian in X”, or “locum veterinarian at clinic YZ”.

The strength of the tablet/capsule/volume of the ampoule or  bottle x package size x the number of packages.

For ex tempore preparations, please see the answer to the question above.