Frequently Asked Questions

Pharmaceutical wholesalers supplying the products have the most up-to-date information about the products and their availability.

You can search for product information submitted to Fimea using a search for medicinal products requiring a special permit. Please note that the search does not cover all products and the search terms are only in Finnish.

Prescribers can search information on medicinal products from the websites of foreign authorities and inquire about available products from a pharmacy or a hospital pharmacy.

A user of a medicinal product may contact a pharmacy for information about availability and additional information.

A medicinal product subject to a special permit does not have a marketing authorisation in Finland. Because of that, there is no package leaflet in Finnish or in Swedish. However, it is still possible to use the medicinal product under a special permit procedure.

The physician prescribing the medicine and the pharmacy dispensing the medicine to the patient must ensure that the patient has sufficient information on the appropriate and safe use of the product, including instructions for storage and other instructions.

A prescription related to a special permit may be valid for a maximum of one year. The releasing party no longer needs to provide a copy of the written or electronic prescription to Fimea. 

Medicinal products that require a special permit are not included in the Pharmaceutical Database (excluding medicinal products released for consumption under a fixed-term special permit).

• For technological reasons, prescriptions requiring a patient-specific special permit should primarily be issued as written prescriptions. However, if the prescription related to the special permit application has been issued electronically, the releasing party may apply for the special permit based on an electronic prescription (incl. narcotic and PKV medicinal products). 
• In exceptional situations where the use of a telephone prescription is justified, the legislative amendment restricting their period of validity must be taken into account. As of 1 January 2024, telephone prescriptions may be valid for a maximum of three months. 
• Narcotics must be prescribed in writing using a confirmed narcotics prescription form.
• European prescriptions are not possible.
• You do not have to attach an order for a medicinal product or a prescription to an application for an institutional permit submitted to Fimea.
• Pro auctore prescriptions are approved as an attachment to a pro auctore application.

E-prescriptions can be used for medicinal products that have a fixed-term special permit Fimea has granted on its own initiative. The prescription may be valid up to one year.

In a special permit, the maximum allowed amount is the amount required for one year of treatment. In an application for a patient-specific special permit, this should be also considered in the prescription. The application must correspond to the prescription.

Before submitting the application to Fimea, if the medicine is prescribed for the duration of treatment, you must calculate the total quantity based on the dosage instructions indicated in the prescription and check that the quantity corresponds to the quantity indicated in the application.

In principle, the quantity is indicated considering the package size (number of packages x package size) to ensure that the pharmacy and the customer can clearly see how much of the product can be dispensed for one year of treatment.

For example, do not apply for a total of 365 tablets, if the product is only sold in packages of 100 tablets. The dose for one year corresponds to the appropriate quantity of an authorised product supplied based on a prescription. If the package size is not fully compatible with the total quantity prescribed, the pharmacy must assess the quantity to be dispensed based on pharmaceutical considerations.

The party releasing the product for consumption checks the package size and the quantity applied for before submitting the application to Fimea and appropriately marks any necessary corrections. If the total quantity and duration of treatment indicated in the prescription are ambiguous, the pharmacy must contact the prescriber for more information.

In ex tempore manufacture, you write down the required number of commercial packages x package size. When a medicinal product is used for ex tempore manufacture, you must apply for a special permit for the quantity of the commercial product required for ex tempore manufacture, considering the package size. In other words, the quantity to be applied for is not the number of single dose oral powder sachets to be manufactured, for example.

In the special permit application, strength is indicated based on the commercial product and not the strength of the single dose oral powder sachets to be manufactured, for example.

Yes. You can search for importers and pharmaceutical wholesalers known to the authority using a search for medicinal products requiring a special permit (Fimea). Please note that search is only in Finnish and search terms are also in Finnish.

If you need more information, please contact us at [email protected].

You can order a medicinal product in accordance with the application/decision from all pharmaceutical wholesalers known to the authority. You can check this using a search for medicinal products requiring a special permit (Fimea). Please note that search is only in Finnish and search terms are also in Finnish.

If you need more information, please contact us at [email protected].

Applications for a special permit are processed within 30 days of receipt by Fimea in line with the Medicines Decree. Expedited special permit applications are processed as quickly as possible.

Processing is delayed if information is omitted in the application, and the time required for any further clarifications is not included in the processing time.

To speed up the processing, send the special permit application by Fimea’s secure email instead of by post.

No. In Finland, generic substitution is not allowed for unauthorised medicinal products. A prescription for a medicinal product subject to a fixed-term special permit must be written for the trade name. Electronic prescriptions can be used, and they may be valid up to one year.

Yes. You can create a medicinal product in the pharmacy system. This may be relevant when, for example, Fimea has granted a fixed-term special permit on its own initiative to a new medicinal product, because changes made to the database are updated twice a month and enter into force on the 1st or the 15th day of the month.

In this situation, you can apply for a special permit beforehand to safeguard the continuity of pharmacotherapy. Applications for a special permit are processed within 30 days in line with the Medicines Decree.