Frequently Asked Questions

Until now, it has only been possible to apply for a special permit by filling in Fimea’s application form either mechanically or manually and submitting the application by secure mail or as a letter to Fimea. The application form for a special permit is processed by several parties and organisations, each individually. Regulatory processing is also manual, and the maintenance of special permits is carried out in several registers. The need for the update and digitisation of the procedure and a single system of special permits has been evident for a long time.

Fimea’s Current Events web page has a separate section, which provides an explanation on the digitised special permits application process and what will change as a result of the reform. There is also a separate section in Frequently Asked Questions related to the special permits reform and instructions videos on the use of e-services.

Special permit applications to be submitted electronically (ERKKA) (in Finnish)

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.

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 FimeaWeb.

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. The information can be checked in FimeaWeb.

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.

The e-service for special permits will streamline the application process for all parties. All parties will fill in the same electronic application online, and the application will not need to be transferred separately from one operator to the next. The electronic form provides instructions on how to fill the form in, which will reduce errors and the need for further clarifications. The e-service also contains a menu of medicines requiring a special permit, from which searching for a medicine is easy with a trade name or an active substance. The participants will also have an up-to-date view of the progress of their own application. The decision can be downloaded from the e-service throughout its validity period.

If digitalised application is not possible for some reason, you can apply for a special permit using the old form. Even so, switching to e-services is recommended as soon as possible. Processing of a special permit application submitted in writing with the old form will begin faster if the special permit application is sent 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.

It is possible to change the processing of the application from normal to urgent, for example, by sending the application/application data on the pending special permit application again to Fimea by secure mail. When submitting the special permit application again, it must be clearly stated when the application in question has been submitted for normal processing and that you want to change the application's type to urgent. The subject line should also clearly indicate a request to change the processing, e.g. Change of a normal special permit application to an application for urgent processing. The urgent processing fee is higher than that of normal processing.