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Responsible for the service Finnish Medicines Agency Fimea

Marketing authorisations and registrations of medicinal products

  • Permit or other obligation
  • Nationwide
  • Public service

All medicine and veterinary medicine sold and used in Finland must have a marketing authorisation or registration. Marketing authorisations are granted by Fimea or the European Commission and registrations by Fimea. A marketing authorisation can be applied for in a national, centralised, decentralised or mutual recognition procedure. The application procedures are described on Fimea’s website.

Do the following

National procedure

If a product does not have a marketing authorisation in another EU country, Norway or Iceland, a marketing authorisation can be applied for via a national procedure. In this case, the application is only submitted to Fimea (or the national medicines agency of another country), who evaluates the application and may grant a marketing authorisation.

Mutual recognition procedure (MRP)

In the mutual recognition procedure, a national authorisation granted in an EU country, Norway or Iceland is also recognised in other countries based on a marketing authorisation granted by a Reference Member State (RMS). As a result of the mutual recognition procedure, Fimea will grant the medicinal product a marketing authorisation in Finland. Read more: Fimea as a Reference Member State in the MRP

Decentralised procedure (DCP)

In the decentralised procedure, a new marketing authorisation is simultaneously applied for several (or even all) EU countries, Norway and Iceland. The marketing authorisation holder requests for one of the Member States to act as a Reference Member State, whose assessment report can be commented by the other Member States. As a result of the decentralised procedure, Fimea will grant the medicinal product a marketing authorisation in Finland. Read more: Fimea as a Reference Member State in the DCP

Centralised procedure (CP)

In the centralised procedure, a marketing authorisation is simultaneously applied for all EU countries, Norway and Iceland. In the centralised procedure, the marketing authorisation applications are submitted to the European Medicines Agency (EMA) that coordinates the processing of the applications. In the centralised procedure, the marketing authorisation is granted by the European Commission. The centralised procedure must be used for new biotechnological medicines and other innovative medicinal products. Read more: Finland as a reported in the CP and EMA pre-authorisation guidance.

From laboratory to patinet - the journey of a centrally authorised medicine

Herbal medicines

Herbal medicinal products, homeopathic products and anthroposophic products are also medicinal products

To whom and on what terms

The condition for a marketing authorisation is that the preparation has been found appropriate as a medicine.

The benefits-risks-ratio of the preparation is positive, considering the indication.

The preparation fulfils the requirements for manufacture and quality laid out in the pharmacopoeia or other sources.

The composition of the preparation and other information are appropriately reported.

A fee is charged for the service.


Processing time

National procedure: 210 days Mutual recognition procedure: 90 days + 30 days for the review of translations Decentralised procedure: 210 says + 30 days for the review of translations Centralised procedure: 210 days + the time required by the decision process of the European Commission. The processing time does not include the time spent by the marketing authorisation holder in answering requests for further clarifications

Basic information

The service is provided byFimea
Responsible for the serviceFimea
Area Whole Finland
Available languagesFinnish, Swedish, English
Text edited by: Finnish Medicines Agency Fimea
Updated: 3/5/2021