A medicinal product must have a marketing authorisation before it can be introduced to market. There are several options for applying a marketing authorisation within the EU. They are described below.
25.2.2019 Changes in clinical trials due to Brexit
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.
Herbal medicinal products, homeopathic products and anthroposophic products are also medicinal products. For more information about the marketing authorisation procedure for these product, see Herbal remedies
For more information on the special characteristics of marketing authorisation application for veterinary medicines, see Veterinary medicines
Queries related to the marketing authorisation processes
- The national, mutual recognition and decentralised procedure: MRP(a)fimea.fi
- Centralised procedure: CP(a)fimea.fi
- Veterinary medicines: vet.applications(a)fimea.fi
Further information, steering of coordinator activity
- Human medicines:
- Veera Torkko-Huuskonen, Head of division tel. +35829 522 3342
- Hanna Varakas, Head of division, tel. +35829 522 3328
- Veterinary medicines:
- Heidi Mustalammi, Procedure Manager, tel. +358 29 522 3329
Email address format: firstname.lastname@example.org