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Marketing authorisations

Marketing authorisations

Marketing Authorisations

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.

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One-time payback charge to be collected from pharmaceutical companies and wholesalers in 2016

Marketing authorisations

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 presubmission guidance, question 1

Herbal medicines

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

Veterinary medicines

For more information on the special characteristics of marketing authorisation application for veterinary medicines, see Veterinary medicines

Queries related to the marketing authorisation processes

Further information, steering of coordinator activity

  • Evaluation unit 1, ATC: A, J, N, P, R, S, V: Leena Pietilä, Procedure Manager, tel. +358 29 522 3360
  • Evaluation unit 2, ATC: B, C, D, G, H, L, M: Tommi Koskela, Procedure Manager, tel. +358 29 522 3430
  • Regulation of veterinary medicines: Heidi Mustalammi, Procedure Manager, tel. +358 29 522 3329

Email address format: firstname.lastname@fimea.fi

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