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Marketing authorisations

Marketing authorisations

How can I find more information about applying for a marketing authorisation for a medicinal product for human use?

Classification as a medicinal product

Fees related to the processing of a marketing authorisation application: Decree issued by the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency

Fimea regulation 02/2018: Applying for and maintaining a marketing authorisation for a medicinal product

Fimea’ guidelines on marketing authorisations

Application forms: Applications related to marketing authorisations

Scientific advice

Pharmaceutical legislation of the EU Eudralex

Instructions of the European Commission for applicants of marketing authorisation: European Commission: Reference documents: Eudralex: Volume 2 - Pharmaceutical Legislation: Notice to applicants and regulatory guidelines medicinal products for human use

Instructions on marketing authorisation processes:

Centralised procedure: EMA guidelines

Mutual recognition and decentralised procedures: CMDh instructions (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human)

3 Oct 2018
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