How can I find more information about applying for a marketing authorisation for a medicinal product for human use?
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
Application forms: Applications related to marketing authorisations
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)