Marketing authorisation application

A marketing authorisation can be applied via the national, decentralised or mutual recognition procedure. The procedures are described on the main page. The assessment of data associated with a marketing authorisation application for a medicinal product is ex-ante control. To fulfil the conditions for a marketing authorisation, the medicinal product must be efficient, safe and of sufficient quality. This is assessed by reviewing the results of non-clinical and clinical trials conducted on the medicinal substance, and the reports on the quality of the substance. This information serves as the basis for an assessment statement and a proposal for a decision.

Dossier

The marketing authorisation dossier consists of a cover letter, application form, administrative information, expert statements, and pre-clinical, clinical and quality sections. The required scope of documentation depends on the legal grounds for the marketing authorisation.

The structure of the application materials must conform to the CTD (Common Technical Document) format. The application material is usually submitted in an electronic format (eCTD or NeeS) either to national authorities (national procedure, MRP or DCP) or to EMA (centralised procedure).

Instruction for assembling the applications materials and the application forms themselves can be found in the European Commission guideline for marketing authorisation applicant: Notice to applicants, Volume 2B - Presentation and content of the dossier

More information on the submission of electronic applications material

More information on marketing authorisation applications for veterinary medicines

Legal grounds for a marketing authorisation

A marketing authorisation application can be based on complete or abbreviated documentation. Preparations whose marketing authorisation is based on a complete set of documents are called reference medicines. An shortened documentation set can be used for applying for a marketing authorisation for a generic preparation or biosimilar. The complete set of legal grounds is described in Article 8 and 10 in the Directive on human medicines 2001/83/EC and the Fimea regulation on applying for and maintaining a marketing authorisation and registration for a medicinal product (PDF).

Conditions for a marketing authorisation

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.

Processing times

The processing times for marketing authorisation applications are as follows:

  • 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.

Fees for a marketing authorisation application

The application fee for a national procedure, mutual recognition procedure and decentralised procedure must be paid to Fimea.

The fees for a centralised procedure are paid to the EMA.

The marketing authorisation process

The CMDh site contains process descriptions and detailed instructions on the mutual recognition procedure and the decentralised procedure.

The EMA site contains instructions and process descriptions for the centralised procedure.

The national procedure follows the instructions for the decentralised procedure when applicable. The applicant must submit a summary of product characteristics (sPC), a package leaflet and package labelling in Finnish already among the original application materials. The first assessment statement will be completed in approximately 120 days after the reception of the application.

Queries related to the marketing authorisation processes

National, decentralised and mutual recognition procedure for preparations intended for human consumption. MRP(a)fimea.fi

Centralised procedure: CP(a)fimea.fi

Veterinary medicines: vet.applications(a)fimea.fi

 

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.