Scientific Advice

The Finnish Medicines Agency Fimea provides, at a case-by-case decision to a written request, scientific advice on the quality, efficacy and safety documentation of medicinal products intended for human or veterinary use.

Advice may relate to planned or implemented studies and reports. Fimea does not issue precedents or assessments of the adequacy of data that will be or has been produced for the purpose of receiving marketing authorisation. Advice given will not be binding on Fimea or the body requesting advice.

Scientific advice can be sought on questions which are not addressed by national regulations and guidance or the official EU guidance (Guidelines, Notes for Guidance, Points to Consider).

Fimea offers scientific advice independent of any subsequent industry marketing authorisation process. If scientific advice has been previously sought from the European Medicines Agency (EMA), a new request concerning the same product should be first addressed to the EMA. A request for advice must be sent to the EMA if the marketing authorisation application has already been submitted to the centralised procedure.

Scientific advice meeting is usually held as an online meeting.

Seeking scientific advice

Please send your request for advice and other contacs to: [email protected]

Security mail for confidential materials (Instructions for using the secure mail service can be found under the question mark symbol in the service.)

Include the following information and reports to your free-form request for advice:

• Contact person(s) and contact information
• Details of advice sought from other authorities and details of any clinical studies conducted in Finland
• Specific questions to be addressed
• Applicant’s justified proposal to resolve the issues 
• Background information to enable responses to the questions
• Copies of bibliographical references
• The applicant’s possible preference for the timing of the meeting.

Fimea will inform the applicant in writing of the acceptance or rejection of the request. If the request is accepted, Fimea will propose a meeting date. The applicant is requested to submit a presentation of the drug development project (preferably in PowerPoint format) no later than one week prior to the agreed meeting. In addition, the applicant is requested to send the minutes of the advice meeting to Fimea for approval within two weeks of the meeting.

Upon completion of the advice process, the scientific advice given will incur a fee in accordance with the valid Decree issued by the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency.