The Finnish Medicines Agency Fimea provides scientific advice, upon a written request or case-by-case basis, 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 is usually given at a meeting held at Fimea's premises.
Seeking scientific advice
Please send free-form requests for advice to Fimea's registry office:
Tieteellisen neuvonnan koordinaattori
Lääkealan turvallisuus- ja kehittämiskeskus
PL 55, 00301 Helsinki
Include the following information and reports to your request for advice:
- Contact person(s), details of advice sought from other authorities and details of any clinical studies conducted in Finland
- Specific questions to be addressed
- Sufficient background information to enable responses to the questions
- Copy of bibliographical references
- Suggested time and participants of the meeting, given no later than two weeks before the suggested date.
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 must submit the minutes of the advice meeting to Fimea for approval, preferably 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.