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Responsible for the service Finnish Medicines Agency Fimea

Scientific advice on medicinal products

  • Service
  • Nationwide
  • Public service

Scientific advice shall be provided on the basis of a written request and on a case-by-case basis on the documentation of the quality, efficacy and safety of a medicinal product for human or veterinary use. The advisory services may focus on planned or existing studies and reviews. There are no estimates or advance decisions on the adequacy of the information to be produced or that has been produced for the possibility of obtaining a marketing authorisation for the product. The advice provided does not bind Fimea or the person requesting the advice.

Do the following

A free-form request for guidance and other contacts shall be sent to:

innovation.office@fimea.fi

Security mail instructions for confidential material:

https://www.fimea.fi/web/en/about_us/contact_information/secure-mail

The following information and explanations are attached to the request for guidance:

• contact person(s)

• information on guidance sought from other authorities and on possible clinical trials in Finland

• detailed questions for which advice is sought

• sufficient background information to answer the questions

• copy of literature references

• proposed date and attendees of the meeting, at least two weeks before the proposed date

To whom and on what terms

Scientific advice can be sought for questions that cannot be answered in the national regulations and guidelines or the EU guidelines (Guideline, Note for Guidance, Points to Consider).

A fee is charged for the service.

Basic information

The service is provided byFimea
Responsible for the serviceFimea
Area Whole Finland
Available languagesFinnish, Swedish, English
Text edited by: Finnish Medicines Agency Fimea
Updated: 19/3/2021