Scientific advice on medicinal products
- 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 produc ...
Do the following
A free-form request for guidance and other contacts shall be sent to:
Security mail instructions for confidential material:
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).