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Responsible for the service Finnish Medicines Agency Fimea

Informal Regulatory Guidance

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The Finnish Medicines Agency Fimea provides, at a case-by-case decision to a written request, Informal Regulatory Guidance at an early stage of drug development for clients without sufficient experience of regulatory requirements of drug development.

The discussions may relate to planned or implemented studies and reports or regulatory guidelines. Fimea does not issue precedents or assessments of ...

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Text edited by: Finnish Medicines Agency Fimea
Updated: 19/3/2021