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Responsible for the service Finnish Medicines Agency Fimea

Informal Regulatory Guidance

  • Service
  • Nationwide
  • Public service

Informal Regulatory Guidance provides information on regulatory instructions related to pharmaceutical development (scientific advice, guidelines, GMP, GCP, GLP) and general guidance on official requirements.

Informal Regulatory Guidance is intended for small and medium-sized enterprises, especially if the product is innovative. Informal Regulatory Guidance offers an opportunity for free-form discussion between the authority and the pharmaceutical developer when the customer does not yet have sufficient knowledge of the requirements and instructions of the authorities.

Do the following

A free-form request for guidance 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

• the topic or potential problem to be addressed in the form of a short summary

• sufficient background information to select experts for the medication guidance centre

• 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

Informal Regulatory Guidance is intended for small and medium-sized enterprises

The service is free of charge.

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