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Responsible for the service Finnish Medicines Agency Fimea

Classification decision

  • Service
  • Nationwide
  • Public service

Under the Medicines Act, Fimea has the task of deciding whether a substance or product is classified as a medicinal product. The classification is based on an assessment of the composition and intended use of each product. In addition to the information provided by the applicant, Fimea uses the product’s marketing information and information based on scientific literature on the effects of the ingredients in the product to classify it.

Do the following

You can apply for classification with a signed request for classification in writing. Send the classification request to Fimea’s registry office:

By email:

By post:

Finnish Medicines Agency FIMEA

Registrar’s office

PL 55

00034 FIMEA

You can find more information on Fimea’s website.

To whom and on what terms

If you are uncertain whether the product is a medicine or a food supplement, cosmetic product, biocide or medical device or tool, you must apply for Fimea to classify the product.

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: 27/11/2020