Classification application

Classification application

Classification application

Classification is requested with a signed, written request for classification.

The classification request and its attachments must include:

1. The name, composition, and justification of the product, if you consider that the product is not a medicine
2. Exact information about the composition of the preparation with regard to botanical herbs, especially additional information about the form of the herb in the preparation (e.g. extract quality and strength, extraction solvent, amount of active substances in the final product)
3. The product's intended use and exact mechanism of action
4. Information related to the safety of using the product
5. Up-to-date materials used in marketing the product and justifications for marketing claims,
6. Dosage
7. When has the product entered the market in Finland
8. How the product has been marketed and sold in Finland
9. Where the product is manufactured
10. How the product is imported
11. Possible official classification decisions from different countries.

The classification request must contain the complete contact information of the applicant for the classification in order to ask for additional information that may be needed.

The classification request is sent to Fimea's registry office:

Finnish Medicines Agency FIMEA / Registry

P.O. 55

00034 FIMEA

Registrar's office: [email protected]

The classification decision costs 500 euros. Classification as a medicine takes about 4–6 months, including consultation times. If the product is not a medicine, the decision is made without a hearing and you will receive it approximately 1-2 months after submitting the request.

Decree of the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency 798/2022.