Classification application

Classification application


Applications for classification are made in writing with a signed request.

The request and its appendices should include:

1.The name of the product

2.The exact qualitative and quantitative content of the product (precise information about an extract)

3.The intended use of the product (copies marketing materials)

4.Copies picturing the package must be included

5.Safety information concerning the product

6.Any information on classification in other EU countries

7.Number of packages sold in Finland/to Finland

8.When did The Company start to import this product to Finland.

The request should also include the applicant’s full contact information if more information is required.

Classification requests are sent to

Finnish Medicines Agency FIMEA / Registrar's office
P.O. BOX 55
FI-00034 Helsinki

The classification decision fee is EUR 500 and the processing time 1 to 6 months.


Further information

Further information

  • Pellas Kristiina
    Senior Pharmaceutical Inspector / Fimea, Turvallisuus ja vaikuttavuus, Lääketurvallisuusyksikkö tel. +358295223422