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Responsible for the service Finnish Medicines Agency Fimea

Licences relating to industrial production of pharmaceuticals

  • Permit or other obligation
  • Nationwide
  • Public service

Licences relating to industrial production of pharmaceuticals are pharmaceutical plant, contract manufacturing, and contract analysing licence. A licence may be granted to an applicant that meets the requirements of article 1 of the Medicines Decree.

Do the following

Applications for a licence can be submitted to the registry of Fimea in a free format.

To whom and on what terms

The applicant must present information about the responsible manager who meet the requirements of article 9 of the Medicines Act and, when needed, about a person who meets the qualification requirements of the Medicines and Veterinary medicines directive if the applicant intends to produce preparations in whole or in part. Additional requirements are described in article 1 of the Medicines Decree.

A fee is charged for the service.


Deadline

Prior to starting the operation

Processing time

90 days or 30 days (changes of licence), the processing time does not include the time used to providing additional clarification or providing a clarification. Inspection of the applicant’s premises and activity shall be carried out withing the processing time.

Period of validity

Until further notice if the activity is in accordance with good manufacturing practices for medicinal products.

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: 1/21/2021