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Responsible for the service Finnish Medicines Agency Fimea

Registration to the NIS2 Entity List

  • Permit or other obligation
  • Nationwide
  • Public service

Cybersecurity legislation applies to several sectors. Fimea supervises the implementation of the obligations laid down in cybersecurity legislation in certain sectors of health and manufacturing in Finland.

Entities supervised by Fimea in the health sector (Cybersecurity Act, Annex I):

- Entities involved in manufacture of basic pharmaceutical products

- Entities involved in manufacture of pharma ...

Do the following

The electronic service of the NIS2 entity list is used to report information on blood establishments and companies that supply medicinal products and medical devices that are supervised by Fimea, which is required by the Cyber Security Act. By logging in, you can select the authorization and conduct transactions in the service.

To whom and on what terms

Essential and important entities

The obligations of cybersecurity legislation apply to entities that meet the criteria of either an essential entity or an important entity. The sector, size and criticality of an organisation affect whether it is an essential or important entity. Essential and important entities are supervised in different ways. Essential entities are subject to advance supervision and risk-based supervision. Important actors are only subject to risk-based supervision.

The service is provided by

Finnish Medicines Agency Fimea

Responsible for the service

Finnish Medicines Agency Fimea
Text edited by: Finnish Medicines Agency Fimea
Updated: 6/11/2025