Permits for organ transplantation activities

Fimea grants permits for organ transplants in the case of kidney transplants from a living donor. A similar permit is required if a minor or an incapacitated person donates stem cells.

The permit is applied for by the healthcare unit in which the removal is to be carried out.

The Finnish Medicines Agency Fimea processes the permit applications related to organ and tissue transplants immediately.

Requirements for the content of the permit application

The application must be worded freely, but it must contain all the reports required in section 22 of the Act on the Medical Use of Human Organs, Tissues and Cells and section 2 of the Decree on the Medical Use of Human Organs, Tissues and Cells.

If the donor is a minor or an incapacitated person, the documents referred to in section 3 of the Decree must also be attached to the application.

Submitting the application

Please send permit applications and any requests for additional information by e-mail to: elinsiirtolupa(at)fimea.fi using secure e-mail.