The procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for clinical use must be carried out in an authorised tissue establishment.
Fimea grants operating licences on application after assessing the tissue establishment's capabilities for compliance with the regulations. The assessment is based on an ex-ante inspection of the tissue applicant's documents, premises and processes. The purpose of the inspection is to examine the applicant's practical capabilities for working as a tissue establishment. Fimea will decide on the permit application within six months of the submission of the application. If Fimea asks the applicant to supplement its application with additional information, the time it takes to provide additional information is not included in the processing time. An applicant for a permit may only start operating in a tissue establishment after obtaining an authorisation.
If changes occur later in the information submitted to Fimea, the tissue establishment must notify Fimea of the changes, which will decide whether the change requires a change in the licence.
Licence applications and notifications of changes are sent either by e-mail or by post to Fimea's registry office.
Fimea charges a fee for decisions under the Tissue Act and the processing of notifications in accordance with the Payment Decree. No fee is charged for notifications of minor changes, such as changes to the responsible persons or their contact details.
Application form for a tissue establishment licence (dot)