Licence of a Blood Establishment

A Blood Establishment collects and tests human blood or blood components, whatever their intended purpose, and is responsible for their processing, storage and distribution when intended for transfusion. The Blood Establishment must have a licence granted by Fimea. Fimea may grant a licence on a written application after assessing the applicant’s ability to comply with the regulations. The assessment is based on an inspection of the applicant’s documents, premises and processes. The licence application must include information on the applicant’s personnel, facilities, equipment and materials, as well as information on procedures concerning the donation, testing, processing, storage, distribution and hemovigilance of blood and blood components (according to section 4 of the Blood Service Act). The licence applicant may only start operating after receiving the licence. 

Fimea must be notified of any essential changes in Blood Establishment activities. Fimea will then decide whether the change requires an update in the licence. Licence applications and notifications of any changes are sent in free form either by e-mail, by secure mail or by post to Fimea’s registry.

Fimea charges a fee for licence decisions and the processing of notifications in accordance with the Payment Decree. The inspection is invoiced separately. No fee is charged for notifications of minor changes, such as changes to the responsible persons or their contact details.