Fimea directs and supervises the activities of tissue establishments in Finland (Act 101/2001 on the Medical Use of Human Organs and Tissues ("Tissue Act"), Section 20 j) and collaborates with the relevant international authorities.
The purpose of tissue legislation is to ensure the quality and safety of human tissues and cells intended for use in humans. Implementation of quality and safety requirements is ensured by subjecting the services to licence, appointing persons in charge, employing professional personnel well-acquainted with their duties, and seeing that the facilities, devices and materials are appropriate and that comprehensive documentation is used.
According to the Tissue Act (101/2001) amended in 2007, procurement, testing, processing, preservation, storage and distribution must take place in a licensed tissue establishment. The amendment served to implement the "Tissue Directive" of the European Parliament and of the Council (2004/23/EC) with the aim to ensure a high level of protection of human health when using human tissues and cells. The tissue directive is supplemented by Commission directives (2006/17/EC, 2006/86/EC), whose technical requirements were implemented by the Ministry of Social Affairs and Health "Tissue Decree" (1302/2007) and the administrative regulation (3/2014) of Finnish Medicines Agency.
Fimea decides about issuing tissue establishment licences based on an application after evaluating the capabilities of the applicant to function in accordance with the provisions. The evaluation is based on document review and a preliminary inspection of the applicant's facilities. The purpose of the preliminary inspection is to assess the applicant's practical capabilities to operate a tissue establishment. According to the Tissue Act, Fimea must issue a decision on the licence application within six months of its submission.
If Fimea requests additional clarifications from the applicant, the time required for submitting them is not considered part of the processing time. The applicant may start tissue establishment operations only after the licence has been issued.
Fimea maintains a public registry of licensed tissue establishments. Licensed tissue establishments are regularly inspected by Fimea at least every two years. In addition, tissue establishments provide Fimea with annual reports.
The requirements relating to the activities of tissue establishments include the following:
• Tissue establishments must be licensed by Fimea.
• Tissue establishments must have an appointed responsible person to see that the activities comply with the applicable laws.
• The personnel of tissue establishments must be appropriately qualified, and regular training must be arranged.
• Tissue establishments must have an up-to-date quality system that is based on Good Practice.
• Tissue establishments must have a system to implement the traceability of cells and tissues.
• Tissue establishments must keep a registry of adverse effects and hazardous situations related to tissues and cells. However, the duty to report to Fimea only applies to serious adverse effects and hazardous situations.
• If a tissue establishment commissions with Fimea's permission a third party for individual tasks, the tissue establishment must have a written contract with the party in question.
• The tissue establishment must keep a registry of its activities and store any data necessary for traceability requirements for at least 30 years after clinical use.
Fimea provides on request guidance and advice on how to apply regulations concerning tissue establishment activities.