Regulations on human tissues and cells
The purpose of tissue legislation is to ensure the quality and safety of human tissues and cells intended for human use.
Requirements for the operation of the tissue establishment include:
- The tissue establishment must have a licence granted by Fimea
- A person responsible for the legality of the activities must be appointed to the tissue establishment.
- The personnel of tissue establishments must be trained and familiarised with their tasks
- The tissue establishment must have an up-to-date quality system based on the principles of Good Practice
- The tissue establishment must have appropriate facilities, equipment and materials
- The tissue establishment must keep a register of its activities that allows the cells and tissues to be traced from the donor to the transplant recipient
Legislation
Act on the Medical Use of Human Organs, Tissues and Cells 101/2001
Government Decree on the Medical Use of Human Organs, Tissues and Cells 594/2001 (in Finnish, no English translation available)
Decree of the Ministry of Social Affairs and Health on the Medical Use of Human Tissues and Cells 1302/2007 (in Finnish, no English translation available)
Fimea regulation on the operation of tissue establishments 3/2014 (in Finnish, no English translation available)
Directive 2004/23/EY of the European Parliament and of the Council
Commission Directive 2006/17/EC
Commission Directive 2006/86/EC