Tissues and cells is an area of medical science in rapid growth. The use of human tissues and cells has given us more and better treatment options to treat infertility and a variety of diseases.
Supervised and monitored
We place requirements on the quality and safety of human tissues and cells used in Denmark. Therefore, all tissue establishments must obtain an authorisation from us before they may handle human tissues and cells for human use.
We regularly inspects all Danish tissue establishments to ensure that they comply with the requirements of the law.
How to apply for authorisation to handle human tissues and cells
You can find forms for authorisation of tissue establishment activity and for washing of sperm cells under application for tissue establishment activity.
What are tissues and cells used for?
Human tissues and cells are used by many, for example:
- gynaecology clinics, which wash sperm cells for reproductive inseminations
- fertility clinics, which 'make' test-tube babies
- bone banks, which store bones
- establishments, which store stem cells from umbilical cord blood - and
- commercial establishments, which process chondrocytes for the treatment of cartilage damage.
New common regulation
The Danish Tissue Act from 2006 is to ensure high and consistent quality and safety standards for the handling of human tissues and cells. The act was fully implemented in Denmark in 2007.
The Danish Tissue Act derives from three European directives, which all set standards for the quality and safety of the procurement, testing, processing, preservation, storage, distribution as well as import and export of bones, cartilage, heart valves, corneas, stem cells and sperm cells; collectively referred to as human tissues and cells.
The authorities in all EU member states are responsible for implementing and supervising the quality and safety of tissues and cells on the European market.
Report a side effect
Report side effects and adverse incidents with tissues and cells