Legislation
The purpose of the legislation is to ensure the quality and safety of human blood and its components as well as tissues and cells used for transfusion or other therapeutic purposes. National legislation has been used to implement the EU regulations concerning blood and tissue establishment activities and blood, tissue and cell safety.
Blood establishments and blood centres must as part of their quality system follow the good practices developed jointly by the Commission and the European Directorate for the Quality of Medicines & Healthcare (EDQM).
- Guide to the preparation, use and quality assurance of blood components, which can be downloaded by registering.
Separate EDQM guidelines apply to the operation of tissue establishments.
- Guide to the quality and safety of tissues and cells for human application, which can be downloaded by registering.