The European
Blood Directive: a new era of blood regulation has begun.
Following the example of the
blood directive', the proposal establishes common binding standards for the quality and safety of human organs intended for transplantation.
(1.) The legislation which applies is the Human Tissues Act 2004, the UK Quality and Safety Regulations 2007 (implementing the EU Tissues and Cells Directive 2004/23/EC), the EU
Blood Directive 2002/98/EC (administered by the Medicines and Healthcare products Regulatory Agency) and Europe-wide Advanced Therapy Medicinal Products Regulations (administered by the European Medicines Agency).
It is also planned to set up surveillance systems as foreseen in the recently adopted
blood Directive and the proposed Directive on human tissues and cells.
For the time being, Libya does not comply with World Health Organization (WHO)
Blood Directives produced in 2006.