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If the UK leaves the EU without a deal, it will become a third country for the purposes of the EU Tissues and Cells Directive and the EU Organ Donation Directives.
Today the Department of Health (DH) has published the Government’s response to the consultation on Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017.
The HTA is the UK Competent Authority for the purposes of the EU Tissues and Cells Directives, which set standards of quality and safety in relation to human tissues and cells intended for human application.
EU Directives are being put in place for the coding and import of tissues and cells for human application (HA). These will be transposed into UK law during 2016 and the process of writing the UK Regulations is underway.Copies of these Directives and an overview from the Department of Health (DH...
Coding and Import Directives for Tissues and Cells are being put into place in order to implement a single European coding system. This will verify equivalent standards of quality and safety for imported tissues and cells.
In our communication of 8 October we advised that other agencies and organisations were developing specific guidance on the Risks of Transmission of Ebola virus related to donated blood and other substances of human origin (SoHO).