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Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations), the HTA licenses and inspects establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human...
The Department of Health and Social Care has published guidance for industry and organisations involved in health and care about plans for a no-deal Brexit.
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.
Importing tissue establishments must ensure that imports from third countries meet standards of quality and safety equivalent to those in the UK. The majority of imports originate in the US and we have identified a number of key differences in regulatory requirements.
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...