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Written agreements with a 3CS must include a clause that guarantees the importing tissue establishment (ITE) the right to perform regular audits.
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.
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...
Biosamples may be obtained for analytical purposes to provide data for a clinical trial or a research project. These types of samples are considered relevant material under the Human Tissue Act 2004 (HT Act). For the purposes of the HT Act, import and export is considered as into and out of...
The HTA regulates establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human use. This includes any steps involved in the handling of tissues and cells prior to them being manufactured into medicines.
Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) biological samples may be required from the donor to demonstrate the quality and safety of any tissues and cells used in human application.
Importing tissue establishments must ensure written agreements are in place with suppliers in the third country as set out in paragraph 255 in the HTA’s Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient
Establishments exporting tissues and cells must ensure written agreements are in place with recipient organisations in the third country setting out responsibilities for all parties throughout the tissue or cell pathway.
Importing establishments may only carry out the import of tissues or cells from a third country supplier under the terms specified in an Importing Tissue Establishment Licence Certificate (ITELC).