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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...
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.
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.
End users in GB returning tissue and cell products for human application to any third country supplier will require an export licence that covers this activity.
An export licence is not required if tissue and cell products are returned for disposal or investigation provided there is no...
The regulatory changes following the end of the UK Transition Period only apply to human tissue and cell products imported:
An importing tissue establishment (ITE) is an organisation based in the United Kingdom which holds an HTA licence for import. The ITE will be party to a contractual agreement with a third country supplier (3CS) for the import of tissues and cells.
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).
Under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended), a third country is defined as: