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. Establishments wishing to import human tissues and cells for human application from a country outside of the EU into the UK must be licensed by the HTA for the activity of import.
Please see here for guidance on licence applications.
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. We have prepared this resource, with technical assistance from the Food and Drug Administration (FDA) and American Association of Tissue Banks (AATB), to help UK-based importing tissues establishments (UK-ITEs) and US-based third country suppliers (US-3CSs) demonstrate with confidence that UK regulatory requirements have been met for human tissues and cells imported into the UK from the US for human application.
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