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.
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We have prepared this resource, with technical assistance from the FDA and AATB, to help UK-based importing tissues establishments (UK-ITEs) and US-based third country suppliers (US-3CSs) demonstrate 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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