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​Regulatory changes regarding the import/export of human tissues and cells

16 March 2021

 

Following EU Exit, regulatory changes regarding the import or export of human tissues and cells came into effect in Great Britain. These changes will affect your practice if you send (export) or receive (import) human tissues or cells to/from the European Economic Area (EEA) for human application.

 

If your practice buys human bone, pericardium or dermal tissue products from an EU company you will need an HTA licence from 1 July 2021. However, if you buy these products via a UK supplier, the UK supplier will be the importer and they will require the licence rather than you as a user.

 

How many practices are likely to be affected? We understand that the use of tissue transplanted from a donor to a recipient of the same species (allografts) is more common in the USA, and when used in the UK tends to be used by more experienced operators.

 

Grafts of tissue taken from donor of one species and grafted into recipient of another species (xenografts), for example using bovine bone granules in implants sites, is more commonly available and used in the UK. These are not affected by these new licensing arrangements.

 

How much will it cost? If your practice requires an import/export licence as a result of EU exit, you are not required to pay a licence fee for these activities in 2021/22. However, the HTA will be announcing 2022/23 licence fees in December 2021.

 

The regulatory requirements are different for Northern Ireland dental practices and came into effect on 1 January 2021. NI establishments now require an import licence if receiving tissues/cells from GB, see our Brexit page for more info.

 

If you think your practice may be affected by these changes, you’re advised to contact the HTA directly for advice enquiries@hta.gov.uk or visit the HTA website for further information.

 

The Human Tissue Authority (HTA) is the regulator of human tissue, cells and organs in the United Kingdom. Their regulatory oversight extends to the use of human tissues and cells for human application (patient treatment).