If you are an establishment based in Great Britain (GB) that exports or imports human tissues or cells for human application between GB and a country in the European Economic Area (EEA), you may need a HTA licence that covers these activities.
Human application means using human tissues or cells on or in a human recipient. This includes use in extracorporeal applications. It excludes the use of an autologous graft within the same surgical procedure.
If you want to import or export human tissues and cells from 1 July 2021, you will need a HTA licence in place.
Establishments affected by this change are:
Existing HTA Human Application licence holders requiring a licence variation: Including, hospitals, manufacturers and other commercial organisations that import and export human tissues and cells between GB and the EEA.
Previously unlicensed establishments who must apply for a new licence: Including, dental practices, dental surgeries, organisations performing cosmetic or orthopaedic procedures, and commercial distributors that import and export human tissues and cells between GB and the EEA.
The changes also apply to the import and export of tissues and cells that form the starting material for Advanced Therapy Medicinal Products (ATMPs).
If you think these changes apply to you, please contact us to discuss your activities. Alternatively, you can visit our Human Application sector licence forms page to submit your application.
Please also see our FAQs on UK Transition licensing.
The HTA licensing changes introduced by the end of UK Transition affect some establishments that previously did not require an HTA licence for importing or exporting human tissues and cells.
Examples include dental practices and dental surgeries, organisations performing cosmetic or orthopaedic procedures using human tissues and cells for human application.
Examples of human application in these instances include:
- The use of bone, pericardium, and dermal tissue products in dentistry.
- Bone products used for orthopaedic treatment.
- Amnion tissue products used as barriers in wound healing.
- Skin grafts used to replace damaged skin tissue.
- Corneal grafts used in ocular surgery.
Please note that the above list is not exhaustive and other activities may be affected.
If you import or export tissues and cells between GB and the EEA from 1 July 2021, you will need an HTA licence in place. Please apply now to prevent delays to supply.
To apply for a new HTA licence, please visit our Human Application sector licence form page. Alternatively, please contact us so that we can understand your activities and provide you with advice.
You can also find further HTA licensing information on the following pages: