If you are an establishment in Great Britain (GB) that sends (exports) or receives (imports) tissues or cells to or from a country in the European Economic Area (EEA), you will need an HTA licence that covers these activities from 1 July 2021.
This only applies to establishments that import or export human tissues and cells for human application. Human application means using human tissues or cells, on or in a human recipient, including use in extracorporeal applications. It excludes the use of an autologous graft within the same surgical procedure.
This licensing change may affect:
- existing HTA Human Application licence holders such as hospitals, manufacturers and other commercial organisations that import and export human tissues and cells to/from the EEA, such as bone products, heart valves, peripheral blood stem cells, bone marrow, cord blood, corneas, vessels and amnion; and
- previously unlicensed establishments that import or export human tissues and cells to/from the EEA, such as dentists, dental surgeons, organisations performing cosmetic or orthopaedic procedures, and commercial distributors.
If you think this applies to you, please contact us to discuss your arrangements so that we can provide you with further guidance.
Licences must be in place before import and/or export takes place after 1 July 2021.
If you need to apply for a new HTA licence and we have not already been in contact with you, please contact us so that we can understand your activities and provide you with guidance.
You can also find information about the Human Application sector on our website.