Importing and exporting human tissues and cells if you are an establishment based in Great Britain

If you are an establishment based in Great Britain (GB) that imports or exports human tissues or cells for human application between GB and a country in the European Economic Area (EEA), you may need an HTA licence that covers these activities.

This requirement came into force on 1 July 2021.

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.

The new licensing requirements 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.