The six-month phase for Human Application sector establishments to comply with new import and export licensing requirements ended on 1 July 2021.
If you import or export tissues and cells between GB and the EEA, you may need a suitable HTA licence in place covering this activity. If you think this applies to you and you have not previously contacted us to discuss your arrangements, please contact us as soon as possible.
The HTA-related licensing changes introduced at the end of the UK Transition Period affect some establishments that previously did not require an HTA licence for importing or exporting human tissues and cells for human application.
Examples of human application include:
Assessment tool to demonstrate that imported tissues and cells meet equivalent standards of quality and safety to those required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Regulations).
For establishments based in NI a third country is defined as:
Therefore, if you intend to receive tissues and cells for human application from a supplier based in the EEA, or export tissues and cells for human application to an EEA State or GB, you do not require an import or export licence to do so.
The Regulations that retain the existing quality and safety standards and provide legal and regulatory certainty after the end of the UK Transition Period can be found below:
The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019
The Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2019
Since 1 January 2021, the United Kingdom (UK) has operated a full border with the European Economic Area (EEA). This means that there are changes to the checks and controls on goods (including blood, organs, tissues and cells) as they move between the UK and the EEA.
The regulatory changes introduced at the end of the UK Transition Period differ for Great Britain (GB) and Northern Ireland (NI) as the Government ensures it meets its obligation of implementing the Northern Ireland Protocol.
The HTA continues as the ‘Competent Authority’ in Northern Ireland for the regulation of tissues and cells for human application.
Establishments in NI need to treat tissue and cell suppliers in GB as third country suppliers (3CSs). This requirement came into force on 1 January 2021.
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.
