Human application

Advance Therapy Medicinal Products (ATMPs) are medicinal products which are prepared industrially or manufactured by a method involving an industrial process. ATMPs fall into three categories; Gene Therapies, Somatic Cell Therapies and Tissue Engineered Products.

RASRM is a ‘one stop shop’ for research and development professionals across academia, industry, and the NHS. It offers a single point of access to free, clear, expert responses to queries about the regulation of regenerative medicines.

The following guidance has been issued to set out the HTA’s expectations regarding the use of alternative reagents and materials during the processing of tissues and cells in the event there is a supply disruption to critical reagents and materials as a result of the UK exiting the EU.

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:

1. in relation to the import of tissues or cells into NI, a country other than NI or an EEA State; and
2. in relation to the export of tissues or cells from NI, a country other than the UK or an EEA State.

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.