From 1 January 2021 there will be a six-month phase to allow Human Application sector establishments time to comply with any new UK import and export licensing requirements. Licence variations must be in place by 30 June 2021.
If you indicated in your annual activity submission that your establishment sends tissues or cells for human application to the EU or receives tissues and cells from the EU for human application, the HTA will contact you directly about varying your licence in due course. If this applies to you, there are steps you can take to prepare in advance of us contacting you.
You will need to ensure that you have written agreements in place with your suppliers in the third country as set out in paragraph 255 in the HTA Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment.
Importers must be able to demonstrate that imported tissue or cells meet equivalent quality and safety standards to those set out in the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended).
Exporters must demonstrate that exported tissue or cells meet the quality and safety standards as set out in the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended). The release process should include confirmation by a suitably trained and experienced person that the material meets the requirements of the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended).
The agreements with your recipient organisation(s) in the third country must set out the responsibilities of each party throughout the tissue or cell pathway, including transportation and Serious Adverse Events and Reactions (SAEARs) reporting arrangements.
New import or export licences
If you intend to import from or export to a country in the EU from 1 January 2021, and do not currently hold a HTA-issued Human Application sector licence, you will need to apply for a licence to undertake these activities.
If you need to apply for an HT licence, please refer to the information on our website about applying for a licence in the Human Application sector and contact us to discuss your application.
Please contact us if you require further advice.