From 1 July 2021, the six-month phase for Human Application sector establishments to comply with new import and export licencing requirements will end.
If you indicated in your last Annual Activity submission that your establishment sends tissues or cells for human application to the European Economic Area (EEA) or receives tissues and cells from the EEA for human application, we will contact you directly about updating your licence in due course.
If this applies to you, there are steps you can take to prepare in advance of us contacting you.
Import certificates are specific to the tissue type, supplier and country of origin. Therefore, if you already hold an authorisation to import tissues and cells for human application you will need to apply to update this if you intend to receive tissues and cells for human application from a supplier based in the EEA after the 1 July 2021.
You will need to make sure 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.
Export licences are not destination specific. Therefore, if you hold an export licence for the tissue type(s) in question because you already export them to third countries, you do not need to update this authorisation to include recipient countries in the EEA.