For establishments based in NI a third country is defined as:
- in relation to the import of tissues or cells into NI, a country other than NI or an EEA State; and
- 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.
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Do you already hold a HTA HA sector licence? |
What are you applying to do? |
Link to application form |
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Yes |
Update the licence to add import of tissues and cells for human application from suppliers based in GB only.*
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Please complete and return to the HTA along with the supporting documents requested within the form licence application form for end users based in Northern Ireland |
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Update the licence to add import of tissues and cells for human application from suppliers who are not based in the EEA or GB.*
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Please complete and return to the HTA along with the supporting documents requested within the form licence variation form for import including one-off imports |
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Update the licence to add export to a third country of tissues and cells for human application.*
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Please complete and return to the HTA along with the supporting documents requested within the form licence variation form exporting to third countries |
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No |
Apply for a HTA HA sector licence to import tissues and cells intended for human application from suppliers based in GB only* | Please complete and return to the HTA along with the supporting documents requested within the form licence application form for end users based in Northern Ireland |
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Apply for a HTA HA sector licence to undertake any of the following activities with tissues and cells intended for human application: procurement, testing, storage, processing and/or distribution. |
Please complete and return to the HTA along with the supporting documents requested within the form HA licence application form If you also intend to undertake import or export, please so that we can discuss your requirements and provide you with the appropriate forms contact us |
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Apply for a HTA HA sector licence to export to a third country* |
Please contact us so that we can discuss your requirements and provide you with the appropriate forms contact us |
*If you intend to undertake other regulated activities under your licence such as procurement, testing, storage, distribution or import from the 3CS based outside the EEA, and do not already hold a licence for these activities, please contact us so that we can ensure you are completing the correct form.
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).