One off (non-routine) import/export of tissues and cells intended for human application

Import

Import of tissues or cells for human application is defined as receipt of tissues/cells from countries outside the EU (i.e. third countries). This is a prescribed activity which tissue establishments must be authorised to perform.

Tissue establishments in Ireland can also be authorised by the HPRA for the import of tissues/cells from organisations outside the EU 'on a one-off (non-routine) basis'. This specific activity can be listed on the tissue establishment authorisation granted by the HPRA.

This means that these tissue establishments may import tissues/cells from an organisation outside the EU on a one-off basis (e.g. at the patient's request)

Applicants must submit a notification of one-off import of human tissues and cells to the HPRA prior to the shipment taking place. There is a fee associated with the review and approval of these notifications. Please see here for more information on fees.

Export

Export of tissues or cells for human application is defined as sending tissues or cells to countries outside the EU (i.e. third countries). This is a prescribed activity which tissue establishments must be authorised to perform.

Tissue establishments in Ireland can be authorised by the HPRA for the export of tissues or cells to organisations outside the EU on a 'one-off (non-routine) basis'. This specific activity is listed on the tissue establishment authorisation granted by the HPRA to those tissue establishments.

This means that these tissue establishments may export tissues or cells to an organisation outside the EU on a one-off basis (e.g. at the patient's request).

Applicants must submit a notification of one-off export of human tissues and cells to the HPRA prior to the shipment taking place. There is a fee associated with the review and approval of these notifications. Please see here for more information on fees.

Relevant documents for one-off (non-routine) import/export of human tissues and cells

Where a tissue establishment wishes to import/export tissues and cells from an organisation outside the EU on a regular basis, they must submit an application for a variation to a tissue or importing tissue establishment authorisation.

There are specific requirements that a tissue establishment must meet in order to import tissues and cells from third countries. These are outlined in our  Guide to routine import-export of tissues and cells for human application involving countries outside the EU.