Regulatory Information

Tissues and Cells Regulation


Application for Tissue Establishment Authorisation

Any individual or site which carries out any prescribed activity is required to be authorised by the HPRA. In order to obtain authorisation, an application must be made to the HPRA for tissue establishment authorisation.

In doing so, the applicant is required to complete the Application for a Tissue Establishment Authorisation.


Variation to Tissue Establishment Authorisation

Regulation 6 (9) of S.I. 158 of 2006 states that “A tissue establishment shall not make any substantial change in the prescribed activities which it undertakes without the prior written approval of the HPRA.”

Should a tissue establishment authorisation holder need to change any detail contained in their authorisation, they must submit an application to the HPRA to vary the Tissue Establishment authorisation.

All applications must be submitted prior to the change being implemented by the authorisation holder.

Variations to the tissue establishment authorisation can be classified as administrative – or technical. 

 

Non-routine import/export of tissues and cells

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

Authorised tissue establishments in Ireland can be additionally authorised by the HPRA for the import of tissues/cells from organisations outside the EEA ‘on a 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 EEA on a once-off basis (e.g. at the patient’s request).

Export of tissues or cells for human application is defined as sending tissues or cells to countries outside the EEA (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 EEA ‘on a 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 EEA on a once-off basis (e.g. at the patient’s request).

Documents for Non-routine import/export of tissues and cells

Notification of non-routine import-export of tissues and cells for human application

Guide to routine import/export of tissues and cells

Guide to non-routine import/export of tissues and cells

Fees

The guide to fees and application form can be found at the following links:

Guide to Fees for Human Products
Fee Application Form Human Products


The appropriate codes are 310, 311, 312, 313, 314, 315, 316, 371 & 372.