Commission Directive (EU) 2015/566Show full title

1.

Detailed information on the specifications of the importing tissue establishment aimed at ensuring that the quality and safety standards laid down in Directive 2004/23/EC are met and the mutually agreed roles and responsibilities of both parties in ensuring that imported tissues and cells are of equivalent standards of quality and safety;

2.

A clause ensuring that the third country supplier provides the information set out in Annex III B to this Directive to the importing tissue establishment;

3.

A clause ensuring that the third country supplier informs the importing tissue establishment of any suspected or actual serious adverse events or reactions which may influence the quality and safety of tissues and cells imported or to be imported by the importing tissue establishment;

4.

A clause ensuring that the third country supplier informs the importing tissue establishment of any substantial changes to its activities, including any revocation or suspension, in part or in full, of its authorisation to export tissue and cells or other such decisions of non-compliance by the third country competent authority or authorities, which may influence the quality and safety of tissues and cells imported or to be imported by the importing tissue establishment;

5.

A clause guaranteeing the competent authority or authorities the right to inspect the activities of the third country supplier, including on-site inspections, should it wish to do so as part of its inspection of the importing tissue establishment. The clause should also guarantee the importing tissue establishment the right to regularly audit its third country supplier;

6.

The agreed conditions to be met for the transport of tissues and cells between the third country supplier and importing tissue establishment;

7.

A clause ensuring that donor records relating to imported tissues and cells are kept by the third country supplier or its sub-contractor, in line with EU data protection rules, for 30 years following procurement and that suitable provision is made for their retention should the third country supplier cease to operate;

8.

Provisions for the regular review and, where necessary, revision of the written agreement including in order to reflect any changes in the requirements of the EU quality and safety standards laid out in Directive 2004/23/EC;

9.

A list of all standard operating procedures of the third country supplier relating to the quality and safety of imported tissues and cells and a commitment to provide these on request.