1.Tissue establishments shall establish written agreements with a third party each time an external activity takes place which influences the quality and safety of tissues and cells processed in cooperation with a third party, and in particular in the following circumstances:
(a)where a tissue establishment entrusts one of the stages of tissue or cell processing to a third party;
(b)where a third party provides goods and services that affect tissue or cell quality and safety assurance, including their distribution;
(c)where a tissue establishment provides services to a tissue establishment which is not accredited;
(d)where a tissue establishment distributes tissue or cells processed by third parties.
2.Tissue establishments shall evaluate and select third parties on the basis of their ability to meet the standards laid down in this Directive.
3.Tissue establishments shall keep a complete list of the agreements referred to in paragraph 1 that they have established with third parties.
4.Agreements between tissue establishments and third parties shall specify the responsibilities of the third parties and detailed procedures.
5.Tissue establishments shall provide copies of agreements with third parties at the request of the competent authority or authorities.