CHAPTER IV

PROVISIONS ON THE QUALITY AND SAFETY OF TISSUES AND CELLS

Relations between tissue establishments and third parties
Article 24
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.