1. TEs 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 co-operation with a third party, and in particular in the following circumstances:
a) Where a TE entrusts one of the stages of tissue or cell processing, control, packaging, storing or distribution 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 TE provides services to a TE which is not accredited;
d) Where a TE distributes tissue or cells processed by third parties.'
2. The written agreements should include at least:
a) A clear description of the scope of the agreement;
b) Names, roles and signatures of those taking responsibility for each party;
c) Detailed description of the responsibilities of each party in relation to safety and quality of tissues, including any quality system requirements considered necessary;
d) Provision for auditing of the third party by tissue establishment staff on a routine and/or exceptional basis;
e) Requirements for data protection where third parties have access to any information of a personal nature (donor or recipient);
f) Requirements for maintenance of traceability for tissues and any materials that come into contact with them;
g) Requirements for archiving of traceability and quality system records;
h) Any requirements for certification/licensing of the third party that might be appropriate (e.g. in the case of a serology testing laboratory);
i) Duration of the agreement and the timing of reviews;
j) Details of when and how adverse incidents (reactions or events) should be communicated between the TE and the third party and how they should be investigated;
k) The way in which the Responsible Person releasing the tissue/cell batch for application ensures that any critical step performed by a third party was carried out in compliance with the requirements laid down;
l) Where tissue processing is carried out by a third party, the agreement should specify who is responsible for purchasing materials, testing and releasing materials, undertaking processing and quality controls, including in-process controls, and who has responsibility for sampling and analysis;
m) Where relevant, processing, analytical and distribution records, and reference samples should be kept by, or be available to, the tissue establishment. Any records relevant to assessing the quality of tissue/cells in the event of complaints or a suspected defect must be accessible and specified in the defect/recall procedures of the Contract Giver;
n) The contract should permit the competent authorities to inspect the third party if they wish to do so;
o) The way in which data and samples affecting the traceability, quality or safety of tissues and cells, are provided to the tissue establishment in case of resolution of the agreement.
3. TEs shall evaluate and select third parties on the basis of their ability to meet the standards laid down in in 2004/23/EC.
4. TEs shall keep a complete list of the agreements that they have established with third parties.
5. Agreements between TEs and third parties shall specify the responsibilities of the third parties and detailed procedures.
6. TEs shall provide copies of agreements with third parties at the request of the competent authority or authorities.