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Duty to maintain system of traceability for CTGT product

Health Products (Clinical Research Materials) Regulations 2016

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—(1) Every manufacturer, importer, supplier or registrant of clinical research material that is a CTGT product must establish and maintain a system of traceability that complies with paragraph (2).(2) The system mentioned in paragraph (1) must at the minimum enable the traceability of the CTGT product and its starting and raw materials, including all substances that may come into contact with the cells or tissue it contains, during any of the following processes:(a)sourcing;(b)procurement;(c)processing;(d)testing;(e)packaging;(f)storage;(g)transport;(h)delivery to the clinical research site where the CTGT product is used, administered, supplied or dispensed, as the case may be;(i)any other final reconciliation, disposal or destruction of the CTGT product.(3) Every supplier must ensure that a system of traceability is in place and maintained at the clinical research site in order that the CTGT product administered or supplied may be linked to the patient who received it, and vice versa.(4) Every manufacturer, importer or supplier mentioned in paragraphs (1) and (3) must keep all data obtained from the system of traceability for at least 30 years after the expiry date of the CTGT product or any other shorter period that the Authority allows in a particular case.

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