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The Quality and Safety of Organs Intended for Transplantation Regulations 2012

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Licensing conditions

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8.  It shall be a condition of a licence for a procurement activity or a transplantation activity that arrangements to transport an organ are made by the licence holder—

(a)to maintain the integrity of the organ during transport and that the transport time is suitable to optimise the quality and safety of the organ;

(b)to ensure that, subject to paragraph 9, the shipping containers used for transporting organs are labelled with the following information—

(i)identification of the licence holder responsible for the retrieval of the organ and the place where the retrieval took place, including an address and telephone number for that place,

(ii)identification of the place that an organ will be implanted in a recipient, including its address and telephone number,

(iii)a statement that the package contains an organ, specifying the type of organ and, where applicable, its left or right location and marked “HANDLE WITH CARE”, and

(iv)recommended transport conditions, including instructions for keeping the container at an appropriate temperature and position;

(c)to ensure that the organs transported are accompanied by a report on the organ and donor characterisation; and

(d)to have in place operating procedures demonstrating how the requirements in sub-paragraphs (a) to (c) shall be complied with.

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