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The Quality and Safety of Organs Intended for Transplantation Regulations 2012

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Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).

Framework and compliance with licensing conditions and directions

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13.—(1) The Authority shall establish and keep updated a framework which shall specify how their requirements for the quality and safety of organs for transplantation shall be met in compliance with the Directive.

(2) The framework shall cover all stages of the chain from donation to transplantation or disposal and shall include information about the—

(a)procurement activities and transplantation activities that are required to be carried on under the authority of a licence under Schedule 1;

(b)licensing application process;

(c)requirements that licensees must comply with, including the licensing conditions and any directions that the Authority has given under section 23(1) (conduct of licensed activities) of, or paragraph 2(4)(c) to (f) (characteristics of licence) of Schedule 3 to, the 2004 Act, as applied by regulation 6; and

(d)guidance that the Authority has given under regulation 12.

(3) The Authority shall ensure that licence holders are audited for the purposes of ensuring compliance with—

(a)the licensing conditions in Schedule 1; and

(b)any requirements imposed by directions given under section 23(1) or 24(1) (change of licence circumstance) of, or paragraph 2(4) of Schedule 3 to, the 2004 Act, as applied by regulation 6;

at such intervals that the Authority considers appropriate to ensure compliance with such licensing conditions and directions.

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