The Quality and Safety of Organs Intended for Transplantation Regulations 2012 No. 1501

PART 4 U.K. Other obligations of the Authority

Serious adverse events and serious adverse reactions U.K.

16.—(1) When a licence holder reports a serious adverse event or a serious adverse reaction to the Authority, or the Authority is otherwise made aware of such an event or reaction, the Authority shall—

(a) rapidly notify that information to [F1 the] persons that the Authority considers may be affected by that information;

(b) investigate the matter where the Authority considers that an investigation will promote the quality and safety of organs; and

(c) register that information.

(2) In carrying out its duties under paragraph (1), the Authority shall ensure the interconnection with the reporting systems established under regulation 20 (duties of the Authority in relation to serious adverse events and serious adverse reactions) of the 2007 Regulations.

Textual Amendments

F1 Word in reg. 16(1)(a) substituted (14.7.2014) by The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (S.I. 2014/1459), regs. 1(1), 7