Part 6Amendment to Part 5 (Pharmacovigilance)

Insertion of new regulation A32

regulation 23 + 23.  In Part 5, before regulation 32 (notification of adverse events) insert—

Record keeping

A32.—(1) A sponsor shall keep detailed records of all serious adverse events and serious adverse reactions, including suspected unexpected serious adverse reactions, which occur during the course of a clinical trial—

(a)in the United Kingdom;

(b)conducted outside of the United Kingdom where—

(i)the sponsor of both the trial in the United Kingdom and the trial outside of the United Kingdom is the same or, where the sponsor is a company, in the same group, and

(ii)the investigational medicinal product being tested or used in the trial conducted outside of the United Kingdom is the same as the investigational medicinal product being tested or used in the clinical trial mentioned in sub-paragraph (a).

(2) A sponsor shall evaluate the events and reactions mentioned in paragraph (1), with a view to—

(a)minimising and preventing any risk presented by the use of the investigational medicinal product to which those events and reactions relate; and

(b)taking appropriate measures as soon as reasonably practicable to investigate the risks presented and implement actions for minimising and preventing those risks.

(3) For purposes of paragraph (1)(b)(i), “group” has the same meaning as in Part 15 of the Companies Act 2006 (see section 474(1) of that Act).”.