Part 4Amendment to Part 3 (Authorisation for Clinical Trials and Ethics Committee Opinion)

Substitution of regulation 27B

regulation 16 + 16.  For regulation 27B (publication of information) substitute—

Publication of information

27B.—(1) Subject to paragraph (3), the Authority may make accessible to the public information contained in the items listed in paragraph (2) insofar as it relates to a clinical trial carried out, or being carried out, under these Regulations.

(2) The items listed in this paragraph are—

(a)the request for approval made under regulation 16;

(b)any amended request for approval made under regulation 18A;

(c)any substantial modification to the clinical trial approval made under regulation 21, 22, 22A or 22B;

(d)the favourable opinion of the ethics committee given in accordance with regulation 18(1)(b);

(e)the notification of the end of the clinical trial made under regulation 27.

(3) Prior to making information available to the public under paragraph (1), the Authority must, after consulting such persons as they consider appropriate, publish a list of the information which may be made accessible to the public under paragraph (1).”.