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11.—(1) Where the Commission considers an explanation of a relevant matter(1) necessary or expedient for the purposes of any of its regulatory functions, the persons specified in paragraph (3) must, if so requested, provide an explanation of that matter to the Commission or to persons authorised by it.
(2) Explanations required under paragraph (1) must be provided at such times and such places as may be specified by the Commission.
(3) The persons referred to in paragraph (1) are—
(a)a person carrying on a regulated activity;
(b)a chair, director or employee of an English NHS body;
(c)a member of an English NHS body other than an NHS foundation trust;
(d)a member of a committee or sub-committee of an English NHS body other than an NHS foundation trust;
(e)a member of a committee or sub-committee of the board of directors of an NHS foundation trust;
(f)a person (other than a person prescribed in sub-paragraphs (b) to (e)) who is assisting a person carrying on a regulated activity in the provision of that activity;
(g)a person providing equipment or premises to a person carrying on a regulated activity;
(h)a chair, director or employee of a person providing equipment or premises to a person carrying on a regulated activity; and
(i)a person (other than a person prescribed in sub-paragraph (h)) who is assisting a person providing equipment or premises to a person carrying on a regulated activity.
“Relevant matter” is defined in section 65(2) of the Act.
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