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3.—(1) If a decision notified in accordance with paragraphs 1(6) or 2(4) is a decision to which this paragraph applies, the sponsor may within the time allowed after the notification was given, give notice of his wish to appear before and be heard by a person appointed for the purpose by the licensing authority, or of making representations in writing to the licensing authority with respect to the decision referred to in the notification.
(2) Where the sponsor gives notice under sub-paragraph (1) of his wish to appear before and be heard by a person appointed for the purpose by the licensing authority, the licensing authority shall make that appointment and—
(a)the person so appointed shall not, except with the consent of the applicant or holder, be an officer or servant of any of the Ministers specified in paragraphs (a) and (b) of section 1(1) of the Act;
(b)if the applicant or holder so requests, the hearing shall be in public; and
(c)if the applicant or holder so requests, the licensing authority shall furnish to him a copy of the report of the person so appointed.
(3) The licensing authority shall take into account the report of the person appointed and decide whether to confirm or alter their decision.
(4) The decisions to which this paragraph applies are decisions of the licensing authority—
(a)to confirm—
(i)that they have grounds for not accepting a request for authorisation or an amendment to the clinical trial authorisation,
(ii)their decision to impose a condition, or
(iii)the notice to suspend or terminate the trial,
against the advice of the Medicines Commission under paragraph 1(2);
(b)to impose conditions in accordance with paragraph 1(3)(b) or alter a condition in accordance with paragraph 1(4)(b), in a way which differs from the advice given by the Medicines Commission under paragraph 1(2); or
(c)to confirm a decision under paragraph 1(3), (4) or (5) against the advice of the Medicines Commission under paragraph 2(3);
(d)to alter a decision under paragraph 1(3), (4) or (5) in a way which differs from the advice of the Medicines Commission under paragraph 2(3).
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