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There are currently no known outstanding effects for the The Human Medicines Regulations 2012, Section 45H.
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45H.—(1) This regulation applies where—
(a)regulation 45I does not apply; and
(b)the licensing authority proposes to exercise the power in regulation 45G(1).
(2) The licensing authority must notify the broker in writing of—
(a)its proposal;
(b)the reasons for it; and
(c)the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, variation or revocation should take effect.
(3) The registered broker may before the date specified in the notice—
(a)make written representations to the licensing authority with respect to the proposal; or
(b)notify the licensing authority that the broker wishes the licensing authority to submit the proposal to review upon oral representations.
(4) If the broker makes written representations in accordance with paragraph (3)(a) the licensing authority must take those representations into account before making a decision in the matter.
(5) Schedule 5 has effect if the registered broker—
(a)notifies the licensing authority of the proposal to review upon oral representations in accordance with paragraph (3)(b); and
(b)pays the fee for a review upon oral representations in accordance with the Fees Regulations.
(6) If the licensing authority proceeds to suspend or vary a registration or remove a broker from the register in accordance with the provisions of regulation 45G it must give a notice to the broker.
(7) A notice under paragraph (6) must—
(a)give particulars of the suspension, variation or removal; and
(b)give reasons for the decision to suspend, vary or remove a broker from the register.
(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.]
Textual Amendments
F1Pt. 3 Chs. 3, 4 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 16
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