# The Human Medicines Regulations 2012, Regulation 45R: Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register


(1) This regulation applies where—
(a) the provisions of regulation 45S do not apply; and
(b) the licensing authority proposes to exercise the power in regulation 45Q(1).
(2) The licensing authority must notify the person with an active substance registration 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 removal from the active substance register should take effect.
(3) The person with an active substance registration 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 person wishes the licensing authority to submit the proposal to review upon oral representations.
(4) If the person with an active substance registration makes written representations in accordance with sub-paragraph (3)(a) the licensing authority must take those representations into account before making a decision in the matter.
(5) If the person with an active substance registration notifies the licensing authority that the person wishes the licensing authority to submit the proposal to review upon oral representations in accordance with paragraph (3)(b)—
(a) Schedule 5 has effect; and
(b) the person with an active substance registration must pay a 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 person from the active substance register in accordance with the provisions of regulation 45Q it must give a notice to that person.
(7) The notice must—
(a) give particulars of the suspension, variation or removal; and
(b) give reasons for the decision to suspend, vary or remove a person’s entry on the active substance register.
(8) Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/45R (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-45R
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.