# The Human Medicines Regulations 2012, Paragraph 13D: Oral representations


(1) If the applicant requests the opportunity to make oral representations, the applicant must provide the appropriate committee with a written summary of those representations and any documents on which the applicant wishes to rely in support of them—
(a) before the end of the period of 28 days beginning with the date of the request; or
(b) before the end of such shorter period as the licensing authority may specify in the notification under paragraph 13B.
(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of 56 days beginning with the date of the request under paragraph 13B.
(3) The applicant may submit additional representations or documents after the end of the period for doing so only with the permission of the appropriate committee.
(4) After receiving the summary and any other documents provided under this paragraph, the appropriate committee must arrange for the applicant to make oral representations at a hearing before the committee.
(5) The appropriate committee must—
(a) take the representations made under this paragraph into account; and
(b) report its findings and advice to the licensing authority together with the reasons for that advice.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/11/paragraph/13D (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-11/paragraph-13D
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.