# The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994, Paragraph 8: Confirmation or alteration of the decision after taking into account the advice of the Medicines Commission


(1) If a person is dissatisfied with the decision as notified to him under paragraph 7, and he has not made representations to the Medicines Commission under paragraph 6, he may give notice to the licensing authority of his wish to make written or oral representations to the Medicines Commission.
(2) On receipt of a notice under sub-paragraph (1) above the licensing authority shall arrange for the person who gave it to be heard by the Medicines Commission or, as the case may be, for his written representations to be considered by them.
(3) After considering the representations (oral or written) the Medicines Commission shall report their findings and advice, and the reasons for their advice, to the licensing authority who shall take it into account in deciding whether to confirm or alter its decision under paragraph 7.
(4) The licensing authority shall give notice to the applicant or holder of the Medicines Commission’s advice and of the reasons for it, and of the confirmation or alteration of its decision under paragraph 7.

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Source: https://www.legislation.gov.uk/uksi/1994/3144/schedule/2/paragraph/8 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.