Point in time view as at 01/01/2022.
The Human Medicines Regulations 2012, Paragraph 18 is up to date with all changes known to be in force on or before 04 May 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
18.—(1) This paragraph applies if the licensing authority notifies the applicant for a variation to which this Part applies that it has decided, on grounds relating to safety, quality or efficacy—U.K.
(a)to refuse to grant the application, or
(b)to grant it otherwise than in accordance with the application.
(2) The applicant may by notice in writing to the licensing authority request the opportunity to make written or oral representations to the appropriate committee.
(3) The applicant must make the request within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.
(4) The licensing authority must inform the appropriate committee of the applicant or holder's request.
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