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The Human Medicines Regulations 2012

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Changes over time for: Cross Heading: Written representations

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Point in time view as at 01/01/2022.

Changes to legislation:

The Human Medicines Regulations 2012, Cross Heading: Written representations is up to date with all changes known to be in force on or before 07 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. Help about Changes to Legislation

Written representationsU.K.

26.—(1) If the applicant requests the opportunity to make written representations, the applicant must provide the appropriate committee with those representations and any documents on which the applicant wishes to rely in support of them—U.K.

(a)before the end of the period of six months 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 25.

(2) The appropriate committee may, at the request of the applicant, extend the period mentioned in sub-paragraph (1) up to a maximum of twelve months beginning with the date of the request under paragraph 25.

(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) 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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