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The Human Medicines Regulations 2012

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Changes over time for: Paragraph 55

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Point in time view as at 01/01/2022.

Changes to legislation:

The Human Medicines Regulations 2012, Paragraph 55 is up to date with all changes known to be in force on or before 10 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

[F1Proposals to refer an application for a traditional herbal registration to the Committee for Herbal Medicinal Products and the procedure in Part 3 of Schedule 11 that were on-going at IP completion dayU.K.

This section has no associated Explanatory Memorandum

55.(1) This paragraph applies where—

(a)the licensing authority has proposed to refer an application for a traditional herbal registration to be in force in Great Britain only to the Committee on Herbal Medicinal Products in accordance with Article 16c(4) of the 2001 Directive before IP completion day; but

(b)that application has not been determined in accordance with Part 7 of these Regulations before IP completion day.

(2) Where the licensing authority has received an opinion of the Committee for Herbal Medicinal Products before IP completion day in relation to the application, it must take that decision in to account and determine that application.

(3) Where the licensing authority has not received an opinion of the Committee for Herbal Medicinal Products before IP completion day, notwithstanding the amendments made to Part 3 of Schedule 11 by the EU Exit Regulations, it may—

(a)proceed to determine the application, taking into account any proceedings that took place before IP completion day under Part 3 of Schedule 11 (prior to its amendment by the EU Exit Regulations), or any opinion of the Committee on Herbal Medicinal Products in relation to the application that is given on or after IP completion day; or

(b)it may refer the matter under regulation 130A in order to obtain the findings and advice of the appropriate committee before determining the application.]

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