- Y Diweddaraf sydd Ar Gael (Diwygiedig)
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The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
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- Offerynnau Statudol y Deyrnas Unedig
- 2019 No. 775
- PART 7
- Regulation 126
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- Dangos Graddfa Ddaearyddol(e.e. Lloegr, Cymru, Yr Alban aca Gogledd Iwerddon)
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Rhagor o Adnoddau
Changes to legislation:
There are currently no known outstanding effects for the The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Section 126.
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Insertion of new regulation 143A (establishment of herbal monographs)U.K.
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Memorandwm Esboniadol
126. After regulation 143 (obligation to take account of scientific or technical progress) insert—
“Establishment of herbal monographs
143A.—(1) The licensing authority may establish herbal monographs for herbal medicinal products and traditional herbal medicinal products [F1to be placed on the market in Great Britain].
(2) Subject to paragraph (3), the licensing authority must—
(a)consult the appropriate committee, within the meaning of paragraph 2(4) of Schedule 11, on a proposal to establish herbal monographs under paragraph (1); and
(b)take the advice of the appropriate committee into account in determining whether to proceed with that proposal.
(3) Where an application for a traditional herbal registration has been referred to the appropriate committee by the licensing authority under regulation 130A, the licensing authority must consider whether to exercise its powers under paragraph (1), taking into account any relevant advice of the appropriate committee given under Part 3 of Schedule 11 in relation to that application.
(4) The licensing authority must publish a list of any herbal monographs established under this regulation.
(5) Until the licensing authority exercises the power under paragraph (1), the Community herbal monographs published from time to time under Article 16h(3) of the 2001 Directive continue to apply, and holders of a traditional herbal registration and the licensing authority must continue to take them into account in exercising any function or in relation to any obligation to which they are relevant under this Part.”.
Textual Amendments
F1Words in reg. 126 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 95
Commencement Information
I1Reg. 126 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
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