The Human Medicines Regulations 2012, Cross Heading: List of herbal substances, preparations and combinations for use in traditional herbal medicinal products is up to date with all changes known to be in force on or before 06 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.
Textual Amendments
F1Reg. 126A and cross-heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 112 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 83); 2020 c. 1, Sch. 5 para. 1(1)
126A.—(1) The licensing authority may establish, and publish a list of, herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products for which a THR(GB) may be granted.
(2) A list established under paragraph (1) must contain, with regard to each herbal substance—
(a)the indication;
(b)the specified strength and posology;
(c)the route of administration; and
(d)any other information necessary for the safe use of the herbal substance as a traditional medicinal product.
(3) The licensing authority may review and amend any list it publishes under paragraph (1) at such intervals as it considers appropriate.]
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