Regulation 126A Licensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal productsF1
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.
A list established under paragraph (1) must contain, with regard to each herbal substance—
the indication;
the specified strength and posology;
the route of administration; and
any other information necessary for the safe use of the herbal substance as a traditional medicinal product.
The licensing authority may review and amend any list it publishes under paragraph (1) at such intervals as it considers appropriate.
Annotations
Textual amendments
- F1
Reg. 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)