Regulation 112 Insertion of new italic heading and regulation 126A (list of herbal substances, preparations and combinations for use in traditional herbal medicinal products)I1

After regulation 126 (addition of vitamins or minerals) insert—

“List of herbal substances, preparations and combinations for use in traditional herbal medicinal products

Licensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal products

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 F1for 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.”.