The Human Medicines Regulations 2012

Traditional herbal medicinal products U.K.

125.—(1) This Part applies to a herbal medicinal product (a “traditional herbal medicinal product”) if the following conditions are met.

(2) Condition A is met if by virtue of its composition and indications the product is appropriate for use without the need for a medical practitioner to—

(a) diagnose the condition to be treated by the product;

(b) prescribe the product; or

(c) monitor the product's use.

(3) Condition B is met if the product is intended to be administered at a particular strength and in accordance with a particular posology.

(4) Condition C is met if the product is intended to be administered externally, orally or by inhalation.

(5) Condition D is met if—

(a) the product has been in medicinal use for a continuous period of at least 30 years, and

[F1 (b) in relation to—

(i) a THR(NI) or THR(UK), the product has been in medicinal use in the European Union for a continuous period of at least 15 years;

(ii) a THR(GB), the product has been in medicinal use in the United Kingdom or a country included in the list published under regulation 125A(1) for a continuous period of at least 15 years.]

(6) It is immaterial for the purposes of condition D whether or not during a period mentioned in that condition—

(a) the sale or supply of the product has been based on a specific authorisation; or

(b) the number or quantity of the ingredients (or any of them) has been reduced.

(7) Condition E is met if there is sufficient information about the use of the product as mentioned in condition D (referred to in this Part as its “traditional use”), so that (in particular)—

(a) it has been established that the traditional use of the product is not harmful; and

(b) the pharmacological effects or efficacy of the product are plausible on the basis of long-standing use and experience.

Textual Amendments

F1 Reg. 125(5)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 110 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 82); 2020 c. 1, Sch. 5 para. 1(1)