Regulation 125 Traditional herbal medicinal products

(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.

Annotations

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)

Notes on Interpretation and application of Part

Textual amendments

F1: Pt. 7 cross-heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 108; 2020 c. 1, Sch. 5 para. 1(1)