The Human Medicines Regulations 2012

[F1 Interpretation and application of Part] U.K.

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)

[F2 Interpretation of this Part U.K.

124A.   In this Part, “relevant list” means—

(a) the list referred to in Article 16f(1) of the 2001 Directive, as that list may be amended from time to time; or

(b) if the licensing authority publishes a list under regulation 126A(1), that list.]

Textual Amendments

F2 Reg. 124A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 109; 2020 c. 1, Sch. 5 para. 1(1)

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

[F3 (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

F3 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)

[F4 List of approved countries for traditional use of a herbal medicinal product U.K.

125A.— (1) The licensing authority may publish a list of countries for the purposes of regulation 125(5)(b) (condition D).

(2) In establishing the list under paragraph (1), the licensing authority may only include a country in that list if it is satisfied that—

(a) continuous use evidence in respect of that country can be sufficiently validated by the licensing authority; and

(b) the country has a level of pharmacovigilance that is equivalent to that in the United Kingdom to ensure that any safety issues in respect of the herbal medicinal product have been properly identified.

(3) The licensing authority must—

(a) review any list it publishes under paragraph (1) to determine if a country still satisfies the criteria for inclusion in the list specified in paragraph (2), and if it is not so satisfied, remove that country from the list; and

(b) undertake such a review at least every three years beginning with the date on which the country is included in that list.]

Textual Amendments

F4 Reg. 125A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 111; 2020 c. 1, Sch. 5 para. 1(1)

Addition of vitamins or minerals U.K.

126.  The addition to a traditional herbal medicinal product of a vitamin or mineral does not prevent a traditional herbal registration from being granted for the product if—

(a) there is well-documented evidence of the safety of the vitamin or mineral; and

(b) the action of the vitamin or mineral is ancillary to the action of the product's active herbal ingredients in connection with the use authorised by the traditional herbal registration.