The Human Medicines Regulations 2012

Application of Part

Traditional herbal medicinal products

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

(b) the product has been in medicinal use in the European Union 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.

Addition of vitamins or minerals

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.