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The Human Medicines Regulations 2012

Changes over time for: Section 125

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Version Superseded: 31/12/2020

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Traditional herbal medicinal productsU.K.

This adran has no associated Memorandwm Esboniadol

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.

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