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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.
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.
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