Paragraph 15

Where the medicinal product consists of a combination of one or more herbal substances and one or more herbal preparations, or the medicinal product contains one or more vitamins or minerals—

(a)

data on the traditional use of the medicinal product as a whole; and

(b)

if any of the medicinal product's individual active ingredients are not sufficiently known, data on the traditional use of those active ingredients.

This covers (in particular)—

(c)

evidence that the product is not harmful in the specified conditions of use; and

(d)

evidence as to the pharmacological effects or efficacy of the product on the basis of long-standing use and experience.