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Paragraph 7 Complex variation application

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A complex variation application is an application by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of a medicinal product comprising one or more of the following changes—

(a)

a change in that product’s active ingredients which involves the addition of one or more active ingredients which are active ingredients from a new source;

(b)

a change in that product’s excipients which involves the addition of one or more TSE risk excipients from a new source; or

(c)

a change which involves the addition of one or more vitamins or minerals which are vitamins or minerals from a new source where no European Pharmacopoeia certificate of suitability covering those vitamins or minerals has been submitted with the application.