# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 7: Complex variation application


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.

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/7 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.