The Human Medicines Regulations 2012

This section has no associated Explanatory Memorandum

15.—(1) In paragraph 14(b)(i) “complex variation application” means an application by the holder of the registration to vary it so that one or more of the following changes can be made to the product to which it relates—U.K.

(a)a change in the product's active ingredients by the addition of an active ingredient from a new source;

(b)a change in the product's excipients by the addition of a TSE risk excipient from a new source; or

(c)a change by the addition of a vitamin or mineral from a new source, where no European Pharmacopoeia certificate of suitability for the vitamin or mineral is submitted with the application.

(2) For the purpose of sub-paragraph (1), an ingredient, vitamin or mineral is “from a new source” if its manufacturer as named in the application has not been named as its manufacturer in a [F1UK] marketing authorisation or traditional herbal registration granted for a medicinal product including the ingredient, vitamin or mineral.

(3) For the purpose of sub-paragraph (1), an excipient is a “TSE risk excipient from a new source” if—

(a)it has been manufactured from raw materials of ruminant origin or such raw materials have been used in its manufacture; and

(b)its manufacturer as named in the application has not been named as its manufacturer in a [F2UK] marketing authorisation or traditional herbal registration granted for a medicinal product that includes the excipient.

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