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The Medicines (Products for Human Use) (Fees) Regulations 2012
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Extended Type II Complex Variation Application
9. An Extended Type II Complex Variation Application is an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) so that the medicinal product is indicated for use—
(a)in a therapeutic area for which the product was not previously indicated for use; or
(b)in respect of an organ, or any other part, of the human body for which the product was not previously indicated for use, if the application is supported by data which comprises or includes the results of clinical trials or physico-chemical, microbiological or pharmacological and toxicological tests.
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