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Paragraph 7 Marketing authorization: derivatives

Original text. Later amendments are not shown.

Unless paragraph 8 applies, where a marketing authorization is held in respect of a derivative of a new active substance, the fee payable under regulation 31(3) is—

(a)

£8,692 where the medicinal product to which the authorization relates has a different route of administration from that of the new active substance;

(b)

£5,868, in any other case.