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56. Unless paragraph 57 applies, the fee payable under regulation 29(1) in connection with regulatory assistance provided by the United Kingdom acting as reference member State where an application is made to the licensing authority for the renewal of a United Kingdom marketing authorisation in relation to a medicinal product which has been subject to the procedures specified in regulation 29(2), is—
(a)£9,682 if the application for renewal relates to a medicinal product which, at the time the United Kingdom marketing authorisation was granted, contained a new active ingredient and that renewal is the first renewal in relation to which the United Kingdom is to provide regulatory assistance acting as reference member State; or
(b)£747 in any other case.
57.—(1) This paragraph applies if more than one application falling within regulation 29(1) is made by the same applicant at the same time, each of which relates to medicinal products which have the same active ingredient or combination of ingredients, dosage form and therapeutic indications, and the United Kingdom marketing authorisations for those products have the same date for renewal.
(2) The fee payable under regulation 29(1) for applications to which sub-paragraph (1) applies is—
(a)if the applications fall within paragraph 56(a)—
(i)£9,682 for the first application considered by the licensing authority; and
(ii)£747 for each other application;
(b)if the applications fall within paragraph 56(b)—
(i)£747 for the first application considered by the licensing authority; and
(ii)£374 for each other application.
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