# The Medicines (Products for Animal Use—Fees) Regulations 1997, Paragraph 5: Marketing authorisations and product licences


(1) Subject to sub-paragraphs (2) and (3) and the original application for a marketing authorisation or product licence received at any time before grant containing the active ingredient being granted, where an application for a marketing authorisation or product licence consists of an application for more than one such product containing the same active ingredient or combination of ingredients, the fee shall be of an amount equal to the aggregate of the amounts payable under paragraph 1 in respect of separate applications for each such authorisation or licence but where an original application is withdrawn and a subsequent application for more than one such product proceeds in place of the original application, then an additional fee shall be payable on that subsequent application equal to the difference between the amount paid on that application and that payable for a major application.
(2) If the application is a major application, the fee shall be the amount payable in respect of a major application under paragraph 1 plus—
(a) in respect of each additional marketing authorisation or product licence applied for which relates to a product of a different dosage form, the amount payable in respect of a complex application under paragraph 1; and
(b) in respect of each additional marketing authorisation or product licence applied for which relates to a product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 1.
(3) If the application is a complex application, the amount payable shall be the amount payable in respect of a complex application under paragraph 1 plus—
(a) in respect of each additional marketing authorisation or product licence applied for which relates to a product of a different dosage form, the amount payable in respect of a standard application under paragraph 1; and
(b) in respect of each additional marketing authorisation or product licence applied for which relates to a product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a simple application under paragraph 1.

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Source: https://www.legislation.gov.uk/uksi/1997/1469/schedule/1/part/II/paragraph/5 (the official version)
Page: https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1997/schedule-1/part-II/paragraph-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.