# The Medicines (Products for Human Use-Fees) Regulations 2008, Paragraph 6: Applications for multiple authorisations


(1) Unless sub-paragraphs (2), (3) or (4) apply, where an application for a marketing authorization is for more than one such authorization each relating to a medicinal product containing the same active ingredient or combination of ingredients, the fee payable under regulation 12(1)(a) is an amount equal to the aggregate of the amounts payable under paragraph 2 in respect of a separate application for each such authorization.
(2) If the application is a major application, the amount payable is the amount payable in respect of a major application under paragraph 2 plus—
(a) in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form with a different route of administration, the amount payable in respect of a complex application under paragraph 2;
(b) in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form but with the same route of administration, the amount payable in respect of a standard application under paragraph 2; and
(c) in respect of each additional marketing authorization applied for which relates to a medicinal 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 2.
(3) If the application is a complex application, the amount payable is the amount payable in respect of a complex application under paragraph 2 plus—
(a) in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form with a different route of administration, the amount payable in respect of a complex application under paragraph 2;
(b) in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form but with the same route of administration, the amount payable in respect of a standard application under paragraph 2; and
(c) in respect of each additional marketing authorization applied for which relates to a medicinal 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 2.
(4) If the application includes any applications for marketing authorizations that include a reclassification element, the amount payable is the amount payable in accordance with sub-paragraphs (1) to (3) plus—
(a) in respect of the first marketing authorization applied for that includes a reclassification element, the additional amount payable under paragraph 3(1); and
(b) in respect of each other marketing authorization applied for that includes a reclassification element, £778, except in the case of an eCTD format application in which case the additional amount payable is £744.

---
Source: https://www.legislation.gov.uk/uksi/2008/552/schedule/1/paragraph/6 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.