# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 28: Application for multiple authorisations


(1) Unless sub-paragraph (2), (3) or (4) applies, where an application for a marketing authorisation is for more than one such authorisation 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 total of the amounts payable under paragraph 24 in respect of a separate application for each such authorisation.
(2) If the application is a major application, the amount payable is the amount payable in respect of a major application under paragraph 24 and—
(a) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form with a different route of administration—
(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £19,063; or
(ii) in any other case, the amount payable in respect of a complex application under paragraph 24;
(b) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form but with the same route of administration—
(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or
(ii) in any other case, the amount payable in respect of a standard application under paragraph 24; and
(c) in respect of each additional marketing authorisation 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—
(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or
(ii) in any other case, the amount payable in respect of a standard application under paragraph 24.
(3) If the application is a complex application, the amount payable is the amount payable in respect of a complex application under paragraph 24 plus—
(a) in respect of each additional marketing authorisation 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 24;
(b) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form but with the same route of administration—
(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or
(ii) in any other case, the amount payable in respect of a standard application under paragraph 24; and
(c) in respect of each additional marketing authorisation 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—
(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,985; or
(ii) in any other case, the amount payable in respect of a standard application under paragraph 24.
(4) If the application includes any applications for marketing authorisations that include a reclassification element, the amount payable is the amount payable in accordance with sub-paragraphs (1) to (3) and—
(a) in respect of the first marketing authorisation applied for that includes a reclassification element, the additional amount payable in respect of the relevant category of reclassification variation application under paragraph 25(1); and
(b) in respect of each other marketing authorisation applied for that includes a reclassification element, £1,593.
(5) For the purposes of sub-paragraph (4), a “reclassification element” has the meaning given in paragraph 25(2).

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/28 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-28
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.