Paragraph 6 Applications for multiple authorisations
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.
If the application is a major application, the amount payable is the amount payable in respect of a major application under paragraph 2 plus—
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;
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
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.
If the application is a complex application, the amount payable is the amount payable in respect of a complex application under paragraph 2 plus—
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;
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
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.
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—
in respect of the first marketing authorization applied for that includes a reclassification element, the additional amount payable under paragraph 3(1); and
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.