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Paragraph 4 Marketing authorizations

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

(1)

Subject to sub-paragraphs (2) and (3), 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 4(a) shall be of an amount equal to the aggregate of the amounts payable under paragraph 1 in respect of a separate application for each such authorization.

(2)

If the application is a major application, the amount payable shall be the amount payable in respect of a major application under paragraph 1 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 1;

(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 1; 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 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 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 1;

(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 1; 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 1.