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Paragraph 5 Marketing authorisations and product licences

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 authorisation or product licence consists of an application for more than one such authorisation or licence each relating to a 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.

(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.