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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), (3) and (4) below, where an applicant applies in one or more applications, which are all pending, for a marketing authorisation or product licence for more than one product and each product contains the same active ingredient or the same combination of active ingredients, the total of the fees payable by him shall equal the aggregate of the amounts payable under paragraph 1 in respect of separate applications for each product licence or type of authorisation.

(2)

Subject to sub-paragraphs (3) and (4) below, where an applicant has made an original request (that is to say a set of one or more applications as described in sub-paragraph (1) above) and either–

(a)

withdraws each application in the original request and substitutes for them a new application for one or more products containing the same active ingredients or combination of active ingredients as those in the original request, or

(b)

withdraws some but not all of the applications in the original request,

then there shall be calculated in respect of the new or (as the case may be) remnant applications the total of the fees which would have been charged for them had they alone comprised the original request, and that total shall be payable in respect of the new or (as the case may be) remnant applications, but there shall be allowed against it the net total of any fees payable in respect of the original request (that is to say the total so payable less any amount of that total waived, reduced or refunded under these Regulations).

(3)

Where an applicant applies in one or more major applications, which are all pending, for a marketing authorisation or product licence for more than one product and each product contains the same active ingredient or combination of active ingredients the fee payable for each major application for a marketing authorisation or product licence shall be the amount payable in respect of a major application under paragraph 1 in respect of the first major application and for each major application additional to the first–

(a)

which relates to a product of a different dosage form, the amount payable in respect of a complex application under paragraph 1; and

(b)

which relates to a product of the same dosage form but of a different strength of any active ingredient, the amount payable in respect of a standard application under paragraph 1.

(4)

Where an applicant applies in one or more complex applications, which are all pending, for a marketing authorisation or product licence for more than one product and each product contains the same active ingredient or combination of active ingredients, the fee payable for each complex application for a marketing authorisation or product licence shall be the amount payable in respect of a complex application under paragraph 1 in respect of the first complex application, and for each complex application additional to the first–

(a)

which relates to a product of a different dosage form, the amount payable in respect of a standard application under paragraph 1; and

(b)

which relates to a product of the same dosage form but of a different strength of any active ingredient, the amount payable in respect of a simple application under paragraph 1.

(5)

This paragraph applies in relation to fees which would, but for this paragraph, be payable by reference to paragraph 1, whether or not as qualified by paragraph 4.