# The Medicines (Products for Human Use—Fees) Amendment Regulations 1996, Regulation 7: Amendment of Schedule 5 to the principal Regulations


(1) In paragraph 3(1)(c) (withdrawal of application after a request to supply information) of Schedule 5 (waiver, reduction or refund of capital fees) to the principal Regulations, after “of the Act” insert “or in pursuance of a Community provision which applies to applications for marketing authorizations”.
(2) After paragraph 4 (fees for manufacturer’s and wholesale dealer’s licences) of Schedule 5 to the principal Regulations insert—
“4A (1) Where an application for the grant of a marketing authorization or a clinical trial certificate is refused by the licensing authority and—
(a) the information contained in it, or submitted with it, was not sufficient to enable a full medical, scientific or pharmaceutical assessment to be undertaken; and
(b) if the applicant had withdrawn it before it was refused, part of the fee payable in respect of it would have been refunded or waived under paragraph 3;
there shall be refunded or waived the amount which would have been refunded or waived if the application had been withdrawn before it was refused by the licensing authority.”.
(3) In Schedule 5 to the principal Regulations omit paragraph 6(3) (fees for variations).
(4) After paragraph 6 of Schedule 5 to the principal Regulations insert—
“7 (1) Subject to sub-paragraphs (2) and (3), where an applicant applies to vary a marketing authorization in the circumstances set out in paragraph 4(4) of Part III of Schedule 3, the fee payable under regulation 7(1) shall be refunded or waived.
(2) Subject to paragraph (3), where an applicant on the same occasion submits more than one such application which relates to medicinal products containing the same active ingredients but no other active ingredient, sub-paragraph (1) shall apply only to one of those applications.
(3) Where in respect of any two or more of the applications mentioned in sub-paragraph (2) provision is made for fees of different amounts by paragraphs 13 and 14 of Part III of Schedule 1, sub-paragraph (1) shall apply to the application in respect of which those paragraph makes provision for the higher or highest fee”.

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Source: https://www.legislation.gov.uk/uksi/1996/683/regulation/7 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-usefees-amendment-regulations-1996/regulation-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.