# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 28A: Application by pre-assessment of modules


(1) Where an applicant for a United Kingdom marketing authorisation submits material in accordance with regulation 50(5) of the Human Medicines Regulations for pre-assessment by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is—
(a) £31,049 in respect of Module 3 (chemical, pharmaceutical and biological information);
(b) £31,049 in respect of Module 4 (non-clinical reports);
(c) £31,049 in respect of Module 5 (clinical study reports).
(2) Where an applicant for a United Kingdom marketing authorisation for a similar biological medicinal product submits material in accordance with regulations 53, 53A or 53B of the Human Medicines Regulations for pre-assessment of a complex abridged application by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is—
(a) £5,802 in respect of Module 3 (chemical, pharmaceutical and biological information);
(b) £5,802 in respect of Module 4 (non-clinical reports);
(c) £5,802 in respect of Module 5 (clinical study reports).
(3) The fee payable under sub-paragraphs (1) and (2) must be paid within a period of 14 days, commencing on the date of the written notice issued by the licensing authority requiring payment of the fee.
(4) Where a fee has been paid under this paragraph, any fee payable under regulation 12(1) in connection with an application for the grant of a United Kingdom marketing authorisation in respect of the same product is reduced by the amount paid under this paragraph provided that no further assessment of the Module concerned is required.

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/28A (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-28A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.