# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Paragraph 4: Insertion of regulation 27A (fee for renewals of a marketing authorisation)


After regulation 27, insert—
“Fee for renewals of a marketing authorisation
27A. Where an application is made to the licensing authority for the renewal of a marketing authorisation and the application for renewal—
(a) relates to a medicinal product which, at the time the marketing authorisation was granted, contained a new active ingredient; and
(b) is the first renewal in relation to that product,
the fee payable by the applicant is the fee prescribed in Part 6 of Schedule 2.”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179185/schedule/1/paragraph/4 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/schedule-1/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.