# The Human Medicines (Amendment etc.) (EU Exit) (No. 2) Regulations 2021, Regulation 27: Amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates)


In Schedule 2, in paragraph 56—
(a) in sub-paragraph (a), after “unfettered access route,” insert “provided a corresponding renewal has been made to the related European Union marketing authorisation or UKMA(NI) for the same product,”;
(b) in sub-paragraph (b), after “(an automatic recognition application),” insert “provided a corresponding renewal has been made to the related European Union marketing authorisation or UKMA(NI) for the same product,”;
(c) for sub-paragraph (c), substitute—
“(c) in respect of an application for renewal of a UKMA(UK) or a UKMA(GB) granted under an application other than under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive, provided a corresponding renewal has been made to the related marketing authorisation or UKMA(NI) for the same product, £747;”;
(d) at the end insert—
“(d) in all other cases, £9,682.”.

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Source: https://www.legislation.gov.uk/ukdsi/2021/9780348228755/regulation/27 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-27
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.