Regulation 27 Amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates)

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,”;

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,”;

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;”;

at the end insert—

“(d)

in all other cases, £9,682.”.