# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 26


In regulation 36 (amendment of regulation 45 (requirement as to responsible persons))—
(a) for paragraph (2) substitute—
“(2) After paragraph (1) insert—
“(1A) In respect of a licence holder in Great Britain, paragraph (1) is subject to regulation 45AA.”.”;
(b) for paragraph (3) substitute—
“(3) For paragraph (2)(b) substitute—
“(b) ensuring that the quality of medicinal products handled by the licence holder is being maintained in accordance with the requirements of—
(i) in the case of a licence holder in Great Britain, the UK marketing authorisations, certificates of registration or traditional herbal registrations, and
(ii) in the case of a licence holder in Northern Ireland, the marketing authorisations, Article 126a authorisations, certificates of registration or traditional herbal registrations,
applicable to those products.”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/26 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-26
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.