# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 15


For regulation 21 (amendment of regulation 26 (general power to suspend, revoke or vary licences)) substitute—
“21. For regulation 26(5)(a) substitute—
“(a) that the holder of the manufacturer’s licence has manufactured or assembled medicinal products to the order of a person who holds—
(i) in the case of a product for sale or supply in Great Britain, a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), or
(ii) in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI) or a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”),
and has habitually failed to comply with the provisions of that authorisation; or”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/15 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-15
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.