# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 21: Amendment of regulation 26 (general power to suspend, revoke or vary licences)

Extent: E+W+S+N.I.

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/uksi/2019/775/regulation/21 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-21
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.