# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 121


In regulation 154 (omission of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive))—
(a) in the heading, for “omission” substitute “amendment”; and
(b) for “Omit regulation 194.” substitute “In regulation 194(1) after “medicinal product” insert “authorised under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/121 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-121
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.