# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 154: Amendment of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive)

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

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/uksi/2019/775/regulation/154 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-154
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.