# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 59: Amendment of regulation 54 (applications relating to products in well-established medicinal use)

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

(1) Regulation 54 is amended as follows.
(2) In paragraph (1) before “European Union”, insert “ United Kingdom or the ”.
(3) For paragraph (2), substitute—
“(2) The applicant may, by way of derogation from paragraph 10 of Schedule 8, replace the results of pre-clinical tests or clinical trials with appropriate scientific literature.”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/59 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-59
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.