# The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, Regulation 13: Amendment of regulation 31A (trial master file and archiving)


In regulation 31A(4)(b)—
(a) for “applicable”, substitute “relevant”; and
(b) for the words “Directive 2001/83/EC” to the end, substitute “these Regulations”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179116/regulation/13 (the official version)
Page: https://openlegislation.uk/draft-medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019/regulation-13
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.