# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 143: Amendment of regulation 184 (obligation on holder to audit pharmacovigilance system)

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

In regulation 184, after paragraph (2) insert—
“(3) The holder of a UKMA(GB) or THR(GB) must also comply with the requirements of paragraph 13 of Schedule 12A in relation to auditing the pharmacovigilance system.”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/143 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-143
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.