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


In regulation 184, after paragraph (2) insert—
“(3) The holder 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/ukdsi/2019/9780111179185/regulation/143 (the official version)
Page: https://openlegislation.uk/draft-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.