# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 142: Amendment of regulation 182 (obligation on holder to operate a pharmacovigilance system)


(1) Regulation 182 is amended as follows.
(2) In paragraph (2)(a), for “resides and operates in the EU” substitute “is ordinarily resident, and operates, in the United Kingdom”.
(3) In paragraph (3), insert at the beginning “Without prejudice to the requirements set out in regulation 65C and Schedule 10A (variations to a UK marketing authorisation)”.
(4) Omit paragraph (6).

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/142 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-142
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.