# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 158: Amendment of regulation 198 (post-authorisation safety studies: general provisions)


(1) Regulation 198 is amended as follows.
(2) In paragraph (2), for “competent authorities of the EEA States in which the study is conducted” substitute “licensing authority”.
(3) In paragraph (3)—
(a) in sub-paragraph (c), for “relevant competent authorities” substitute “licensing authority”;
(b) in sub-paragraph (d), for “competent authorities of the EEA States in which the study was conducted” substitute “the licensing authority if the study is conducted in the United Kingdom”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/158 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-158
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.