# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 152: Amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements)

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

(1) Regulation 192 is amended as follows.
(2) In paragraph (1)(a), insert “ UK ” before “marketing authorisation”.
(3) In paragraph (3), after “EMA” insert “and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only,
(4) In paragraph (9), after “paragraph (3)(a)” insert “from the holder of a UKMA(UK), UKMA(NI), THR(UK), THR(NI) or Article 126a authorisation”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/152 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-152
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.