# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 45: Amendment of regulation 46 (requirement for authorisation)


(1) Regulation 46 is amended as follows.
(2) In paragraph (2)—
(a) in sub-paragraph (a), before “marketing authorisation”, insert “UK”;
(b) at the end of sub-paragraph (b), insert “or”; and
(c) omit sub-paragraph (d) (and “or” immediately preceding it).
(3) In paragraph (3), before “European Economic Area” insert “United Kingdom or the”.
(4) In paragraph (6)—
(a) in sub-paragraph (a), before “marketing authorisation”, insert “UK”;
(b) at the end of sub-paragraph (b), insert “or”; and
(c) omit sub-paragraph (d) (and “or” immediately preceding it).
(5) In paragraph (7), omit sub-paragraph (b) (and “and” immediately preceding it).
(6) In paragraph (9), before “European Economic Area” insert “United Kingdom or the”.
(7) In paragraph (11)(a), before “European Economic Area” insert “United Kingdom or the”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/45 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-45
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.