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

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

(1) Regulation 46 is amended as follows.
(2) In paragraph (2)—
(a) in sub-paragraph (a), before “marketing authorisation”, insert “ UK ”;
(b) after sub-paragraph (a) insert—
“(aa) an EU marketing authorisation;”.
(3) In paragraph (3), before “European Economic Area” insert “ United Kingdom or the ”.
(4) In paragraph (6)—
(a) after “in force for the product” insert “in the country in which the product is intended to be sold or supplied, or offered for sale or supply”;
(b) in sub-paragraph (a), before “marketing authorisation”, insert “UK”; and
(c) after sub-paragraph (a) insert—
“(aa) an EU marketing authorisation;”.
(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(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/uksi/2019/775/regulation/45 (the official version)
Page: https://openlegislation.uk/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.