Amendment of regulation 46 (requirement for authorisation)
45.—(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”.