PART 4Amendment of Part 4 (requirement for authorisation)

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”.