PART 4Amendment of Part 4 (requirement for authorisation)
Amendment of regulation 46 (requirement for authorisation)I145
1
Regulation 46 is amended as follows.
2
In paragraph (2)—
a
in sub-paragraph (a), before “marketing authorisation”, insert “
UK
”
;
F1b
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)—
F3a
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;
F25
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
”
.