PART 3Amendment of Part 3 (manufacture and distribution of medicinal products and active substances)
Amendment of regulation 33 (offence concerning data for advanced therapy medicinal products)I125
1
Regulation 33 is amended as follows.
2
In paragraph (1)(a)—
a
for “Article 15(1) of Regulation 1394/2007” substitute “
paragraph 8 of Schedule 6
”
; and
b
for “Article 15(4) of that Regulation” substitute “
paragraph 9 of that Schedule
”
.
3
In paragraph (1)(b), for “Article 15(1)” substitute “
paragraph 8
”
.
4
In paragraph (2) for “Article 15(4)” substitute “
paragraph 9
”
.