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 ”.