PART 2Amendment of Part 1 (General)

Amendment of regulation 5 (classification of medicinal products)I17

1

Regulation 5 is amended as follows.

F12

In paragraph (1)(b), before “a product that” insert “in the case of a medicinal product for sale or supply in Northern Ireland,”.

3

In paragraph (2)—

F2a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3b

in sub-paragraph (d), before “an Article 126a” insert “in the case of a medicinal product for sale or supply in Northern Ireland,”.

4

In paragraph (3)—

F4a

in sub-paragraph (b), before “a medicinal product” insert “in the case of a medicinal product for sale or supply in Northern Ireland, ”;

F5b

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

In paragraph (4), F6in sub-paragraph (b), before “an Article” insert “in the case of a medicinal product for sale or supply in Northern Ireland,”.

6

In paragraph (5)—

F7a

in sub-paragraph (b), before “a product that” insert “in the case of a medicinal product for sale or supply in Northern Ireland,”; and

F8b

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .