SCHEDULE 2AMENDMENTS TO RETAINED DIRECT EU LEGISLATION

Regulation (EU) No 528/201267

1

Article 7 is amended as follows.

2

For paragraph 1 substitute—

1

The applicant shall submit an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance, to the competent authority.

3

Omit paragraph 2.

4

In paragraph 3—

a

in the first subparagraph—

i

for “Agency accepting” substitute “competent authority receiving”;

ii

for “the evaluating competent authority” substitute “it”;

b

in the second subparagraph omit “evaluating”;

c

in the third subparagraph—

i

omit “evaluating”;

ii

for “the Agency has accepted” substitute “it has received”;

iii

omit “under Article 80(2)”.

5

In paragraph 4—

a

omit “evaluating” in each place it occurs;

b

in the third subparagraph—

i

omit “and the Agency accordingly”;

ii

omit “in accordance with Article 80(1) and (2)”.

6

In paragraph 5—

a

omit “evaluating”;

b

omit “, the Agency and other competent authorities”.

7

Omit paragraph 6.