SCHEDULE 2AMENDMENTS TO RETAINED DIRECT EU LEGISLATION

Regulation (EU) No 528/2012

67.

(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.