SCHEDULE 2AMENDMENTS TO RETAINED DIRECT EU LEGISLATION
Regulation (EU) No 528/2012141
1
Annex III is amended as follows.
2
In paragraph 2—
a
in the fourth subparagraph, for “Agency” substitute “competent authority”;
b
in the sixth subparagraph, for “available on the website of the Agency” substitute “to be made available online by the competent authority”;
c
in the seventh subparagraph, omit “that will evaluate the dossier”;
d
in the eighth subparagraph, omit “or Article 44(2)”.
3
For paragraph 4, substitute
4
Dossiers must be formatted, prepared and submitted in accordance with the data requirements and guidance as specified by the competent authority.
4
In paragraph 6, for “Commission or the Agency” substitute “competent authority”.
5
In paragraph 8, omit “of the Member State”.