SCHEDULE 2AMENDMENTS TO RETAINED DIRECT EU LEGISLATION
Regulation (EU) No 528/2012140
1
Annex II is amended as follows.
2
In paragraph 2—
a
in the fourth subparagraph, for “available on the website of the Agency” substitute “to be made available online by the competent authority”;
b
in the fifth subparagraph, omit “that will evaluate the dossier”.
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 concerned”.