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14.—(1) Schedule 1 is amended as follows.
(2) In paragraph 1—
(a)in the table—
(i)in item 4 in the second column, after “application(2)” omit “(3)”;
(ii)omit items 5, 5a and 5b;
(iii)in item 11 in the second column, for “for lead zonal re-registration and new product applications” substitute “to discuss potential product applications”;
(iv)omit item 12;
(b)in the notes following the table—
(i)omit notes (3), (5) and (6);
(ii)in note (7) for “items 1-5, 10, 11 and 12” substitute “items 1-4, 10 and 11”;
(iii)in note (16) omit “to the United Kingdom to act as lead zonal rapporteur”;
(iv)omit note (17);
(v)in note (18) for “the United Kingdom” substitute “a United Kingdom competent authority”.
(3) In paragraph 2—
(a)in the heading, for “or synergist” substitute “, synergist or basic substance”;
(b)in the first sentence, for “or synergist” substitute “, synergist or basic substance”;
(c)in the table—
(i)in the heading before item 1, for “or synergist” substitute “, synergist or basic substance”;
(ii)omit item 2;
(iii)in item 3 for the words in the second column substitute “Co-ordination of scientific advice and public consultation and finalising the draft assessment report”;
(iv)in items 7 and 10, for the words in the second column substitute “Co-ordination of scientific advice and public consultation, and finalising the draft assessment report”;
(v)in item 12, in the second column, after “synergist,” insert “basic substance,”;
(d)in the notes following the table—
(i)omit note (2);
(ii)in note (3)—
(aa)at the beginning insert “In relation to active substances, safeners or synergists,”;
(bb)after the first sentence insert “In relation to basic substances, a full data package comprises the complete dossier (the information referred to in Article 23(3) of Regulation 1107/2009) to support one or more uses of the basic substance.”;
(cc)in the second sentence after “the product” insert “or basic substance”;
(iii)in note (4)—
(aa)omit paragraph (c);
(bb)in paragraph (d) at the beginning insert “in relation to active substances, safeners or synergists,”;
(cc)omit paragraph (e);
(dd)in paragraphs (f) and (g), at the beginning insert “in relation to active substances, safeners or synergists,”;
(ee)after paragraph (g) insert—
“(h)in relation to basic substances, resubmissions (for example where the previous application for approval under Regulation 1107/2009 has been unsuccessful and a new application is made in an attempt to address all the concerns raised from that earlier submission);
(i)in relation to basic substances, data to support a change to the conditions of approval of the basic substance.”;
(iv)for the final sentence substitute—
“The evaluation of scientific peer reviewed open literature on the active substance or basic substance and its relevant metabolites will be treated as a partial data package.”
(4) Omit paragraph 4 (including the table, and the notes following the table, in that paragraph).
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