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17.—(1) The Veterinary Medicines Regulations 2013 M1 are amended as follows.
(2) In regulation 4, after paragraph (3) insert—
“(4) Schedule 1A (converted EU marketing authorisations) has effect.”.
(3) After Schedule 1 insert the Schedule in Part 1 of Schedule 8.
(4) In Schedule 7—
(a)in paragraph 1—
(i)omit the definition of “national application”;
(ii)in the definition of “simultaneous application” omit the text after sub-paragraph (b);
(b)in paragraph 7—
(i)for the heading substitute “ Application for a marketing authorisation for a pharmaceutical veterinary medicinal product ”;
(ii)in sub-paragraph (a), for “a national application” substitute “ an application ”;
(iii)omit sub-paragraphs (b) and (c);
(iv)in the table—
(aa)in the heading, in the second column omit “national”;
(bb)in the heading, in the third column omit “national”;
(cc)for the heading for the fourth column (including the heading which straddles the fourth and fifth columns) substitute “Pharmacologically equivalent application”;
(dd)omit the fifth and sixth columns;
(c)omit paragraph 8;
(d)in paragraph 9—
(i)in sub-paragraph (1)—
(aa)for “a national application” substitute “ an application ”;
(bb)omit the words from “a decentralised” to “another member State”;
(ii)in the table—
(aa)in the heading, in the second column omit “National”;
(bb)omit the third column;
(e)omit paragraph 10;
(f)in paragraph 11—
(i)for the heading substitute “ Application for a marketing authorisation based on informed consent ”;
(ii)for “fees” substitute “ fee ”;
(iii)for the text from “are in accordance” to the end (including the table) substitute “is £945 per application.”;
(g)in paragraph 15, for the table substitute the table in Part 2 of Schedule 8;
(h)omit paragraph 16;
(i)in paragraph 17—
(i)in the heading omit the words from “dealt with” to the end;
(ii)in the table—
(aa)omit the heading for the second column;
(bb)omit the third and fourth columns;
(j)in paragraph 18—
(i)for sub-paragraph (2) substitute—
“(2) The fees for a worksharing application are specified in the following table.”;
(ii)omit sub-paragraphs (3) to (5);
(iii)in the table—
(aa)omit the heading for the second column;
(bb)omit the third, fourth, fifth, sixth, seventh and eighth columns;
(k)omit paragraphs 19 and 20;
(l)in paragraph 21 omit the words from “in the case” to the end;
(m)in paragraph 22, in the heading omit “national”;
(n)omit paragraph 23;
(o)in paragraph 24, in the first column of the table omit “or in another member State”;
(p)in paragraph 48—
(i)in sub-paragraph (1), for the words from “£345” to the end substitute “ £815 ”;
(ii)omit sub-paragraph (3);
(q)in paragraph 49(1)—
(i)omit sub-paragraph (a);
(ii)in sub-paragraph (b), for “a third” substitute “ another ”.
Commencement Information
I1Reg. 17 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)
Marginal Citations
M1S.I. 2013/2033, amended by S.I. 2014/599, 2018/761.