The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019

The Veterinary Medicines Regulations 2013 E+W+S

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

I1 Reg. 17 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations

M1 S.I. 2013/2033, amended by S.I. 2014/599, 2018/761.