PART 4Amendment of subordinate legislation relating to veterinary medicines

The Veterinary Medicines Regulations 201317.

(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 ”.