PART 6Veterinary Medicines

Amendments to the Veterinary Medicines Regulations 201310

1

The Veterinary Medicines Regulations (Northern Ireland) 201312 are amended as follows.

2

In regulation 2(2), after the definition of “Regulation (EC) No 767/2009” insert—

“Regulation (EU) 2017/625” means Regulation (EU) 2017/625 of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products;

3

In regulation 8(a), for “the United Kingdom” substitute “Northern Ireland”.

4

In regulation 9(1), for “the United Kingdom” substitute “Northern Ireland”.

5

In regulation 25—

a

in paragraphs (5) and (6)(a), for “another” substitute “a”;

b

in paragraph (6)(b)(iii), for “the United Kingdom” substitute “Northern Ireland”;

c

after paragraph (8), insert—

9

For the purpose of this regulation, references to import or importation of an unauthorised veterinary medicinal product include the movement of such a product from Great Britain to Northern Ireland.

6

For regulation 26(4) substitute—

4

A veterinary surgeon who practices in Northern Ireland and a member State may hold veterinary medicinal products authorised in the member State provided that the amount held does not exceed the amount expected to be used in that member State.

7

In regulation 31(1), for “member State”, in each place it occurs, substitute “country”.

8

In regulation 34—

a

in paragraph (5), omit sub-paragraph (b) and the word “and” immediately before it;

b

in paragraph (10), for “another” substitute “a”;

c

for paragraph (11), substitute—

11

In this regulation, a reference to justice of the peace is a reference to a lay magistrate.

9

In regulation 39—

a

in paragraph (1), after “magistrates’ court” omit “or, in Scotland, to the sheriff”;

b

omit paragraph (3).

10

In regulation 41—

a

in paragraph (6), after “magistrates’ court” omit “(or in Scotland, the sheriff court)”;

b

omit paragraph (8).

11

For regulation 45(3)(c), substitute—

c

Regulation (EU) 2017/625; and

12

In regulation 46—

a

in paragraph (2), omit “other”;

b

for paragraph (3)(f), substitute—

f

Regulation (EU) 2017/625;

13

In Schedule 1—

a

in the heading, after “Marketing Authorisations” insert “in Northern Ireland”;

b

in Part 1, in paragraph 2(3)(n)(i), for “another” substitute “a” and omit “other”;

c

in Part 2, paragraph 10(6)—

i

for “another” substitute “a”;

ii

for “the United Kingdom”, in each place it occurs, substitute “Northern Ireland”;

d

in paragraph 13—

i

in sub-paragraph (1), for “another” substitute “a”;

ii

in sub-paragraphs (1), (2), (3), (6) and (7), for “the United Kingdom” substitute “Northern Ireland”;

e

in paragraph 16, for “another” substitute “a”;

f

in Part 3—

i

in paragraph 18, after “established in” insert “the United Kingdom or”;

ii

in paragraph 20, for “another” substitute “a”;

iii

in paragraph 29(1)(b) and (3), in each place it occurs, for “another” substitute “a”;

iv

in paragraph 31(1) and (2), in each place it occurs, for “the United Kingdom” substitute “Northern Ireland”;

v

in paragraph 32(8) and (9), in each place it occurs, for “the United Kingdom” substitute “Northern Ireland”;

g

in Part 5—

i

paragraph 39(3)(b), for “the United Kingdom” substitute “Northern Ireland” and omit “other”;

ii

in paragraph 41(3), for “another” substitute “a”;

h

in Part 6—

i

in paragraph 42—

aa

in the heading and sub- paragraph (1), for “another” substitute “a”;

bb

in sub-paragraph (1), for “the United Kingdom” substitute “Northern Ireland”;

ii

in paragraph 43—

aa

in the heading, for “another” substitute “a”;

bb

in sub-paragraph (1), for “another” substitute “a”;

i

in Part 7, in paragraph 46—

i

for “UK” substitute “UK(NI)”;

ii

for “the United Kingdom” substitute “Northern Ireland”;

j

in Part 8—

i

in paragraph 55, after “a member State” insert “or the United Kingdom”.

ii

in paragraph 57, in the heading and in sub-paragraph (1), for “the United Kingdom” substitute “Northern Ireland”;

iii

in paragraph 58—

aa

in sub-paragraph (1), for “the United Kingdom” substitute “Northern Ireland”;

bb

in sub-paragraph (4), omit “other”;

iv

in paragraph 59(2) and (3), in each place where it occurs, for “the United Kingdom” substitute “Northern Ireland”;

v

in paragraph 61—

aa

in sub-paragraph (1), for “another” substitute “a” and omit “other”;

bb

in sub-paragraph (2), omit “other”;

k

in Part 9, in paragraph 64(4), for “another” substitute “a”.

14

In Schedule 4—

a

in paragraph 1, in each place it occurs, for “United Kingdom” substitute “Northern Ireland”;

b

in paragraph 5, for “the United Kingdom” substitute “Northern Ireland”;

c

in paragraph 6—

i

in the heading, omit “other”;

ii

in sub-paragraph (1), for “another” substitute “a”;

iii

in sub-paragraphs (1), 1(d) and 3(b) for “the United Kingdom”, in each place it occurs, substitute “Northern Ireland”.

iv

for sub-paragraph (3)(a), substitute—

a

ensure that the withdrawal period specified on the label of the product is complied with, or the Northern Ireland withdrawal period for the equivalent product authorised in Northern Ireland if this is longer than the one on the label; and

15

In Schedule 5—

a

in the Contents, in item 4, for “Regulation (EC) No 882/2004” substitute “Regulation (EU) 2017/625”;

b

for paragraph 4, and the heading substitute—

Enforcement of Regulation (EU) 2017/6254

For the purposes of Regulation (EU) 2017/625 the competent authority is the Secretary of State.

c

in paragraph 28—

i

in the heading, for “between” substitute “with”;

ii

for “another” substitute “a”;

iii

in sub-paragraph (b), for “the United Kingdom” substitute “Northern Ireland”;

d

in paragraph 29—

i

in sub-paragraph (1), for “another” substitute “a”;

ii

in sub-paragraph (2), for “the United Kingdom” substitute “Northern Ireland”.

16

In Schedule 6, in paragraph (3)(b), for “another” substitute “a”.