2019 No. 865

Exiting The European Union
Agriculture
Food
Intellectual Property
Medicines
Tribunals And Inquiries

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

Made

Coming into force in accordance with regulation 1

The Secretary of State makes these Regulations in exercise of the powers conferred by section 8 of, and paragraph 1 of Schedule 4 and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018 M1.

In accordance with paragraphs 1(1) and 12(1) of Schedule 7 to that Act, a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.

In accordance with paragraph 3(1) of Schedule 4 to that Act, the Treasury have consented to the making of regulations 17 and 18(2), Schedule 8 and Part 1 of Schedule 9.

In relation to Parts 2 and 3 of, and Schedules 1 to 7 to, this instrument, there has been consultation as required by Article 9 of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety M2.

Annotations:
Marginal Citations
M2

OJ No L 31, 1.2.2002, p. 1, to which there are amendments not relevant to these Regulations.

PART 1Introductory

Citation F16, commencement and extentI11

1

These Regulations may be cited as the Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019.

2

These Regulations come into force on the later of exit day or the day after the day on which they are made.

F173

Regulation 17 and Schedule 8 extend to Great Britain.

PART 2Amendment of subordinate legislation relating to food and drink

The Spirit Drinks Regulations 2008F12

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Tribunal Procedure (First-tier Tribunal) (General Regulatory Chamber) Rules 2009F13

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Wine Regulations 2011F14

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Quality Schemes (Agricultural Products and Foodstuffs) Regulations 2018F15

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 3Amendment and revocation of retained direct EU legislation relating to food and drink

Commission Regulation (EC) No 2870/2000F16

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation (EU) No 1151/2012 of the European Parliament and of the CouncilF17

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Commission Implementing Regulation (EU) No 716/2013F18

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation (EU) No 251/2014 of the European Parliament and of the CouncilF19

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Commission Delegated Regulation (EU) No 664/2014F110

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Commission Delegated Regulation (EU) No 665/2014I211

1

Commission Delegated Regulation (EU) No 665/2014 supplementing Regulation (EU) No 1151/2012 of the European Parliament and of the Council with regard to conditions of use of the optional quality term ‘mountain product’ is amended as follows.

2

Omit Article 6(2).

3

After Article 7 omit the words from “This Regulation” to “Member States.”.

Commission Implementing Regulation (EU) No 668/2014F212

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Commission Delegated Regulation (EU) 2018/273F213

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Commission Implementing Regulation (EU) 2018/274F214

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annex 2 to the EEA AgreementI315

In Annex 2 to the EEA Agreement, in Chapter 27, omit points 8, 9, 9a, 9b and 9ba.

RevocationsI416

The retained direct EU legislation listed in Schedule 7 is revoked.

PART 4Amendment of subordinate legislation relating to veterinary medicines

The Veterinary Medicines Regulations 2013I517

1

The Veterinary Medicines Regulations 2013 M3 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 ”.

PART 5Amendment of retained direct EU legislation relating to veterinary medicines and residues

Regulation (EC) No 470/2009 of the European Parliament and of the CouncilI618

1

Regulation (EC) No 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin is amended as follows.

2

For Article 8 substitute the Article in Part 1 of Schedule 9.

3

For Article 9 substitute the Article in Part 2 of Schedule 9.

4

In Article 10—

a

for paragraph 1 substitute the paragraphs in Part 3 of Schedule 9;

b

in paragraph 2—

i

in the first subparagraph—

aa

for “Commission” substitute “ Secretary of State ”;

bb

for “paragraph 1” substitute “ paragraphs 1 and 1A ”;

cc

after “Article 14” insert “ , subject to the consent requirement in Article 83B of Regulation (EU) 528/2012 (treating this Article as a provision of that Regulation for the purposes of construing Article 83B(1)) ”;

dd

omit the second sentence;

ii

in the second subparagraph, for “Article 10(2) of Directive 98/8/EC” substitute “ Article 19(7) of Regulation (EU) No 528/2012 ”;

c

omit paragraph 3.

5

In Article 14—

a

for paragraph 1 substitute—

1

The F18Secretary of State must classify pharmacologically active substances in accordance with this Article.

b

in paragraph 3, for the words after “human health” to the end substitute “ , and when laying down a limit regard may be had to any international decisions in respect of that substance. ”;

c

in paragraph 5 omit the words from “, pursuant to” to “as appropriate,”;

d

in paragraph 6 omit the words from “, pursuant to” to “as appropriate,”.

6

After Article 14 insert the Article in Part 4 of Schedule 9.

David Rutley Parliamentary Under Secretary of State Department for Environment, Food and Rural Affairs

We consent

Craig WhittakerMike Freer Two of the Lords Commissioners of Her Majesty's Treasury

F3SCHEDULE 1Regulation (EU) No 1151/2012 of the European Parliament and of the Council: new provisions

Regulation 7(4)(b), (27), (50), (53), (55) and (60)

Annotations:
Amendments (Textual)
F3

Schs. 1-6 omitted (31.12.2020 immediately before IP completion day) by virtue of The Agricultural Products, Food and Drink (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1637), regs. 1(6), 6

F3PART 1Article 3: new definitions

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3PART 2Article 28: new Article

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3PART 3New Article 52a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3PART 4New Title 5A

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3PART 5New Article 56

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3PART 6New Annex 3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3SCHEDULE 2Commission Implementing Regulation (EU) No 716/2013: new Annexes 1 to 5

Regulation 8(14)

F3ANNEX 1APPLICATION TO REGISTER A GEOGRAPHICAL INDICATION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3ANNEX 2TECHNICAL FILE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3ANNEX 3OBJECTION TO A GEOGRAPHICAL INDICATION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3ANNEX 4APPLICATION TO CANCEL A GEOGRAPHICAL INDICATION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3ANNEX 5APPLICATION TO AMEND THE TECHNICAL FILE OF A GEOGRAPHICAL INDICATION

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3SCHEDULE 3Regulation (EU) No 251/2014 of the European Parliament and of the Council: new provisions

Regulation 9(3)(b), (20) (c), (22), (29), (34)(b) and (36)

F3PART 1Article 2(1): new definitions

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3PART 2Article 24: new paragraph 3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3PART 3New Articles 25a to 25d

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3PART 4New Article 33

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3PART 5Annex 1, point (5): new subparagraph

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3PART 6New Annex 4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3SCHEDULE 4Commission Delegated Regulation (EU) No 664/2014, Article 6: new paragraphs 3a to 3d and 4 to 4l

Regulation 10(9)

F33a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F33b

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F33c

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F33d

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34b

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34c

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34d

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34e

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34f

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34g

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34h

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34i

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34j

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34k

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34l

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3SCHEDULE 5Commission Implementing Regulation (EU) No 668/2014, Article 14: new paragraphs 3, 3a, 3b and 4

Regulation 12(11)(e)

F33

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F33a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F33b

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F34

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3SCHEDULE 6Commission Delegated Regulation (EU) 2018/273, Annex 7, Parts 1 and 2: new Parts

Regulation 13(32)(a)

SCHEDULE 7Revocations

Regulation 16

I71

Council Decision 94/184/EC concerning the conclusion of an Agreement between the European Community and Australia on trade in wine.

Annotations:
Commencement Information
I7

Sch. 7 para. 1 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I82

Council Decision 97/361/EC concerning the conclusion of an Agreement between the European Community and the United Mexican States on the mutual recognition and protection of designations for spirit drinks.

Annotations:
Commencement Information
I8

Sch. 7 para. 2 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I93

Commission Decision 2000/192/EC concerning the conclusion of an Agreement amending the Agreement between the European Community and Australia on trade in wine.

Annotations:
Commencement Information
I9

Sch. 7 para. 3 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I104

Commission Decision 2001/339/EC concerning an Exchange of Letters amending point B of the Annex to the Agreement between the European Community and the Republic of Bulgaria on the reciprocal protection and control of wine names.

Annotations:
Commencement Information
I10

Sch. 7 para. 4 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I115

Commission Decision 2001/581/EC concerning the conclusion of an Agreement amending the Agreement between the European Community and Australia on trade in wine.

Annotations:
Commencement Information
I11

Sch. 7 para. 5 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I126

Council Decision 2001/916/EC on the conclusion of an Additional Protocol adjusting the trade aspects of the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the former Yugoslav Republic of Macedonia, of the other part, to take account of the outcome of the negotiations between the parties on reciprocal preferential concessions for certain wines, the reciprocal recognition, protection and control of wine names and the reciprocal recognition, protection and control of designations for spirits and aromatised drinks.

Annotations:
Commencement Information
I12

Sch. 7 para. 6 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I137

Council Decision 2001/917/EC on the conclusion of an Additional Protocol adjusting the trade aspects of the Interim Agreement between the European Community, of the one part, and the former Yugoslav Republic of Macedonia, of the other part, to take account of the outcome of the negotiations between the parties on reciprocal preferential concessions for certain wines, the reciprocal recognition, protection and control of wine names and the reciprocal recognition, protection and control of designations for spirits and aromatised drinks.

Annotations:
Commencement Information
I13

Sch. 7 para. 7 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I148

Council Decision 2001/918/EC on the conclusion of an Additional Protocol adjusting the trade aspects of the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the Republic of Croatia, of the other part, to take account of the outcome of the negotiations between the parties on reciprocal preferential concessions for certain wines, the reciprocal recognition, protection and control of wine names and the reciprocal recognition, protection and control of designations for spirits and aromatised drinks.

Annotations:
Commencement Information
I14

Sch. 7 para. 8 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I159

Council Decision 2001/919/EC on the conclusion of an Additional Protocol adjusting the trade aspects of the Interim Agreement between the European Community, of the one part, and the Republic of Croatia, of the other part, to take account of the outcome of the negotiations between the parties on reciprocal preferential concessions for certain wines, the reciprocal recognition, protection and control of wine names and the reciprocal recognition, protection and control of designations for spirits and aromatised drinks.

Annotations:
Commencement Information
I15

Sch. 7 para. 9 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I1610

Council Decision 2001/920/EC on the conclusion of an Additional Protocol adjusting the trade aspects of the Europe Agreement establishing an association between the European Communities and their Member States, acting within the framework of the European Union, of the one part, and the Republic of Slovenia, of the other part, to take account of the outcome of the negotiations between the parties on reciprocal preferential concessions for certain wines, the reciprocal recognition, protection and control of wine names and the reciprocal recognition, protection and control of designations for spirits and aromatised drinks.

Annotations:
Commencement Information
I16

Sch. 7 para. 10 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I1711

Council Decision 2002/51/EC on the conclusion of an Agreement between the European Community and the Republic of South Africa on trade in wine.

Annotations:
Commencement Information
I17

Sch. 7 para. 11 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I1812

Council Decision 2002/53/EC concerning the provisional application of the Agreement between the European Community and the Republic of South Africa on trade in wine.

Annotations:
Commencement Information
I18

Sch. 7 para. 12 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I1913

Council Decision 2002/55/EC on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the Republic of South Africa on trade in wine.

Annotations:
Commencement Information
I19

Sch. 7 para. 13 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I2014

Commission Decision 2002/650/EC concerning the conclusion of an Agreement amending the Agreement between the European Community and Australia on trade in wine.

Annotations:
Commencement Information
I20

Sch. 7 para. 14 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I2115

Commission Decision 2003/898/EC concerning the conclusion of an agreement amending the Agreement between the European Community and Australia on trade in wine.

Annotations:
Commencement Information
I21

Sch. 7 para. 15 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I2216

Council Decision 2004/91/EC on the conclusion of the agreement between the European Community and Canada on trade in wines and spirit drinks.

Annotations:
Commencement Information
I22

Sch. 7 para. 16 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I2317

Commission Decision 2004/387/EC on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the United Mexican States concerning amendments to Annex I to the Agreement between the European Community and the United Mexican States on the mutual recognition and protection of designations for spirit drinks, taking into account the enlargement.

Annotations:
Commencement Information
I23

Sch. 7 para. 17 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I2418

Commission Decision 2004/483/EC on the conclusion of an Agreement in the form of an exchange of letters between the European Community and the United Mexican States concerning amendments to Annex I of the Agreement between the European Community and the United Mexican States on the mutual recognition and protection of designations for spirit drinks, taking into account the enlargement.

Annotations:
Commencement Information
I24

Sch. 7 para. 18 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I2519

Commission Decision 2004/785/EC on the conclusion of an Agreement in the form of an exchange of letters between the European Community and the United Mexican States concerning amendments to Annex II of the Agreement between the European Community and the United Mexican States on the mutual recognition and protection of designations for spirit drinks.

Annotations:
Commencement Information
I25

Sch. 7 para. 19 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I2620

Council Decision 2005/798/EC concerning the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the United States of America on matters related to trade in wine.

Annotations:
Commencement Information
I26

Sch. 7 para. 20 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I2721

Council Decision 2006/136/EC on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the Republic of Chile concerning amendments to the Agreement on Trade in Wines annexed to the Agreement establishing an Association between the European Community and its Member States, of the one part, and the Republic of Chile, of the other part.

Annotations:
Commencement Information
I27

Sch. 7 para. 21 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I2822

Council Decision 2006/232/EC on the conclusion of the Agreement between the European Community and the United States of America on trade in wine.

Annotations:
Commencement Information
I28

Sch. 7 para. 22 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I2923

Commission Decision 2006/567/EC on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the Republic of Chile concerning amendments to Appendices I, II, III and IV of the Agreement on Trade in Wines annexed to the Association Agreement between the European Community and its Member States, of the one part, and the Republic of Chile, of the other part.

Annotations:
Commencement Information
I29

Sch. 7 para. 23 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I3024

Commission Decision 2006/569/EC on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the Republic of Chile concerning amendments to Appendix VI of the Agreement on Trade in Wines annexed to the Association Agreement between the European Community and its Member States, of the one part, and the Republic of Chile, of the other part.

Annotations:
Commencement Information
I30

Sch. 7 para. 24 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I3125

Commission Regulation (EC) No 555/2008 laying down detailed rules for implementing Council Regulation (EC) No 479/2008 on the common organisation of the market in wine as regards support programmes, trade with third countries, production potential and on controls in the wine sector.

Annotations:
Commencement Information
I31

Sch. 7 para. 25 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I3226

Council Decision 2009/49/EC on the conclusion of the Agreement between the European Community and Australia on trade in wine.

Annotations:
Commencement Information
I32

Sch. 7 para. 26 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I3327

Commission Decision 2009/104/EC on the conclusion of an Agreement in the form of an Exchange of Letters between the European Community and the Republic of Chile concerning amendments to Appendix V of the Agreement on Trade in Wines annexed to the Association Agreement between the European Community and its Member States, of the one part, and the Republic of Chile, of the other part.

Annotations:
Commencement Information
I33

Sch. 7 para. 27 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I3428

Council Decision 2011/51/EU on the signing of the Agreement between the European Union and the Swiss Confederation on the protection of designations of origin and geographical indications for agricultural products and foodstuffs, amending the Agreement between the European Community and the Swiss Confederation on trade in agricultural products.

Annotations:
Commencement Information
I34

Sch. 7 para. 28 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I3529

Council Decision 2011/620/EU on the signing, on behalf of the Union, of the Agreement between the European Union and Georgia on protection of geographical indications of agricultural products and foodstuffs.

Annotations:
Commencement Information
I35

Sch. 7 para. 29 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I3630

Council Decision 2011/738/EU on the conclusion of the Agreement between the European Union and the Swiss Confederation on the protection of designations of origin and geographical indications for agricultural products and foodstuffs, amending the Agreement between the European Community and the Swiss Confederation on trade in agricultural products.

Annotations:
Commencement Information
I36

Sch. 7 para. 30 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I3731

Commission Implementing Decision 2011/751/EU on the notification of a proposal for amendment to the Annexes to the EC-US Agreement on trade in wine.

Annotations:
Commencement Information
I37

Sch. 7 para. 31 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I3832

Council Decision 2012/164/EU on the conclusion of the Agreement between the European Union and Georgia on protection of geographical indications of agricultural products and foodstuffs.

Annotations:
Commencement Information
I38

Sch. 7 para. 32 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I3933

Commission Implementing Decision 2012/275/EU on the inclusion of vine varieties in Appendix IV of the Protocol on wine labelling as referred to in Article 8(2) of the EC-US Agreement on trade in wine.

Annotations:
Commencement Information
I39

Sch. 7 para. 33 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I4034

Council Decision 2012/292/EU on the signing, on behalf of the Union, of the Agreement between the European Union and the Republic of Moldova on the protection of geographical indications of agricultural products and foodstuffs.

Annotations:
Commencement Information
I40

Sch. 7 para. 34 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I4135

Council Decision 2012/533/EU on the position to be taken by the European Union within the Joint Committee set up by Article 11 of the Agreement between the European Union and Georgia on protection of geographical indications of agricultural products and foodstuffs, as regards the adoption of the rules of procedure of the Joint Committee.

Annotations:
Commencement Information
I41

Sch. 7 para. 35 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I4236

Council Decision 2013/7/EU on the conclusion of the Agreement between the European Union and the Republic of Moldova on the protection of geographical indications of agricultural products and foodstuffs.

Annotations:
Commencement Information
I42

Sch. 7 para. 36 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I4337

Council Decision 2013/482/EU on the position to be taken by the European Union within the Joint Committee set up by Article 11 of the Agreement between the European Union and the Republic of Moldova on protection of geographical indications of agricultural products and foodstuffs, as regards the adoption of the rules of procedure of the Joint Committee.

Annotations:
Commencement Information
I43

Sch. 7 para. 37 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I4438

Council Decision 2014/429/EU on the position to be adopted on behalf of the European Union within the Association Council set up by the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America, on the other, as regards the adoption of a decision by the Association Council on the inclusion in Annex XVIII of the respective geographical indications protected in the territory of the parties.

Annotations:
Commencement Information
I44

Sch. 7 para. 38 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I4539

Commission Delegated Regulation (EU) 2016/1149 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the national support programmes in the wine sector.

Annotations:
Commencement Information
I45

Sch. 7 para. 39 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I4640

Commission Implementing Regulation (EU) 2016/1150 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the national support programmes in the wine sector.

Annotations:
Commencement Information
I46

Sch. 7 para. 40 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I4741

Council Decision (EU) 2016/2136 on the signing, on behalf of the European Union, of the Agreement between the European Union and Iceland on the protection of geographical indications for agricultural products and foodstuffs.

Annotations:
Commencement Information
I47

Sch. 7 para. 41 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

I4842

Council Decision (EU) 2017/1912 on the conclusion of the Agreement between the European Union and Iceland on the protection of geographical indications for agricultural products and foodstuffs.

Annotations:
Commencement Information
I48

Sch. 7 para. 42 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

SCHEDULE 8The Veterinary Medicines Regulations 2013: new provisions

Regulation 17(3) and (4) (g)

I49PART 1New Schedule 1A

Annotations:
Commencement Information
I49

Sch. 8 Pt. 1 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Marginal Citations
M4

OJ No L 136, 30.4.2004, p 1, as last amended by Regulation (EU) No 1027/2012 (OJ No L 316, 14.11.2012, p 38).

SCHEDULE 1AConverted EU marketing authorisations

Regulation 4(4)

1

In this Schedule—

  • “converted EU marketing authorisation” means an EU marketing authorisation to which paragraph 2 applies;

  • “EU marketing authorisation” means a marketing authorisation for a veterinary medicinal product granted by the European Commission in accordance with Title 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency M4.

2

This paragraph applies to an EU marketing authorisation which—

a

was granted before exit day, and

b

remains in force immediately before exit day.

3

A converted EU marketing authorisation has effect on and after exit day for the purposes of these regulations as if it were a marketing authorisation granted by the Secretary of State under these Regulations on the date it was originally granted—

a

on the terms which were in force immediately before exit day,

b

with the benefit of any periods of data marketing exclusivity from which the holder benefited immediately before exit day, and

c

subject to any suspension or post-authorisation obligations which were in force immediately before exit day.

4

Without prejudice to the generality of paragraph 3—

a

the holder of a converted EU marketing authorisation is subject to the annual fee as set out in paragraph 26 of Schedule 7;

b

a converted EU marketing authorisation is to be treated as having been granted in accordance with regulation 4(3) and Schedule 1 for the purposes of Regulation (EC) No 469/2009.

I50PART 2Schedule 7, paragraph 15: new table

Annotations:
Commencement Information
I50

Sch. 8 Pt. 2 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Amendments (Textual)
F4

Words in Sch. 8 Pt. 2 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(4)

Parallel imports

Application

Fee (£)

Application where the imported product is identical to F4a product which is authorised for sale in the United Kingdom

2,130

Application where the imported product is therapeutically similar to F4a product which is authorised for sale in the United Kingdom (can only be applied to imported products for non-food producing species)

4,710

SCHEDULE 9Regulation (EC) No 470/2009 of the European Parliament and of the Council: new provisions

Regulation 18(2), (3),(4) (a) and (6)

I51PART 1New Article 8

Annotations:
Commencement Information
I51

Sch. 9 Pt. 1 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Amendments (Textual)
F5

Words in Sch. 9 Pt. 1 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(a)(i)

F6

Words in Sch. 9 Pt. 1 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(a)(ii)

F7

Words in Sch. 9 Pt. 1 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(a)(iii)

F8

Words in Sch. 9 Pt. 1 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(a)(iv)

F9

Words in Sch. 9 Pt. 1 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(a)(v)(aa)

F10

Words in Sch. 9 Pt. 1 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(a)(v)(bb)

F11

Words in Sch. 9 Pt. 1 omitted (31.12.2020 immediately before IP completion day) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(a)(vi)

Article 8Application for a maximum residue limit

1

An application under these Regulations for a new or amended maximum residue limit for a substance intended for use in a veterinary medicinal product must be made to the F5Secretary of State.

2

An application must include all necessary administrative information, and all scientific documentation necessary for demonstrating the safety of the substance.

3

The applicant must pay to the F6Secretary of State the application fee, which is—

a

for a new maximum residue limit in respect of a substance, £62,300;

b

for an amended maximum residue limit in respect of a substance, £18,850.

4

The F7Secretary of State must ensure that where a valid application is received, the substance is classified under Article 14 within 210 days.

5

For the purposes of paragraph 4 an application is valid when both the requirements in paragraphs 2 and 3 have been complied with.

6

As soon as practicable after the substance is classified under Article 14, the F8Secretary of State must publish—

a

a notice setting out the classification;

b

the assessment report that has been prepared, with any commercially confidential or personal information deleted.

7

If the F9Secretary of State classifies a substance under Article 14(2)(b) or (d), F10the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee under regulation 29 of the Veterinary Medicines Regulations 2013.

F118

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

I52PART 2New Article 9

Annotations:
Commencement Information
I52

Sch. 9 Pt. 2 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Amendments (Textual)
F12

Words in Sch. 9 Pt. 2 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(b)

Article 9Further power for appropriate authority to classify substances

1

The F12Secretary of State may classify a substance intended for use in a veterinary medicinal product which is to be administered to food-producing animals under Article 14 without an application having been made under these Regulations.

2

The power in paragraph 1 includes power to classify a substance which has previously been classified under Article 14.

I53PART 3Article 10(1): new paragraphs

Annotations:
Commencement Information
I53

Sch. 9 Pt. 3 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Amendments (Textual)
F13

Words in Sch. 9 Pt. 3 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(c)

1

An application for the classification of a pharmacologically active substance intended to be used in a biocidal product used in animal husbandry pursuant to Article 19(7) of Regulation (EU) 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products must be made under Article 8, notwithstanding that it is not a substance intended for use in a veterinary medicinal product to be administered to food-producing animals.

1A

The power to classify a substance under Article 9 may be exercised in respect of a pharmacologically active substance intended to be used in a biocidal product used in animal husbandry, notwithstanding that it is not a substance intended for use in a veterinary medicinal product to be administered to food-producing animals, where the Secretary of State considers it appropriate to do so for the purposes of Article 19(1)(e) of Regulation (EU) 528/2012.

1B

Where proposals are made for the classification of a substance under Article 9 in the circumstances described in paragraph 1A by a devolved authority, the Secretary of State must have regard to such proposals when exercising functions under that paragraph.

1C

In this Article, “devolved authority” F13means the Scottish Ministers or the Welsh Ministers.

I54PART 4New Article 14A

Annotations:
Commencement Information
I54

Sch. 9 Pt. 4 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)

Amendments (Textual)
F14

Words in Sch. 9 Pt. 4 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(d)(i)

F15

Words in Sch. 9 Pt. 4 substituted (31.12.2020 immediately before IP completion day) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(a), 2(5)(d)(ii)

Article 14AMRL register

1

The F14Secretary of State must maintain a register (“the MRL register”) in accordance with this Article.

2

The MRL register must contain—

a

a list of substances which have been classified under Article 14;

b

in respect of each such substance—

i

any maximum residue limit or other matter established under paragraph 2 of Article 14;

ii

any conditions or restrictions included in the classification pursuant to paragraph 7 of Article 14.

3

The MRL register must be kept up to date.

4

The MRL register must contain a search facility.

5

The F15Secretary of State must make the MRL register available for inspection by the public on a website maintained by the F15Secretary of State.

(This note is not part of the Regulations)

These Regulations are made in exercise of the powers conferred by the European Union (Withdrawal) Act 2018 (c. 16) (in particular under section 8(2)(a), (b), (c), (d), (e) and (g)) in order to address failures of retained EU law to operate effectively and other deficiencies arising from the withdrawal of the United Kingdom from the European Union.

These Regulations make amendments to legislation relating to—

  1. a

    aromatised wine;

  2. b

    the quality scheme for agricultural products and foodstuffs;

  3. c

    spirit drinks;

  4. d

    wine;

  5. e

    veterinary medicines;

  6. f

    residues.

Part 2 amends subordinate legislation and Part 3 amends and revokes retained direct EU legislation as regards the subjects in paragraphs (a) to (d). Part 4 amends subordinate legislation as regards the subject in paragraph (e) and Part 5 amends retained direct EU legislation as regards the subjects in paragraphs (e) and (f).

An impact assessment has not been produced for this instrument as no, or no significant, impact on the private or voluntary sector is foreseen.