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

• Citation: S.I. 2019/865
• Sections: 104

Section 1 Citation , commencement and extent

(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.

(3) Regulation 17 and Schedule 8 extend to Great Britain.

Section 2 The Spirit Drinks Regulations 2008

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Section 3 The Tribunal Procedure (First-tier Tribunal) (General Regulatory Chamber) Rules 2009

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Section 4 The Wine Regulations 2011

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Section 5 The Quality Schemes (Agricultural Products and Foodstuffs) Regulations 2018

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Section 6 Commission Regulation (EC) No 2870/2000

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Section 7 Regulation (EU) No 1151/2012 of the European Parliament and of the Council

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Section 8 Commission Implementing Regulation (EU) No 716/2013

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Section 9 Regulation (EU) No 251/2014 of the European Parliament and of the Council

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Section 10 Commission Delegated Regulation (EU) No 664/2014

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Section 11 Commission Delegated Regulation (EU) No 665/2014

(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.”.

Section 12 Commission Implementing Regulation (EU) No 668/2014

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Section 13 Commission Delegated Regulation (EU) 2018/273

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Section 14 Commission Implementing Regulation (EU) 2018/274

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Section 15 Annex 2 to the EEA Agreement

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

Section 16 Revocations

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

Section 17 The Veterinary Medicines Regulations 2013

(1) The Veterinary Medicines Regulations 2013 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 ” .

Section 18 Regulation (EC) No 470/2009 of the European Parliament and of the Council

(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 Secretary 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.

Section 3a

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Section 3b

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Section 3c

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Section 3d

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Section 4

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Section 4a

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Section 4b

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Section 4c

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Section 4d

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Section 4e

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Section 4f

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Section 4g

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Section 4h

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Section 4i

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Section 4j

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Section 4k

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Section 4l

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Section 3

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Section 3a

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Section 3b

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Section 4

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Section 1

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

Section 2

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.

Section 3

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

Section 4

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.

Section 5

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

Section 6

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.

Section 7

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.

Section 8

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.

Section 9

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.

Section 10

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.

Section 11

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.