Exiting The European Union PART 1 Introductory Citation , commencement and extent 1 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. PART 2 Amendment of subordinate legislation relating to food and drink The Spirit Drinks Regulations 2008 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Tribunal Procedure (First-tier Tribunal) (General Regulatory Chamber) Rules 2009 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Wine Regulations 2011 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Quality Schemes (Agricultural Products and Foodstuffs) Regulations 2018 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 3 Amendment and revocation of retained direct EU legislation relating to food and drink Commission Regulation (EC) No 2870/2000 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Regulation (EU) No 1151/2012 of the European Parliament and of the Council 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Commission Implementing Regulation (EU) No 716/2013 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Regulation (EU) No 251/2014 of the European Parliament and of the Council 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Commission Delegated Regulation (EU) No 664/2014 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Commission Delegated Regulation (EU) No 665/2014 11 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 668/2014 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Commission Delegated Regulation (EU) 2018/273 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Commission Implementing Regulation (EU) 2018/274 14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Annex 2 to the EEA Agreement 15 In Annex 2 to the EEA Agreement, in Chapter 27, omit points 8, 9, 9a, 9b and 9ba. Revocations 16 The retained direct EU legislation listed in Schedule 7 is revoked. PART 4 Amendment of subordinate legislation relating to veterinary medicines The Veterinary Medicines Regulations 2013 17 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 ” . PART 5 Amendment of retained direct EU legislation relating to veterinary medicines and residues Regulation (EC) No 470/2009 of the European Parliament and of the Council 18 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. David Rutley Parliamentary Under Secretary of State Department for Environment, Food and Rural Affairs We consent Craig Whittaker Mike Freer Two of the Lords Commissioners of Her Majesty's Treasury