11Commission 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.”.
12Commission Implementing Regulation (EU) No 668/2014#
(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 ”.
18Regulation (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.
(1)Council Decision 94/184/EC concerning the conclusion of an Agreement between the European Community and Australia on trade in wine.
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(12)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.
(13)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.
(14)Commission Decision 2002/650/EC concerning the conclusion of an Agreement amending the Agreement between the European Community and Australia on trade in wine.
(15)Commission Decision 2003/898/EC concerning the conclusion of an agreement amending the Agreement between the European Community and Australia on trade in wine.
(16)Council Decision 2004/91/EC on the conclusion of the agreement between the European Community and Canada on trade in wines and spirit drinks.
(17)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.
(18)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.
(19)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.
(20)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.
(21)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.
(22)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.
(23)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.
(24)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.
(25)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.
(26)Council Decision 2009/49/EC on the conclusion of the Agreement between the European Community and Australia on trade in wine.
(27)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.
(28)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.
(29)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.
(30)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.
(31)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.
(32)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.
(33)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.
(34)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.
(35)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.
(36)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.
(37)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.
(38)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.
(39)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.
(40)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.
(41)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.
(42)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.