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Official Journal L 180 of the European Union Volume 64 English edition Legislation 21 May 2021 Contents II Non-legislative acts REGULATIONS ★ Council Implementing Regulation (EU) 2021/804 of 20 May 2021 implementing Article 15(3) of Regulation (EU) No 747/2014 concerning restrictive measures in view of the situation in Sudan . 1 ★ Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (1) . 3 ★ Commission Delegated Regulation (EU) 2021/806 of 10 March 2021 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include carbon dioxide generated from propane, butane or a mixture of both by combustion as an active substance in Annex I thereto (1) . 78 ★ Commission Delegated Regulation (EU) 2021/807 of 10 March 2021 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include potassium sorbate as an active substance in Annex I thereto (1) . 81 ★ Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling and repealing Decisions 2002/657/EC and 98/179/EC (1) . 84 ★ Commission Implementing Regulation (EU) 2021/809 of 20 May 2021 concerning the non- approval of fermented extract from leaves of Symphytum officinale L. (comfrey) as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (1) . 110 ★ Commission Implementing Regulation (EU) 2021/810 of 20 May 2021 amending Implementing Regulation (EU) 2021/2021/808 as regards transitional provisions for certain substances listed in Annex II to Decision 2002/657/EC (1) . 112 (1) Text with EEA relevance. Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. EN The titles of all other acts are printed in bold type and preceded by an asterisk. ★ Commission Implementing Regulation (EU) 2021/811 of 20 May 2021 amending Annex I to Implementing Regulation (EU) 2021/605 laying down special control measures for African swine fever (1) . 114 DECISIONS ★ Council Decision (EU) 2021/812 of 10 May 2021 on the position to be taken on behalf of the European Union within the Association Committee in Trade configuration and in the Association Council established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Georgia, of the other part, as regards a favourable opinion on the comprehensive roadmap approved by the Government of Georgia for the implementation of legislation related to public procurement and recognising the completion of Phase 1 of Annex XVI-B of that Association Agreement . 147 ★ Council Decision (CFSP) 2021/813 of 20 May 2021 amending Decision 2014/486/CFSP on the European Union Advisory Mission for Civilian Security Sector Reform Ukraine (EUAM Ukraine) . 149 ★ Council Decision (CFSP) 2021/814 of 20 May 2021 amending Decision (CFSP) 2017/915 on Union outreach activities in support of the implementation of the Arms Trade Treaty . 151 ★ Council Implementing Decision (CFSP) 2021/815 of 20 May 2021 implementing Decision 2014/450/CFSP concerning restrictive measures in view of the situation in Sudan . 152 (1) Text with EEA relevance. 21.5.2021 EN Offi cial Jour nal of the European Union L 180/1 II (Non-legislative acts) REGULATIONS COUNCIL IMPLEMENTING REGULATION (EU) 2021/804 of 20 May 2021 implementing Article 15(3) of Regulation (EU) No 747/2014 concerning restrictive measures in view of the situation in Sudan THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Regulation (EU) No 747/2014 of 10 July 2014 concerning restrictive measures in view of the situation in Sudan and repealing Regulations (EC) No 131/2004 and (EC) No 1184/2005 (1), and in particular Article 15(3) thereof, Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy, Whereas: (1) On 10 July 2014 the Council adopted Regulation (EU) No 747/2014. (2) On 5 March 2021 the United Nations Security Council (UNSC) Committee established pursuant to UNSC Resolution 1591(2005) approved the removal of one person from the list of persons and entities subject to restrictive measures. (3) Annex I to Regulation (EU) No 747/2014 should therefore be amended accordingly, HAS ADOPTED THIS REGULATION: Article 1 Annex I to Regulation (EU) No 747/2014 is amended as set out in the Annex to this Regulation. Article 2 This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 May 2021. For the Council The President A. SANTOS SILVA (1) OJ L 203, 11.7.2014, p. 1. L 180/2 EN Offi cial Jour nal of the European Union 21.5.2021 ANNEX In the list set out in Annex I to Regulation (EU) No 747/2014, the entry for the following person is deleted: 3. SHAREIF, Adam. 21.5.2021 EN Offi cial Jour nal of the European Union L 180/3 COMMISSION DELEGATED REGULATION (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (1), and in particular Article 146(2) thereof, Whereas: (1) It is appropriate to substantially update the requirements set out in Annex II to Regulation (EU) 2019/6, which took over the dossier requirements set out in Annex I to Directive 2001/82/EC of the European Parliament and of the Council (2), as that Regulation did not update those dossier requirements at the time of repealing that Directive. The dossier requirements set out in Annex I to Directive 2001/82/EC had last been updated in 2009. Therefore, Annex II should be amended to take account of scientific progress and developments since 2009, including international guidance from the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), World Health Organisation (WHO) and the organisation of Economic cooperation and development (OECD) standards. (2) It is also appropriate to set out requirements for biological veterinary medicinal products and novel therapy veterinary medicinal products introduced as new categories of veterinary medicinal products by Regulation (EU) 2019/6. For those products, specific technical requirements to be presented when applying for a marketing authorisation should be defined. (3) Recognising that antimicrobial resistance to medicinal products is a growing health problem in the Union and worldwide, Regulation (EU) 2019/6 introduced specific legal provisions aimed at limiting the risk of development of antimicrobial resistance to medicinal products. It is therefore appropriate to introduce specific technical requirements for antimicrobial veterinary medicinal products. (4) This Regulation should apply from 28 January 2022 in accordance with Article 153(3) of Regulation (EU) 2019/6. (5) Regulation (EU) 2019/6 should therefore be amended accordingly, HAS ADOPTED THIS REGULATION: Article 1 Annex II to Regulation (EU) 2019/6 is replaced by the text in the Annex to this Regulation. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 28 January 2022. (1) OJ L 4, 7.1.2019, p. 43. (2) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1). L 180/4 EN Offi cial Jour nal of the European Union 21.5.2021 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 8 March 2021. For the Commission The President Ursula VON DER LEYEN 21.5.2021 EN Offi cial Jour nal of the European Union L 180/5 ANNEX ‘ANNEX II REQUIREMENTS REFERRED TO IN ARTICLE 8(1), POINT (B) Table of Contents SECTION I GENERAL PRINCIPLES AND REQUIREMENTS . .11 I.1. General principles . .11 I.2. Dossier composition requirements . .11 I.2.1. Part 1: Summary of the dossier . .11 I.2.2. Part 2: Quality documentation (physicochemical, biological or microbiological information) . .12 I.2.3. Part 3: Safety documentation (safety and residues tests) . .13 I.2.4. Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s)) . .13 I.2.5. Detailed requirements for different types of veterinary medicinal products or marketing authorisation dossiers . .14 SECTION II REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS OTHER THAN BIOLOGICAL VETERINARY MEDICINAL PRODUCTS . .14 II.1. Part 1: Summary of the dossier . .14 II.2. Part 2: Quality documentation (physicochemical, biological or microbiological information) . .14 II.2A. Product description . .14 II.2A1. Qualitative and quantitative composition . .14 II.2A2. Product development . .16 II.2B. Description of the manufacturing method . .16 II.2C. Production and control of starting material . .16 II.2C1. Active substance(s) . .17 II.2C1.1.