Entry into force

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union .

It shall apply from 2 July 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 27 June 2023.

For the European Parliament

The President

R. METSOLA

For the Council

The President

J. ROSWALL

( 1 ) OJ C 323, 26.8.2022, p. 88 .

( 2 ) Position of the European Parliament of 13 June 2023 (not yet published in the Official Journal) and decision of the Council of 27 June 2023.

( 3 ) Council Regulation (EEC) No 302/93 of 8 February 1993 on the establishment of a European Monitoring Centre for Drugs and Drug Addiction ( OJ L 36, 12.2.1993, p. 1 ).

( 4 ) Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction ( OJ L 376, 27.12.2006, p. 1 ).

( 5 ) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA ( OJ L 135, 24.5.2016, p. 53 ).

( 6 ) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents ( OJ L 145, 31.5.2001, p. 43 ).

( 7 ) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 ( OJ L 248, 18.9.2013, p. 1 ).

( 8 ) OJ L 136, 31.5.1999, p. 15 .

( 9 ) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission ( OJ L 72, 17.3.2015, p. 41 ).

( 10 ) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information ( OJ L 72, 17.3.2015, p. 53 ).

( 11 ) Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking ( OJ L 335, 11.11.2004, p. 8 ).

( 12 ) Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors ( OJ L 47, 18.2.2004, p. 1 ).

( 13 ) Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Union and third countries in drug precursors ( OJ L 22, 26.1.2005, p. 1 ).

( 14 ) Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA ( OJ L 295, 21.11.2018, p. 138 ).

( 15 ) Council Regulation (EC) No 168/2007 of 15 February 2007 establishing a European Union Agency for Fundamental Rights ( OJ L 53, 22.2.2007, p. 1 ).

( 16 ) Regulation (EU) 2015/2219 of the European Parliament and of the Council of 25 November 2015 on the European Union Agency for Law Enforcement Training (CEPOL) and replacing and repealing Council Decision 2005/681/JHA ( OJ L 319, 4.12.2015, p. 1 ).

( 17 ) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency ( OJ L 136, 30.4.2004, p. 1 ).

( 18 ) Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control ( OJ L 142, 30.4.2004, p. 1 ).

( 19 ) Regulation (EU) 2019/127 of the European Parliament and of the Council of 16 January 2019 establishing the European Foundation for the improvement of living and working conditions (Eurofound), and repealing Council Regulation (EEC) No 1365/75 ( OJ L 30, 31.1.2019, p. 74 ).

( 20 ) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( OJ L 311, 28.11.2001, p. 67 ).

( 21 ) 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 ( OJ L 4, 7.1.2019, p. 43 ).

( 22 ) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use ( OJ L 121, 1.5.2001, p. 34 ).

( 23 ) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( OJ L 396, 30.12.2006, p. 1 ).

( 24 ) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 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 ( OJ L 31, 1.2.2002, p. 1 ).

( 25 ) Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU ( OJ L 314, 6.12.2022, p. 26 ).

( 26 ) Commission Decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority 2021/C 393 I/02 ( OJ C 393 I, 29.9.2021, p. 3 ).

( 27 ) OJ L 56, 4.3.1968, p. 1 .

( 28 ) Commission Decision 1999/352/EC, ECSC, Euratom of 28 April 1999 establishing the European Anti-fraud Office (OLAF) ( OJ L 136, 31.5.1999, p. 20 ).

( 29 ) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) ( OJ L 283, 31.10.2017, p. 1 ).

( 30 ) Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council ( OJ L 122, 10.5.2019, p. 1 ).

( 31 ) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 ( OJ L 193, 30.7.2018, p. 1 ).

( 32 ) Council Regulation No 1 determining the languages to be used by the European Economic Community ( OJ 17, 6.10.1958, p. 385 ).

( 33 ) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC ( OJ L 295, 21.11.2018, p. 39 ).

( 34 ) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities ( OJ L 292, 15.11.1996, p. 2 ).

( 35 ) OJ L 207, 11.6.2021, p. 1 .

REGULATION (EU) 2023/1322 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 June 2023 on the European Union Drugs Agency (EUDA) and repealing Regulation (EC) No 1920/2006 ANNEX