Official Journal
of the European Union
EN
L series
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Official Journal |
EN L series |
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2026/1535 |
3.7.2026 |
COUNCIL DECISION (EU) 2026/1535
of 25 June 2026
on the position to be adopted on behalf of the European Union within the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco concerning amendments to the Annex to that Agreement
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(4), first subparagraph, in conjunction with Article 218(9), thereof,
Having regard to Council Decision 2003/885/EC of 17 November 2003 concerning the conclusion of the Agreement on the application of certain Community acts on the territory of the Principality of Monaco (1), and in particular Article 3(2) thereof,
Having regard to the proposal from the European Commission,
Whereas:
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(1) |
The Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco (2) (the ‘Agreement’) was concluded by the Community by means of Decision 2003/885/EC. |
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(2) |
Pursuant to Article 1(1) of the Agreement, the Joint Committee established by Article 3(1) thereof (the ‘Joint Committee’) is able to amend the Annex to the Agreement in order to ensure that Union acts falling within the scope of the Agreement apply on the territory of the Principality of Monaco. |
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(3) |
The Annex to the Agreement was last amended by Decision No 1/2013 of the Joint Committee (3). Since the adoption of that Decision, the Union has adopted a number of acts that fall within the scope of the Agreement, while certain acts listed in the Annex to the Agreement have been repealed. The Joint Committee is scheduled to adopt, by written procedure, a decision amending the Annex to the Agreement in order to include the new acts that fall within the scope of the Agreement and remove the acts that have been repealed (the ‘Joint Committee Decision’). |
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(4) |
The Joint Committte Decision will, if adopted, produce legal effects for the Union. |
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(5) |
It is therefore appropriate to establish the position to be taken within the Joint Committee concerning the amendments to the Annex to the Agreement, |
HAS ADOPTED THIS DECISION:
Article 1
The position to be taken on the Union’s behalf within the Joint Committee established by Article 3(1) of the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco shall be based on the draft Decision of the Joint Committee (the ‘Joint Committee Decision’) attached to this Decision.
Article 2
Minor technical changes to the position set out in the attached draft Joint Committee Decision may be agreed upon without a further decision of the Council.
Article 3
The Joint Committee Decision shall be published in the Official Journal of the European Union.
Article 4
This Decision shall enter into force on the day of its adoption.
Done at Luxembourg, 25 June 2026.
For the Council
The President
M. PANAYIOTOU
(1) OJ L 332, 19.12.2003, p. 41, ELI: http://data.europa.eu/eli/dec/2003/885/oj.
(2) OJ L 332, 19.12.2003, p. 42, ELI: http://data.europa.eu/eli/agree_internation/2003/885/oj.
(3) Decision No 1/2013 of the EU-Monaco Joint Committee established under the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco of 12 July 2013 amending the Annex to the Agreement (OJ L 279, 19.10.2013, p. 73, ELI: http://data.europa.eu/eli/dec/2013/513/oj).
DRAFT
DECISION No …/… OF THE EU-MONACO JOINT COMMITTEE ESTABLISHED BY THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE PRINCIPALITY OF MONACO ON THE APPLICATION OF CERTAIN COMMUNITY ACTS ON THE TERRITORY OF THE PRINCIPALITY OF MONACO
of …
amending the Annex to that Agreement
THE JOINT COMMITTEE,
Having regard to the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco (1) (the ‘Agreement’), and in particular Article 1(1) thereof,
Whereas:
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(1) |
The Annex to the Agreement was last amended by Decision No 1/2013 of the EU-Monaco Joint Committee (2) established by the Agreement (the ‘Joint Committee’). Since the adoption of that Decision, the Union has undertaken a reform of Union legislation concerning health products, including a fundamental revision of the rules on medical devices and in vitro diagnostic medical devices, in order to establish a robust regulatory framework to ensure a high level of safety and health protection. |
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(2) |
A decision of the Joint Committee (the ‘Joint Committee Decision’) is therefore necessary to amend the Annex to the Agreement to include the new Union acts concerning health products, including medical devices and in vitro diagnostic medical devices. |
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(3) |
The Joint Committee Decision should also address certain difficulties encountered in the conduct of joint inspections by the Monegasque and French authorities of laboratories and production facilities established in the Principality of Monaco. |
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(4) |
The Joint Committee Decision should not extend the scope of the Agreement nor should it create any additional rights beyond those arising under the Agreement. |
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(5) |
It is recalled that, pursuant to Article 1(2) of the Agreement, acts of the European Commission adopted in application of the acts listed in the Annex to the Agreement apply on the territory of the Principality of Monaco without the need for a decision of the Joint Committee, |
HAS ADOPTED THIS DECISION:
Article 1
The text set out in the Annex to the Agreement is replaced by the text set out in the Annex to this Decision.
Article 2
This Decision shall enter into force on the day of its adoption.
Done at …, …
For the Joint Committee
The Chair
Head of the delegation of …
The Secretaries
(1) OJ L 332, 19.12.2003, p. 42, ELI: http://data.europa.eu/eli/agree_internation/2003/885/oj.
(2) OJ L 279, 19.10.2013, p. 73, ELI: http://data.europa.eu/eli/dec/2013/513/oj.
ANNEX
‘ANNEX
I. MEDICINES
ACTS REFERRED TO
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1. |
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), as amended by:
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2. |
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1), as amended by:
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3. |
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). |
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4. |
Regulation (EU) 2022/839 of the European Parliament and of the Council of 30 May 2022 laying down transitional rules for the packaging and labelling of veterinary medicinal products authorised or registered in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 (OJ L 148, 31.5.2022, p. 6). |
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5. |
Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1), as amended by:
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6. |
Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95 (OJ L, 2024/568, 14.2.2024, ELI: http://data.europa.eu/eli/reg/2024/568/oj). |
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7. |
Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p. 7), as amended by:
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8. |
Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1), as amended by:
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9. |
Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009, p. 10). |
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10. |
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121), as amended by:
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11. |
Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10), as amended by:
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12. |
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1), as amended by:
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13. |
Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, p. 6). |
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14. |
Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (OJ L 329, 16.12.2005, p. 4). |
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15. |
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13). |
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16. |
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44), as amended by:
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17. |
Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ L 50, 20.2.2004, p. 28), as amended by:
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18. |
Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L 238, 16.9.2017, p. 44). |
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19. |
Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines (OJ L 135, 3.6.2003, p. 5), as amended by:
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20. |
Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1), as amended by:
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21. |
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70). |
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22. |
Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8). |
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23. |
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), as amended by:
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24. |
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30) (only as regards the collection and testing of blood and blood components used as starting materials for manufacturing medicinal products), as amended by:
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25. |
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48) (only as regards the procurement, donation, coding and testing of tissue and cells, as well as the coding of donations and packaging thereof, used as starting materials for advanced therapy medicinal products as referred to in Regulation (EC) No 1394/2007 of the European Parliament and of the Council), as amended by:
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26. |
Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (OJ L, 2024/1938, 17.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1938/oj) (only as regards registration of substances of human origin (SoHO) from donors, history reviews of SoHO donors and medical examinations, testing of SoHO donors or of persons from whom SoHO are collected for autologous or within-relationship use, and collection, in the case of SoHO collected for the purposes of manufacturing medical devices, regulated by Regulation (EU) 2017/745, medicinal products, regulated by Directive 2001/83/EC, advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, or investigational medicinal products, regulated by Regulation (EU) No 536/2014, and as regards storage, distribution, import and export, where carried out on SoHO up to and including their distribution to a manufacturer regulated by other Union legislation). |
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27. |
Commission Regulation (EU) 2017/880 of 23 May 2017 laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 135, 24.5.2017, p. 1). |
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28. |
Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (OJ L 132, 30.5.2018, p. 5), as amended by:
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29. |
Commission Regulation (EU) 2019/1871 of 7 November 2019 on reference points for action for non-allowed pharmacologically active substances present in food of animal origin and repealing Decision 2005/34/EC (OJ L 289, 8.11.2019, p. 41), as amended by:
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30. |
Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93 (OJ L 55, 11.3.1995, p. 5). |
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31. |
Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93 (OJ L 286, 8.11.1996, p. 6). |
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32. |
Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts “similar medicinal product” and “clinical superiority” (OJ L 103, 28.4.2000, p. 5), as amended by:
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33. |
Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae (OJ L 367, 22.12.2006, p. 33), as amended by:
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34. |
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), as amended by:
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35. |
Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (OJ L 328, 6.12.2008, p. 42), as amended by:
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36. |
Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19) (OJ L 231, 17.7.2020, p. 12). |
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37. |
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33), as amended by:
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38. |
Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (OJ L 93, 9.4.2015, p. 56). |
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39. |
Commission Decision 2010/453/EU of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council (OJ L 213, 13.8.2010, p. 48). |
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40. |
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1), as amended by:
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II. COSMETIC PRODUCTS
ACTS REFERRED TO
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1. |
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59), as amended by:
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2. |
First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 383, 31.12.1980, p. 27), as amended by:
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3. |
Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 185, 30.6.1982, p. 1), as amended by:
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4. |
Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products (OJ L 190, 11.7.2013, p. 31). |
III. MEDICAL DEVICES
ACTS REFERRED TO
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1. |
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17). |
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2. |
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). |
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3. |
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1). |
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4. |
Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, p. 17), as amended by:
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5. |
Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p. 43). |
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6. |
Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p. 41). |
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7. |
Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p. 45). |
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8. |
Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3). |
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9. |
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1), as amended by:
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10. |
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176), as amended by:
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11. |
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj). |
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12. |
Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices referred to in Article 34(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council (OJ L, 2025/2371, 27.11.2025, ELI: http://data.europa.eu/eli/dec/2025/2371/oj).’ |
ELI: http://data.europa.eu/eli/dec/2026/1535/oj
ISSN 1977-0677 (electronic edition)