EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

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 4 December 2003[1] facilitates economic activities and trade in medicines for human and veterinary use, cosmetic products and medical devices between the Parties to the Agreement.

The Agreement provides in its Article 1, paragraph 1, that the Joint Committee established by the Agreement shall amend its Annex to ensure that European Union Acts falling within the scope of the Agreement apply on the territory of Monaco.

The Annex to the Agreement has never been updated since its entry into force in 2004. Since then, the European Union has adopted a number of acts that fall within the scope of the Agreement and some acts appearing in the Annex have been repealed.

In addition, it is necessary to include acts falling within the scope of the Agreement but not currently referenced in the Annex, including Directives 2002/98/EC and 2004/23/EC because certain of their provisions apply to the manufacturing of medicinal products.

The present proposal therefore aims to update and revise the Annex so that it includes all EU acts falling within the scope of the Agreement and to remove the acts that have been repealed. In order to establish the position to be taken on behalf of the Union in the Joint Committee, a Council Decision is necessary.

2.           LEGAL ELEMENTS OF THE PROPOSAL

Summary of the proposed action

This is a proposal for a Council Decision on the position to be taken on behalf of the Union within the Joint Committee established by the Agreement, which should be based on the draft Joint Committee Decision in annex.

Legal basis

Article 207 of the Treaty on the Functioning of the European Union in conjunction with Article 218(9) thereof.

Choice of instrument

Article 218(9) of the Treaty on the Functioning of the European Union provides that a Council Decision establishes the position to be adopted on behalf of the European Union in a body set up by an agreement, when that body is called upon to adopt decisions having legal effects.

Proportionality

The proposal is in line with the principle of proportionality because its effects are strictly limited to what is necessary to update the Annex to the Agreement to reflect the state of EU legislation in the areas falling within its scope.

2013/0116 (NLE)

Amended proposal for a

COUNCIL DECISION

on the position to be adopted, on behalf of the European Union, in 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

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207 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[2], and in particular Article 3(2) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(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 of 4 December 2003[3] ('the Agreement') entered into force on 1 May 2004.

(2)       The Agreement provides in its Article 1(1) paragraph 1, that the Joint Committee established by the Agreement is to shall amend its Annex to ensure that Union Acts falling within the scope of the Agreement apply on the territory of Monaco.

(3)       Since the entry into force of the Agreement, the European Union has adopted a number of acts that fall within its scope and some acts appearing in the Annex have been repealed. It is therefore necessary to update the Annex to include the new acts and to remove the acts that have been repealed. In addition, it is necessary to include acts falling within the scope of the Agreement but not currently referenced in the Annex, including Directives 2002/98/EC and 2004/23/EC because certain of their provisions apply to the manufacturing of medicinal products.

(5)       The position of the Union in the Joint Committee should be based on the attached draft Decision.

Council Decision 2003/885/EC of 17 November 2003 on the conclusion of the Agreement on the application of certain Community Acts on the territory of the Principality of Monaco, notably its article 3, paragraph 1, provides that the European Union shall be represented by the Commission on the Joint Committee,

(6)       Council Decision 2003/885/EC of 17 November 2003, notably its article 3, paragraph 2, provides that the position to be taken by the European Union in the Joint Committee shall be determined by the Council on a proposal from the Commission; the Council shall act by the same voting rule as that applicable for the adoption of the Union act concerned,

HAS ADOPTED THIS DECISION:

Article 1

The position to be taken by the European Union within the Joint Committee set up 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 4 December 2003 shall be based on the draft Decision of the Joint Committee attached to this Decision.

Technical modificationsMinor changes to the draft Decision may be agreed to by the representatives of the Union in the Joint Committee without further decision of the Council.

Article 2

The Decision of the Joint Committee shall be published in the Official Journal of the European Union.

Article 3

This Decision shall enter into force on the day of its adoption.

This Decision is addressed to the Member States in accordance with the Treaties.

Done at Brussels,

                                                                       For the Council

                                                                       The President

Draft

DECISION No. … OF THE EU-MONACO JOINT COMMITTEE

of…

Aamending the Annex to the 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, signed in Brussels of 4 December 2003[4], hereinafter referred to as 'the Agreement', and in particular Article 1(1) paragraph 1 thereof,

Whereas:

(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 of 4 December 2003[5] entered into force on 1 May 2004,

(2) The Agreement provides in its Article 1, paragraph 1, that the Joint Committee established by the Agreement shall amend its Annex to ensure that European Union acts falling within the scope of the Agreement apply on the territory of Monaco,

(1)          Since the entry into force of the Agreement on 1 May 2004, the European Union has adopted a number of acts that fall within its scope and some acts appearing in the Annex have been repealed. A Decision of the Joint Committee is therefore necessary to update the Annex to include the new acts and to remove the acts that have been repealed,

(2)          It is recalled that acts of the European Commission adopted in application of the acts listed in the Annex to the Agreement are applicable on the territory of Monaco without the need for a Joint Committee Decision, as provided for by Article 1(2) paragraph 2 of the Agreement,

HAS ADOPTED THIS DECISION:

Article 1

The Annex 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 of 4 December 2003 is hereby 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.

Date:

                                                                        By the Joint Committee

                                                                        The Chairman

                                                                       

"ANNEX

To Decision No. … of the 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 4 December 2003

I. MEDICINAL PRODUCTS

ACTS REFERRED TO

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

– Amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 as regards pharmacovigilance (OJ L 299, 27.10.2012, p. 1–4)

– Amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products(Official Journal L174, 1.7.2011, p. 74-87)

– Amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. (Official Journal L 348, 31.12.2010, p. 74 - 99).

– Amended by Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (Official Journal L 242 15.9.2009, p. 3 - 12) .

– Amended by Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. (Official Journal L 168, 30.6.2009, p. 33 - 34).

– Amended by Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission (Official Journal L 81, 20.3.2008, p. 51 - 52 ).

– Amended by 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 (Official Journal L 324, 10.12.2007, p. 121-137)

– Amended by 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 (Official Journal L 378, 27.12.2006, p. 1-19).

– Amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L 136, 30.4.2004, p. 34-57).

– Amended by Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L 136, 30.4.2004, p. 85-90).

– Amended by Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Official Journal L 159, 27.6.2003, p. 46-94)

– Amended by 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 (Official Journal L 33, 8.2.2003, p 30-40)

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

– Amended by Regulation (EU) no 1027/2012 of the European Parliament and of the Council of 25 October 2012 as regards pharmacovigilance. (OJ L 316, 14.11.2012, p. 38-40)

– Amended by Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products Text with EEA relevance (OJ L 348, 31.12.2010, p. 1–16)

– Amended by Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 152, 16.6.2009 p. 11 - 22).

– Amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny - Part Two (Official Journal L 87, 231.3.2009, p. 109 - 154, especially p. 116 - 118, Annex 2.9, where Regulation (EC) No 726/2004 is adapted).

– Amended by 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. ( Official Journal L 324 10.12.2007, p. 121-137)

– Amended by 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. (Official Journal L 378, 27.12.2006, p. 1–19)

3. 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

– Amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four (Official Journal L 188, 18.7.2009, p. 14-92)

– Amended by Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (Official Journal L 168, 30.6.2009, p. 33-34)

– Amended by Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council ( Official Journal L 152, 16.6.2009, p. 11-22)

– Amended by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Official Journal L 44, 14.2.2009, p.10-61)

– Amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (Official Journal L 136, 30.4.2004, p. 58-84)

4. Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products

– Amended by Council Regulation (EC) No 2743/98 of 14 December 1998

– Amended by Commission Regulation (EC) No 494/2003 of 18 March 2003

– Amended by Council Regulation (EC) No 1905/2005 of 14 November 2005

– Amended by Commission Regulation (EC) No 312/2008 of 3 April 2008

– Amended by Commission Regulation (EC) No 249/2009 of 23 March 2009

– Amended by Commission Regulation (EU) No 261/2010 of 25 March 2010

– Amended by Commission Regulation (EU) No 301/2011 of 28 March 2011

– Amended by Commission Regulation (EU) No 273/2012 of 27 March 2012

– Amended by Commission Regulation (EU) No 220/2013 of 13 March 2013

5. Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 152, 16/6/2009 p. 11 - 22).

6. Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (Official Journal L 194, 25/7/2009 p. 7 - 10).

7. Commission Regulation (EU) N° 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin

– Amended by Commission Regulation (EU) No 758/2010 of 24 August 2010

– Amended by Commission Regulation (EU) No 759/2010 of 24 August 2010

– Amended by Commission Regulation (EU) No 761/2010 of 25 August 2010

– Amended by Commission Regulation (EU) No 890/2010 of 8 October 2010

– Amended by Commission Regulation (EU) No 914/2010 of 12 October 2010

– Amended by Commission Regulation (EU) No 362/2011 of 13 April 2011

– Amended by Commission Regulation (EU) No 363/2011 of 13 April 2011

– Amended by Commission Implementing Regulation (EU) No 84/2012 of 1 February 2012

– Amended by Commission Implementing Regulation (EU) No 85/2012 of 1 February 2012

– Amended by Commission Implementing Regulation (EU) No 86/2012 of 1 February 2012

– Amended by Commission Implementing Regulation (EU) No 107/2012 of 8 February 2012

– Amended by Commission Implementing Regulation (EU) No 122/2012 of 13 February 2012

– Amended by Commission Implementing Regulation (EU) No 123/2012 of 13 February 2012

– Amended by Commission Implementing Regulation (EU) No 201/2012 of 8 March 2012

– Amended by Commission Implementing Regulation (EU) No 202/2012 of 8 March 2012

– Amended by Commission Implementing Regulation (EU) No 221/2012 of 14 March 2012

– Amended by Commission Implementing Regulation (EU) No 222/2012 of 14 March 2012

– Amended by Commission Implementing Regulation (EU) No 436/2012 of 23 May 2012

– Amended by Commission Implementing Regulation (EU) No 466/2012 of 1 June 2012

– Amended by Commission Implementing Regulation (EU) No 1161/2012 of 7 December 2012

– Amended by Commission Implementing Regulation (EU) No 1186/2012 of 11 December 2012

– Amended by Commission Implementing Regulation (EU) No 1191/2012 of 12 December 2012

– Amended by Commission Implementing Regulation (EU) No 59/2013 of 23 January 2013

– Amended by Commission Implementing Regulation (EU) No 115/2013 of 8 February 2013

– Amended by Commission Implementing Regulation (EU) No 116/2013 of 8 February 2013

– Amended by Commission Implementing Regulation (EU) No 394/2013 of 29 April 2013

– Amended by Commission Implementing Regulation (EU) No 406/2013 of 2 May 2013

8. Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Regulation (EC) No 658/2007 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 150, 9.6.2012, p. 68–70)

9. 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

– Amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Official Journal L 209, 4.8.2012, p. 4 - 14).

10. Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (Official Journal L 65, 8/3/2013, p. 17–18)

11. 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 (Official Journal, L 276, 20.10.2010, p. 33–79)

12. 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 (Official Journal L 152, 16.6.2009, p. 1–10)

13. 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 (Official Journal L 109, 30.4.2009, p. 10–13)

14. 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 (Official Journal L 324, 10.12.2007, p. 121–137)

– Amended by Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010

15. 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 (Official Journal L 155, 15.6.2007, p. 10–19)

16. 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 (Official Journal L 378, 27.12.2006, p. 1–19)

– Amended by Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009

– Amended by Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006

17. 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 (Official Journal L 92, 30.3.2006, p. 6–9)

18. 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 (Official Journal L 329, 16.12.2005, p. 4–7)

19. 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(Official Journal L 91, 9.4.2005, p. 13–19)

20. 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 ( Official Journal L 50, 20.2.2004, p. 44–59)

– Amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009

21. 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) (Official Journal L 50, 20.2.2004, p. 28–43)

– Amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009

22. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Official Journal L 262, 14.10.2003, p. 22–26)

23. Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines ( Official Journal L 135, 3.6.2003, p. 5–11)

– Amended by Commission Regulation (EC) No 1876/2004 of 28 October 2004

– Amended by Commission Regulation (EC) No 1662/2005 of 11 October 2005

24. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (Official Journal L 18, 22.1.2000)

– Amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009

25. Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (Official Journal L 228 du 17.8.1991, p. 70–73) Directive 91/412/CEE de la Commission, du 23 juillet 1991, établissant les principes et lignes directrices de bonnes pratiques de fabrication pour les médicaments vétérinaires (Official Journal L 228 du 17.8.1991, p. 70–73)

26. 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. (Official Journal L 40 of 11.2.1989, p. 8–11) Directive 89/105/CEE du Conseil du 21 décembre 1988 concernant la transparence des mesures régissant la fixation des prix des médicaments à usage humain et leur inclusion dans le champ d'application des systèmes d'assurance-maladie (Official Journal L 40 of 11.02.1989, p. 8–11)

27. 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 (Official Journal L 121 of 1.5.2001, p. 34-44)

– - Amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 (OJ L 378, 27.12.2006, p. 1);

– - Amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14).

28. 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 of 8.2.2003, p. 30) (only as regards insofar as it is applicable to the collection and testing of blood and blood components used as starting materials for manufacturing medicinal products).

29. 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, resting, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p.48) (only as regards insofar as it is applicable tothe 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)

II. COSMETICS

ACTS REFERRED TO

1. Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, 27.9.1976, p. 169), as amended by:

– Council Directive 79/661/EEC of 24 July 1979 (OJ L 192, 31.7.1979, p.35)

– Commission Directive 82/147/EEC of 11 February 1982 (OJ L 63, 6.3.1982, p. 26)

– Council Directive 82/368/EEC of 17 May 1982 (OJ L 167, 15.6.1982, p. 1)

– Commission Directive 83/191/EEC of 30 March 1983 (OJ L 109, 26.4.1983, p.25)

– Commission Directive 83/341/EEC of 29 June 1983 (OJ L 188, 13.7.1983, p. 15)

– Commission Directive 83/496/EEC of 22 September 1983 (OJ L 275, 8.10.1983, p. 20)

– Council Directive 83/574/EEC of 26 October 1983 (OJ L 332, 28.11.1983, p. 38)

– Commission Directive 84/415/EEC of 18 July 1984 (OJ L 228, 25.8.1984, p. 31)

– Commission Directive 85/391/EEC of 16 July 1985 (OJ L 224, 22.8.1985, p.40)

– Commission Directive 86/179/EEC of 28 February 1986 (OJ L 138, 24.5.1986, p. 40)

– Commission Directive 86/199/EEC of 26 March 1986 (OJ L 149, 3.6.1986, p. 38)

– Commission Directive 87/137/EEC of 2 February 1987 (OJ L 56, 26.2.1987, p. 20)

– Commission Directive 88/233/EEC of 2 March 1988 (OJ L 105, 26.4.1988, p.11)

– Council Directive 88/667/EEC of 21 December 1988 (OJ L 382, 31.12.1988, p.46)

– Commission Directive 89/174/EEC of 21 February 1989 (OJ L 64, 8.3.1989, p. 10)

– Council Directive 89/679/EEC of 21 December 1989 (OJ L 398, 30.12.1989, p.25)

– Commission Directive 90/121/EEC of 20 February 1990 (OJ L 71, 17.3.1990, p. 40)

– Commission Directive 91/184/EEC of 12 March 1991 (OJ L 91, 12.4.1991, p. 59)

– Commission Directive 92/8/EEC of 18 February 1992 (OJ L 70, 17.3.1992, p. 23)

– Commission Directive 92/86/EEC of 21 October 1992 (OJ L 325, 11.11.1992, p. 18)

– Council Directive 93/35/EEC of 14 June 1993 (OJ L 151, 23.6.1993, p. 32)

– Commission Directive 93/47/EEC of 22 June 1993 (OJ L 203, 13.8.1993, p. 24)

– Commission Directive 94/32/EC of 29 June 1994 (OJ L 181, 15.7.1994, p. 31)

– Commission Directive 95/34/EC of 10 July 1995 (OJ L 167, 18.7.1995, p. 19)

– Commission Directive 96/41/EC of 25 June 1996 (OJ L 1988.8.1996, p. 36)

– Commission Directive 97/1/EC of 10 January 1997 (OJ L 16, 18.1.1997, p. 85)

– Commission Directive 97/18/EC of 17 April l997 (OJ L 114, 1.5.1997, p. 43)

– Commission Directive 97/45/EC of 14 July 1997 (OJ L 196, 24.7.1997, p. 77)

– Commission Directive 98/16/EC of 5 March 1998 (OJ L 77, 14.3.1998, p. 44)

– Commission Directive 98/62/EC of 3 September 1998 (OJ L 253, 15.9.1998, p. 20)

– Commission Directive 2000/6/EC of 29 February 2000 (OJ L 56, 1.3.2000, p. 42)

– Commission Directive 2000/11/EC of 10 March 2000 (OJ L 65, 14.3.2000, p. 22)

– Commission Directive 2000/41/EC of 19 June 2000 (OJ L 145, 20.6.2000, p. 25)

– Commission Directive 2002/34/EC of 15 April 2002 (OJ L 102, 18.4.2002, p. 19)

– Commission Directive 2003/1/EC of 6 January 2003 (L 5, 10.1.2003, p. 14)

– Commission Directive 2003/16/EC of 19 February 2003 (OJ L 46, 20.2.2003, p. 24)

– Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 (OJ L 66, 11.3.2003, p. 26)

– Commission Directive 2003/80/EC of 5 September 2003 (OJ L 224, 6.9.2003, p. 27)

– Commission Directive 2003/83/EC of 24 September 2003 (OJ L 238, 25.9.2003, p. 23)

– Commission Directive 2004/87/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 4)

– Commission Directive 2004/88/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 5)

– Commission Directive 2004/94/EC of 15 September 2004 (OJ L 294, 17.9.2004, p. 28)

– Commission Directive 2004/93/EC of 21 September 2004 (OJ L 300, 25.9.2004, p. 13)

– Commission Directive 2005/9/EC of 28 January 2005 (OJ L 27, 29.1.2005, p. 46)

– Commission Directive 2005/42/EC of 20 June 2005 (OJ L 158, 21.6.2005, p. 17)

– Commission Directive 2005/52/EC of 9 September 2005 (OJ L 234, 10.9.2005, p. 9)

– Commission Directive 2005/80/EC of 21 November 2005 (OJ L 303, 22.11.2005, p. 32)

– Commission Directive 2006/65/EC of 19 July 2006 (OJ L 198, 20.7.2006, p. 11)

– Commission Directive 2006/78/EC of 29 September 2006 (OJ L 271, 30.9.2006, p. 56)

– Commission Directive 2007/1/EC of 29 January 2007 (OJ L 25, 1.2.2007, p. 9)

– Commission Directive 2007/17/EC of 22 March 2007 (OJ L 82, 23.3.2007, p. 27)

– Commission Directive 2007/22/EC of 17 April 2007 (OJ L 101, 18.4.2007, p. 11)

– Commission Directive 2007/53/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 19)

– Commission Directive 2007/54/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 21)

– Commission Directive 2007/67/EC of 22 November 2007 (OJ L 305, 23.11.2007, p. 22)

– Commission Directive 2008/14/EC of 15 February 2008 (OJ L 42, 16.2.2008, p. 43)

– Commission Directive 2008/42/EC of 3 April 2008 (OJ L 93, 4.4.2008, p. 13)

– Commission Directive 2008/88/EC of 23 September 2008 (OJ L 256, 24.9.2008, p. 12)

– Commission Directive 2008/123/EC of 18 December 2008 (OJ L 340, 19.12.2008, p. 71)

– Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008 (L 345, 23.12.2008, p. 68)

– Commission Directive 2009/6/EC of 4 February 2009 (L 36, 5.2.2009, p. 15)

– Commission Directive 2009/36/EC of 16 April 2009 (OJ L 98, 17.4.2009, p. 31)

– Commission Directive 2009/129/EC of 9 October 2009 (L 267, 10.10.2009, p. 18)

– Commission Directive 2009/130/EC of 12 October 2009 (L 268, 13.10.2009, p. 5)

– Commission Directive 2009/134/EC of 28 October 2009 (L 282, 29.10.2009, p. 15)

– Commission Directive 2009/159/EU of 16 December 2009 (OJ L 336, 18.12.2009, p. 29)

– Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 (OJ L 342, 22.12.2009, p. 59)

– Commission Directive 2009/164/EU of 22 December 2009 (OJ L 344, 23.12.2009, p. 41)

– Commission Directive 2010/3/EU of 1 February 2010 (OJ L 29, 2.2.2010, p. 5)

– Commission Directive 2010/4/EU of 8 February 2010 (OJ L 36, 9.2.2010, p. 21)

– Commission Directive 2011/59/EU of 13 May 2011 (OJ L 125, 14.5.2011, p. 17)

– Council Directive 2011/84/EU of 20 September 2011 (OJ L 283, 29.10.2011, p. 36)

– Commission Implementing Directive 2012/21/EU of 2 August 2012 (OJ L 208, 3.8.2012, p. 8)

Directive 76/768/EEC will be repealed with effect from 11 July 2013 and will be replaced by: Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.

2. 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:

– Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 114, 25.4.2013, p. 1)

– Commission Regulation (EU) No 483/2013 of 24 May 2013 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 139, 25.5.2013, p.8)

3. 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:

– Commission Directive 87/143/EEC of 10 February 1987 (OJ L 57, 27.2.1987, p. 56).

4. 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:

– Commission Directive 90/207/EEC of 4 April 1990 (OJ L 108, 28.4.1990, p. 92).

5. Commission Directive 83/514/EEC of 27 September 1983 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 291, 24.10.1983, p. 9).

6. Commission Directive 85/490/EEC of 11 October 1985 on the approximation of laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 295, 7.11.1985, p. 30).

7. Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking the composition of cosmetic products (OJ L 231, 14.9.1993, p. 34).

8. Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products (OJ L 140, 23.6.1995, p. 26).

– Amended by Commission Directive 2006/81/EC of 23 October 2006 (OJ L 362, 20.12.2006, p. 92)

– Amended by Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded (OJ L 236, 23.9.2003, p.33)

Commission Directive 95/17/EC This dDirective will be repealed with effect from 11 July 2013.

9. Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 178, 28.7.1995, p. 20).

10. Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 213, 22.8.1996, p. 8).

11. Commission Decision of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products ( OJ L 132, 1.6.1996, p. 1––)

– Amended by Commission Decision 2006/257/EC, (OJ L 97, 5.4.2006, p. 1)

III. MEDICAL DEVICES

ACTS REFERRED TO

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), as amended by:

– Amended by Council Directive 93/42/EEC of 14 June 1993 (OJ L 169, 12.7.1993, p. 1).

– Amended by Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p.1).

– Amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1).

– Amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (OJ L 247, 21.09.2007, p. 21).

2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).

– Amended by 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).

– Amended by Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma (OJ L 313, 13.12.2000, p. 22).

– Amended by Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices (OJ L 6, 10.1.2002, p. 50).

– Amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p.1).

– Amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p.1).

– Amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 (OJ L 247, 21.9.2007, p.21).

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).

– Amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1).

– Amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.07.2009, p.14).

– Amended by Commission Directive 2011/100/EU of 20 December 2011 (OJ L 341, 22.12.2011, p. 50).

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)

– Amended by Commission Decision 2009/108/EC of 3 February 2009 (OJ L 39, 10.02.2009, p.34).

– Amended by Commission Decision 2009/886/EC of 27 November 2009 (OJ L 318, 4.12.2009, p.25).

– Amended by Commission Decision 2011/869/EU of 20 December 2011 (OJ L 341, 22.12.2011, p.63).

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).

6. Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p.18).

7. 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, 12.08.2005, p.41).

8. Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L102, 23.04.2010, p.45).

9. Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L72, 10.03.2012, p.28).

10. 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 212, 9.08.2012, p.3)."

[1]               OJ L 332, 19.12.2003, pp.42-43.

[2]               OJ L 332, 19.12.2003, p.41.

[3]               OJ L 332, 19.12.2003, pp.42-43.

[4]               OJ L 332, 19.12.2003, pp.42-43.

[5]               OJ L 332, 19.12.2003, pp.42-43.