Proposal for a Council Decision on the conclusion of the Agreement on the application of certain Community acts on the territory of the Principality of Monaco /* COM/2003/0290 final - ACC 2003/0102 */





Proposal for a COUNCIL DECISION on the conclusion of the Agreement on the application of certain Community acts on the territory of the Principality of Monaco (presented by the Commission) EXPLANATORY MEMORANDUM 1. Introduction The Principality of Monaco is not a member of the European Union. EU legislation does not normally apply to Monaco, nor is it consulted on changes to that legislation. However, it has been part of EU customs territory and applies EU rules on the free movement of goods. Monaco has a special relationship with France, which defends its independence, sovereignty and territorial integrity. In return, Monaco's government exercises its rights in a manner consistent with France's interests. 2. Medicinal products, cosmetic products and medical devices The manufacture and placing on the market of medicinal products, cosmetic products and medical devices in the EU is regulated by a highly technical set of harmonised Community laws which has, as its main purpose, the protection of public health. The application and administration of these legal instruments is very resource-intensive and requires the existence of highly specialised competent national administrations in Member States. As it is, in practice, neither possible nor proportionate for a very small State like Monaco to create such administrative structures, the task of applying and supervising administrative law in the field of medicinal products, cosmetic products and medical devices in Monaco has traditionally been carried out by - or in close cooperation with - the French competent authorities. There has, however, previously been no clear legal basis to provide legal certainty that the relevant provisions of Community law in the abovementioned fields are consistently applied and appropriately controlled on the territory of Monaco. This legal certainty is needed to provide manufacturers established in Monaco access to the EU market and to give to EU authorities the confirmation that Community law is applied and supervised in a stringent way on the territory of Monaco. 3. Purpose of the agreement On the Commission's recommendation the Council, on 20 December 2000, adopted negotiating directives for a bilateral agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of Monaco. The Commission has now negotiated the annexed agreement, which provides for Community acts on medicinal products for human and veterinary use, cosmetic products and medical devices to apply mutatis mutandis to the territory of Monaco. Monaco undertakes to transpose these acts into its legislation. As Monaco does not possess the infrastructure (authorities, laboratories, etc.) required for implementation, the French authorities will be responsible for this. If approved by the competent French authorities, products originating in Monaco will be eligible to be placed on the market, according to the applicable rules. A joint committee will be established, made up of representatives of the parties; it will be responsible for the management and proper application of the agreement. 4. Statements When the attached Council decision is adopted the Commission will make the following statement: "The Commission will invite the Member States to attend the meetings of the joint committee as observers and will call on them for expert advice where appropriate." The Commission will propose that the Council make the following statement when it adopts the attached decision: "The President of the Council will authorise the signing of this Agreement when the legislation included in the Annex to the Agreement is transposed into Monegasque law." 5. Conclusion The Commission recommends that the Council adopt the attached proposal for a decision on the conclusion 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. 2003/0102 (ACC) Proposal for a COUNCIL DECISION on the conclusion of the Agreement 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 establishing the European Community and in particular Article 133 in conjunction with Article 300, Having regard to the proposal from the Commission [1], [1] OJ C [...], [...], p. [...]. Whereas: (1) The Commission has negotiated on behalf of the Community an Agreement with the Principality of Monaco; (2) This Agreement on the application of certain Community acts on the territory of the Principality of Monaco, between the European Community and the Principality of Monaco, attached to this Decision, should be approved; (3) Certain tasks for implementation have been attributed to the Joint Committee established under the Agreement, and in particular the power to amend certain aspects of the annexes thereto; (4) The appropriate internal procedures should be established to ensure the proper functioning of the Agreement, and whereas it is necessary to empower the Commission to agree to certain amendments to the Agreement and to take certain decisions for its implementation; HAS DECIDED AS FOLLOWS: Article 1 The Agreement on the application of certain Community acts on the territory of the Principality of Monaco between the European Community and the Principality of Monaco is hereby approved on behalf of the European Community. The text of the Agreement is attached to this Decision. Article 2 The President of the Council is hereby authorised to designate the person empowered to sign, on behalf of the European Community the Agreement referred to in Article 1 in order to express the consent of the Community to be bound thereby. On the occasion of signature, the President of the Council or his designate shall, on behalf of the Community, notify to Monaco the approval provided for in Article 6 of the Agreement. Article 3 The Community shall be represented on the Joint Committee set up under Article 3 of the Agreement, referred to hereafter as the « Committee », by the Commission. The position to be taken by the Community in the Committee shall be determined by the Council on a proposal by the Commission by the same majority as that required for the adoption of the act concerned. In derogation of paragraph 2, the Commission shall adopt the Community's position on decisions concerning integration of acts into the Annex of the agreement, when the acts in question amend acts already integrated. Done at Brussels, For the Council The President 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 European Community, hereinafter referred to as "the Community", and the Principality of Monaco, hereinafter referred to as "Monaco", (1) Considering the close relations between the Community and Monaco, (2) Considering the special relationship between Monaco and the French Republic, (3) Desirous to conclude an agreement facilitating certain economic activities and trade between them, (4) Conscious of the need to create and maintain a common legislative framework for the activities in question, have decided to conclude the following agreement: Article 1 Aim 1 The Parties agree that the Community acts covering medicines for human and veterinary use, cosmetic products and medical devices listed in the Annex shall also apply on the territory of Monaco. The Joint Committee referred to in Article 3 will amend the Annex to achieve this aim, in particular adding any new Community act in these fields. 2. Acts adopted by the Commission of the European Communities in application of the acts referred to in paragraph 1 shall apply on the territory of Monaco without the need for a decision of the Joint Committee. When applying the rules governing matters covered by this Agreement, such rules must be interpreted in accordance with the case-law of the Court of Justice of the European Communities. Article 2 Implementation 1. Monaco shall take all proper measures to ensure the application of the acts and decisions referred to in Article 1. 2. To ensure uniform application and interpretation of the provisions referred to in Article 1, taking particular account of the relevant case-law of the Court of Justice, Monaco's authorities may have recourse to their special administrative relationship with the French Republic. 3. Any problem concerning the application of this Agreement will be brought to the attention of the Joint Committee. 4. Each year Monaco shall report to the Joint Committee on the manner in which its administrative authorities and courts have applied and interpreted the provisions referred to in Article 1, as interpreted, where relevant, by the Court of Justice. 5. If, within three months of being notified of a substantial divergence between the Court of Justice's case-law and that of Monaco's courts or between the Member States' authorities and Monaco's in their application of the provisions referred to in Article 1, the Joint Committee is unable to ensure uniform application or interpretation, the procedure provided for in Article 4 shall be initiated. Article 3 Joint Committee 1. A Joint Committee composed of representatives of the Parties is hereby established. It shall be responsible for the management and proper application of the Agreement. It will formulate recommendations for that purpose. It shall take decisions in the circumstances provided for in Article 1. The Joint Committee shall reach its decisions by mutual agreement. 2. The Joint Committee shall be chaired by each of the Parties in turn according to arrangements to be determined in its rules of procedure. 3. The Joint Committee shall meet as and when necessary. Either Party may request the convening of a meeting. 4. The Joint Committee shall establish its rules of procedure. Article 4 Dispute settlement 1. In the event of a dispute concerning the application of this Agreement or if a Community act is not added to the Annex within six months of its adoption in accordance with Article 1(1), the matter shall be placed on the agenda of the Joint Committee. 2. The Joint Committee shall have ninety days to settle the dispute, counting from the date of adoption of the agenda on which the dispute has been placed. 3. Should the dispute not be settled by the Joint Committee in the period laid down in paragraph 2, this Agreement shall cease to apply six months after that period expires. Article 5 Territorial scope This Agreement shall apply, on the one hand, to the territories to which the Treaty establishing the European Community applies and under the conditions laid down in that Treaty and, on the other hand, to the territory of Monaco. Article 6 Entry into force and duration 1. This Agreement will be ratified or approved by the Parties according to their own procedures. It will enter into force on the first day of the second month following the last notification between the Parties of the completion of the procedures referred to in the previous sentence. 2. This Agreement is concluded for an indefinite period. Either Party may denounce it with six months' notice. Done at Brussels, [...], in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic, in a single copy to be deposited in the archives of the General Secretariat of the Council of the European Union. For the Council The President ANNEX I. MEDICINAL PRODUCTS ACTS REFERRED TO 1. 378 L 0025: Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products (OJ L 11, 14.1.1978, p. 18), as amended by: - 179 H: Acts concerning the Conditions of Accession and the Adjustments to the Treaties - Accession to the European Communities of the Hellenic Republic (OJ L 291, 19.11.1979, p. 108), - 381 L 0464: Council Directive 81/464/EEC of 24 June 1981 (OJ L 183, 4.7.1981, p. 33), - 185 I: Act concerning the Conditions of Accession and Adjustment to the Treaties - Accession to the European Communities of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985), - 194 N: Act concerning the conditions of accession of the Kingdom of Norway, the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded (OJ C 241, 29.8.1994, p. 21), 2. 386 L 0609: Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (OJ L 358, 18.12.1986, p. 1). 3. 389 L 0105: Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing 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). 4. 390 R 2377: Council Regulation No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1), as amended by: - 392 R 0675: Commission Regulation (EEC) No 675/92 of 18 March 1992 (OJ L 73, 19.3.1992, p. 8), - 392 R 0762: Commission Regulation (EEC) No 762/92 of 27 March 1992 (OJ L 83, 28.3.1992, p.14), - 392 R 3093: Commission Regulation (EEC) No 3093/92 of 27 October 1992 (OJ L 311, 28.10.1992, p. 18), - 393 R 0895: Commission Regulation (EEC) No 895/93 of 16 April 1993 (OJ L 93, 17.4.1993, p. 10), - 393 R 2901: Council Regulation (EEC) No 2901/93 of 18 October 1993 (OJ L 264, 23.10.1993, p. 1), - 393 R 3425: Commission Regulation (EC) No 3425/93 of 14 December 1993 (OJ L 312, 15.12.1993, p. 12), - 393 R 3426: Commission Regulation (EC) No 3426/93 of 14 December 1993 (OJ L 312, 15.12.1993, p. 15), - 394 R 0955: Commission Regulation (EC) No 955/94 of 28 April 1994 (OJ L 108, 29.4.1994, p. 8), - 394 R 1430: Commission Regulation (EC) No 1430/94 of 22 June 1994 (OJ L 156, 23.6.1994, p. 6), - 394 R 2701: Commission Regulation (EC) No 2701/94 of 7 November 1994 (OJ L 287, 8.11.1994, p. 7), - 394 R 2703: Commission Regulation (EC) No 2703/94 of 7 November 1994 (OJ L 287, 8.11.1994, p. 19), - 395 R 1102: Commission Regulation (EC) No 1102/95 of 16 May 1995 (OJ L 110, 10.5.1995, p. 9), - 395 R 1441: Commission Regulation (EC) No 1441/95 of 26 June 1995 (OJ L 143, 27.6.1995, p. 22), - 395 R 1442: Commission Regulation (EC) No 1442/95 of 26 June 1995 (OJ L 143, 27.6.1995, p. 26), - 395 R 1798: Commission Regulation (EC) No 1798/95 of 25 July 1995 (OJ L 174, 26.7.1995, p. 20), - 395 R 2796: Commission Regulation (EC) No 2796/95 of 4 December 1995 (OJ L 290, 5.12.1995, p. 1), - 395 R 2804: Commission Regulation (EC) No 2804/95 of 5 December 1995 (OJ L 291, 6.12.1995, p. 8), - 396 R 0281: Commission Regulation (EC) No 281/96 of 14 February 1996 (OJ L 37, 15.2.1996, p. 9), - 396 R 0282: Commission Regulation (EC) No 282/96 of 14 February 1996 (OJ L 37, 15.2.1996, p. 12), - 396 R 1140: Commission Regulation (EC) No 1140/96 of 25 June 1996 (OJ L 151, 26.6.1996, p. 6), - 396 R 1147: Commission Regulation (EC) No 1147/96 of 25 June 1996 (OJ L 151, 26.6.1996, p. 26), - 396 R 1311: Commission Regulation (EC) No 1311/96 of 8 July 1996 (OJ L 170, 9.7.1996, p. 4), - 396 R 1312: Commission Regulation (EC) No 1312/96 of 8 July 1996 (OJ L 170, 9.7.1996, p. 8), - 396 R 1433: Commission Regulation (EC) No 1433/96 of 23 July 1996 (OJ L 184, 24.7.1996, p. 21), - 396 R 1742: Commission Regulation (EC) No 1742/96 of 6 September 1996 (OJ L 226, 7.9.1996, p. 5), - 396 R 2017: Commission Regulation (EC) No 2017/96 of 22 October 1996 (OJ L 270, 23.10.1996, p. 2), - 396 R 2034: Commission Regulation (EC) No 2034/96 of 24 October 1996 (OJ L 272, 25.10.1996, p. 2), - 397 R 0017: Commission Regulation (EC) No 17/97 of 8 January 1997 (OJ L 5, 9.1.1997, p. 12), - 397 R 0270: Commission Regulation (EC) No 270/97 of 14 February 1997 (OJ L 45, 15.2.1997, p. 8), - 97 R 0434: Council Regulation (EC) No 434/97 of 3 March 1997 (OJ L 67, 7.3.1997, p. 1), - 397 R 0716: Commission Regulation (EC) No 716/97 of 23 April 1997 (OJ L 106, 24.4.1997, p.10), - 397 R 0748: Commission Regulation (EC) No 748/97 of 25 April 1997 (OJ L 110, 26.4.1997, p. 21), - 397 R 0749: Commission Regulation (EC) No 749/97 of 25 April 1997 (OJ L 110, 26.4.1997, p. 24), - 396 R 2010: Commission Regulation (EC) No 2010/96 of 21 October 1996 (OJ L 269, 22.10.1996, p. 5), - 397 R 1836: Commission Regulation (EC) No 1836/97 of 24 September 1997 (OJ L 263, 25.9.1997, p. 6), - 397 R 1837: Commission Regulation (EC) No 1837/97 of 24 September 1997 (OJ L 263, 25.9.1997, p. 9), - 397 R 1838: Commission Regulation (EC) No 1838/97 of 24 September 1997 (OJ L 263, 25.9.1997, p. 14), - 397 R 1850: Commission Regulation (EC) No 1850/97 of 25 September 1997 (OJ L 264, 26.9.1997, p. 12), - 396 R 1798: Commission Regulation (EC) No 1798/96 of 17 September 1996 (OJ L 236, 18.9.1996, p. 23), - 397 R 0211: Commission Regulation (EC) No 211/97 of 4 February 1997 (OJ L 35, 5.2.1997, p. 1), - 398 R 0426: Commission Regulation (EC) No 426/98 of 23 February 1998 (OJ L 53, 24.2.1998, p. 3), - 398 R 0613: Commission Regulation (EC) No 613/98 of 18 March 1998 (OJ L 82, 19.3.1998, p. 14), - 398 R 0121: Commission Regulation (EC) No 121/98 of 16 January 1998 (OJ L 11, 17.1.1998, p.11), - 398 R 1000: Commission Regulation (EC) No 1000/98 of 13 May 1998 (OJ L 142, 14.5.1998, p. 18), - 398 R 1076: Commission Regulation (EC) No 1076/98 of 27 May 1998 (OJ L 154, 28.5.1998, p. 14), - 398 R 1191: Commission Regulation (EC) No 1191/98 of 9 June 1998 (OJ L 165, 10.6.1998, p. 6), - 394 R 3059: Commission Regulation (EC) No 3059/94 of 15 December 1994 (OJ L 323, 16.12.1994, p. 15), - 398 R 1568: Commission Regulation (EC) No 1568/98 of 17 July 1998 (OJ L 205, 22.7.1998, p. 1), as corrected by OJ No L 271, 8.10.1998, p. 42, - 398 R 1569: Commission Regulation (EC) No 1569/98 of 17 July 1998 (OJ L 205, 22.7.1998, p. 7), - 398 R 1570: Commission Regulation (EC) No 1570/98 of 17 July 1998 (OJ L 205, 22.7.1998, p. 10), - 398 R 1916: Commission Regulation (EC) No 1916/98 of 9 September 1998 (OJ L 250, 10.9.1998, p. 8), - 398 R 1917: Commission Regulation (EC) No 1917/98 of 9 September 1998 (OJ L 250, 10.9.1998, p. 13), - 398 R 1958: Commission Regulation (EC) No 1958/98 of 15 September 1998 (OJ L 254, 16.9.1998, p. 7), - 398 R 2560: Commission Regulation (EC) No 2560/98 of 27 November 1998 (OJ L 320, 28.11.1998, p. 28), - 398 R 2686: Commission Regulation (EC) No 2686/98 of 11 December 1998 (OJ L 337, 12.12.1998, p. 20), - 398 R 2692: Commission Regulation (EC) No 2692/98 of 14 December 1998 (OJ L 338, 15.12.1998, p. 5), - 398 R 2728: Commission Regulation (EC) No 2728/98 of 17 December 1998 (OJ L 343, 18.12.1998, p. 8). - 399 R 508: Commission Regulation (EEC) No 3426/1999 of 4 March 1999 (OJ L 60, 9.3.1999, p. 15), - 399 R 0804: Commission Regulation (EEC) No 804/99 of 16 April 1999 (OJ L 102, 17.4.1999, p. 58), - 399 R 0953: Commission Regulation (EC) No 953/99 of 5 May 1999 (OJ L 118, 6.5.1999, p. 23), - 399 R 0954: Commission Regulation (EC) No 954/99 of 5 May 1999 (OJ L 118, 6.5.1999, p. 8), - 399 R 0997: Commission Regulation (EC) No 997/99 of 12 May 1999 (OJ L 122, 125.1999, p. 24), - 399 R 0998: Commission Regulation (EC) No 998/99 of 12 May 1999 (OJ L 122, 12.5.1999, p. 30), - 399 R 1308: Commission Regulation (EEC) No 1308/99 of 15 June 1999 (OJ L 156, 236.1999, p. 1), - 399 R 1931: Commission Regulation (EC) No 1931/99 of 9 September 1999 (OJ L 240, 109.1999, p. 3), - 399 R 1942: Commission Regulation (EEC) No 1942/99 of 11 September 1999 (OJ No L 241, 119.1999, p. 4), - 399 R 1943: Commission Regulation (EEC) No 1943/99 of 11 September 1999 (OJ L 241, 11.9.1999, p. 9), - 399 R 2385: Commission Regulation (EEC) No 2385/99 of 10 November 1999 (OJ L 288, 11.11.1999, p. 14), - 399 R 2393: Commission Regulation (EC) No 2393/99 of 11 November 1999 (OJ L 290, 12.11.1999, p. 5), - 399 R 2593: Commission Regulation (EC) No 2593/99 of 8 December 1999 (OJ L 315, 9.12.1999, p. 26), - 399 R 2728: Commission Regulation (EC) No 2728/99 of 20 December 1999 (OJ L 328, 22.12.1999, p. 23), - 399 R 2757: Commission Regulation (EEC) No 2757/99 of 22 December 1999 (OJ L 331, 23.12.1999, p. 45), - 399 R 2758: Commission Regulation (EEC) No 2758/99 of 22 December 1999 (OJ L 331, 23.12.1999, p. 49), - 32000 R 1286: Commission Regulation (EEC) No 1286/2000 of 19 June 2000 (OJ L 145, 20.6.2000, p. 15), - 32000 R 1295: Commission Regulation (EEC) No 1295/2000 of 20 June 2000 (OJ L 146, 21.6.2000, p. 11), - 32000 R 1960: Commission Regulation (EEC) No 1960/2000 of 15 September 2000 (OJ L 234, 16.9.2000, p. 5), - 32000 R 2338: Commission Regulation (EEC) No 2338/2000 of 14 October 2000 (OJ L 269, 21.10.2000, p. 21), - 32000 R 2391: Commission Regulation (EEC) No 2391/2000 of 27 October 2000 (OJ L 276, 28.10.2000, p. 5), - 32000 R 2535: Commission Regulation (EEC) No 2535/2000 of 17 November 2000 (OJ L 291, 18.11.2000, p. 9), - 32000 R 2908: Commission Regulation (EEC) No 2908/2000 of 29 December 2000 (OJ L 336, 30.12.2000, p. 72), - 32001 R 0749: Commission Regulation (EC) No 749/2001 of 18 April 2001 (OJ L 109, 19.4.2001, p. 32), - 32001 R 0750: Commission Regulation (EC) No 750/2001 of 18 April 2001 (OJ L 109, 19.4.2001, p. 35), - 32001 R 0807: Commission Regulation (EC) No 807/2001 of 25 April 2001 (OJ L 118, 27.4.2001, p. 6), - 32001 R 1274: Commission Regulation (EEC) No 1274/2001 of 27 June 2001 (OJ L 175, 28.6.2001, 14), - 32001 R 1322: Commission Regulation (EEC) No 1322/2001 of 29 June 2001 (OJ L 177, 30.6.2001, 52), - 32001 R 1478: Commission Regulation (EEC) No 1478/2001 of 18 July 2001 (OJ L 195, 19.7.2001, 32), - 32001 R 1553: Commission Regulation (EEC) No 1553/2001 of 30 July 2001 (OJ L 205, 31.7.2001, p. 16), - 32001 R 1680: Commission Regulation (EEC) No 1680/2001 of 22 August 2001 (OJ L 227, 23.8.2001, p. 33), - 32001 R 1815: Commission Regulation (EEC) No 1815/2001 of 14 September 2001 (OJ L 246, 15.9.2001, p. 11), - 32001 R 1879: Commission Regulation (EEC) No 1879/2001 of 26 September 2001 (OJ L 258, 27.9.2001, p. 11), - 32001 R 2162 : Commission Regulation (EEC) No 2162/2001 of 7 November 2001 (OJ L 291, 8.11.2001, p. 9). - 32001 R 2584 : Council Regulation (EEC) No 2584/2001 of 19 December 2001 (OJ L 345, 29.12.2001, p. 7). - 32002 R 0077 : Commission Regulation (EEC) No 77/2002 of 17 January 2002 (OJ L 16 du 18.1.2002, p. 9). 5. 391 L 0356: Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L 193, 17.7.1991, p. 30). 6. 391 L 0412: 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). 7. 393 L 0041: Council Directive 93/41/EEC of 14 June 1993 repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology (OJ L 214, 24.8.1993, p. 40). 8. 393 R 2309: Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of Medicinal Products (OJ L 214, 24.8.1993, p. 1), as amended by: - 398 R 0649: Commission Regulation (EC) No 649/98 of 23 March 1998 (OJ L 88, 24.3.1998, p.7). 9. 395 R 0297: Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 35, 15.2.1995, p. 1), as amended by: - 398 R 2743: Commission Regulation (EC) No 2743/98 of 14 December 1998 (OJ L 345, 19.12.1998, p. 3), 10. 395 R 0540: 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 authorised in accordance with the provisions of Council Regulation (EEC) No 2309/93 (OJ L 55, 11.3.1995, p. 5). 11. 395 R 0541: Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State (OJ L 55, 11.3.1995, p. 7), as amended by: - 398 R 1146: Commission Regulation (EC) No 1146/98 of 2 June 1998 (OJ L 159, 3.6.1998, p. 31). 12. 395 R 0542: Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No 2309/93 (OJ L 55, 11.3.1995, p. 15), as amended by: - 398 R 1069: Commission Regulation (EEC) No 1069/98 of 26 May 1998 (OJ L 153, 27.3.1998, p. 11). 13. 396 R 2141: Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of marketing authorisation for a medicinal product falling within the scope of Council Regulation (EEC) No 2309/93 (OJ L 286, 8.11.1996, p. 6). 14. 32000 R 0141: 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). 15. 32000 R 0847: 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). 16. 32001 L 0020: 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). 17. 32001 L 0082: 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) 18. 32001 L 0083: 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) ACTS OF WHICH THE CONTRACTING PARTIES SHALL TAKE NOTE The Contracting Parties take note of the content of the following acts: 19. C/310/86/p.7: Commission Communication on the compatibility with Article 30 of the Treaty of measures taken by Member States relating to price controls and reimbursement of medicinal products (OJ C 310, 4.12.1986, p. 7). 20. C/115/82/p. 5: Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted (OJ C 115, 6.5.1982, p. 5). 21. C/229/98/p. 4: Commission Communication on the Community marketing authorisation procedures for medicinal products (OJ C 229, 22.7.1998, p. 4). II. COSMETICS ACTS REFERRED TO 1. 376 L 0768: 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: - 379 L 0661: Council Directive 79/661/EEC of 24 July 1979 (OJ L 192, 31.7.1979, p. 35), - 179 H: Acts concerning the Conditions of Accession and the Adjustments to the Treaties - Accession to the European Communities of the Hellenic Republic (OJ L 291, 19.11.1979, p. 108), - 382 L 0147: Commission Directive 82/147/EEC of 11 February 1982 (OJ L 63, 6.3.1982, p. 26), - 382 L 0368: Council Directive 82/368/EEC of 17 May 1982 (OJ L 167, 15.6.1982, p. 1), - 383 L 0191: Second Commission Directive 83/191/EEC of 30 March 1983 (OJ L 109, 26.4.1983, p. 25), - 383 L 0341: Third Commission Directive 83/341/EEC of 29 June 1983 (OJ L 188, 13.7.1983, p. 15), - 383 L 0496: Fourth Commission Directive 83/496/EEC of 22 September 1983 (OJ L 275, 8.10.1983, p. 20), - 383 L 0574: Council Directive 83/574/EEC of 26 October 1983 (OJ L 332, 28.11.1983, p. 38), - 384 L 0415: Fifth Commission Directive 84/415/EEC of 18 July 1984 (OJ L 228, 25.8.1984, p. 31), as corrected by OJ No L 255, 25.9.1984, p. 28, - 385 L 0391: Sixth Commission Directive 85/391/EEC of 16 July 1985 (OJ L 224, 22.8.1985, p. 40), - 1 85 I: Act concerning the Conditions of Accession and Adjustments to the Treaties - Accession of the Kingdom of Spain and the Portuguese Republic (OJ L 302, 15.11.1985, p. 218), - 386 L 0179: Seventh Commission Directive 86/179/EEC of 28 February 1986 (OJ L 138, 24.5.1986, p. 40), - 386 L 0199: Eighth Commission Directive 86/199/EEC of 26 March 1986 (OJ L 149, 3.6.1986, p. 38), - 387 L 0137: Ninth Commission Directive 87/137/EEC of 2 February 1987 (OJ L 56, 26.2.1987, p. 20), - 388 L 0233: Tenth Commission Directive 88/233/EEC of 2 March 1988 (OJ L 105, 26.4.1988, p. 11), - 388 L 0667: Council Directive 88/667/EEC of 21 December 1988 (OJ L 382, 31.12.1988, p. 46), - 389 L 0174: Eleventh Commission Directive 89/174/EEC of 21 February 1989 (OJ L 64, 8.3.1989, p. 10), as corrected by OJ No L 199, 13.7.1989, p. 23, - 389 L 0679: Council Directive 89/679/EEC of 21 December 1989 (OJ L 398, 30.12.1989, p. 25), - 390 L 0121: Twelfth Commission Directive 90/121/EEC of 20 February 1990 (OJ L 71, 17.3.1990, p. 40), - 391 L 0184: Thirteenth Commission Directive 91/184/EEC of 12 March 1991 (OJ L 91, 12.4.1991, p. 59), - 392 L 0008: Fourteenth Commission Directive 92/8/EEC of 18 February 1992 (OJ L 70, 17.3.1992, p. 23) - 392 L 0086: Fifteenth Commission Directive 92/86/EEC of 21 October 1991 (OJ L 325, 11.11.1992, p. 18), - 393 L 0035: Council Directive 93/35/EEC of 14 June 1993 (OJ L 151, 23.6.1993, p. 32), - 393 L 0047: Sixteenth Commission Directive 93/47/EEC of 22 June 1993 (OJ L 203, 13.8.1993, p. 24), - 394 L 0032: Seventeenth Commission Directive 94/32/EC of 29 June 1994 (OJ L 181, 15.7.1994, p.31), - 395 L 0034: Eighteenth Commission Directive 95/34/EC of 10 July 1995 (OJ L 167, 18.7.1995, p. 19), - 396 L 0041: Nineteenth Commission Directive 96/41/EC of 25 June 1996 (OJ L 198, 8.8.1996, p. 36), - 397 L 0001: Twentieth Commission Directive 97/1/EC of 10 January 1997 (OJ L 16, 18.1.1997, p. 85), - 397 L 0018: Commission Directive 97/18/EC of 17 April 1997 (OJ L 114, 1.5.1997, p. 43), - 397 L 0045: Commission Directive 97/45/EC of 14 July 1997 (OJ L 196, 24.7.1997, p. 77), - 398 L 0016: Commission Directive 98/16/EC of 5 March 1998 (OJ L 77, 14.3.1998, p. 44), - 398 L 0062: Commission Directive 98/62/EC of 3 September 1998 (OJ L 253, 15.9.1998, p. 20), - 32000 L 0006: 24th Commission Directive 2000/6/EC of 29 February 2000 (OJ L 56, 1.3.2000, p. 42), - 32000 L 0011: 25th Commission Directive 2000/11/EC of 10 March 2000 (OJ L 65, 14.3.2000, p. 22), - 32000 L 0041: Commission Directive 2000/41/EC of 19 June 2000 (OJ L 145, 20.6.2000, p. 25). 2. 380 L 1335: 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: - 387 L 0143: Commission Directive 87/143/EEC of 10 February 1987 (OJ L 57, 27.2.1987, p. 56). 3. 382 L 0434: 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: - 390 L 0207: Commission Directive 90/207/EEC of 4 April 1990 (OJ L 108, 28.4.1990, p. 92). 4. 383 L 0514: Third 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). 5. 385 L 0490: Fourth 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). 6. 393 L 0073: Fifth 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). 7. 395 L 0032: Sixth 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). 8. 396 L 0045: Seventh Commission Directive 96/45/EC of 8 May 1996 relating to methods of analysis necessary for checking the composition of cosmetic products (OJ L 213, 22.8.1996, p. 8.) 9. 395 L 0017: 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). 10. 396 D 0335: Commission Decision 96/335/EC of 2 July 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products (OJ L 132, 1.6.1996, p. 1). III. MEDICAL DEVICES ACTS REFERRED TO 1. 390 L 0385: 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), as amended by: - 393 L 0068: Council Directive 93/68/EEC of 22 July 1993 (OJ L 220, 30.8.1993, p.1). 2. 393 L 0042: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) 3. 398 L 0079: 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), as corrected by OJ L 22, 29.1.1999, p. 75. 4. 32000 L 070: 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).