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
Date: 2003-12-04
Institutions: European Community, Monaco
Subjects: Monaco, agreement (EU), application of EU law, pharmaceutical legislation, veterinary legislation

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between the European Community and the Principality of Monaco on the application of certain
Community acts on the territory of the Principality of Monaco

AGREEMENT

THE EUROPEAN COMMUNITY, hereinafter referred to as ‘the Community’,

and

THE PRINCIPALITY OF MONACO, hereinafter referred to as ‘Monaco’,

CONSIDERING the close relations between the Community and Monaco,

CONSIDERING the special relationship between Monaco and the French Republic,

DESIROUS to conclude an agreement facilitating certain economic activities and trade between them,

CONSCIOUS of the need to create and maintain a common legislative framework for the activities in question,

HAVE DECIDED TO CONCLUDE THIS AGREEMENT:

Article 1

Aim

1.
The Parties agree that the Community acts covering medi-
cines 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.

Acts adopted by the Commission of

2.
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

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
It shall be responsible for the
Parties is hereby established.
management and proper application of the Agreement. It will
formulate recommendations for that purpose. It shall take deci-
sions 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.

1. Monaco shall take all proper measures to ensure the
application of the acts and decisions referred to in Article 1.

The Joint Committee shall meet as and when necessary.

3.
Either Party may request the convening of a meeting.

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 authori-
ties may have recourse to their special administrative relation-
ship with the French Republic.

Any problem concerning the application of this Agree-

3.
ment will be brought to the attention of the Joint Committee.

4.

The Joint Committee shall establish its rules of procedure.

Article 4

Dispute settlement

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.

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.

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The Joint Committee shall have 90 days to settle the
2.
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 procedures
referred to in the previous sentence.

the completion of

This Agreement is concluded for an indefinite period.

2.
Either Party may denounce it with six months' notice.

Done at Brussels, on the fourth day of December in the year
in the Danish, Dutch,
two thousand and three,
English, Finnish, French, German, Greek,
Italian, Portuguese,
Spanish and Swedish languages, each text being equally
authentic.

in duplicate,

Por la Comunidad Europea

For Det Europæiske Fællesskab

Für die Europäische Gemeinschaft
Για την Ευρωπαϊκή Κοινότητα

For the European Community

Pour la Communauté européenne

Per la Comunità europea

Voor de Europese Gemeenschap

Pela Comunidade Europeia

Euroopan yhteisön puolesta

På Europeiska gemenskapens vägnar

Por el Principado de Mónaco

For Fyrstendømmet Monaco

Für das Fürstentum Monaco
Για το Πριγκιπάτο του Μονακό

For the Principality of Monaco

Pour la Principauté de Monaco

Per il Principato di Monaco

Voor het Vorstendom Monaco

Pelo Principado do Mónaco

Monacon ruhtinaskunnan puolesta

På Furstendömet Monacos vägnar

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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 regu-
lating 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 (EEC) 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),

— 394 R 3059: Commission Regulation (EC) No 3059/94 of 15 December 1994 (OJ L 323, 16.12.1994, p. 15),

— 395 R 1102: Commission Regulation (EC) No 1102/95 of 16 May 1995 (OJ L 110, 17.5.1995, 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),

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— 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 1798: Commission Regulation (EC) No 1798/96 of 17 September 1996 (OJ L 236, 18.9.1996, p. 23),

— 396 R 2010: Commission Regulation (EC) No 2010/96 of 21 October 1996 (OJ L 269, 22.10.1996, 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),

— 397 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),

— 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),

— 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),

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— 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),

— 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 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 0508: Commission Regulation (EC) No 3426/1999 of 4 March 1999 (OJ L 60, 9.3.1999, p. 15),

— 399 R 0804: Commission Regulation (EC) No 804/1999 of 16 April 1999 (OJ L 102, 17.4.1999, p. 58),

— 399 R 0953: Commission Regulation (EC) No 953/1999 of 5 May 1999 (OJ L 118, 6.5.1999, p. 23),

— 399 R 0954: Commission Regulation (EC) No 954/1999 of 5 May 1999 (OJ L 118, 6.5.1999, p. 28),

— 399 R 0997: Commission Regulation (EC) No 997/1999 of 11 May 1999 (OJ L 122, 12.5.1999, p. 24),

— 399 R 0998: Commission Regulation (EC) No 998/1999 of 12 May 1999 (OJ L 122, 12.5.1999, p. 30),

— 399 R 1308: Council Regulation (EC) No 1308/1999 of 15 June 1999 (OJ L 156, 23.6.1999, p. 1),

— 399 R 1931: Commission Regulation (EC) No 1931/1999 of 9 September 1999 (OJ L 240, 10.9.1999, p. 3),

— 399 R 1942: Commission Regulation (EC) No 1942/1999 of 10 September 1999 (OJ L 241, 11.9.1999, p. 4),

— 399 R 1943: Commission Regulation (EC) No 1943/1999 of 10 September 1999 (OJ L 241, 11.9.1999, p. 9),

— 399 R 2385: Commission Regulation (EC) No 2385/1999 of 10 November 1999 (OJ L 288, 11.11.1999,

p. 14),

— 399 R 2393: Commission Regulation (EC) No 2393/1999 of 11 November 1999 (OJ L 290, 12.11.1999, p. 5),

— 399 R 2593: Commission Regulation (EC) No 2593/1999 of 8 December 1999 (OJ L 315, 9.12.1999, p. 26),

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— 399 R 2728: Commission Regulation (EC) No 2728/1999 of 20 December 1999 (OJ L 328, 22.12.1999,

p. 23),

— 399 R 2757: Commission Regulation (EC) No 2757/1999 of 22 December 1999 (OJ L 331, 23.12.1999,

p. 45),

— 399 R 2758: Commission Regulation (EC) No 2758/1999 of 22 December 1999 (OJ L 331, 23.12.1999,

p. 49),

— 32000 R 1286: Commission Regulation (EC) No 1286/2000 of 19 June 2000 (OJ L 145, 20.6.2000, p. 15),

— 32000 R 1295: Commission Regulation (EC) No 1295/2000 of 20 June 2000 (OJ L 146, 21.6.2000, p. 11),

— 32000 R 1960: Commission Regulation (EC) No 1960/2000 of 15 September 2000 (OJ L 234, 16.9.2000,

p. 5),

— 32000 R 2338: Commission Regulation (EC) No 2338/2000 of 14 October 2000 (OJ L 269, 21.10.2000,

p. 21),

— 32000 R 2391: Commission Regulation (EC) No 2391/2000 of 27 October 2000 (OJ L 276, 28.10.2000,

p. 5),

— 32000 R 2535: Commission Regulation (EC) No 2535/2000 of 17 November 2000 (OJ L 291, 18.11.2000,

p. 9),

— 32000 R 2908: Commission Regulation (EC) 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 (EC) No 1274/2001 of 27 June 2001 (OJ L 175, 28.6.2001, p. 14),

— 32001 R 1322: Commission Regulation (EC) No 1322/2001 of 29 June 2001 (OJ L 177, 30.6.2001, p. 52),

— 32001 R 1478: Commission Regulation (EC) No 1478/2001 of 18 July 2001 (OJ L 195, 19.7.2001, p. 32),

— 32001 R 1553: Commission Regulation (EC) No 1553/2001 of 30 July 2001 (OJ L 205, 31.7.2001, p. 16),

— 32001 R 1680: Commission Regulation (EC) No 1680/2001 of 22 August 2001 (OJ L 227, 23.8.2001, p. 33),

— 32001 R 1815: Commission Regulation (EC) No 1815/2001 of 14 September 2001 (OJ L 246, 15.9.2001,

p. 11),

— 32001 R 1879: Commission Regulation (EC) No 1879/2001 of 26 September 2001 (OJ L 258, 27.9.2001,

p. 11),

— 32001 R 2162: Commission Regulation (EC) No 2162/2001 of 7 November 2001 (OJ L 291, 8.11.2001, p. 9),

— 32001 R 2584: Council Regulation (EC) No 2584/2001 of 19 December 2001 (OJ L 345, 29.12.2001, p. 7),

— 32002 R 0077: Commission Regulation (EC) No 77/2002 of 17 January 2002 (OJ L 16, 18.1.2002, p. 9),

— 32002 R 0868: Commission Regulation (EC) No 868/2002 of 24 May 2002 (OJ L 137, 25.5.2002, p. 6),

— 32002 R 0869: Commission Regulation (EC) No 869/2002 of 24 May 2002 (OJ L 137, 25.5.2002 p. 10),

— 32002 R 1181: Commission Regulation (EC) No 1181/2002 of 1 July 2002 (OJ L 172, 2.7.2002, p. 13),

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— 32002 R 1530: Commission Regulation (EC) No 1530/2002 of 27 August 2002 (OJ L 230, 28.8.2002, p. 3),

— 32002 R 1752: Commission Regulation (EC) No 1752/2002 of 1 October 2002 (OJ L 264, 2.10.2002, p. 18),

— 32002 R 1937: Commission Regulation (EC) No 1937/2002 of 30 October 2002 (OJ L 297, 31.10.2002, p. 3),

— 32003 R 0061: Commission Regulation (EC) No 61/2003 of 15 January 2003 (OJ L 11, 16.1.2003, p. 12),

— 32003 R 0544: Commission Regulation (EC) No 544/2003 of 27 March 2003 (OJ L 81, 28.3.2003, p. 7),

— 32003 R 0665: Commission Regulation (EC) No 665/2003 of 11 April 2003 (OJ L 96, 12.4.2003, p. 7),

— 32003 R 0739: Commission Regulation (EC) No 739/2003 of 28 April 2003 (OJ L 106, 29.4.2003, 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 Community 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: Council 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. 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).

12. 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).

13. 32000 R 0847: Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for imple-
mentation 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).

14. 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 imple-
mentation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121,
1.5.2001, p. 34).

15. 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).

16. 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).

— 32002 L 0098: 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),

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— 32003 L 0063: 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
(OJ L 159, 27.6.2003, p. 46).

17. 32003 R 1084: Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of varia-
tions to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal
products granted by a competent authority of a Member State (OJ L 159, 27.6.2003, p. 1).

18. 32003 R 1085: Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of varia-
tions to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal
products falling within the scope of Council Regulation (EC) No 2309/93 (OJ L 159, 27.6.2003, p. 24).

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: 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: 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: 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 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),

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— 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 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 1992 (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: 21st Commission Directive 97/45/EC of 14 July 1997 (OJ L 196, 24.7.1997, p. 77),

— 398 L 0016: 22nd Commission Directive 98/16/EC of 5 March 1998 (OJ L 77, 14.3.1998, p. 44),

— 398 L 0062: 23rd 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),

— 32002 L 0034: 26th Commission Directive 2002/34/EC of 15 April 2002 (OJ L 102, 18.4.2002, p. 191),

— 32003 L 0001: Commission Directive 2003/1/EC of 6 January 2003 (OJ L 5, 10.1.2003, p. 14),

— 32003 L 0016: Commission Directive 2003/16/EC of 19 February 2003 (OJ L 46, 20.2.2003, p. 24),

— 32003 L 0015: Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 (OJ

L 66, 11.3.2003, p. 26).

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).

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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 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 label-
ling of cosmetic products (OJ L 140, 23.6.1995, p. 26).

8. 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).

9. 396 L 0045: Seventh 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).

10. 396 D 0335: Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomencla-

ture 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, p. 17), 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 diag-

nostic medical devices (OJ L 331, 7.12.1998, p. 1).

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).

5. 32001 L 0104: 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).

6. 32002 D 0364: 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).

7. 32003 L 0012: 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).

8. 32003 L 0032: 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).