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


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22003A1219(01)
 
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
 
Official Journal L 332 , 19/12/2003 P. 0042 - 0051 
 
Dates:
of effect:   01/05/2004; Entry into force See Art 6 And
22004X0408(01)
end of validity:   99/99/9999
 
Authentic language: German ; English ; Danish ; Spanish ; Finnish ;
French ; Greek ; Italian ; Dutch ; Portuguese ; Swedish
Author:
European Community ; Monaco
 
Subject matter: External relations ; Health protection
Directory code: 11401040 ; 15300000
EUROVOC descriptor: EC agreement ; Monaco ; national implementation
of Community law ; pharmaceutical legislation ; drug surveillance
 
Legal basis:
102E133................... Adoption
102E300-P3L1.............. Adoption
Amended by:
Adopted by.... 303D0885.......... from 17/11/2003
 
 
 
 
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",
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 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 90 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, on the fourth day of December in the year two
thousand and three, in duplicate, in the Danish, Dutch, English,
Finnish, French, German, Greek, Italian, Portuguese, Spanish and
Swedish languages, each text being equally authentic.
 
 
 
Por la Comunidad Europea/For Det Europöiske Föllesskab/FŽr die
Europōische Gemeinschaft/>ISO_7>Ćłń Į÷ż ÅįęųĘńŪśČ
Ź˙łżŽĮ÷Įń/>ISO_1>For the European Community/Pour la Communautł
europłenne/Per la Comunitš europea/Voor de Europese Gemeenschap/Pela
Comunidade Europeia/Euroopan yhteisŠn puolesta/Põ Europeiska
gemenskapens vōgnar
>PIC FILE= "L_2003332EN.004301.TIF">
 
Por el Principado de Mėnaco/For FyrstendŲmmet Monaco/FŽr das
FŽrstentum Monaco/>ISO_7>Ćłń Į˙ ŠęłóśłĘĄĮ˙ Į˙į Ģ˙żńśŽ/>ISO_1>For the
Principality of Monaco/Pour la Principautł de Monaco/Per il
Principato di Monaco/Voor het Vorstendom Monaco/Pelo Principado do
Mėnaco/Monacon ruhtinaskunnan puolesta/Põ FurstendŠmet Monacos
vōgnar
>PIC FILE= "L_2003332EN.004302.TIF">
 
 
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 (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),
- 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),
- 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),
- 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),
- 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 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).
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 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).
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),
- 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 variations 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 variations 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),
- 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).
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 labelling 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 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, 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 diagnostic 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).