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,

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.

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.

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,

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,

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,

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,

II. COSMETICS

ACTS REFERRED TO

III. MEDICAL DEVICES

ACTS REFERRED TO

down in Council Directive 93/42/EEC with respect to medical devices

manufactured utilising tissues of animal origin (OJ L 105,