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
Date: 2003-05-23
Institutions: European Commission
Subjects: Monaco, agreement (EU), application of EU law, customs territory (EU), drug surveillance, pharmaceutical legislation

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 23.5.2003
COM(2003) 290 final

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

(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.

2

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.

3

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,

Whereas:

(1)

(2)

(3)

(4)

The Commission has negotiated on behalf of the Community an Agreement with the
Principality of Monaco;

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;

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;

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.

1

OJ C […], […], p. […].

4

                                                
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

5

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)

(2)

(3)

(4)

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 the following agreement:

Article 1

Aim

1

2.

1.

2.

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.

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

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

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.

6

3.

4.

5.

1.

2.

3.

4.

1.

2.

3.

Any  problem  concerning  the  application  of  this  Agreement  will  be  brought  to  the
attention of the Joint Committee.

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.

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

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.

The  Joint  Committee  shall  be  chaired  by  each  of  the  Parties  in  turn  according  to
arrangements to be determined in its rules of procedure.

The Joint Committee shall meet as and when necessary. Either Party may request the
convening of a meeting.

The Joint Committee shall establish its rules of procedure.

Article 4 

Dispute settlement

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.

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.

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.

7

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.

2.

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.

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

8

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:

2.

3.

4.

– 

– 

– 

– 

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),

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).

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).

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),

9

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

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),

10

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– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

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),

11

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– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

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),

12

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– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

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 
11 September 1999 (OJ No L 241, 119.1999, p. 4),

1942:  Commission  Regulation 

(EEC)  No 

1942/99  of

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 
15 September 2000 (OJ L 234, 16.9.2000, p. 5),

(EEC)  No  1960/2000  of

13

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– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

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 
17 November 2000 (OJ L 291, 18.11.2000, p. 9),

(EEC)  No  2535/2000  of

32000  R  2908:  Commission  Regulation 
29 December 2000 (OJ L 336, 30.12.2000, p. 72),

(EEC)  No  2908/2000  of

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 
22 August 2001 (OJ L 227, 23.8.2001, p. 33),

(EEC)  No  1680/2001  of

32001  R  1815:  Commission  Regulation 
14 September 2001 (OJ L 246, 15.9.2001, p. 11),

(EEC)  No  1815/2001  of

32001  R  1879:  Commission  Regulation 
26 September 2001 (OJ L 258, 27.9.2001, p. 11),

(EEC)  No  1879/2001  of

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).

14

5.

6.

7.

8.

9.

10.

11.

12.

13.

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).

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).

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).

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).

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),

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).

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).

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).

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).

15

14.

15.

16.

17.

18.

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).

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).

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).

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)

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.

20.

21.

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).

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).

C/229/98/p.  4:  Commission  Communication  on 
authorisation procedures for medicinal products (OJ C 229, 22.7.1998, p. 4).

the  Community  marketing

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),

16

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

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),

17

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

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).

18

2.

3.

4.

5.

6.

7.

8.

9.

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).

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).

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).

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).

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).

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).

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.)

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).

19

III.

MEDICAL DEVICES

ACTS REFERRED TO

1.

2.

3.

4.

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).

393  L  0042:  Council  Directive  93/42/EEC  of  14  June  1993  concerning  medical
devices (OJ L 169, 12.7.1993, p. 1)

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.

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).

20