Amended proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, in the Joint Committee established by 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
Date: 2013-06-25
Institutions: European Commission
Subjects: Monaco, cosmetic product, medical device, medicinal product, revision of an agreement, trade agreement (EU), veterinary drug

EUROPEAN 
COMMISSION 

Brussels, 25.6.2013  
COM(2013) 487 final 

2013/0116 (NLE) 

Amended proposal for a 

COUNCIL DECISION 

on the position to be adopted, on behalf of the European Union, in the Joint Committee 
established by 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 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

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  of  4 
December  20031  facilitates  economic  activities  and  trade  in  medicines  for  human  and 
veterinary use, cosmetic products and medical devices between the Parties to the Agreement.  

The Agreement provides in its Article 1, paragraph 1, that the Joint Committee established by 
the Agreement shall amend its Annex to ensure that European Union Acts falling within the 
scope of the Agreement apply on the territory of Monaco.  

The Annex to the Agreement has never been updated since its entry into force in 2004. Since 
then,  the  European  Union  has  adopted  a  number  of  acts  that  fall  within  the  scope  of  the 
Agreement and some acts appearing in the Annex have been repealed. 

In addition, it is necessary to include acts falling within the scope of the Agreement but 
not currently referenced in the Annex, including Directives 2002/98/EC and 2004/23/EC 
because certain of their provisions apply to the manufacturing of medicinal products. 

The present proposal therefore aims to update and revise the Annex so that it includes all 
EU acts falling within the scope of the Agreement and to remove the acts that have been 
repealed.  In  order  to  establish  the  position  to  be  taken  on  behalf  of  the  Union  in  the  Joint 
Committee, a Council Decision is necessary. 

2. 

LEGAL ELEMENTS OF THE PROPOSAL 

Summary of the proposed action 

This is a proposal for a Council Decision on the position to be taken on behalf of the Union 
within the Joint Committee established by the Agreement, which should be based on the draft 
Joint Committee Decision in annex. 

Legal basis 

Article  207  of  the  Treaty  on  the  Functioning  of  the  European  Union  in  conjunction  with 
Article 218(9) thereof. 

Choice of instrument 

Article  218(9)  of  the  Treaty  on  the  Functioning  of  the  European  Union  provides  that  a 
Council Decision establishes the position to be adopted on behalf of the European Union in a 
body set up by an agreement, when that body is called upon to adopt decisions having legal 
effects. 

Proportionality 

The  proposal  is  in  line  with  the  principle  of  proportionality  because  its  effects  are  strictly 
limited to what is necessary to update the Annex to the Agreement to reflect the state of EU 
legislation in the areas falling within its scope. 

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OJ L 332, 19.12.2003, pp.42-43. 

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2013/0116 (NLE) 

Amended proposal for a 

COUNCIL DECISION 

on the position to be adopted, on behalf of the European Union, in the Joint Committee 
established by 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 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 207 in conjunction with Article 218(9) thereof,  

Having  regard  to  Council  Decision  2003/885/EC  of  17  November  2003  concerning  the 
conclusion  of  the  Agreement  on  the  application  of  certain  Community  Acts  on  the 
territory of the Principality of Monaco2, and in particular Article 3(2) thereof,  

Having regard to the proposal from the European Commission, 

Whereas:  

(1) 

(2) 

(3) 

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 of 4 December 20033 ('the Agreement') entered into force on 1 May 2004. 

The  Agreement  provides  in  its  Article  1(1)  paragraph  1,  that  the  Joint  Committee 
established by the Agreement is to shall amend its Annex to ensure that Union Acts 
falling within the scope of the Agreement apply on the territory of Monaco. 

Since  the  entry  into  force  of  the  Agreement,  the  European  Union  has  adopted  a 
number of acts that fall within its scope and some acts appearing in the Annex have 
been  repealed.  It  is  therefore  necessary  to  update  the  Annex  to  include  the  new  acts 
and to remove the acts that have been repealed. In addition, it is necessary to include 
acts falling within the scope of the Agreement but not currently referenced in the 
Annex, including Directives 2002/98/EC and 2004/23/EC because certain of their 
provisions apply to the manufacturing of medicinal products. 

(5) 

The position of the Union in the Joint Committee should be based on the attached 
draft Decision. 

Council  Decision  2003/885/EC  of  17  November  2003  on  the  conclusion  of  the 
Agreement  on  the  application  of  certain  Community  Acts  on  the  territory  of  the 
Principality of Monaco, notably its article 3, paragraph 1, provides that the European 
Union shall be represented by the Commission on the Joint Committee, 

(6) 

Council Decision 2003/885/EC of 17 November 2003, notably its article 3, paragraph 
2, provides that the position to be taken by the European Union in the Joint Committee 
shall be determined by the Council on a proposal from the Commission; the Council 

2 
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OJ L 332, 19.12.2003, p.41. 
OJ L 332, 19.12.2003, pp.42-43. 

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shall act by the same voting rule as that applicable for the adoption of the Union act 
concerned, 

HAS ADOPTED THIS DECISION:  

Article 1 

The  position  to  be  taken  by  the  European  Union  within  the  Joint  Committee  set  up  by  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  of  4 
December 2003 shall be based on the draft Decision of the Joint Committee attached to this 
Decision. 

Technical  modificationsMinor  changes  to  the  draft  Decision  may  be  agreed  to  by  the 
representatives of the Union in the Joint Committee without further decision of the Council. 

The  Decision  of  the  Joint  Committee  shall  be  published  in  the  Official  Journal  of  the 
European Union. 

Article 2 

Article 3 

This Decision shall enter into force on the day of its adoption. 

This Decision is addressed to the Member States in accordance with the Treaties. 

Done at Brussels,  

For the Council 
The President 

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DECISION No. … OF THE EU-MONACO JOINT COMMITTEE 

Draft 

of… 

Aamending the Annex to the Agreement 

THE JOINT COMMITTEE, 

Having  regard  to  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,  signed  in  Brussels  of  4  December  20034,  hereinafter  referred  to  as  'the 
Agreement', and in particular Article 1(1) paragraph 1 thereof, 

Whereas: 

(1) 

(2) 

(1) 

(2) 

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 of 4 December 20035 entered into force on 1 May 2004, 

The  Agreement  provides  in  its  Article  1,  paragraph  1,  that  the  Joint  Committee 
established by the Agreement shall amend its Annex to ensure that European Union 
acts falling within the scope of the Agreement apply on the territory of Monaco, 

Since the entry into force of the Agreement on 1 May 2004, the European Union has 
adopted  a  number  of  acts  that  fall  within  its  scope  and  some  acts  appearing  in  the 
Annex have been repealed. A Decision of the Joint Committee is therefore necessary 
to update the Annex to include the new acts and to remove the acts that have been 
repealed, 

It is recalled that acts of the European Commission adopted in application of the acts 
listed  in  the  Annex  to  the  Agreement  are  applicable  on  the  territory  of  Monaco 
without  the  need  for  a  Joint  Committee  Decision,  as  provided  for  by  Article  1(2) 
paragraph 2 of the Agreement, 

HAS ADOPTED THIS DECISION: 

Article 1 

The  Annex  to  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  of  4  December  2003  is  hereby  replaced  by  the  text  set  out  in  the  Annex  to  this 
Decision. 

This Decision shall enter into force on the day of its adoption.  

Article 2 

Date:  

By the Joint Committee 

The Chairman  

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OJ L 332, 19.12.2003, pp.42-43. 
OJ L 332, 19.12.2003, pp.42-43. 

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"ANNEX  

To Decision No. … of the Committee established by 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 of 4 December 2003 

I. MEDICINAL PRODUCTS 

ACTS REFERRED TO 

1.  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 

–  Amended by Directive 2012/26/EU of the European Parliament and of the Council of 

25 October 2012 as regards pharmacovigilance (OJ L 299, 27.10.2012, p. 1–4) 

–  Amended by Directive 2011/62/EU of the European Parliament and of the Council of 
8  June  2011  amending  Directive  2001/83/EC  on  the  Community  code  relating  to 
medicinal products for human use, as regards the prevention of the entry into the legal 
supply  chain  of  falsified  medicinal  products(Official  Journal  L174,  1.7.2011,  p.  74-
87) 

–  Amended by Directive 2010/84/EU of the European Parliament and of the Council of 
15  December  2010  amending,  as  regards  pharmacovigilance,  Directive  2001/83/EC 
on  the  Community  code  relating  to  medicinal  products  for  human  use.  (Official 
Journal L 348, 31.12.2010, p. 74 - 99). 

–  Amended  by  Commission  Directive  2009/120/EC  of  14  September  2009  amending 
Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  on  the 
Community  code  relating  to  medicinal  products  for  human  use  as  regards  advanced 
therapy medicinal products (Official Journal L 242 15.9.2009, p. 3 - 12) . 

–  Amended by Directive 2009/53/EC of the European Parliament and of the Council of 
18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards 
variations  to  the  terms  of  marketing  authorisations  for  medicinal  products.  (Official 
Journal L 168, 30.6.2009, p. 33 - 34). 

–  Amended by Directive 2008/29/EC of the European Parliament and of the Council of 
11 March 2008 amending Directive 2001/83/EC on the Community code relating to 
medicinal products for human use, as regards the implementing powers conferred on 
the Commission (Official Journal L 81, 20.3.2008, p. 51 - 52 ). 

–  Amended by Regulation (EC) No 1394/2007 of the European Parliament and of the 
Council of 13 November 2007 on advanced therapy medicinal products and amending 
Directive  2001/83/EC  and  Regulation  (EC)  No  726/2004  (Official  Journal  L  324, 
10.12.2007, p. 121-137) 

–  Amended by Regulation (EC) No 1901/2006 of the European Parliament and of the 
Council of 12 December 2006 on medicinal products for paediatric use and amending 
Regulation  (EEC)  No  1768/92,  Directive  2001/20/EC,  Directive  2001/83/EC  and 
Regulation (EC) No 726/2004 (Official Journal L 378, 27.12.2006, p. 1-19). 

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–  Amended by Directive 2004/27/EC of the European Parliament and of the Council of 
31 March 2004 amending Directive 2001/83/EC on the Community code relating to 
medicinal products for human use (Official Journal L 136, 30.4.2004, p. 34-57). 

–  Amended by Directive 2004/24/EC of the European Parliament and of the Council of 
31 March 2004 amending, as regards traditional herbal medicinal products, Directive 
2001/83/EC  on  the  Community  code  relating  to  medicinal  products  for  human  use 
(Official Journal L 136, 30.4.2004, p. 85-90). 

–  Amended by 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  (Official  Journal  L  159,  27.6.2003,  p. 
46-94) 

–  Amended by 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 (Official Journal L 33, 8.2.2003, p 30-40) 

2.  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 
2004  laying  down  Community  procedures  for  the  authorisation  and  supervision  of 
medicinal products for human and veterinary use and establishing a European Medicines 
Agency  

–  Amended  by  Regulation  (EU)  no  1027/2012  of  the  European  Parliament  and  of  the 
Council of 25 October 2012 as regards pharmacovigilance. (OJ L 316, 14.11.2012, p. 
38-40) 

–  Amended by Regulation (EU) No 1235/2010 of the European Parliament and of the 
Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal 
products  for  human  use,  Regulation  (EC)  No  726/2004  laying  down  Community 
procedures for the authorisation and supervision of medicinal products for human and 
veterinary use and establishing a European Medicines Agency, and Regulation (EC) 
No 1394/2007 on advanced therapy medicinal products Text with EEA relevance (OJ 
L 348, 31.12.2010, p. 1–16) 

–  Amended  by  Regulation  (EC)  No  470/2009  of  the  European  Parliament  and  of  the 
Council of 6 May 2009 laying down Community procedures for the establishment of 
residue limits  of pharmacologically  active  substances in  foodstuffs of animal origin, 
repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC 
of the European Parliament and of the Council and Regulation (EC) No 726/2004 of 
the European Parliament and of the Council (Official Journal L 152, 16.6.2009 p. 11 - 
22). 

–  Amended  by  Regulation  (EC)  No  219/2009  of  the  European  Parliament  and  of  the 
Council of 11 March 2009 adapting a number of instruments subject to the procedure 
referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard 
to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with 
scrutiny - Part Two (Official Journal L 87, 231.3.2009, p. 109 - 154, especially p. 116 
- 118, Annex 2.9, where Regulation (EC) No 726/2004 is adapted). 

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–  Amended by Regulation (EC) No 1394/2007 of the European Parliament and  of the 
Council of 13 November 2007 on advanced therapy medicinal products and amending 
Directive  2001/83/EC  and  Regulation  (EC)  No  726/2004.  (  Official  Journal  L  324 
10.12.2007, p. 121-137) 

–  Amended by Regulation (EC) No 1901/2006 of the European Parliament and of the 
Council of 12 December 2006 on medicinal products for paediatric use and amending 
Regulation  (EEC)  No  1768/92,  Directive  2001/20/EC,  Directive  2001/83/EC  and 
Regulation (EC) No 726/2004. (Official Journal L 378, 27.12.2006, p. 1–19) 

3.  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  

–  Amended  by Regulation  (EC)  No 596/2009  of  the  European  Parliament  and  of  the 
Council  of  18 June  2009  adapting  a  number  of  instruments  subject  to  the  procedure 
referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard 
to  the  regulatory  procedure  with  scrutiny  —  Adaptation  to  the  regulatory  procedure 
with scrutiny — Part Four (Official Journal L 188, 18.7.2009, p. 14-92) 

–  Amended by Directive 2009/53/EC of the European Parliament and of the Council of 
18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards 
variations  to  the  terms  of  marketing  authorisations  for  medicinal  products  (Official 
Journal L 168, 30.6.2009, p. 33-34) 

–  Amended  by Regulation  (EC)  No  470/2009  of  the  European  Parliament  and  of  the 
Council of 6 May 2009 laying down Community procedures for the establishment of 
residue limits  of pharmacologically  active  substances in  foodstuffs of animal origin, 
repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC 
of the European Parliament and of the Council and Regulation (EC) No 726/2004 of 
the  European  Parliament  and  of  the  Council  (  Official  Journal  L  152,  16.6.2009,  p. 
11-22) 

–  Amended  by Commission  Directive  2009/9/EC  of  10  February  2009  amending 
Directive  2001/82/EC  of  the  European  Parliament  and  of  the  Council  on  the 
Community code relating to medicinal products for veterinary use (Official Journal L 
44, 14.2.2009, p.10-61) 

–  Amended by Directive 2004/28/EC of the European Parliament and of the Council of 
31 March  2004  amending  Directive  2001/82/EC  on  the  Community  code  relating  to 
veterinary medicinal products (Official Journal L 136, 30.4.2004, p. 58-84) 

4.  Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European 

Agency for the Evaluation of Medicinal Products 

–  Amended by Council Regulation (EC) No 2743/98 of 14 December 1998  

–  Amended by Commission Regulation (EC) No 494/2003 of 18 March 2003  

–  Amended by Council Regulation (EC) No 1905/2005 of 14 November 2005  

–  Amended by Commission Regulation (EC) No 312/2008 of 3 April 2008  

–  Amended by Commission Regulation (EC) No 249/2009 of 23 March 2009  

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–  Amended by Commission Regulation (EU) No 261/2010 of 25 March 2010  

–  Amended by Commission Regulation (EU) No 301/2011 of 28 March 2011  

–  Amended by Commission Regulation (EU) No 273/2012 of 27 March 2012 

–  Amended by Commission Regulation (EU) No 220/2013 of 13 March 2013 

5.  Regulation (EC) No  470/2009  of  the  European Parliament and of the Council  of 6  May 
2009  laying  down  Community  procedures  for  the  establishment  of  residue  limits  of 
pharmacologically  active  substances  in  foodstuffs  of  animal  origin,  repealing  Council 
Regulation  (EEC)  No  2377/90  and  amending  Directive  2001/82/EC  of  the  European 
Parliament  and  of  the  Council  and  Regulation  (EC)  No  726/2004  of  the  European 
Parliament and of the Council (Official Journal L 152, 16/6/2009 p. 11 - 22).  

6.  Commission  Regulation  (EC)  No  668/2009  of  24  July  2009  implementing  Regulation 
(EC)  No  1394/2007  of  the  European  Parliament  and  of  the  Council  with  regard  to  the 
evaluation and certification of quality and non-clinical data relating to advanced therapy 
medicinal  products  developed  by  micro,  small  and  medium-sized  enterprises  (Official 
Journal L 194, 25/7/2009 p. 7 - 10). 

7.  Commission  Regulation  (EU)  N°  37/2010  of  22  December  2009  on  pharmacologically 
active substances and their classification regarding maximum residue limits in foodstuffs 
of animal origin 

–  Amended by Commission Regulation (EU) No 758/2010 of 24 August 2010  

–  Amended by Commission Regulation (EU) No 759/2010 of 24 August 2010  

–  Amended by Commission Regulation (EU) No 761/2010 of 25 August 2010  

–  Amended by Commission Regulation (EU) No 890/2010 of 8 October 2010  

–  Amended by Commission Regulation (EU) No 914/2010 of 12 October 2010  

–  Amended by Commission Regulation (EU) No 362/2011 of 13 April 2011  

–  Amended by Commission Regulation (EU) No 363/2011 of 13 April 2011  

–  Amended by Commission Implementing Regulation (EU) No 84/2012 of 1 February 

2012 

–  Amended by Commission Implementing Regulation (EU) No 85/2012 of 1 February 

2012 

–  Amended by Commission Implementing Regulation (EU) No 86/2012 of 1 February 

2012 

–  Amended by Commission Implementing Regulation (EU) No 107/2012 of 8 February 

2012 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  122/2012  of  13 

February 2012 

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–  Amended  by  Commission  Implementing  Regulation  (EU)  No  123/2012  of  13 

February 2012 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  201/2012  of  8  March 

2012 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  202/2012  of  8  March 

2012 

–  Amended by Commission Implementing Regulation (EU) No 221/2012 of 14 March 

2012 

–  Amended by Commission Implementing Regulation (EU) No 222/2012 of 14 March 

2012 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  436/2012  of  23  May 

2012 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  466/2012  of  1  June 

2012 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  1161/2012  of  7 

December 2012 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  1186/2012  of  11 

December 2012 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  1191/2012  of  12 

December 2012 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  59/2013  of  23 

January 2013 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  115/2013  of  8 

February 2013 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  116/2013  of  8 

February 2013 

–  Amended  by  Commission  Implementing  Regulation  (EU)  No  394/2013  of  29 

April 2013 

–  Amended by Commission Implementing Regulation (EU) No 406/2013 of 2 May 

2013 

8.  Commission Regulation (EU) No 488/2012 of 8 June 2012 amending Regulation (EC) No 
658/2007  concerning  financial  penalties  for  infringement  of  certain  obligations  in 
connection with marketing authorisations granted under Regulation (EC) No 726/2004 of 
the European Parliament and of the Council (OJ L 150, 9.6.2012, p. 68–70) 

9.  Commission  Regulation  (EC)  No  1234/2008  of  24  November  2008  concerning  the 
examination of variations to the terms of marketing authorisations for medicinal products 
for human use and veterinary medicinal products 

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–  Amended by Commission Regulation (EU) No 712/2012 of 3 August 2012 amending 
Regulation (EC) No 1234/2008 concerning the examination of variations to the terms 
of  marketing  authorisations  for  medicinal  products  for  human  use  and  veterinary 
medicinal products (Official Journal L 209, 4.8.2012, p. 4 - 14). 

10. Commission  Implementing  Regulation  (EU)  No 198/2013  of  7 March  2013  on  the 
selection of a symbol for the purpose of identifying medicinal products for human use that 
are subject to additional monitoring (Official Journal L 65, 8/3/2013, p. 17–18) 

11. Directive  2010/63/EU  of  the  European  Parliament  and  of  the  Council  of  22 September 
2010  on  the  protection  of  animals  used  for  scientific  purposes  (Official  Journal,  L  276, 
20.10.2010, p. 33–79) 

12. Regulation  (EC)  No  469/2009  of  the  European Parliament and of the Council  of 6  May 
2009 concerning the supplementary protection certificate for medicinal products (Official 
Journal L 152, 16.6.2009, p. 1–10) 

13. Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on 
the colouring matters which may be added to medicinal products (Official Journal L 109, 
30.4.2009, p. 10–13) 

14. Regulation  (EC)  No  1394/2007  of  the  European  Parliament  and  of  the  Council  of  13 
November  2007  on  advanced  therapy  medicinal  products  and  amending  Directive 
2001/83/EC  and  Regulation  (EC)  No  726/2004  (Official  Journal  L  324,  10.12.2007,  p. 
121–137) 

–  Amended by Regulation (EU) No 1235/2010 of the European Parliament and of the 

Council of 15 December 2010 

15. Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties 
for  infringement  of  certain  obligations  in  connection  with  marketing  authorisations 
granted  under  Regulation  (EC)  No 726/2004  of  the  European  Parliament  and  of  the 
Council (Official Journal L 155, 15.6.2007, p. 10–19) 

16. Regulation  (EC)  No  1901/2006  of  the  European  Parliament  and  of  the  Council  of  12 
December 2006 on medicinal products for paediatric use and amending Regulation (EEC) 
No  1768/92,  Directive  2001/20/EC,  Directive  2001/83/EC  and  Regulation  (EC)  No 
726/2004 (Official Journal L 378, 27.12.2006, p. 1–19) 

–  Amended  by  Regulation  (EC)  No  469/2009  of  the  European  Parliament  and  of  the 

Council of 6 May 2009 

–  Amended by Regulation (EC) No 1902/2006 of the European Parliament and of the 

Council of 20 December 2006 

17. Commission  Regulation  (EC)  No  507/2006  of  29  March  2006  on  the  conditional 
marketing authorisation for medicinal products for human use falling within the scope of 
Regulation  (EC)  No  726/2004  of  the  European  Parliament  and  of  the  Council  (Official 
Journal L 92, 30.3.2006, p. 6–9) 

18. Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant 
to  Regulation  (EC)  No 726/2004  of  the  European  Parliament  and  of  the  Council,  rules 
regarding  the  payment  of  fees  to,  and  the  receipt  of  administrative  assistance  from,  the 
European  Medicines  Agency  by  micro,  small  and  medium-sized  enterprises  (Official 
Journal L 329, 16.12.2005, p. 4–7) 

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19. Commission  Directive  2005/28/EC  of  8  April  2005  laying  down  principles  and  detailed 
guidelines  for  good  clinical  practice  as  regards  investigational  medicinal  products  for 
human  use,  as  well  as  the  requirements  for  authorisation  of  the  manufacturing  or 
importation of such products(Official Journal L 91, 9.4.2005, p. 13–19) 

20. Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 
on  the  harmonisation  of  laws,  regulations  and  administrative  provisions  relating  to  the 
application  of  the  principles  of  good  laboratory  practice  and  the  verification  of  their 
applications for tests on chemical substances ( Official Journal L 50, 20.2.2004, p. 44–59) 

–  Amended  by  Regulation  (EC)  No  219/2009  of  the  European  Parliament  and  of  the 

Council of 11 March 2009 

21. Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 
on  the  inspection  and  verification  of  good  laboratory  practice  (GLP)  (Official  Journal  L 
50, 20.2.2004, p. 28–43) 

–  Amended  by  Regulation  (EC)  No  219/2009  of  the  European  Parliament  and  of  the 

Council of 11 March 2009 

22. Commission  Directive  2003/94/EC  of  8  October  2003  laying  down  the  principles  and 
guidelines of good manufacturing practice in respect of medicinal products for human use 
and investigational medicinal products for human use (Official Journal L 262, 14.10.2003, 
p. 22–26) 

23. Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the 
European Union of certain key medicines ( Official Journal L 135, 3.6.2003, p. 5–11) 

–  Amended by Commission Regulation (EC) No 1876/2004 of 28 October 2004  

–  Amended by Commission Regulation (EC) No 1662/2005 of 11 October 2005 

24. Regulation  (EC)  No  141/2000  of  the  European  Parliament  and  of  the  Council  of  16 

December 1999 on orphan medicinal products (Official Journal L 18, 22.1.2000) 

–  Amended  by  Regulation  (EC)  No  596/2009  of  the  European  Parliament  and  of  the 

Council of 18 June 2009 

25. Commission  Directive  91/412/EEC  of  23  July  1991  laying  down  the  principles  and 
guidelines  of  good  manufacturing  practice  for  veterinary  medicinal  products 
(Official  Journal  L  228  du  17.8.1991,  p.  70–73)  Directive  91/412/CEE  de  la 
Commission,  du  23  juillet  1991,  établissant  les  principes  et  lignes  directrices  de  bonnes 
pratiques  de  fabrication  pour  les  médicaments  vétérinaires  (Official  Journal  L  228  du 
17.8.1991, p. 70–73) 

26. Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of 
measures  regulating  the  prices  of  medicinal  products  for  human  use  and  their 
inclusion in the scope of national health insurance systems. (Official Journal L 40 of 
11.2.1989, p. 8–11) Directive 89/105/CEE du Conseil du 21 décembre 1988 concernant la 
transparence des mesures régissant la fixation des prix des médicaments à usage humain et 
leur  inclusion  dans  le  champ  d'application  des  systèmes  d'assurance-maladie  (Official 
Journal L 40 of 11.02.1989, p. 8–11) 

27. 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 

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conduct  of  clinical  trials  on  medicinal  products  for  human  use  (Official  Journal  L 
121 of 1.5.2001, p. 34-44) 

–  - Amended by Regulation (EC) No 1901/2006 of the European Parliament and of 

the Council of 12 December 2006 (OJ L 378, 27.12.2006, p. 1); 

–  - Amended by Regulation (EC) No 596/2009 of the European Parliament and of 

the Council of 18 June 2009 (OJ L 188, 18.7.2009, p. 14). 

28. 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  of  8.2.2003,  p.  30)  (only  as  regards  insofar  as  it  is 
applicable  to  the  collection  and  testing  of  blood  and  blood  components  used  as 
starting materials for manufacturing medicinal products). 

29. Directive  2004/23/EC  of  the  European  Parliament  and  of  the  Council  of  31  March 
2004  on  setting  standards  of  quality  and  safety  for  the  donation,  procurement, 
resting, processing, preservation, storage and distribution of human tissues and cells 
(OJ  L  102,  7.4.2004,  p.48)  (only  as  regards  insofar  as  it  is  applicable  tothe 
procurement, donation, coding and testing of tissue and cells, as well as the coding of 
donations  and  packaging  thereof,  used  as  starting  materials  for  advanced  therapy 
medicinal products as referred to in Regulation (EC) No 1394/2007 of the European 
Parliament and of the Council) 

II. COSMETICS 

ACTS REFERRED TO  

1.  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: 

–  Council Directive 79/661/EEC of 24 July 1979 (OJ L 192, 31.7.1979, p.35) 

–  Commission Directive 82/147/EEC of 11 February 1982 (OJ L 63, 6.3.1982, p. 26) 

–  Council Directive 82/368/EEC of 17 May 1982 (OJ L 167, 15.6.1982, p. 1) 

–  Commission Directive 83/191/EEC of 30 March 1983 (OJ L 109, 26.4.1983, p.25) 

–  Commission Directive 83/341/EEC of 29 June 1983 (OJ L 188, 13.7.1983, p. 15) 

–  Commission  Directive  83/496/EEC  of  22  September  1983  (OJ  L  275,  8.10.1983,  p. 

20) 

–  Council Directive 83/574/EEC of 26 October 1983 (OJ L 332, 28.11.1983, p. 38) 

–  Commission Directive 84/415/EEC of 18 July 1984 (OJ L 228, 25.8.1984, p. 31) 

–  Commission Directive 85/391/EEC of 16 July 1985 (OJ L 224, 22.8.1985, p.40) 

–  Commission Directive 86/179/EEC of 28 February 1986 (OJ L 138, 24.5.1986, p. 40) 

–  Commission Directive 86/199/EEC of 26 March 1986 (OJ L 149, 3.6.1986, p. 38) 

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–  Commission Directive 87/137/EEC of 2 February 1987 (OJ L 56, 26.2.1987, p. 20) 

–  Commission Directive 88/233/EEC of 2 March 1988 (OJ L 105, 26.4.1988, p.11) 

–  Council Directive 88/667/EEC of 21 December 1988 (OJ L 382, 31.12.1988, p.46)  

–  Commission Directive 89/174/EEC of 21 February 1989 (OJ L 64, 8.3.1989, p. 10) 

–  Council Directive 89/679/EEC of 21 December 1989 (OJ L 398, 30.12.1989, p.25) 

–  Commission Directive 90/121/EEC of 20 February 1990 (OJ L 71, 17.3.1990, p. 40) 

–  Commission Directive 91/184/EEC of 12 March 1991 (OJ L 91, 12.4.1991, p. 59) 

–  Commission Directive 92/8/EEC of 18 February 1992 (OJ L 70, 17.3.1992, p. 23) 

–  Commission Directive 92/86/EEC of 21 October 1992 (OJ L 325, 11.11.1992, p. 18) 

–  Council Directive 93/35/EEC of 14 June 1993 (OJ L 151, 23.6.1993, p. 32) 

–  Commission Directive 93/47/EEC of 22 June 1993 (OJ L 203, 13.8.1993, p. 24) 

–  Commission Directive 94/32/EC of 29 June 1994 (OJ L 181, 15.7.1994, p. 31) 

–  Commission Directive 95/34/EC of 10 July 1995 (OJ L 167, 18.7.1995, p. 19) 

–  Commission Directive 96/41/EC of 25 June 1996 (OJ L 1988.8.1996, p. 36) 

–  Commission Directive 97/1/EC of 10 January 1997 (OJ L 16, 18.1.1997, p. 85) 

–  Commission Directive 97/18/EC of 17 April l997 (OJ L 114, 1.5.1997, p. 43) 

–  Commission Directive 97/45/EC of 14 July 1997 (OJ L 196, 24.7.1997, p. 77) 

–  Commission Directive 98/16/EC of 5 March 1998 (OJ L 77, 14.3.1998, p. 44) 

–  Commission Directive 98/62/EC of 3 September 1998 (OJ L 253, 15.9.1998, p. 20) 

–  Commission Directive 2000/6/EC of 29 February 2000 (OJ L 56, 1.3.2000, p. 42) 

–  Commission Directive 2000/11/EC of 10 March 2000 (OJ L 65, 14.3.2000, p. 22) 

–  Commission Directive 2000/41/EC of 19 June 2000 (OJ L 145, 20.6.2000, p. 25) 

–  Commission Directive 2002/34/EC of 15 April 2002 (OJ L 102, 18.4.2002, p. 19) 

–  Commission Directive 2003/1/EC of 6 January 2003 (L 5, 10.1.2003, p. 14) 

–  Commission Directive 2003/16/EC of 19 February 2003 (OJ L 46, 20.2.2003, p. 24) 

–  Directive 2003/15/EC of the European Parliament and of the Council of 27 February 

2003 (OJ L 66, 11.3.2003, p. 26) 

–  Commission Directive 2003/80/EC of 5 September 2003 (OJ L 224, 6.9.2003, p. 27) 

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–  Commission  Directive  2003/83/EC  of  24  September  2003  (OJ  L  238,  25.9.2003,  p. 

23) 

–  Commission Directive 2004/87/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 4) 

–  Commission Directive 2004/88/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 5) 

–  Commission  Directive  2004/94/EC  of  15  September  2004  (OJ  L  294,  17.9.2004,  p. 

28) 

–  Commission  Directive  2004/93/EC  of  21  September  2004  (OJ  L  300,  25.9.2004,  p. 

13) 

–  Commission Directive 2005/9/EC of 28 January 2005 (OJ L 27, 29.1.2005, p. 46) 

–  Commission Directive 2005/42/EC of 20 June 2005 (OJ L 158, 21.6.2005, p. 17) 

–  Commission Directive 2005/52/EC of 9 September 2005 (OJ L 234, 10.9.2005, p. 9) 

–  Commission Directive 2005/80/EC of 21 November 2005 (OJ L 303, 22.11.2005, p. 

32) 

–  Commission Directive 2006/65/EC of 19 July 2006 (OJ L 198, 20.7.2006, p. 11) 

–  Commission  Directive  2006/78/EC  of  29  September  2006  (OJ  L  271,  30.9.2006,  p. 

56) 

–  Commission Directive 2007/1/EC of 29 January 2007 (OJ L 25, 1.2.2007, p. 9) 

–  Commission Directive 2007/17/EC of 22 March 2007 (OJ L 82, 23.3.2007, p. 27) 

–  Commission Directive 2007/22/EC of 17 April 2007 (OJ L 101, 18.4.2007, p. 11) 

–  Commission Directive 2007/53/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 19) 

–  Commission Directive 2007/54/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 21) 

–  Commission Directive 2007/67/EC of 22 November 2007 (OJ L 305, 23.11.2007, p. 

22) 

–  Commission Directive 2008/14/EC of 15 February 2008 (OJ L 42, 16.2.2008, p. 43) 

–  Commission Directive 2008/42/EC of 3 April 2008 (OJ L 93, 4.4.2008, p. 13) 

–  Commission  Directive  2008/88/EC  of  23  September  2008  (OJ  L  256,  24.9.2008,  p. 

12) 

–  Commission Directive 2008/123/EC of 18 December 2008 (OJ L 340, 19.12.2008, p. 

71) 

–  Directive  2008/112/EC  of  the  European  Parliament  and  of  the  Council  of  16 

December 2008 (L 345, 23.12.2008, p. 68) 

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–  Commission Directive 2009/6/EC of 4 February 2009 (L 36, 5.2.2009, p. 15) 

–  Commission Directive 2009/36/EC of 16 April 2009 (OJ L 98, 17.4.2009, p. 31) 

–  Commission Directive 2009/129/EC of 9 October 2009 (L 267, 10.10.2009, p. 18) 

–  Commission Directive 2009/130/EC of 12 October 2009 (L 268, 13.10.2009, p. 5) 

–  Commission Directive 2009/134/EC of 28 October 2009 (L 282, 29.10.2009, p. 15) 

–  Commission Directive 2009/159/EU of 16 December 2009 (OJ L 336, 18.12.2009, p. 

29) 

–  Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 

November 2009 (OJ L 342, 22.12.2009, p. 59) 

–  Commission Directive 2009/164/EU of 22 December 2009 (OJ L 344, 23.12.2009, p. 

41) 

–  Commission Directive 2010/3/EU of 1 February 2010 (OJ L 29, 2.2.2010, p. 5) 

–  Commission Directive 2010/4/EU of 8 February 2010 (OJ L 36, 9.2.2010, p. 21) 

–  Commission Directive 2011/59/EU of 13 May 2011 (OJ L 125, 14.5.2011, p. 17) 

–  Council Directive 2011/84/EU of 20 September 2011 (OJ L 283, 29.10.2011, p. 36) 

–  Commission  Implementing  Directive  2012/21/EU  of  2  August  2012  (OJ  L  208, 

3.8.2012, p. 8)  

Directive 76/768/EEC will be repealed with effect from 11 July 2013 and will be replaced by: 
Regulation  (EC)  No  1223/2009  of  the  European  Parliament  and  of  the  Council  of  30 
November 2009 on cosmetic products. 

2.  Regulation  (EC)  No  1223/2009  of  the  European  Parliament  and  of  the  Council  of  30 
November 2009 on cosmetic products. (OJ L 342, 22.12.2009, p.59), as amended by: 

–  Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, 
III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and 
of the Council on cosmetic products (OJ L 114, 25.4.2013, p. 1) 

–  Commission Regulation (EU) No 483/2013 of 24 May 2013 amending Annex III 
to Regulation (EC) No 1223/2009 of the European Parliament and of the Council 
on cosmetic products (OJ L 139, 25.5.2013, p.8) 

3.  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: 

–  Commission Directive 87/143/EEC of 10 February 1987 (OJ L 57, 27.2.1987, p. 56). 

4.  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: 

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–  Commission Directive 90/207/EEC of 4 April 1990 (OJ L 108, 28.4.1990, p. 92). 

5.  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). 

6.  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). 

7.  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). 

8.  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).  

–  Amended  by  Commission  Directive  2006/81/EC  of  23  October  2006  (OJ  L  362, 

20.12.2006, p. 92) 

–  Amended by Act concerning the conditions of accession of the Czech Republic, the 
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of 
Lithuania,  the  Republic of Hungary, the  Republic of Malta,  the  Republic of Poland, 
the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties 
on which the European Union is founded (OJ L 236, 23.9.2003, p.33) 

Commission Directive 95/17/EC This dDirective will be repealed with effect from 11 July 
2013. 

9.  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). 

10. 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). 

11. Commission  Decision  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––) 

–  Amended by Commission Decision 2006/257/EC, (OJ L 97, 5.4.2006, p. 1) 

III. MEDICAL DEVICES 

ACTS REFERRED TO 

1.  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: 

–  Amended by Council Directive 93/42/EEC of 14 June 1993 (OJ L 169, 12.7.1993, p. 

1). 

–  Amended  by  Council  Directive  93/68/EEC  of  22  July  1993  (OJ  L  220,  30.8.1993, 

p.1). 

–  Amended by Regulation (EC) No 1882/2003 of the European Parliament  and  of the 

Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). 

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–  Amended by Directive 2007/47/EC of the European Parliament and of the Council of 

5 September 2007 (OJ L 247, 21.09.2007, p. 21).  

2.  Council  Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices  (OJ  L  169, 

12.7.1993, p. 1). 

–  Amended by 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). 

–  Amended by 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). 

–  Amended by 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). 

–  Amended by Regulation (EC) No 1882/2003 of the European Parliament and of the 

Council of 29 September 2003 (OJ L 284, 31.10.2003, p.1). 

–  Amended by Regulation (EC) No 1882/2003 of the European Parliament and of the 

Council of 29 September 2003 (OJ L 284, 31.10.2003, p.1). 

–  Amended by Directive 2007/47/EC of the European Parliament and of the Council of 

5 September 2007 (OJ L 247, 21.9.2007, p.21). 

3.  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).  

–  Amended by Regulation (EC) No 1882/2003 of the European Parliament and of the 

Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). 

–  Amended  by  Regulation  (EC)  No  596/2009  of  the  European  Parliament  and  of  the 

Council of 18 June 2009 (OJ L 188, 18.07.2009, p.14). 

–  Amended by Commission Directive 2011/100/EU of 20 December 2011 (OJ L 341, 

22.12.2011, p. 50). 

4.  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) 

–  Amended  by  Commission  Decision  2009/108/EC  of  3  February  2009  (OJ  L  39, 

10.02.2009, p.34). 

–  Amended  by  Commission  Decision  2009/886/EC  of  27  November  2009  (OJ  L  318, 

4.12.2009, p.25).  

–  Amended  by  Commission  Decision  2011/869/EU  of  20  December  2011  (OJ  L  341, 

22.12.2011, p.63).  

5.  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). 

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6.  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). 

7.  Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee 
and  shoulder  joint  replacements  in  the  framework  of  Council  Directive  93/42/EEC 
concerning medical devices (OJ L 210, 12.08.2005, p.41). 

8.  Commission  Decision  2010/227/EU  of  19  April  2010  on  the  European  Databank  on 

Medical Devices (Eudamed) (OJ L102, 23.04.2010, p.45).  

9.  Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for 

use of medical devices (OJ L72, 10.03.2012, p.28). 

10. Commission  Regulation  (EU)  No  722/2012  of  8  August  2012  concerning  particular 
requirements  as  regards  the  requirements  laid  down  in  Council  Directives  90/385/EEC 
and  93/42/EEC  with  respect  to  active  implantable  medical  devices  and  medical  devices 
manufactured utilising tissues of animal origin (OJ 212, 9.08.2012, p.3)." 

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