Regulation 2004/726 - Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

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This page contains a limited version of this dossier in the EU Monitor.

Contents

  1. Current status
  2. Key information
  3. Key dates
  4. Legislative text
  5. 32004R0726
  6. Original proposal
  7. Sources and disclaimer
  8. Full version
  9. EU Monitor

1.

Current status

This regulation has been published on April 30, 2004 and entered into force on May 20, 2004.

2.

Key information

official title

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
 
Legal instrument Regulation
Number legal act Regulation 2004/726
Original proposal COM(2001)404 EN
CELEX number261 32004R0726

3.

Key dates

Document 31-03-2004
Publication in Official Journal 30-04-2004; Special edition in Czech: Chapter 13 Volume 034,Special edition in Lithuanian: Chapter 13 Volume 034,Special edition in Maltese: Chapter 13 Volume 034,Special edition in Estonian: Chapter 13 Volume 034,Special edition in Croatian: Chapter 13 Volume 031,OJ L 136, 30.4.2004,Special edition in Slovak: Chapter 13 Volume 034,Special edition in Polish: Chapter 13 Volume 034,Special edition in Latvian: Chapter 13 Volume 034,Special edition in Romanian: Chapter 13 Volume 044,Special edition in Bulgarian: Chapter 13 Volume 044,Special edition in Slovenian: Chapter 13 Volume 034,Special edition in Hungarian: Chapter 13 Volume 034
Effect 20-05-2004; Entry into force Date pub. + 20 See Art 90
20-11-2005; Partial application See Art 90
20-05-2008; Partial application See Art 90
End of validity 31-12-9999

4.

Legislative text

Avis juridique important

|

5.

32004R0726

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 (Text with EEA relevance)

Official Journal L 136 , 30/04/2004 P. 0001 - 0033

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 and Article 152(4)(b) thereof,

Having regard to the proposal from the Commission(1),

Having regard to the Opinion of the European Economic and Social Committee(2),

After consulting the Committee of the Regions,

In accordance with the procedure laid down in Article 251 of the Treaty(3),

Whereas:

  • (1) 
    Article 71 of 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(4) provides that, within six years of the entry into force of the Regulation, the Commission is to publish a general report on the experience acquired as a result of the operation of the procedures laid down in the Regulation.
  • (2) 
    In the light of the Commission's report on the experience gained, it has proved necessary to improve the operation of the authorisation procedures for the placing of medicinal products on the market in the Community and to amend certain administrative aspects of the European Agency for the Evaluation of Medicinal Products. In addition, the name of that Agency should be simplified and changed to the European Medicines Agency, (hereinafter referred to as the "Agency").
  • (3) 
    It emerges from the conclusions of that report that the amendments to be made to the centralised procedure set up by Regulation (EEC) No 2309/93 consist of corrections to some of the operating procedures and adaptations to take account of the probable development of science and technology and the future enlargement of the European Union. It also emerges from the report that the general principles previously established which govern the centralised procedure should be maintained.
  • (4) 
    Moreover, since the European Parliament and the Council have adopted Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use(5) and Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products(6), all the references to the codified Directives in Regulation (EEC) No 2309/93 should be updated.
  • (5) 
    For the sake of clarity, it is necessary to replace the said Regulation with a new Regulation.
  • (6) 
    It is appropriate to preserve the Community mechanism set up by the repealed Community legislation for concertation prior to any national decision relating to a high-technology medicinal product.
  • (7) 
    Experience gained since the adoption of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology(7) has shown that it is necessary to create a centralised authorisation procedure that is compulsory for high-technology medicinal products, particularly those resulting from biotechnical processes, in order to maintain the high level of scientific evaluation of these medicinal products in the European Union and thus to preserve the confidence of patients and the medical...

More

This text has been adopted from EUR-Lex.

6.

Original proposal

 

7.

Sources and disclaimer

For further information you may want to consult the following sources that have been used to compile this dossier:

This dossier is compiled each night drawing from aforementioned sources through automated processes. We have invested a great deal in optimising the programming underlying these processes. However, we cannot guarantee the sources we draw our information from nor the resulting dossier are without fault.

 

8.

Full version

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The full version is available for registered users of the EU Monitor by ANP and PDC Informatie Architectuur.

9.

EU Monitor

The EU Monitor enables its users to keep track of the European process of lawmaking, focusing on the relevant dossiers. It automatically signals developments in your chosen topics of interest. Apologies to unregistered users, we can no longer add new users.This service will discontinue in the near future.

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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 25. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
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    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
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    OJ L

     
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    COM(2001) .... final.

     
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    OJ L

     
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    OJ L

     
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    OJ L 15, 17.1.1987, p. 38; Directive repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40).

     
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    OJ L 18, 22.1.2000, p. 1.

     
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    OJ L 106, 17.4.2001, p. 1; Directive last amended by Regulation (EC) No .../2002 of the European Parliament and of the Council
     
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    OJ L 184, 17.7.1999, p. 23.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
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    OJ L 117, 8.5.1990, p. 15.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 45. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 46. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 47. 
    OJ L 18, 22.1.2000, p. 1.

     
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    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 51. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
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    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 53. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 54. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 55. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 56. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 57. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 58. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 59. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 61. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
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    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 63. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 64. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 65. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 66. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 67. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 68. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
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    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
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    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
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    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 96. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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  • 109. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 110. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
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  • 127. 
    Taken here in broader sense as meaning any new active substance.

     
  • 128. 
    Currently in this Member State the period of data protection will not be applied beyond the date of expiry of the patent. This link will cease to exist under the proposed amendment.

     
  • 129. 
    See note 2.

     
  • 130. 
    See note 2.

     
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    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 132. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 133. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 134. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
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    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
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    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 144. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 145. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 146. 
    Within the meaning of Council Decision 87/373/EEC, OJ L 197, 18.7.1987, p. 33.

     
  • 147. 
    Five opinions by qualified majority, 257 unanimous opinions on 1 May 2001.

     
  • 148. 
    253 opinions given by written procedure out of a total of 262 opinions given on 1 May 2001 in the field of medicinal products for human use.

     
  • 149. 
    OJ L 184, 17.7.1999, p. 23.

     
  • 150. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 151. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 152. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 153. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 154. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 155. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 156. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
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    COM(2000) 716 final; OJ C 96 E, 27.3.2001, p. 247.

     
  • 158. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
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    OJ L

     
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    OJ L

     
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    OJ L

     
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    OJ L

     
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    OJ L 214, 24.8.1993, p. 1; Regulation as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p.

    7).

     
  • 164. 
    COM(2001) .... final.

     
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    OJ L

     
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    OJ L

     
  • 167. 
    OJ L 15, 17.1.1987, p. 38; Directive repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40).

     
  • 168. 
    OJ L 18, 22.1.2000, p. 1.

     
  • 169. 
    OJ L 106, 17.4.2001, p. 1; Directive last amended by Regulation (EC) No .../2002 of the European Parliament and of the Council
     
  • 170. 
    OJ L 184, 17.7.1999, p. 23.

     
  • 171. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 172. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 173. 
    OJ L 117, 8.5.1990, p. 15.

     
  • 174. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 175. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 176. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 177. 
    OJ L 18, 22.1.2000, p. 1.

     
  • 178. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 179. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 180. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 181. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 182. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 183. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 184. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 185. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 186. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 187. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 188. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 189. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 190. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 191. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 192. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 193. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 194. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 195. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 196. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 197. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 198. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 199. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 200. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 201. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 202. 
    OJ L 224, 18.8.1990, p. 1.

     
  • 203. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 204. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 205. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 206. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 207. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 208. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 209. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 210. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 211. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 212. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 213. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 214. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 215. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 216. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 217. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 218. 
    OJ L 125, 23.5.1996, p. 10.

     
  • 219. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 220. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 221. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 222. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 223. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 224. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 225. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 226. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 227. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 228. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 229. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 230. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 231. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 232. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 233. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 234. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 235. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 236. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 237. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 238. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 239. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 240. 
    OJ L 15, 17.1.1987, p. 38. This Directive was repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40) when the Agency and the centralised procedure were created.

     
  • 241. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 242. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 243. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 244. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 245. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 246. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 247. 
    OJ L 121, 1.5.2001, p. 34.

     
  • 248. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceuticals Products.

     
  • 249. 
    OJ L

     
  • 250. 
    OJ L

     
  • 251. 
    International Conference on Harmonisation of Technical Requirements for the Registration of Veterinary Pharmaceutical Products.

     
  • 252. 
    Evaluation of the operation of Community procedures for the authorisation of medicinal products, CMS Cameron McKenna and Andersen Consulting, October 2000.

     
  • 253. 
    See 'Global competitiveness in Pharmaceuticals', Report prepared for the Enterprise DG of the European Commission by Gambardella A, Orsenigol and Pammolli F., November 2000.

     
  • 254. 
    The pharmaceutical industry in figures, European Federation of Pharmaceutical Industries Associations, November 2000.

     
  • 255. 
    Generic Medicines: How to ensure their effective contribution to health care, Euro Health Vol 2 No 3, September 1996.

     
  • 256. 
    Fountain R and Thurman D: Animal Health Market to Face Opportunities and Challenges in 98, Feedstuffs Vol. 69 No 48, November 1997.

     
  • 257. 
    Taken here in broader sense as meaning any new active substance.

     
  • 258. 
    Currently in this Member State the period of data protection will not be applied beyond the date of expiry of the patent. This link will cease to exist under the proposed amendment.

     
  • 259. 
    See note 2.

     
  • 260. 
    See note 2.

     
  • 261. 
    Deze databank van de Europese Unie biedt de mogelijkheid de actuele werkzaamheden (workflow) van de Europese instellingen (Europees Parlement, Raad, ESC, Comité van de Regio's, Europese Centrale Bank, Hof van Justitie enz.) te volgen. EURlex volgt alle voorstellen (zoals wetgevende en begrotingsdossiers) en mededelingen van de Commissie, vanaf het moment dat ze aan de Raad of het Europees Parlement worden voorgelegd.
     
  • 262. 
    EUR-lex provides an overview of the proposal, amendments, citations and legality.