COM(2001)404-2 - Amendment of Directive 2001/83/EC on the EC code relating to medicinal products for human use

Please note

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

Contents

  1. Key information
  2. Key dates
  3. Related information
  4. Resulting legislation
  5. Full version
  6. EU Monitor

1.

Key information

official title

Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
 
Legal instrument Directive
Decision making procedure ordinary legislative procedure (COD)
reference by COM-number211 COM(2001)404 EN
Additional COM-numbers COM(2003)163; SEC(2003)1082; COM(2004)124
procedure number213 2001/0253(COD)
CELEX number214 52001PC0404(02)

2.

Key dates

Document 26-11-2001
Online publication 26-11-2001
Decision 31-03-2004; Richtlijn 2004/27
Publication in Official Journal215 30-04-2004; Special edition in Maltese: Chapter 13 Volume 034,Special edition in Romanian: Chapter 13 Volume 044,Special edition in Polish: Chapter 13 Volume 034,Special edition in Croatian: Chapter 13 Volume 061,Special edition in Lithuanian: Chapter 13 Volume 034,Special edition in Slovenian: Chapter 13 Volume 034,Special edition in Bulgarian: Chapter 13 Volume 044,Special edition in Slovak: Chapter 13 Volume 034,Special edition in Estonian: Chapter 13 Volume 034,OJ L 136, 30.4.2004,Special edition in Czech: Chapter 13 Volume 034,Special edition in Latvian: Chapter 13 Volume 034,Special edition in Hungarian: Chapter 13 Volume 034

3.

Related information

4.

Resulting legislation

 

5.

Full version

This page is also available in a full version containing the latest state of affairs, the summary of the European Parliament Legislative Observatory, the legal basis, the legal context, other dossiers related to the dossier at hand, the stakeholders involved (e.g. European Commission directorates-general, European Parliament committees, Council configurations and even individual EU Commissioners and Members of the European Parliament) and finally documents of the European Parliament, the Council of Ministers and the European Commission.

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

6.

EU Monitor

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  • 1. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 2. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 3. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 4. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 5. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 6. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 7. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 8. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 9. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 10. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 11. 
    OJ L 184, 17.7.1999, p. 23.

     
  • 12. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 13. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 14. 
    OJ C

     
  • 15. 
    OJ C

     
  • 16. 
    OJ C

     
  • 17. 
    OJ C

     
  • 18. 
    OJ L

     
  • 19. 
    OJ L 214, 21.8.1993, p. 1; Regulation as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).

     
  • 20. 
    COM(2001)....final

     
  • 21. 
    OJ L 184, 17.7.1999, p. 23.

     
  • 22. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 23. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 24. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 25. 
    Generic Medicines: How to ensure their effective contribution to healthcare, Euro Health Vol. 2 No 3, September 1996.

     
  • 26. 
    Generic Medicines: How to ensure their effective contribution to healthcare, Euro Health Vol. 2 No 3, September 1996.

     
  • 27. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 28. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 29. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 30. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 31. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 32. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 33. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 34. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 35. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 36. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 37. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 38. 
    OJ C

     
  • 39. 
    OJ C

     
  • 40. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

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

     
  • 42. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 43. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 44. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 45. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 46. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 47. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 48. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 49. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 50. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 51. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 52. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 53. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 54. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 55. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 56. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 57. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 58. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 59. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 60. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 61. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 62. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 63. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 64. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 65. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 66. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 67. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 68. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 69. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 70. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 71. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 72. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 73. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 74. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 75. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 76. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 77. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 78. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 79. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 80. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 81. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 82. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 83. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 84. 
    OJ C

     
  • 85. 
    Since the two authorisation procedures in use at Community level (centralised - decentralised) are inextricably linked and several parts of the legislation on human medicinal products are identical to that on veterinary medicinal products, it was considered appropriate to draw up a global impact sheet, which gives an overview of the effects which the adoption of the three legislative drafts will have. The same impact sheet is therefore annexed to each of the three texts.

     
  • 86. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 87. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 88. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 89. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 90. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 91. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 92. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 93. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 94. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 95. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 96. 
    Since the two authorisation procedures in use at Community level (centralised - decentralised) are inextricably linked and several parts of the legislation on human medicinal products are identical to that on veterinary medicinal products, it was considered appropriate to draw up a global impact sheet, which gives an overview of the effects which the adoption of the three legislative drafts will have. The same impact sheet is therefore annexed to each of the three texts.

     
  • 97. 
    Evaluation of the operation of Community procedures for the authorisation of medicinal products, CMS Cameron McKenna and Anderson Consulting, October 2000.

     
  • 98. 
    See 'Global Competitiveness in Pharmaceuticals', Report prepared for DG Enterprise of the European Commission by Gambardella A, Orsenigol and Pammolli F, November 2000.

     
  • 99. 
    The pharmaceutical industry in figures, European Federation of Pharmaceutical Industries Associations, 2000 Edition.

     
  • 100. 
    Generic Medicines: How to ensure their effective contribution to healthcare, Euro Health Vol. 2 No 3, September 1996.

     
  • 101. 
    Fountain R and Thurman D Animal Health Market to Face Opportunities and Challenges in 98, Feed Stuffs Vol. 69 No 48, November 1997.

     
  • 102. 
    Taken here in a broader sense as meaning any new active substance.

     
  • 103. 
    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 amendments.

     
  • 104. 
    See note 3.

     
  • 105. 
    See note 3.

     
  • 106. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 107. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 108. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 109. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 110. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 111. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 112. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 113. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 114. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 115. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 116. 
    OJ L 184, 17.7.1999, p. 23.

     
  • 117. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 118. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 119. 
    OJ C

     
  • 120. 
    OJ C

     
  • 121. 
    OJ C

     
  • 122. 
    OJ C

     
  • 123. 
    OJ L

     
  • 124. 
    OJ L 214, 21.8.1993, p. 1; Regulation as amended by Commission Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p.

    7).

     
  • 125. 
    COM(2001)....final

     
  • 126. 
    OJ L 184, 17.7.1999, p. 23.

     
  • 127. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 128. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 129. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 130. 
    Generic Medicines: How to ensure their effective contribution to healthcare, Euro Health Vol. 2 No 3, September 1996.

     
  • 131. 
    Generic Medicines: How to ensure their effective contribution to healthcare, Euro Health Vol. 2 No 3, September 1996.

     
  • 132. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 133. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 134. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 135. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 136. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 137. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 138. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 139. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 140. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 141. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 142. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 143. 
    OJ C

     
  • 144. 
    OJ C

     
  • 145. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 146. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 147. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 148. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 149. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 150. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 151. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 152. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 153. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 154. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 155. 
    The national procedure still applies to medicinal products strictly confined to a national market.

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

     
  • 157. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 158. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 159. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 160. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 161. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 162. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 163. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 164. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 165. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 166. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 167. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 168. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 169. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 170. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 171. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 172. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 173. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 174. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 175. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 176. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 177. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 178. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 179. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 180. 
    OJ C 218, 31.7.2000, p. 10.

     
  • 181. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 182. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

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

     
  • 184. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 185. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 186. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 187. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 188. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 189. 
    OJ C

     
  • 190. 
    Since the two authorisation procedures in use at Community level (centralised - decentralised) are inextricably linked and several parts of the legislation on human medicinal products are identical to that on veterinary medicinal products, it was considered appropriate to draw up a global impact sheet, which gives an overview of the effects which the adoption of the three legislative drafts will have. The same impact sheet is therefore annexed to each of the three texts.

     
  • 191. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 192. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 193. 
    International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Pharmaceuticals.

     
  • 194. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 195. 
    Within the meaning of Council Decision 87/373/EEC (OJ L 197, 18.7.1987, p. 33).

     
  • 196. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 197. 
    The national procedure still applies to medicinal products strictly confined to a national market.

     
  • 198. 
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

     
  • 199. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 200. 
    Directives 93/39/EEC, 93/40/EEC, 93/41/EEC and Regulation (EEC) No 2309/93.

     
  • 201. 
    Since the two authorisation procedures in use at Community level (centralised - decentralised) are inextricably linked and several parts of the legislation on human medicinal products are identical to that on veterinary medicinal products, it was considered appropriate to draw up a global impact sheet, which gives an overview of the effects which the adoption of the three legislative drafts will have. The same impact sheet is therefore annexed to each of the three texts.

     
  • 202. 
    Evaluation of the operation of Community procedures for the authorisation of medicinal products, CMS Cameron McKenna and Anderson Consulting, October 2000.

     
  • 203. 
    See 'Global Competitiveness in Pharmaceuticals', Report prepared for DG Enterprise of the European Commission by Gambardella A, Orsenigol and Pammolli F, November 2000.

     
  • 204. 
    The pharmaceutical industry in figures, European Federation of Pharmaceutical Industries Associations, 2000 Edition.

     
  • 205. 
    Generic Medicines: How to ensure their effective contribution to healthcare, Euro Health Vol. 2 No 3, September 1996.

     
  • 206. 
    Fountain R and Thurman D Animal Health Market to Face Opportunities and Challenges in 98, Feed Stuffs Vol. 69 No 48, November 1997.

     
  • 207. 
    Taken here in a broader sense as meaning any new active substance.

     
  • 208. 
    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 amendments.

     
  • 209. 
    See note 3.

     
  • 210. 
    See note 3.

     
  • 211. 
    De Europese Commissie kent nummers toe aan officiële documenten van de Europese Unie. De Commissie maakt onderscheid in een aantal typen documenten door middel van het toekennen van verschillende nummerseries. Het onderscheid is gebaseerd op het soort document en/of de instelling van de Unie van wie het document afkomstig is.
     
  • 212. 
    De Raad van de Europese Unie kent aan wetgevingsdossiers een uniek toe. Dit nummer bestaat uit een vijfcijferig volgnummer gevolgd door een schuine streep met de laatste twee cijfers van het jaartal, bijvoorbeeld 12345/00 - een document met nummer 12345 uit het jaar 2000.
     
  • 213. 
    Het interinstitutionele nummer is een nummerreeks die binnen de Europese Unie toegekend wordt aan voorstellen voor regelgeving van de Europese Commissie.
    Binnen de Europese Unie worden nog een aantal andere nummerseries gebruikt. Iedere instelling heeft één of meerdere sets documenten met ieder een eigen nummering. Die reeksen komen niet overeen met elkaar of het interinstitutioneel nummer.
     
  • 214. 
    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.
     
  • 215. 
    Als dag van bekendmaking van een Europees besluit geldt de dag waarop het besluit in het Publicatieblad wordt bekendgemaakt, en daardoor in alle officiële talen van de Europese Unie bij het Publicatiebureau beschikbaar is.
     
  • 216. 
    This legally binding act of the European Union establishes a set of objectives which all member states of the European Union must fulfil. The member states are required to implement directives. The member states are free to choose the manner they see fit to fulfil the required objectives.