COM(2005)567 - Advanced therapy medicinal products

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 Regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
 
Legal instrument Regulation
Decision making procedure ordinary legislative procedure (COD)
reference by COM-number147 COM(2005)567 EN
Additional COM-numbers SEC(2005)1444
procedure number149 2005/0227(COD)
CELEX number150 52005PC0567

2.

Key dates

Document 16-11-2005
Online publication 16-11-2005
Decision 13-11-2007; Verordening 2007/1394
Publication in Official Journal151 10-12-2007; Special edition in Croatian: Chapter 13 Volume 064,OJ L 324, 10.12.2007

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. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 2. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 3. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 4. 
    OJ L 311, 28.11.2001, p. 67

     
  • 5. 
    OJ L 136, 30.4.2004, p. 1

     
  • 6. 
    OJ L 102, 7.4.2004, p. 48

     
  • 7. 
    OJ L 169, 12.7.1993, p. 1

     
  • 8. 
    OJ L 189, 20.7.1990, p. 17

     
  • 9. 
    Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L 159, 27.6.2003, p. 46.

     
  • 10. 
    See www.emea.eu.int/htms/human/itf/itfguide

     
  • 11. 
    See cases 227/82, Van Bennekom
     
  • 12. 
    Monteil and Samanni, paragraph 29; Delattre, paragraph 35; Commission v. Federal Republic of Germany, paragraph 17.

     
  • 13. 
    See also Article 2(2) of Directive 2001/83/EC, as amended by Directive 2004/27/EC.

     
  • 14. 
    Article 2(1) of Directive 2001/83/EC, as amended by Directive 2004/27/EC.

     
  • 15. 
    OJ C 364, 18.12.2000, p. 1.

     
  • 16. 
    conventions.coe.int/treaty/en/treaties/html/164

     
  • 17. 
    Recital (12) and Article 4(3) of Directive 2004/23/EC.

     
  • 18. 
    Article 14(11) of Regulation (EC) No 726/2004.

     
  • 19. 
    Regulation (EC) No 141/2000, OJ L 18, 22/1/2000, p. 1

     
  • 20. 
    Article 14(9) of Regulation (EC) No 726/2004.

     
  • 21. 
    Article 14(7) and 14(8) of Regulation (EC) No 726/2004.

     
  • 22. 
    Article 70(2) of Regulation (EC) No 726/2004.

     
  • 23. 
    OJ C , , p. .

     
  • 24. 
    OJ C , , p. .

     
  • 25. 
    OJ C , , p. .

     
  • 26. 
    OJ C , , p. .

     
  • 27. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 28. 
    OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).

     
  • 29. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 30. 
    OJ C 364, 18.12.2000, p. 1.

     
  • 31. 
    OJ L 102, 7.4.2004, p. 48.

     
  • 32. 
    OJ L 121, 1.5.2001, p. 34.

     
  • 33. 
    OJ L 91, 9.4.2005, p. 13.

     
  • 34. 
    OJ L 262, 14.10.2003, p. 22.

     
  • 35. 
    OJ L 169, 12.7.1993, p. 1. Directive as last amended by European Parliament and Council Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

     
  • 36. 
    OJ L 189, 20.7.1990, p. 17. Directive as last amended by European Parliament and Council Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

     
  • 37. 
    OJ L 33, 8.2.2003, p. 30.

     
  • 38. 
    OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

     
  • 39. 
    OJ L 184, 17.7.1999, p. 23.

     
  • 40. 
    OJ L 136, 30.4.2004, p. 1

     
  • 41. 
    OJ L 189, 20.7.1990, p. 17

     
  • 42. 
    OJ L 136, 30.4.2004, p. 1

     
  • 43. 
    OJ L 169, 12.7.1993, p. 1

     
  • 44. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 45. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 46. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 47. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 48. 
    OJ L 311, 28.11.2001, p. 67

     
  • 49. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 50. 
    OJ L 311, 28.11.2001, p. 67

     
  • 51. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 52. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 53. 
    OJ L 311, 28.11.2001, p. 67

     
  • 54. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 55. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 56. 
    OJ L 311, 28.11.2001, p. 67

     
  • 57. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 58. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 59. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 60. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 61. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 62. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 63. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 64. 
    OJ L 169, 12.7.1993, p. 1

     
  • 65. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 66. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 67. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 68. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 69. 
    OJ L035, 15.2.1995, p. 1, as amended by Council Regulation (EC) No 2743/98 of 14 December 1998, OJ L345, 19.12.98, p. 3 and by Commission Regulation (EC) No 494/2003 of 18 March 2003, OJ L73, 19.3.2003, p. 6. See also COM(2005)106.

     
  • 70. 
    See Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L18, 22.1.2000, p.1) and www.emea.eu.int.

     
  • 71. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 72. 
    See also Annex 7 of the EMEA 2004 Annual report.

     
  • 73. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 74. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 75. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 76. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 77. 
    OJ L 311, 28.11.2001, p. 67

     
  • 78. 
    OJ L 136, 30.4.2004, p. 1

     
  • 79. 
    OJ L 102, 7.4.2004, p. 48

     
  • 80. 
    OJ L 169, 12.7.1993, p. 1

     
  • 81. 
    OJ L 189, 20.7.1990, p. 17

     
  • 82. 
    Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L 159, 27.6.2003, p. 46.

     
  • 83. 
    See www.emea.eu.int/htms/human/itf/itfguide

     
  • 84. 
    See cases 227/82, Van Bennekom
     
  • 85. 
    Monteil and Samanni, paragraph 29; Delattre, paragraph 35; Commission v. Federal Republic of Germany, paragraph 17.

     
  • 86. 
    See also Article 2(2) of Directive 2001/83/EC, as amended by Directive 2004/27/EC.

     
  • 87. 
    Article 2(1) of Directive 2001/83/EC, as amended by Directive 2004/27/EC.

     
  • 88. 
    OJ C 364, 18.12.2000, p. 1.

     
  • 89. 
    conventions.coe.int/treaty/en/treaties/html/164

     
  • 90. 
    Recital (12) and Article 4(3) of Directive 2004/23/EC.

     
  • 91. 
    Article 14(11) of Regulation (EC) No 726/2004.

     
  • 92. 
    Regulation (EC) No 141/2000, OJ L 18, 22/1/2000, p. 1

     
  • 93. 
    Article 14(9) of Regulation (EC) No 726/2004.

     
  • 94. 
    Article 14(7) and 14(8) of Regulation (EC) No 726/2004.

     
  • 95. 
    Article 70(2) of Regulation (EC) No 726/2004.

     
  • 96. 
    OJ C , , p. .

     
  • 97. 
    OJ C , , p. .

     
  • 98. 
    OJ C , , p. .

     
  • 99. 
    OJ C , , p. .

     
  • 100. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 101. 
    OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).

     
  • 102. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 103. 
    OJ C 364, 18.12.2000, p. 1.

     
  • 104. 
    OJ L 102, 7.4.2004, p. 48.

     
  • 105. 
    OJ L 121, 1.5.2001, p. 34.

     
  • 106. 
    OJ L 91, 9.4.2005, p. 13.

     
  • 107. 
    OJ L 262, 14.10.2003, p. 22.

     
  • 108. 
    OJ L 169, 12.7.1993, p. 1. Directive as last amended by European Parliament and Council Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p.

    1).

     
  • 109. 
    OJ L 189, 20.7.1990, p. 17. Directive as last amended by European Parliament and Council Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p.

    1).

     
  • 110. 
    OJ L 33, 8.2.2003, p. 30.

     
  • 111. 
    OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p.

    1).

     
  • 112. 
    OJ L 184, 17.7.1999, p. 23.

     
  • 113. 
    OJ L 136, 30.4.2004, p. 1

     
  • 114. 
    OJ L 189, 20.7.1990, p. 17

     
  • 115. 
    OJ L 136, 30.4.2004, p. 1

     
  • 116. 
    OJ L 169, 12.7.1993, p. 1

     
  • 117. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 118. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 119. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 120. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 121. 
    OJ L 311, 28.11.2001, p. 67

     
  • 122. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 123. 
    OJ L 311, 28.11.2001, p. 67

     
  • 124. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 125. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 126. 
    OJ L 311, 28.11.2001, p. 67

     
  • 127. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 128. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 129. 
    OJ L 311, 28.11.2001, p. 67

     
  • 130. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 131. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 132. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 133. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 134. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 135. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 136. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 137. 
    OJ L 169, 12.7.1993, p. 1

     
  • 138. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 139. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 140. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
  • 141. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 142. 
    OJ L035, 15.2.1995, p. 1, as amended by Council Regulation (EC) No 2743/98 of 14 December 1998, OJ L345, 19.12.98, p. 3 and by Commission Regulation (EC) No 494/2003 of 18 March 2003, OJ L73, 19.3.2003, p. 6. See also COM(2005)106.

     
  • 143. 
    See Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L18, 22.1.2000, p.1) and www.emea.eu.int.

     
  • 144. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 145. 
    See also Annex 7 of the EMEA 2004 Annual
     
  • 146. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 147. 
    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.
     
  • 148. 
    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.
     
  • 149. 
    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.
     
  • 150. 
    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.
     
  • 151. 
    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.
     
  • 152. 
    This legally binding act of the European Union is directly applicable in all member states of the European Union. The regulation is similar to national legislation in terms of the impact and direct effect it generates. As such the regulation is the most pervasive of all the legal instruments of the EU.