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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 (Text with EEA relevance) (revoked)

EU Regulation No 1394/2007 · Adopted 13 November 2007 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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

(Text with EEA relevance) (revoked)

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations to the whole text

Textual amendments

F1

Regulation revoked (in so far as it applies to medicinal products for human use) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(o) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)

Contents

  1. Chapter 1: SUBJECT MATTER AND DEFINITIONS Repealed
  2. 1Subject matter Repealed
  3. 2Definitions Repealed
  4. Chapter 2: MARKETING AUTHORISATION REQUIREMENTS Repealed
  5. 3Donation, procurement and testing Repealed
  6. 4Clinical trials Repealed
  7. 5Good manufacturing practice Repealed
  8. 6Issues specific to medical devices Repealed
  9. 7Specific requirements for advanced therapy medicinal products containing devices Repealed
  10. Chapter 3: MARKETING AUTHORISATION PROCEDURE Repealed
  11. 8Evaluation procedure Repealed
  12. 9Combined advanced therapy medicinal products Repealed
  13. Chapter 4: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET Repealed
  14. 10Summary of product characteristics Repealed
  15. 11Labelling of outer/immediate packaging Repealed
  16. 12Special immediate packaging Repealed
  17. 13Package leaflet Repealed
  18. Chapter 5: POST-AUTHORISATION REQUIREMENTS Repealed
  19. 14Post-authorisation follow-up of efficacy and adverse reactions, and risk management Repealed
  20. 15Traceability Repealed
  21. Chapter 6: INCENTIVES Repealed
  22. 16Scientific advice Repealed
  23. 17Scientific recommendation on advanced therapy classification Repealed
  24. 18Certification of quality and non-clinical data Repealed
  25. 19Reduction of the fee for marketing authorisation Repealed
  26. Chapter 7: COMMITTEE FOR ADVANCED THERAPIES Repealed
  27. 20Committee for Advanced Therapies Repealed
  28. 21Composition of the Committee for Advanced Therapies Repealed
  29. 22Conflicts of interest Repealed
  30. 23Tasks of the Committee for Advanced Therapies Repealed
  31. Chapter 8: GENERAL AND FINAL PROVISIONS Repealed
  32. 24Amendments to the Annexes Repealed
  33. 25Report and review Repealed
  34. 25aExercise of the delegation Repealed
  35. 26Committee procedure Repealed
  36. 27Amendments to Regulation (EC) No 726/2004 Repealed
  37. 28Amendments to Directive 2001/83/EC Repealed
  38. 29Transitional period Repealed
  39. 30Entry into force Repealed
  40. Signature
  41. Annex IManipulations referred to in the first indent of Article 2(1)(c) Repealed
  42. Annex II: Summary of product characteristics referred to in Article 10 Repealed
  43. 1Division 1 Repealed
  44. Repealed
  45. Repealed
  46. 2.1Division 2.1 Repealed
  47. 2.2Division 2.2 Repealed
  48. 3Division 3 Repealed
  49. Repealed
  50. Repealed
  51. 4.1Division 4.1 Repealed
  52. 4.2Division 4.2 Repealed
  53. 4.3Division 4.3 Repealed
  54. 4.4Division 4.4 Repealed
  55. 4.5Division 4.5 Repealed
  56. 4.6Division 4.6 Repealed
  57. 4.7Division 4.7 Repealed
  58. 4.8Division 4.8 Repealed
  59. 4.9Division 4.9 Repealed
  60. Repealed
  61. Repealed
  62. 5.1Division 5.1 Repealed
  63. 5.2Division 5.2 Repealed
  64. 5.3Division 5.3 Repealed
  65. Repealed
  66. Repealed
  67. 6.1Division 6.1 Repealed
  68. 6.2Division 6.2 Repealed
  69. 6.3Division 6.3 Repealed
  70. 6.4Division 6.4 Repealed
  71. 6.5Division 6.5 Repealed
  72. 6.6Division 6.6 Repealed
  73. 7Division 7 Repealed
  74. 8Division 8 Repealed
  75. 9Division 9 Repealed
  76. 10Division 10 Repealed
  77. Annex IIILabelling of outer/immediate packaging referred to in Article 11 Repealed
  78. Annex IVPackage leaflet referred to in Article 13 Repealed

1Subject matterF1

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2DefinitionsF1

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3Donation, procurement and testingF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4Clinical trialsF1

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5Good manufacturing practiceF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6Issues specific to medical devicesF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7Specific requirements for advanced therapy medicinal products containing devicesF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8Evaluation procedureF1

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9Combined advanced therapy medicinal productsF1

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10Summary of product characteristicsF1

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11Labelling of outer/immediate packagingF1

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12Special immediate packagingF1

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13Package leafletF1

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14Post-authorisation follow-up of efficacy and adverse reactions, and risk managementF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15TraceabilityF1

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16Scientific adviceF1

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17Scientific recommendation on advanced therapy classificationF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18Certification of quality and non-clinical dataF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

19Reduction of the fee for marketing authorisationF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20Committee for Advanced TherapiesF1

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21Composition of the Committee for Advanced TherapiesF1

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22Conflicts of interestF1

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23Tasks of the Committee for Advanced TherapiesF1

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24Amendments to the AnnexesF1

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25Report and reviewF1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25aExercise of the delegationF1

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26Committee procedureF1

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27Amendments to Regulation (EC) No 726/2004F1

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28Amendments to Directive 2001/83/ECF1

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29Transitional periodF1

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30Entry into forceF1

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Signature

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Annex IManipulations referred to in the first indent of Article 2(1)(c)F1

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1F1

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2.1F1

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2.2F1

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3F1

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4.1F1

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4.2F1

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4.3F1

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4.4F1

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4.5F1

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4.6F1

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4.7F1

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4.8F1

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4.9F1

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5.1F1

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5.2F1

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5.3F1

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6.1F1

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6.2F1

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6.3F1

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6.4F1

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6.5F1

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6.6F1

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7F1

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8F1

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9F1

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10F1

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Annex IIILabelling of outer/immediate packaging referred to in Article 11F1

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Annex IVPackage leaflet referred to in Article 13F1

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