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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 (Text with EEA relevance) (revoked)

EU Regulation No 1234/2008 · Adopted 24 November 2008 · 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.

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

(Text with EEA relevance) (revoked)

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Annotations to the whole text

Textual amendments

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Regulation revoked (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 209

Contents

  1. Chapter I: GENERAL PROVISIONS Repealed
  2. 1Subject matter and scope Repealed
  3. 2Definitions Repealed
  4. 3Classification of variations Repealed
  5. 4Guidelines Repealed
  6. 5Recommendation on unforeseen variations Repealed
  7. 6Variations leading to the revision of product information Repealed
  8. 7Grouping of variations Repealed
  9. Chapter II: VARIATIONS TO MARKETING AUTHORISATIONS GRANTED IN ACCORDANCE WITH DIRECTIVE 87/22/EEC, CHAPTER 4 OF DIRECTIVE 2001/82/EC OR CHAPTER 4 OF DIRECTIVE 2001/83/EC Repealed
  10. 8Notification procedure for minor variations of type IA Repealed
  11. 9Notification procedure for minor variations of type IB Repealed
  12. 10‘Prior Approval’ procedure for major variations of type II Repealed
  13. 11Measures to close the procedures of Articles 8 to 10 Repealed
  14. 12Human influenza vaccines Repealed
  15. 13Coordination group and arbitration Repealed
  16. Chapter IIa: VARIATIONS TO PURELY NATIONAL MARKETING AUTHORISATIONS Repealed
  17. 13aNotification procedure for minor variations of type IA Repealed
  18. 13bNotification procedure for minor variations of type IB Repealed
  19. 13c‘Prior Approval’ procedure for major variations of type II Repealed
  20. 13dGrouping of variations to purely national marketing authorisations Repealed
  21. 13eMeasures to close the procedures of Articles 13a to 13c Repealed
  22. 13fHuman influenza vaccines Repealed
  23. Chapter III: VARIATIONS TO CENTRALISED MARKETING AUTHORISATIONS Repealed
  24. 14Notification procedure for minor variations of type IA Repealed
  25. 15Notification procedure for minor variations of type IB Repealed
  26. 16‘Prior Approval’ procedure for major variations of type II Repealed
  27. 17Measures to close the procedures of Articles 14 to 16 Repealed
  28. 18Human influenza vaccines Repealed
  29. Chapter IV Repealed
  30. Special procedures Repealed
  31. 19Extensions of marketing authorisations Repealed
  32. 20Worksharing procedure Repealed
  33. 21Pandemic situation with respect to human influenza Repealed
  34. 22Urgent safety restrictions Repealed
  35. Amendments to the decision granting the marketing authorisation and implementation Repealed
  36. 23Amendments to the decision granting the marketing authorisation Repealed
  37. 23aArticle 23a Repealed
  38. 24Implementation of variations Repealed
  39. 24aApplication of national provisions on variations to purely national marketing authorisations Repealed
  40. Chapter V: FINAL PROVISIONS Repealed
  41. 25Continuous monitoring Repealed
  42. 26Review Repealed
  43. 27Repeal and transitional provision Repealed
  44. 28Entry into force Repealed
  45. Signature
  46. Annex I: Extensions of marketing authorisations Repealed
  47. 1Division 1 Repealed
  48. 2Division 2 Repealed
  49. 3Division 3 Repealed
  50. Annex II: Classification of variations Repealed
  51. 1Division 1 Repealed
  52. 2Division 2 Repealed
  53. Annex III: Cases for grouping variations referred to in Article 7(2)(b) and Article 13d(2)(b) Repealed
  54. 1Division 1 Repealed
  55. 2Division 2 Repealed
  56. 3Division 3 Repealed
  57. 4Division 4 Repealed
  58. 5Division 5 Repealed
  59. 6Division 6 Repealed
  60. 7Division 7 Repealed
  61. 8Division 8 Repealed
  62. 9Division 9 Repealed
  63. 10Division 10 Repealed
  64. 11Division 11 Repealed
  65. 12Division 12 Repealed
  66. 13Division 13 Repealed
  67. 14Division 14 Repealed
  68. Annex IV: Elements to be submitted Repealed
  69. 1Division 1 Repealed
  70. 2Division 2 Repealed
  71. 3Division 3 Repealed
  72. 4Division 4 Repealed
  73. 5Division 5 Repealed
  74. 6Division 6 Repealed
  75. Annex V Repealed
  76. 1Part 1 Repealed
  77. Part 2 Repealed
  78. 1Division 1 Repealed
  79. 2Division 2 Repealed
  80. 3Division 3 Repealed
  81. Annex VIList of Member States referred in Article 24a Repealed

1Subject matter and scopeF1

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2DefinitionsF1

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3Classification of variationsF1

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4GuidelinesF1

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5Recommendation on unforeseen variationsF1

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6Variations leading to the revision of product informationF1

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7Grouping of variationsF1

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8Notification procedure for minor variations of type IAF1

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9Notification procedure for minor variations of type IBF1

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10‘Prior Approval’ procedure for major variations of type IIF1

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11Measures to close the procedures of Articles 8 to 10F1

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12Human influenza vaccinesF1

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13Coordination group and arbitrationF1

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13aNotification procedure for minor variations of type IAF1

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13bNotification procedure for minor variations of type IBF1

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13c‘Prior Approval’ procedure for major variations of type IIF1

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13dGrouping of variations to purely national marketing authorisationsF1

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13eMeasures to close the procedures of Articles 13a to 13cF1

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13fHuman influenza vaccinesF1

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14Notification procedure for minor variations of type IAF1

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15Notification procedure for minor variations of type IBF1

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16‘Prior Approval’ procedure for major variations of type IIF1

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17Measures to close the procedures of Articles 14 to 16F1

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18Human influenza vaccinesF1

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19Extensions of marketing authorisationsF1

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20Worksharing procedureF1

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21Pandemic situation with respect to human influenzaF1

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22Urgent safety restrictionsF1

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23Amendments to the decision granting the marketing authorisationF1

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23aF1

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24Implementation of variationsF1

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24aApplication of national provisions on variations to purely national marketing authorisationsF1

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25Continuous monitoringF1

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26ReviewF1

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27Repeal and transitional provisionF1

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28Entry into forceF1

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Signature

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5F1

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6F1

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3F1

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Annex VIList of Member States referred in Article 24aF1

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