Council of the European Union and European Parliament 13 June 2024, Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance)

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European Union · · · Cited by 52 · 13-06-2024

CHAPTER I. GENERAL PROVISIONS
Article 1. Subject matter
Article 2. Scope
Article 3. Definitions
Article 4. More stringent Member State measures
CHAPTER II. MEMBER STATES’ SOHO COMPETENT AUTHORITIES
Article 5. Designation of SoHO competent authorities
Article 6. Independence and impartiality
Article 7. Transparency
Article 8. General responsibilities and obligations of SoHO competent authorities
Article 9. Delegation of certain SoHO supervisory activities to other bodies
Article 10. Obligations of the delegated bodies
Article 11. Obligations of the delegating SoHO competent authorities
Article 12. Communication and coordination between SoHO competent authorities
Article 13. Consultation and cooperation with authorities of other regulatory sectors
Article 14. Obligations as regards Commission controls
Article 15. Transparency regarding fees for technical services required for making SoHO available
CHAPTER III. SOHO SUPERVISORY ACTIVITIES
Article 16. Register of SoHO entities
Article 17. Registration of SoHO entities
Article 18. SoHO preparation authorisation system
Article 19. Authorisation of SoHO preparations
Article 20. Assessment of SoHO preparations
Article 21. Clinical-outcome monitoring plans
Article 22. Joint SoHO preparation assessments
Article 23. Specific requirements concerning SoHO preparation assessors
Article 24. SoHO establishment authorisation system
Article 25. Authorisation of SoHO establishments
Article 26. Authorisation of importing SoHO establishments
Article 27. Inspections of SoHO establishments
Article 28. Inspections of SoHO entities, other than SoHO establishments, and of third parties
Article 29. Joint inspections
Article 30. Specific requirements concerning inspectors
Article 31. Extraction, submission and publication of activity data
Article 32. Traceability
Article 33. Vigilance
Article 34. SoHO rapid alerts
CHAPTER IV. GENERAL OBLIGATIONS ON SOHO ENTITIES
Article 35. SoHO entity registration
Article 36. Responsible person
Article 37. Quality management system
Article 38. SoHO preparation authorisation
Article 39. Application for SoHO preparation authorisation
Article 40. SoHO clinical studies
Article 41. Activity data collection and reporting
Article 42. Traceability and coding
Article 43. European coding system
Article 44. Vigilance and reporting
CHAPTER V. GENERAL OBLIGATIONS ON SOHO ESTABLISHMENTS
Article 45. SoHO establishment authorisation
Article 46. Application for SoHO establishment authorisation
Article 47. Importing SoHO establishment authorisation
Article 48. Application for importing SoHO establishment authorisation
Article 49. Releasing officer
Article 50. Physician
Article 51. Export
CHAPTER VI. SOHO DONOR PROTECTION
Article 52. Objectives regarding SoHO donor protection
Article 53. Standards concerning SoHO donor protection
Article 54. Standards concerning voluntary and unpaid nature of SoHO donations
Article 55. Standards concerning information to be provided prior to consent
Article 56. Implementation of the standards concerning SoHO donor protection
CHAPTER VII. PROTECTION OF SOHO RECIPIENTS AND OFFSPRING FROM MEDICALLY ASSISTED REPRODUCTION
Article 57. Objectives regarding protection of SoHO recipients and offspring from medically assisted reproduction
Article 58. Standards concerning protection of SoHO recipients and offspring from medically assisted reproduction
Article 59. Implementation of the standards concerning protection of SoHO recipients and offspring from medically assisted reproduction
Article 60. SoHO release
Article 61. Exceptional release
CHAPTER VIII. SUPPLY CONTINUITY
Article 62. Critical SoHO supply sufficiency
Article 63. National SoHO emergency plans
Article 64. Supply alerts for critical SoHO
Article 65. Derogation from the obligations to authorise SoHO preparations in health emergency situations
Article 66. Emergency derogations in man-made or natural disasters
Article 67. SoHO entity emergency plans
CHAPTER IX. SOHO COORDINATION BOARD
Article 68. SoHO Coordination Board
Article 69. Tasks of the SoHO Coordination Board
CHAPTER X. UNION ACTIVITIES
Article 70. Union training and exchange of SoHO competent authorities’ personnel
Article 71. Commission controls
Article 72. Assistance by the Union
CHAPTER XI. EU SOHO PLATFORM
Article 73. Establishment, management and maintenance of the EU SoHO Platform
Article 74. General functionalities of the EU SoHO Platform
CHAPTER XII. PROCEDURAL PROVISIONS
Article 75. Confidentiality
Article 76. Data protection
Article 77. Exercise of the delegation
Article 78. Urgency procedure
Article 79. Committee procedure
Article 80. Penalties
CHAPTER XIII. TRANSITIONAL PROVISIONS
Article 81. Transitional provisions concerning establishments designated, authorised, accredited or licensed under Directives 2002/98/EC and 2004/23/EC
Article 82. Transitional provisions concerning SoHO preparations
Article 83. Transitional provisions concerning SoHO not addressed explicitly in Directive 2002/98/EC or 2004/23/EC
Article 84. Status of SoHO in storage or distributed before the application of this Regulation
CHAPTER XIV. FINAL PROVISIONS
Article 85. Repeals
Article 86. Evaluation
Article 87. Entry into force and application

Official Journal
of the European Union

L series

2024/1938

17.7.2024

REGULATION (EU) 2024/1938 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 13 June 2024

on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE

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