Council of the European Union and European Parliament 16 April 2014, Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

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European Union · · · Cited by 1,004 · 16-04-2014

CHAPTER I. GENERAL PROVISIONS
Article 1. Scope
Article 2. Definitions
Article 3. General principle
CHAPTER II. AUTHORISATION PROCEDURE FOR A CLINICAL TRIAL
Article 4. Prior authorisation
Article 5. Submission of an application
Article 6. Assessment report — Aspects covered by Part I
Article 7. Assessment report — Aspects covered by Part II
Article 8. Decision on the clinical trial
Article 9. Persons assessing the application
Article 10. Specific considerations for vulnerable populations
Article 11. Submission and assessment of applications limited to aspects covered by Part I or Part II of the assessment report
Article 12. Withdrawal
Article 13. Resubmission
Article 14. Subsequent addition of a Member State concerned
CHAPTER III. AUTHORISATION PROCEDURE FOR A SUBSTANTIAL MODIFICATION OF A CLINICAL TRIAL
Article 15. General principles
Article 16. Submission of application
Article 17. Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
Article 18. Assessment of a substantial modification of an aspect covered by Part I of the assessment report
Article 19. Decision on the substantial modification of an aspect covered by Part I of the assessment report
Article 20. Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report
Article 21. Substantial modification of aspects covered by Parts I and II of the assessment report
Article 22. Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II of the assessment report
Article 23. Decision on the substantial modification of aspects covered by Parts I and II of the assessment report
Article 24. Persons assessing the application for a substantial modification
CHAPTER IV. APPLICATION DOSSIER
Article 25. Data submitted in the application dossier
Article 26. Language requirements
Article 27. Update by way of delegated acts
CHAPTER V. PROTECTION OF SUBJECTS AND INFORMED CONSENT
Article 28. General rules
Article 29. Informed consent
Article 30. Informed consent in cluster trials
Article 31. Clinical trials on incapacitated subjects
Article 32. Clinical trials on minors
Article 33. Clinical trials on pregnant or breastfeeding women
Article 34. Additional national measures
Article 35. Clinical trials in emergency situations
CHAPTER VI. START, END, TEMPORARY HALT, AND EARLY TERMINATION OF A CLINICAL TRIAL
Article 36. Notification of the start of a clinical trial and of the end of the recruitment of subjects
Article 37. End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results
Article 38. Temporary halt or early termination by the sponsor for reasons of subject safety
Article 39. Update of the contents of the summary of results and summary for laypersons
CHAPTER VII. SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL
Article 40. Electronic database for safety reporting
Article 41. Reporting of adverse events and serious adverse events by the investigator to the sponsor
Article 42. Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency
Article 43. Annual reporting by the sponsor to the Agency
Article 44. Assessment by Member States
Article 45. Technical aspects
Article 46. Reporting with regard to auxiliary medicinal products
CHAPTER VIII. CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS
Article 47. Compliance with the protocol and good clinical practice
Article 48. Monitoring
Article 49. Suitability of individuals involved in conducting the clinical trial
Article 50. Suitability of clinical trial sites
Article 51. Traceability, storage, return and destruction of investigational medicinal products
Article 52. Reporting of serious breaches
Article 53. Other reporting obligations relevant for subject safety
Article 54. Urgent safety measures
Article 55. Investigator's brochure
Article 56. Recording, processing, handling and storage of information
Article 57. Clinical trial master file
Article 58. Archiving of the clinical trial master file
Article 59. Auxiliary medicinal products
CHAPTER IX. MANUFACTURING AND IMPORT OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS
Article 60. Scope of this Chapter
Article 61. Authorisation of manufacturing and import
Article 62. Responsibilities of the qualified person
Article 63. Manufacturing and import
Article 64. Modification of authorised investigational medicinal products
Article 65. Manufacturing of auxiliary medicinal products
CHAPTER X. LABELLING
Article 66. Unauthorised investigational and unauthorised auxiliary medicinal products
Article 67. Authorised investigational and authorised auxiliary medicinal products
Article 68. Radiopharmaceuticals used as investigational medicinal products or as auxiliary medicinal products for a medical diagnosis
Article 69. Language
Article 70. Delegated act
CHAPTER XI. SPONSOR AND INVESTIGATOR
Article 71. Sponsor
Article 72. Co-sponsorship
Article 73. Principal investigator
Article 74. Legal representative of the sponsor in the Union
Article 75. Liability
CHAPTER XII. DAMAGE COMPENSATION
Article 76. Damage compensation
CHAPTER XIII. SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS
Article 77. Corrective measures to be taken by Member States
Article 78. Member State inspections
Article 79. Union controls
CHAPTER XIV. IT INFRASTRUCTURE
Article 80. EU portal
Article 81. EU database
Article 82. Functionality of the EU portal and the EU database
CHAPTER XV. COOPERATION BETWEEN MEMBER STATES
Article 83. National contact points
Article 84. Support by the Agency and the Commission
Article 85. Clinical Trials Coordination and Advisory Group
CHAPTER XVI. FEES
Article 86. General principle
Article 87. One payment per activity per Member State
CHAPTER XVII. IMPLEMENTING ACTS AND DELEGATED ACTS
Article 88. Committee procedure
Article 89. Exercise of the delegation
CHAPTER XVIII. MISCELLANEOUS PROVISIONS
Article 90. Specific requirements for special groups of medicinal products
Article 91. Relation with other Union legislation
Article 92. Investigational medicinal products, other products and procedures, free of charge for the subject
Article 93. Data protection
Article 94. Penalties
Article 95. Civil and criminal liability
CHAPTER XIX. FINAL PROVISIONS
Article 96. Repeal
Article 97. Review
Article 98. Transitional provision
Article 99. Entry into force
ANNEX I. APPLICATION DOSSIER FOR THE INITIAL APPLICATION

27.5.2014

Official Journal of the European Union

L 158/1

REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 April 2014

on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning

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