Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 Jun... (32024R1938)
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)
- 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)
- 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
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