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  • Notify Booklet
    • 1 INTRODUCTION
    • 2 THE V&S CHAIN FOR MPHOs
    • 3 VIGILANCE AND SURVEILLANCE: HISTORY AND BASIC ELEMENTS
    • 4 MEDICAL PRODUCTS OF HUMAN ORIGIN (MPHO) - DONATION AND ETHICS
    • ANNEX 1. Notify Library - MPHO type taxonomy
    • 5 TOWARDS A GLOBAL GOVERNANCE OF MPHO
    • 6 THE V&S SYSTEM IS PRIMARILY A RESPONSIBILITY FOR HEALTH AUTHORITIES
    • 7 ORGANIZATION FOR A COMPREHENSIVE - VIGILANCE & SURVEILLANCE SYSTEM
    • 8 VIGILANCE & SURVEILLANCE - RECOGNITION RELIES ON HEALTH CARE STAFF
    • 9 INVESTIGATING OCCURRENCES THAT COULD CAUSE HARM - LEARNING FROM ERRORS
    • 10 PROJECT NOTIFY
    • 11 THE NOTIFY DATABASE - LEARNING FROM VIGILANCE
    • 12 RISKS ASSOCIATED WITH LIVING DONATION
    • 13 HARM TO RECIPIENT - INFECTIONS
    • 14 HARM TO RECIPIENT - NON INFECTIOUS BLOOD TRANSFUSION REACTIONS
    • 15 HARM TO RECIPIENTS - MALIGNANCY
    • 16 HARM TO RECIPIENTS - GENETIC TRANSMISSIONS - HPC
    • 17 HARM TO RECIPIENTS - GENETIC TRANSMISSIONS - gamets and embryos
    • 18 CHARACTERISTICS, HANDLING AND CLINICAL ERRORS
    • 19 TRACEABILITY, AN ABSOLUTE PRE-REQUISITE FOR MPHO SAFETY
    • ANNEX 2. Notify Library - Adverse occurrence type taxonomy
    • REFERENCES
  • Background Documents
Home / VIGILANCE GUIDANCE DOCUMENTS / European Commission - Directorate General for Health and Food Safety (EC - DG SANTE)

European Commission - Directorate General for Health and Food Safety (EC - DG SANTE)

Category: 
VIGILANCE GUIDANCE DOCUMENTS
PDF: 
PDF icon Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application
PDF icon Directive 2010/53/EU on standard of quality and safety of human organs intended for transplantation
PDF icon Report on the implementation of Directive 2010/53/EU
PDF icon EU Toolbox Living Kidney donation
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Disclaimer

The cases, bibliography and associated comments included in this website and database have been provided by experts worldwide and reviewed by voluntary editorial working groups. The data and information is not guaranteed to be complete or to be fully up to date at any particular moment and it reflects the knowledge and views of the experts participating, not those of the World Health Organisation or the Italian National Transplant Centre.