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Directive 2002/98/EC of the European Parliament and of the CouncilShow full title

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

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  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Objectives

    2. Article 2.Scope

    3. Article 3.Definitions

    4. Article 4.Implementation

  3. CHAPTER II OBLIGATIONS ON MEMBER STATES AUTHORITIES

    1. Article 5.Designation, authorisation, accreditation or licensing of blood establishments

    2. Article 6.Hospital blood banks

    3. Article 7.Provisions for existing establishments

    4. Article 8.Inspection and control measures

  4. CHAPTER III PROVISIONS FOR BLOOD ESTABLISHMENTS

    1. Article 9.Responsible person

    2. Article 10.Personnel

  5. CHAPTER IV QUALITY MANAGEMENT

    1. Article 11.Quality system for blood establishments

    2. Article 12.Documentation

    3. Article 13.Record keeping

  6. CHAPTER V HAEMOVIGILANCE

    1. Article 14.Traceability

    2. Article 15.Notification of serious adverse events and reactions

  7. CHAPTER VI PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD AND BLOOD COMPONENTS

    1. Article 16.Provision of information to prospective donors

    2. Article 17.Information required from donors

    3. Article 18.Eligibility of donors

    4. Article 19.Examination of donors

    5. Article 20.Voluntary and unpaid blood donation

    6. Article 21.Testing of donations

    7. Article 22.Storage, transport and distribution conditions

    8. Article 23.Quality and safety requirements for blood and blood components

  8. CHAPTER VII DATA PROTECTION

    1. Article 24.Data protection and confidentiality

  9. CHAPTER VIII EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

    1. Article 25.Information exchange

    2. Article 26.Reports

    3. Article 27.Penalties

  10. CHAPTER IX COMMITTEES

    1. Article 28. Committee procedure

    2. Article 29.Technical requirements and their adaptation to technical and scientific progress

    3. Article 30.Consultation of scientific committee(s)

  11. CHAPTER X FINAL PROVISIONS

    1. Article 31.Amendment of Directive 2001/83/EC

    2. Article 32.Transposition

    3. Article 33.Entry into force

    4. Article 34.Addressees

    1. ANNEX I

      INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR THE PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING IN ACCORDANCE WITH ARTICLE 5(2)

      1. Part A: General information:

      2. Part B: A description of the quality system, to include:

    2. ANNEX II

      REPORT OF THE BLOOD ESTABLISHMENT'S PRECEDING YEAR'S ACTIVITY

      1. This annual report will include:

      2. total number of donors who give blood and blood components...

    3. ANNEX III

      LABELLING REQUIREMENTS

      1. The label on the component must contain the following information:...

      2. the official name of the component the volume or weight...

    4. ANNEX IV

      BASIC TESTING REQUIREMENTS FOR WHOLE BLOOD AND PLASMA DONATIONS

      1. The following tests must be performed for whole blood and...

      2. ABO Group (not required for plasma intended only for fractionation)...

      3. Additional tests may be required for specific components or donors...

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