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Commission Directive 2005/61/ECShow full title

Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance)

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  1. Introductory Text

  2. Article 1.Definitions

  3. Article 2.Traceability

  4. Article 3.Verification procedure for issuing blood or blood components

  5. Article 4.Record of data on traceability

  6. Article 5.Notification of serious adverse reactions

  7. Article 6.Notification of serious adverse events

  8. Article 7.Requirements for imported blood and blood components

  9. Article 8.Annual reports

  10. Article 9.Communication of information between competent authorities

  11. Article 10.Transposition

  12. Article 11.Entry into force

  13. Article 12.Addressees

  14. Signature

    1. ANNEX I

      Record of data on traceability as provided for in Article 4

      1. BY BLOOD ESTABLISHMENTS

        1. 1. Blood establishment identification

        2. 2. Blood donor identification

        3. 3. Blood unit identification

        4. 4. Individual blood component identification

        5. 5. Date of collection (year/month/day)

        6. 6. Facilities to which blood units or blood components are distributed,...

      2. BY FACILITIES

        1. 1. Blood component supplier identification

        2. 2. Issued blood component identification

        3. 3. Transfused recipient identification

        4. 4. For blood units not transfused, confirmation of subsequent disposition

        5. 5. Date of transfusion or disposition (year/month/day)

        6. 6. Lot number of the component, if relevant.

    2. ANNEX II

      NOTIFICATION OF SERIOUS ADVERSE REACTIONS

      1. PART A Rapid notification format for suspected serious adverse reactions

      2. PART B

      3. PART C Confirmation format for serious adverse reactions

      4. PART D Annual notification format for serious adverse reactions

    3. ANNEX III

      NOTIFICATION OF SERIOUS ADVERSE EVENTS

      1. PART A Rapid Notification Format for Serious Adverse Events

      2. PART B Confirmation Format for Serious Adverse Events

      3. PART C Annual Notification Format for Serious Adverse Events

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