Chwilio Deddfwriaeth

Commission Implementing Directive 2012/25/EUDangos y teitl llawn

Commission Implementing Directive 2012/25/EU of 9 October 2012 laying down information procedures for the exchange, between Member States, of human organs intended for transplantation (Text with EEA relevance)

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  1. Introductory Text

  2. Article 1.Scope

  3. Article 2.Subject matter

  4. Article 3.Definitions

  5. Article 4.Common procedural rules

  6. Article 5.Information on organ and donor characterisation

  7. Article 6.Information to ensure the traceability of organs

  8. Article 7.Reporting of serious adverse events and reactions

  9. Article 8.Interconnection between Member States

  10. Article 9.Transposition

  11. Article 10.Entry into force

  12. Signature

    1. Ehangu +/Cwympo -

      ANNEX I

      Initial Report for suspected serious adverse events or reactions

      1. 1. Reporting Member State

      2. 2. Report identification number: country (ISO)/national number

      3. 3. Contact details of the reporter (competent authority or delegated body...

      4. 4. Reporting centre/organisation

      5. 5. Contact details of coordinator/contact person (transplant/procurement centre in the reporting...

      6. 6. Reporting date and time (yyyy/mm/dd/hh/mm)

      7. 7. Member State of origin

      8. 8. National donor identification number, as communicated under Article 6

      9. 9. All Member States of destination (if known)

      10. 10. National recipient identification number(s), as communicated under Article 6

      11. 11. Onset date and time of serious adverse event or reaction...

      12. 12. Detection date and time of serious adverse event or reaction...

      13. 13. Description of serious adverse event or reaction

      14. 14. Immediate measures taken/proposed

    2. Ehangu +/Cwympo -

      ANNEX II

      Final Report of serious adverse events or reactions

      1. 1. Reporting Member State

      2. 2. Report identification number: country (ISO)/national number

      3. 3. Contact details of the reporter: telephone, e-mail and, when available,...

      4. 4. Reporting date and time (yyyy/mm/dd/hh/mm)

      5. 5. Identification number(s) of initial report(s) (Annex I)

      6. 6. Description of case

      7. 7. Involved Member States

      8. 8. Outcome of the investigation and final conclusion

      9. 9. Preventive and corrective actions taken

      10. 10. Conclusion/Follow-up, if required

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