European Commission 30 September 2005, 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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European Union · · · Cited by 217 · 30-09-2005

Article 1. Definitions
Article 2. Traceability
Article 3. Verification procedure for issuing blood or blood components
Article 4. Record of data on traceability
Article 5. Notification of serious adverse reactions
Article 6. Notification of serious adverse events
Article 7. Requirements for imported blood and blood components
Article 8. Annual reports
Article 9. Communication of information between competent authorities
Article 10. Transposition
Article 11. Entry into force
Article 12. Addressees
ANNEX I. Record of data on traceability as provided for in Article 4

1.10.2005

Official Journal of the European Union

L 256/32

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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the

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