Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/... (32005L0061)
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)
- 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)
- 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
- BY BLOOD ESTABLISHMENTS
- BY FACILITIES
- ANNEX II
- NOTIFICATION OF SERIOUS ADVERSE REACTIONS
- PART A
- Rapid notification format for suspected serious adverse reactions
- PART B
- PART C
- Confirmation format for serious adverse reactions
- PART D
- Annual notification format for serious adverse reactions
- ANNEX III
- NOTIFICATION OF SERIOUS ADVERSE EVENTS
- PART A
- Rapid Notification Format for Serious Adverse Events
- PART B
- Confirmation Format for Serious Adverse Events
- PART C
- Annual Notification Format for Serious Adverse Events
Feedback