# 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), Part A: Rapid Notification Format for Serious Adverse Events

Extent: E+W+S+N.I.

Reporting establishment
Report identification
Reporting date (year/month/day)
Date of serious adverse event (year/month/day)
Serious adverse event, which may affect quality and safety of blood component due to a deviation in:
Specification
Product defect
Equipment failure
Human error
Other(specify)
Whole blood collection
Apheresis collection
Testing of donations
Processing
Storage
Distribution
Materials
Others (specify)

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Source: https://www.legislation.gov.uk/eudr/2005/61/annex/III/part/A (the official version)
Page: https://openlegislation.uk/eu-directive-2005-61/annex-III/part-A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.