# 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 B: Confirmation Format for Serious Adverse Events

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

Reporting establishment
Report identification
Confirmation date (year/month/day)
Date of serious adverse event (year/month/day)
Root cause analysis (details)
Corrective measures taken (details)

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