# 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 C: Confirmation format for serious adverse reactions

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

Reporting establishment
Report identification
Confirmation date (year/month/day)
Date of serious adverse reaction (year/month/day)
Confirmation of serious adverse reaction (Yes/No)
Imputability level (NA, 0-3)
Change of type of serious adverse reaction (Yes/No)
If Yes, specify
Clinical outcome (if known)
Complete recovery
Minor sequelae
Serious sequelae
Death

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