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Commission Directive 2006/86/ECShow full title

Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance)

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Changes over time for: ANNEX IV

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[F1ANNEX IV U.K.+E.U. NOTIFICATION OF SERIOUS ADVERSE EVENTS

PART A U.K.+E.U. Rapid notification for suspected serious adverse events

Tissue establishment
EU tissue establishment code (if applicable)
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 tissues and cells due to a deviation in: Specification
Tissues and cells defect Equipment failure Human error Other (specify)
Procurement
Testing
Transport
Processing
Storage
Distribution
Materials
Others (specify)

PART B U.K.+E.U. Conclusions of Serious Adverse Events investigation

Tissue establishment

EU tissue establishment code (if applicable)

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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