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Commission Directive 2005/61/ECShow full title

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)

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Article 6Notification of serious adverse events

1.Member States shall ensure that blood establishments and hospital blood banks have procedures in place to retain the record of any serious adverse events which may affect the quality or safety of blood and blood components.

2.Member States shall ensure that reporting establishments have procedures in place to communicate to the competent authority as soon as known, using the notification format set out in Part A of Annex III, all relevant information about serious adverse events which may put in danger donors or recipients other than those directly involved in the event concerned.

3.Member States shall ensure that reporting establishments:

(a)evaluate serious adverse events to identify preventable causes within the process;

(b)complete the serious adverse event notification, upon conclusion of the investigation, using the format set out in Part B of Annex III;

(c)submit a complete report on serious adverse events to the competent authority on an annual basis using the format set out in Part C of Annex III.

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