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Lessons learned from the review of the labelling of centrally authorised pandemic vaccines

The 2009 pandemic outbreak experience showed that due to the urgency of the situation and the logistical constraints that pharmaceutical companies faced to make vaccines available in a very short time, the review of the labelling (outer/immediate packaging) and the package leaflet was a challenging exercise. The scope of this document is to provide guidance on the preparation of labelling for pandemic vaccines, in the light of the experience acquired during the 2009 pandemic outbreak.

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