Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU

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Current effective version

Adopted guideline

Reference numberEMA/PRAC/222346/2014
Published15/04/2014
Effective from15/04/2014
KeywordsInfluenza, seasonal influenza vaccine, strain change, safety surveillance, risk management plan, vaccine reactogenicity, data reporting, post authorisation safety study
DescriptionThis document focuses on the requirements for annual enhanced safety surveillance to rapidly detect any increased local and systemic reactogenicity, or other unexpected adverse immune response that may arise during the influenza vaccine product life-cycle. It also outlines principles to be followed for improved continuous routine surveillance for influenza vaccines.


Document history

First version

Current version

Adopted guideline


Draft guideline

In operation: 15/04/2014–present


Published: 07/03/2014


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