Guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases

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Download document Guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases
Reference number EMA/488220/2012
Status draft: consultation closed
First published 12/04/2013
Last updated 12/04/2013

Summary

The objective of this module is to strengthen the conduct of pharmacovigilance for vaccines. It should be noted that the overall objectives and processes of pharmacovigilance are no different for vaccines and other types of medicinal products and this guidance does not replace the information provided in the other modules of the good pharmacovigilance practices (GVP). This module focuses on vaccine-specific aspects and unique challenges that should be borne in mind when designing and implementing pharmacovigilance activities for vaccines.