Draft guideline on the use of adjuvanted veterinary vaccines

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Document details

Download document Draft guideline on the use of adjuvanted veterinary vaccines
Reference number EMA/CVMP/IWP/315887/2017
Status draft: consultation open
First published 2018-07-05
Last updated 2018-07-05
Consultation start date 2018-07-05
Consultation end date 2019-01-15
Email address for submissions vet-guidelines@ema.europa.eu

Summary

The main aim of the guideline is to outline the information which should be included for the adjuvant in the marketing authorisation application (MAA) of an immunological veterinary medicinal product (IVMP). This guideline replaces the ‘Note for Guidance on the use of adjuvanted veterinary vaccines’. The guideline discusses the important aspects to consider for the adjuvant in an IVMP and provides guidance on the information on the adjuvant which should be included in Parts 2, 3 and 4 of the MAA. The details on the adjuvant which should be referred to in the SPC of the IVMP is also addressed in this guideline.