Data requirements for adjuvants in vaccines for veterinary use - Scientific guideline

The aim of the guideline is to outline the information which should be included for an adjuvant in the marketing authorisation application (MAA) dossier of veterinary vaccines as required in Section IIIb of the Commission Delegated Regulation (EU) 2021/805 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (repealing Directive 2001/82/EC). This guideline replaces the ‘Note for Guidance on the use of adjuvanted veterinary vaccines’ (EMA/CVMP/IWP/043/97).

Keywords: Adjuvant, Immunological Veterinary Medicinal product (IVMP), EMA, IWP