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

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.

The Immunologicals Working Party (IWP) recommends revisiting the contents and replacing the note for guidance on the use of adjuvanted veterinary vaccines with a new guideline, to take into account scientific developments and experience gained since the guidance came into effect. The IWP considers that the following areas in particular will require amendment: types of adjuvants, test procedures, assessment criteria for local and general reaction, the criteria for benefit-risk assessment, data requirements for marketing authorisation application.