EMA: Concept paper for the revision of the note for guidance on the use of adjuvanted veterinary vaccines

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.