The Immunologicals Working Party recommends to review, and possibly revise, the Committee for Medicinal Products for Veterinary Use ‘Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease’, in order to take into account issues identified since the guideline came into effect and experience gained during assessment of recent applications for marketing authorisations. To ensure that all potential issues are covered, the IWP is relying on industry’s cooperation during the consultation period of this concept paper. It is important to identify any remaining issues not covered by the existing guideline or listed in this concept paper and the corresponding level of clarification needed.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/09/WC500213177.pdf