EMA: Draft guideline on requirements for the production and control of immunological veterinary medicinal products

This document provides information on items to be considered for the production and control of all immunological veterinary medicinal products (IVMPs). The guideline outlines important items related to the quality, safety and efficacy parts of the marketing authorisation dossier that are not clearly defined in the requirements of the existing texts (Directive 2001/82/EC as amended, Directive 2009/9/EC and the European Pharmacopoeia). Therefore compliance with this guideline (and with previous mentioned texts) provides an assurance that the IVMP will be considered satisfactory by all the Member States.