Guideline on requirements for the production and control of immunological veterinary medicinal produ
This document provides information on items to be considered for the production and control of all immunological veterinary medicinal products. The guideline outlines important items related to the quality, safety and efficacy parts of the marketing authorisation dossier that are not sufficiently defined in the requirements of Annex I of Directive 2001/82/EC and the European Pharmacopoeia (Ph. Eur.). Therefore compliance with this guideline (and the above mentioned regulatory documents) provides an assurance that the IVMP will be considered satisfactory by all the Member States.
