The new edition of the Technical guide for the elaboration and use of monographs for immunological veterinary medicinal products (2020) was approved by the European Pharmacopoeia Commission at its 166th session.
Fully updated to take into account the latest revisions of European Pharmacopoeia (Ph. Eur.) texts, the guide provides recommendations for authors (and contributors) and users of the Ph. Eur.’s monographs on veterinary vaccines and other immunological veterinary medicinal products (IVMPs). It is intended to help users better understand the requirements and structure of these monographs, particularly the new approach to extraneous agent testing in IVMPs since manufacturers of these products will be required to comply with new standards from 1 July 2020. For more information, consult the summary of what has changed and why.