Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products - Scientific guideline
This guideline provides recommendations on how the risk management may be conducted for elemental impurities for veterinary medicinal products (VMPs) authorised or to be authorised in the European Union in order to comply with the requirement of the European Pharmacopeia (Ph.Eur.) General Monograph 2619 for Pharmaceutical Preparations. It also provides information on the documentation expected to be included in the dossier in order to address this requirement.
Veterinary
Quality of medicines
Scientific guidelines