The European Medicines Agency (EMA) has introduced the QRD Template Version 9.0 for product information used by the Marketing Authorization Holder (MAH). The updated template, aligned with the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), must be adopted by all authorized Veterinary Medicinal Products by January 2027. Notable changes in the updated template include improved alignment between leaflets, Statistical Process Control (SPC) sections, and simplified packaging information.
One significant addition is a new section specifically dedicated to antimicrobial use restrictions. This addition aims to promote responsible practices and minimize the risk of antimicrobial resistance. In addition to providing an overview of the QRD Template Version 9.0 and its significant updates, this article seeks to focus on responsible antimicrobial use, environmental impact, and pharmacovigilance improvements in veterinary medicinal products.