Joint Order No. 83 of the Ministry of Agriculture and Federal Service for Veterinary and Phytosanitary Supervision (Rosselkhoznadzor) validating the Procedure for the provision, composition and scope of information on series and lots of medicinal products for veterinary use entering into civil circulation in the Russian Federation.

The document primarily addresses the procedural framework for providing, composing, and detailing information on veterinary drug series and lots entering civilian circulation within the national territory. The policy aims to regulate the import and distribution of veterinary pharmaceuticals, ensuring traceability and quality assurance through specified information submission requirements. Key measures include mandatory submission of detailed drug information by manufacturers before market entry, such as trade names, pharmacotherapeutic groups, chemical names, manufacturer details, batch numbers, manufacturing and expiry dates, and production quantities. Additionally, manufacturers must provide conformity test reports and certification details, with annual updates required by February 1. Importing organizations are also mandated to submit similar information, including conformity certificates and test reports, prior to the drugs entering civilian circulation. Certain exemptions are noted for specific medicines as per legislative articles. These measures establish clear compliance obligations aimed at maintaining drug quality and traceability. Implementation involves the submission of information to the Federal State Veterinary Information System (VetIS), with responsibilities assigned to pharmaceutical manufacturers and importers. The document specifies procedural details, including the types of information to be provided, the documentation required, and the regulatory references underpinning these requirements, thereby delineating the institutional responsibilities and enforcement mechanisms for stakeholders involved in the veterinary pharmaceutical supply chain.