Resolution of the Ministry of Agriculture and Food No. 116 On some issues of conducting pharmaceutical inspections.

This Resolution primarily addresses the regulatory framework governing pharmaceutical inspections of industrial veterinary production and trade sites within the national territory, excluding matters covered by Eurasian Economic Union law. Its objectives include establishing procedures, conditions, and requirements for such inspections, emphasizing compliance with international treaties and the Eurasian Economic Union's Good Practice Rules. The overarching policy goal is to ensure the quality, safety, and conformity of veterinary pharmaceuticals and related products, aligning national standards with international legal instruments. Key measures outlined involve the development and maintenance of production site dossiers, which must contain detailed information on site operations, quality control, and technological processes, limited to 25-30 pages. The document specifies the assessment criteria for production sites, including general information, management of suppliers, product details, technological processes, and documentation storage. It mandates the submission of production site files and related documents for inspection, with procedures for conducting pre-licensing and industrial production inspections, including sampling, testing, and reporting. The inspection process involves forming specialized teams, planning, and executing site visits within specified timelines, and issuing inspection reports. Post-inspection, entities are required to respond with corrective action plans within 90 days, with provisions for re-inspection to verify compliance. Implementation mechanisms include contractual agreements for inspections, timelines for document submission, and procedures for conducting re-inspections based on initial findings. Responsibilities are assigned to the BelgosvetCentre and veterinary pharmaceutical inspectors, with clear timelines for report preparation and follow-up actions. The document also emphasizes procedural aspects such as the use of audio, photo, and video recordings during inspections, and details the criteria for recognizing a site as compliant. Secondary themes involve enforcement through documentation review, site assessments, and stakeholder engagement, all explicitly detailed to ensure adherence to established standards.