إجراء مقترح من أوكرانيا: أدوية (عدا منتجات البنود 3002 أو 3005 أو 3006) مكونة من…

The draft Order provides for the approval of the Requirements for Good Distribution Practice of Veterinary Medicinal Products. These Requirements are mandatory for veterinary medicinal product market operators holding a licence to carry out activities involving the manufacture and import of veterinary medicinal products and their wholesale distribution, as well as for veterinary medicinal product market operators holding a licence to carry out wholesale distribution of veterinary medicinal products, including those operating under special customs regimes, such as free zones or customs warehouses. The draft Order establishes Good Distribution Practice requirements for veterinary medicinal products regarding: quality management, including the quality system; personnel, including personnel training; premises, equipment, computerized systems, qualification of equipment and validation of processes; documentation, procedures and record-keeping; operations, including the approval of suppliers and customers, requirements for the receipt and storage of veterinary medicinal products, the destruction of unsuitable veterinary medicinal products, order picking, supply and export; handling of complaints, returned and falsified veterinary medicinal products, and the recall of veterinary medicinal products from the market; activities of third-party contractors; self-inspections; transportation of veterinary medicinal products, including those requiring special transportation conditions.