| Regulatory Authorization | 15% | Authorization status in each destination market and conformity with the product classification. | Product registration, import permit or conformity documentation must be valid for the intended country and product category. | Marketing authorization, registration certificate, free-sale certificate where applicable, approved label and package leaflet. | Medicines Vaccines Diagnostics Devices | Check the issuing authority, registration number, legal manufacturer, approved indications and expiry date directly against the importing country’s requirements. |
| Good Manufacturing Practice | 15% | Quality system, manufacturing controls, deviation management, batch release and inspection history. | Manufacturing should operate under applicable veterinary pharmaceutical GMP or the relevant quality standard for the product type. | Current GMP certificate, regulatory inspection report or equivalent third-party audit documentation; batch-release procedure. | Pharmaceuticals Biologics Feed Additives | Confirm that the certificate covers the exact manufacturing site, dosage form, biological process or device scope being purchased. |
| Product Identity and Composition | 10% | Declared active ingredients, concentration, strain or analyte, excipients, dosage form and product specifications. | The certificate of analysis and product label must match the approved composition and the purchase specification. | Master formula, technical data sheet, certificate of analysis, reference standards and approved artwork. | All Categories | Compare the product specification with the purchase order, local label, analytical method and intended animal species. |
| Quality Control and Batch Release | 10% | Testing of identity, assay or potency, purity, sterility or microbial quality, physical attributes and packaging integrity. | Every commercial batch should have documented release results against predefined specifications before shipment. | Batch certificate of analysis, test methods, laboratory qualification records and authorized release statement. | Medicines Vaccines Diagnostics | Request a lot-specific certificate and confirm that test methods are validated or appropriately verified for their intended use. |
| Stability and Shelf Life | 10% | Real-time stability, accelerated stability where relevant, in-use stability and expiry assignment. | Stability protocols should follow applicable regulatory guidance, including VICH stability principles for veterinary pharmaceuticals where applicable. | Approved stability protocol, long-term data, excursion data, in-use period and expiry justification. | Medicines Vaccines Diagnostics | Require at least 75% of the labeled shelf life remaining at shipment as a commercial benchmark, unless the contract specifies a stricter value. |
| Cold-Chain and Transport Control | 10% | Storage range, transport qualification, temperature monitoring and excursion management. | Products labeled for refrigerated storage are commonly maintained at 2–8°C; the approved label always takes precedence. Frozen products require their validated product-specific range. | Validated shipping configuration, temperature logger records, lane qualification, excursion procedure and transport mapping. | Vaccines Biologics Diagnostics | Review temperature data for each shipment and define release, quarantine and disposition rules for excursions before purchase. |
| Safety, Efficacy and Risk Management | 10% | Evidence supporting intended use, target species, dosage, contraindications, adverse reactions and benefit-risk balance. | Claims should be supported by regulatory or scientifically credible evidence and should clearly identify target species and use conditions. | Technical dossier, controlled studies, literature review, risk assessment, contraindications and adverse-event summary. | Medicines Vaccines Devices | Verify that the proposed indication, dose, route and withdrawal information are authorized in the importing market. |
| Residue and Food-Safety Compliance | 8% | Maximum residue limits, withdrawal periods, target tissues and restrictions for food-producing animals. | Residue controls must comply with the importing jurisdiction’s approved maximum residue limits and withdrawal requirements. | Residue studies, approved withdrawal period, maximum residue limit references and food-animal restrictions. | Antimicrobials Antiparasitics Hormonal Products | Compare the withdrawal period and permitted substances with the destination country’s official residue database before sale. |
| Antimicrobial Stewardship | 5% | Responsible use controls, prescription status, antimicrobial classification and resistance-risk information. | Antimicrobial products should include clear responsible-use instructions and comply with national prescription and stewardship rules. | Approved label, prescription classification, antimicrobial-resistance risk information and pharmacovigilance plan. | Antibiotics Antiparasitics | Assess whether the product supports veterinary oversight, correct dosing, treatment duration and prevention of unauthorized use. |
| Pharmacovigilance and Complaint Handling | 5% | Adverse-event reporting, complaint intake, investigation, corrective action and product recall capability. | A documented post-market surveillance system should be available, with defined reporting timelines and responsible personnel. | Pharmacovigilance system summary, complaint procedure, recall procedure, contact details and corrective-action records. | Medicines Vaccines Devices | Include reporting contacts, response times, recall communication rules and batch traceability requirements in the supply agreement. |
| Packaging, Labeling and Traceability | 5% | Batch or lot number, manufacture date, expiry date, storage conditions, dosage instructions and tamper evidence. | Every saleable unit and shipping carton should be traceable to a production batch and linked to the relevant quality records. | Approved label, packaging specification, serialization or coding information where required, and traceability procedure. | All Categories | Confirm label language, units of measure, local warnings, readability, tamper evidence and barcode compatibility with the importer’s system. |
| Diagnostic Performance | 5% | Analytical sensitivity, analytical specificity, diagnostic sensitivity, diagnostic specificity, repeatability and interference resistance. | Performance claims must be supported by a defined intended-use population, reference method and validation or verification data. | Performance evaluation report, validation protocol, reference method, lot release criteria and instructions for use. | Rapid Tests Laboratory Kits Analyzers | Check whether performance data represent the target animal species, specimen type, disease stage and operating environment. |
| Device Safety and Usability | 5% | Electrical or mechanical safety, usability, cleaning requirements, calibration, cybersecurity where relevant and risk controls. | Medical devices should use a documented risk-management process; ISO 14971 is a widely recognized reference for medical-device risk management. | Risk-management file, conformity assessment, user manual, maintenance schedule and calibration certificate where applicable. | Veterinary Devices Imaging Equipment Monitoring Systems | Verify intended-use limitations, operator training, service availability, spare parts and calibration intervals before deployment. |
| Supplier and Laboratory Competence | 2% | Technical capability, quality personnel, laboratory competence and continuity of supply. | Critical testing laboratories should demonstrate competence consistent with ISO/IEC 17025 or an equivalent national standard. | Laboratory accreditation scope, organization chart, quality agreements, business-continuity plan and capacity statement. | All Categories | Confirm that accreditation or qualification covers the specific test methods and product matrices used for release testing. |
