Pharmaceutical Drug Traceability in the Azerbaijan: Comprehensive Overview
Azerbaijan’s Track & Trace System Set to Launch in 2024
The Republic of Azerbaijan is poised to revolutionize its pharmaceutical industry with the upcoming launch of its national track and trace system, DVTIS (Drug Persecution and Tracking System), expected to go live in 2024. This initiative aims to significantly enhance the traceability and safety of pharmaceuticals across the country.
Key Milestones
In the third quarter of 2023, the Azerbaijani government announced the development of the DVTIS. The initial phase will focus on monitoring psychotropic drugs and potent medicines. Starting June 1, 2024, real-time monitoring will expand to include other medications, covering warehouses of domestic manufacturers, wholesale pharmaceutical enterprises, medical institutions, and pharmacies.
Involved Participants
The project involves key stakeholders such as:
- Domestic Manufacturers
- Wholesale Pharmaceutical Enterprises
- Medical Institutions
- Pharmacies
In November of the previous year, a comprehensive three-day training session was conducted for local manufacturers, pharmaceutical representatives, pharmacies, and private medical institutions. This session introduced various subsystems including QR code ordering, production notifications, import notifications, transfer notifications, and pharmacy sales notifications.
In February, the Ministry of Health engaged with representatives from European pharmaceutical companies to discuss system implementation and demonstrate its functionality.
Serialization Requirements
The DVTIS mandates QR codes on the secondary packaging of pharmaceutical products. These codes will contain essential information such as:
- Global Trade Item Number (GTIN)
- Batch/Lot Number
- Serial Number
- Expiry Date
Real-Time Monitoring
From January 2024, the Drug Tracking and Monitoring System (DTMS) will facilitate real-time monitoring throughout the entire pharmaceutical supply chain, ensuring products move safely from production and importation to consumer distribution. The system will initially focus on psychotropic and highly effective drugs before expanding to include all medications.
Compliance and Implementation
Pharmaceutical companies in Azerbaijan must ensure their serialization solutions comply with national regulations. Non-compliance may result in penalties and delays in product registration and market access. Collaboration with supply chain partners and technology vendors is essential to meet these requirements.
How Evoltrace Can Help
Evoltrace offers specialized services to support pharmaceutical companies in navigating and implementing Azerbaijan’s track and trace regulations. Our team provides comprehensive consulting, implementation, and integration services tailored to meet serialization requirements. We leverage our expertise in global regulatory compliance to ensure seamless adoption of DVTIS, helping clients manage end-to-end serialization projects effectively.
Conclusion
Azerbaijan’s implementation of DVTIS represents a significant advancement in pharmaceutical traceability, promising enhanced safety and efficiency in the supply chain. For more information on regulatory compliance and how Evoltrace can assist your company, please visit our website.
For further details and updates, please visit pharma.az and refer to the Analytical Expertise Center of the Azerbaijan Ministry of Health.
Disclaimer
This information is provided ‘As Is’ without any claims of suitability for a particular purpose. It is a general interpretation based on publicly available information and is subject to change. This content does not constitute legal advice. Users should refer to source materials for complete requirements and make their own interpretations before making business decisions. Please consult the provided references to follow updates at the source.