General Overview
Azerbaijan introduced mandatory serialization of medicines from January 1, 2024.
To carry out real-time monitoring of all stages, from the production/import of medicines to their delivery to the final consumer, and to ensure safety and prevent smuggling of medicines, Azerbaijan has gradually introduced the ‘Tracking and Tracing System’ starting January 1, 2024.
At the initial stage, monitoring of psychotropic and potent medicines began. From June 1, 2024, real-time monitoring of other medicines has started in the warehouses of all domestic manufacturers and wholesale pharmaceutical enterprises, as well as in medical institutions and pharmacies.
Regulatory Framework
Regulatory Authority – Analytical Expertise Center of the Ministry of Health , Ministry of health of the Republic of Azerbaijan
In accordance with their duties, they perform the following functions:
- Organization of the activities of the medicine tracking and tracing system, continuous development of the system, regular verification of its effectiveness, as well as taking the necessary corrective or preventive measures;
- Carrying out tracking and tracing of medicines;
- Development of regulatory legal acts on the tracking and tracing of medicines and making proposals to change current legislation;
- Determining and conducting relevant trainings for participants in the circulation of medicines on the topic โTracking and tracing systemโ;
- Perform other duties provided for by law in relation to the system of tracking and tracing of medicines.
Regulations
- โDecree of the President of the Republic of Azerbaijan On application of the Law of the Republic of Azerbaijan dated July 24, 2023 No. 979-VIQD “On Amendments to the Law of the Republic Of Azerbaijan “On Medicines” and on amendments to the Decree No. 528 of the President of the Republic of Azerbaijan dated February 6, 2007โ, dated August 15, 2023 No. 2298
- Law of the Azerbaijan Republic dated July 14, 2023 No. 979-VIQD โOn Amendments to the Law of the Azerbaijan Republic โOn Medicinesโ
Products that require barcoding:
- Psychotropic and potent medicines;
- Prescription pharmaceutical products.
Barcode Requirements
Serialization Barcoding requirements – Mandatory, GS1 2D Data Matrix;
2D Data Matrix:
- Global Trade Item Number (GTIN)
- Expiry date
- Batch/Lot
- Serial number (SN)
Aggregation Barcoding requirements – Not required yet, but it is expected;
Human-readable part:
- Global Trade Item Number (GTIN)
- Expiry date
- Batch/Lot
- Serial number (SN)
General information about the reporting system
Reporting system: Tracking and tracing system of medicines – Dษrman Vasitษlษrinin Tษqib vษ ฤฐzlษmษ Sistemi (DVTIS)
Scope: Providing real-time monitoring of all stages from the production or import of medicines to their delivery to the final consumer, in order to ensure the safety of the circulation of medicines and prevent their smuggling.
Timeline: โTracking and tracing system of medicinesโ is gradually implementing from January 1, 2024 to end of 2024.
Stakeholders:
- All domestic manufacturers;
- Wholesale pharmaceutical enterprises;
- Medical institutions;
Based on the information we have gathered:
An information system for tracking and monitoring medicinal products (DVTIS) has been developed, which allows for electronic tracking of coded medicinal products according to the GS1 2D Data Matrix format. Participants in the circulation of medicines log into this System using the appropriate username and password. These user accounts are created on the basis of information provided by the relevant institutions of the โTracking and Tracing of medicines Departmentโ, which acts as the operator of the System.
Information on the systemโs operation is available via video tutorials on the regulatory authorityโs website: https://pharma.az/en/news/how-to-use-the-track-and-trace-system-of-medicines/
The system allows for (1) the import of previously applied codes regulated by the European Union, the USA, India, and other countries; (2) the generation of codes for placement on packaging either directly during the production process or by stickering by the importer.
Useful links
Web address (link) to access the โTrack and trace system of medicinesโ: