Understanding Azerbaijan’s Pharmaceutical Regulations: Serialization and Traceability
The Ministry of Health of the Republic of Azerbaijan is the primary regulatory authority responsible for overseeing the healthcare sector, including the regulation of pharmaceutical products.
Azerbaijan has seen a steady increase in the demand for high-quality medicines and healthcare products.
Pharmaceutical products marketed in Azerbaijan must comply with specific labeling and packaging requirements to ensure that healthcare professionals and patients have access to accurate and complete information about the product.
Barcoding & Labelling Specification:
The Decree of the President of the Republic of Azerbaijan on the application of the Law of the Republic of Azerbaijan, dated July 24, 2023, says that Serialization on logistics units is mandatory.
The guidelines, at present, do not specify mandates on Aggregation, i.e., Parent-child mapping between packaging hierarchies.
The regulations on aggregation are not required but are expected. Azerbaijan is also implementing the Drug Tracking and Monitoring System (DTMS) to monitor the pharmaceutical process in real-time.
The DTMS will begin with psychotropic and highly effective drugs in June 2024 and will expand to other medications later.
Symbology – GS1 2D DataMatrix.
2D Data Matrix
- Global Trade Item Number (GTIN)
- Expiry date
- Batch/Lot
- Serial number (SN)
Human-readable part
- GTIN
- Expiry date
- Batch/Lot
- Serial number (SN)
The aggregation barcoding requirements are not required yet but are expected.
DVTIS (Drug Persecution and Tracking System) – Track and Trace System:
The “Tracking and tracing system of medicines” on the territory of the country, as one of the main concepts, is mentioned in the Law of the Republic of Azerbaijan “On Medicines.”
Aiming to significantly enhance the traceability and safety of pharmaceuticals across the country, The Republic of Azerbaijan is set to launch its national track and trace system, DVTIS (Drug Persecution and Tracking System), which is expected to go live in 2024.
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
- Pharmacies
The Stakeholders/Users/Operators of the Track & Trace system can login to a system based on the login credentials given, where electronic tracking of drugs can monitor.
The expert guideline in video format is available on the regulatory website- https://pharma.az/en/news/how-to-use-the-track-and-trace-system-of-medicines/
The Department of Tracking and Tracing of Medicines operates as a structural unit of the public legal entity “Analytical Expertise Center” of the Ministry of Health.
Additional relevant resources –
Web address (link) to access the “Track and trace system of medicines”:
https://dvtis.e-health.gov.az/account/login
How is the “Track and Trace” system used by retail pharmaceutical and medical facilities?
Video Link: https://youtu.be/_vPGBf1bmfw
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