The countries of Central Asia – Russia, Kazakhstan, and Uzbekistan – stand at the crossroads of stringent regulations and evolving technology.
The emergence of track and trace systems aimed at ensuring product authenticity and safeguarding public health has become important in these nations.
Here, we share the complex web of regulations governing serialization and traceability in Russia, Kazakhstan, and Uzbekistan, shedding light on how businesses must navigate to thrive in these markets.
The Imperative of Track & Trace: Beyond Compliance
Track & Trace systems have transcended their initial purpose of regulatory compliance. Today, they stand as pillars of transparency, efficiency, and consumer safety.
By enabling the precise monitoring of products throughout the supply chain, these systems not only satisfy legal requirements but also consumer trust and operational excellence.
Russia: Chestny ZNAK and the Fight Against Counterfeits
At the heart of Russia’s track and trace system is Chestny ZNAK, meaning ‘honest badge,’ a centralized platform designed to combat counterfeit drugs.
Enacted in December 2017, this legislation mandates the serialization of various products, including pharmaceuticals, tobacco, and alcohol.
The system employs a 44-character crypto code, providing cryptographic protection through open key encryption algorithms.
The primary objectives are to streamline quality control, prevent counterfeit products from entering the market, and monitor demand and supply dynamics.
Russia’s phased implementation, initiated in 2019 and set to culminate by 2024, demands compliance from every distributor and manufacturer in the pharmaceutical supply chain.
The consequences of non-compliance are severe, including substantial fines and product seizures.
In this landscape, understanding the intricacies of Chestny ZNAK is imperative for every industry player, from manufacturers to distributors.
The law’s phased implementation commenced in 2019, with varying serialization deadlines across industries. Notable deadlines include:
Key Dates to Take Note of:
- By November 1, 2023, importers are mandated to aggregate their goods and transmit the aggregation data to the Chestny ZNAK system.
- By March 1, 2024, stakeholders are obligated to submit returns of their products to the system and remove suspicious items from circulation.
- Starting January 1, 2021, non-serialized light industry products will face a ban.
The government has implemented fines and penalties for those failing to meet these requirements.
Kazakhstan: IS MPT and the Battle Against Counterfeit Drugs
Kazakhstan, like its neighboring countries, faces the challenge of combating counterfeit drugs. The IS MPT traceability system, set to be fully operational by 2025, mandates the serialization of pharmaceutical products.
The timelines are stringent: until July 1, 2024, 100% of drugs must be labeled, and by July 1, 2025, serialization must cover both prescription and non-prescription medications.
The serialization process involves a 14-digit product code (GTIN), a 13-character randomized serial number, a 4-character verification key, and a 44-character verification code.
These codes are not merely regulatory requirements; they are lifelines ensuring the transparent movement of medicines through the supply chain.
By implementing serialization, Kazakhstan aims to create a transparent supply chain, prevent drug shortages, and eliminate counterfeit drugs from circulation.
Key Dates to Take Note of:
As per the most recent information, the schedule for the implementation of serialization and aggregation is outlined as follows:
- Until July 1, 2024 – Mandatory labeling of 100% of drugs.
- From July 1, 2024 – Serialization of drugs purchased by a single distributor (for government procurement – approximately 40%).
- From January 1, 2025 – Prescription drugs (about 30%) must be traceable and labeled.
- From July 1, 2025 – Serialization of non-prescription drugs (about 30%).
These timelines are crucial milestones, indicating specific percentages and categories of drugs that need to comply within each stage.
Uzbekistan: Embracing Transparency and Accountability
Uzbekistan, with its 36 million inhabitants, has embarked on a similar journey. The serialization program, part of the government initiative to combat counterfeit and illegal medicines, has reached its final phase in 2023.
For businesses operating within Uzbekistan, compliance is not just about adhering to regulations about embracing transparency and accountability.
For companies with complex information systems, integrating solutions with specific add-ons has become imperative.
Uzbekistan’s commitment to serialization reflects a broader global trend – one where technology and regulation converge to ensure the authenticity and safety of pharmaceutical products.
Key Dates to Take Note of:
Deadlines to keep in mind for Uzbekistan Pharmaceutical Traceability System are as follows:
- September 1, 2022: Initiation of digital marking for medicines distributed in Uzbekistan
- November 1, 2022: Inclusion of products with primary packaging and medical and agricultural products
- January 1, 2023: Implementation of traceability for labeled medicines and expansion to cover 60% of medicines
- April 1, 2023: Extension of traceability to encompass 80% of medicines produced and imported into the country
Additionally, the government announced a track-and-trace pilot project that was scheduled to run from January 2023 to June 2023.
Jekson Vision: Your Trusted Partner in Serialization Solutions
In the face of Track and trace regulations in Russia, Kazakhstan, and Uzbekistan, Jekson Vision emerges as the thread that binds compliance, efficiency, and innovation.
Our legacy of providing cutting-edge Track and trace solutions transforms mere regulatory requirements into strategic advantages.
With advanced serialization technologies, real-time tracking, seamless integration, and robust data analytics capabilities, our systems not only ensure compliance but give your products a competitive edge.
Beyond technology, we offer comprehensive training and support, empowering your teams to navigate these complex landscapes effectively.
Our state-of-the-art serialization solutions not only ensure compliance with the requirements of Chestny ZNAK, IS MPT, and other global track and trace standards but also elevate your operations to unprecedented levels of efficiency and transparency.
By choosing Jekson Vision, you are not merely investing in a solution; you are investing in peace of mind.
Our tailored serialization systems not only meet regulatory demands but also empower your business with actionable insights, real-time monitoring, and robust data analytics.
As Central Asia propels itself into an era defined by transparent supply chains and safe pharmaceuticals, Jekson Vision is your trusted partner, helping you craft a future where every product is traced, every transaction is transparent, and every consumer is assured of the authenticity of the medicines they consume.
Embrace the future of serialization with Jekson Vision – where innovation meets compliance and trust meets technology.
For more details, reach us at marketing@jeksonvision.com or WhatsApp us on +91 9328233954