[Blog] Track and Trace Compliance Landscape in CIS region (Uzbekistan, Kazakhstan, Kyrgyzstan)
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Uzbekistan, Kazakhstan, and Kyrgyzstan – CIS region countries focused on pharma modernization and traceability enhancement
In the last two years, the Pharma industry in the CIS region is undergoing a transformation. Countries such as Uzbekistan, Kazakhstan, and Kyrgyzstan have put a great effort and strategic actions towards fighting drug counterfeiting and modernization of the pharma sector. Every action produces a result – here is the overview of the current track and trace landscape.
Uzbekistan is one of the countries in the CIS region that work quite proactively on improving the quality of healthcare in different stands and developing a traceability system. The Uzbekistan traceability system is called ASL BELGISI.
Uzbekistan’s Cabinet of Ministers adopted Resolution No. 149, “On the introduction of a system of mandatory digital labeling of medicines and medical devices.”, which announced the deadlines for the four groups of medicinal products:
- On the first day of September, also came the first deadline for the serialization of medicines in Uzbekistan.
- From 1st November 2022 – the serialization became mandatory for medicines from Group 2; these are medicines with primary (inner) packaging (provided there is no secondary (external) packaging) (except orphan drugs);
- From 1st March 2023 – the serialization became mandatory for medicines from Group 3; a) medicines and medical devices for orphan diseases (according to the list approved by the Ministry of Health); b) medicines included in the register of medicines with foreign registrations, the results of which are recognized in Uzbekistan;
- The final stage of 100 % serialization is planned for 1st February 2025, when the medical products according to the list determined by the Ministry of Health/ medical supplies will fall under mandatory serialization
Moreover, on the first day of May 2023, also came the first deadline for the aggregation of medicines in Uzbekistan. Separate terms are established for the four groups of medical products which are as follows: Group 1 – from May 1, 2023; Group 2 – from August 1, 2023; Group 3 – from December 1, 2023; Group 4 – from December 1, 2025. It is foreseen a three-year transitional period.
The next country whose actions are straightforward for the modernization of the pharma sector is Kazakhstan. In 2018, the journey of Kazakhstan toward building a traceability system started. In the next 3 years, the government constantly worked and planned the pharmaceutical track and trace process for the serialization of all medicines.
In June 2022, amendments to the order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021, No. KR DSM-11 “On Approval of the Medicines and Medical Devices Labeling Guidelines” was officially announced. The laid down rules are effective from 1st August 2022. The Kazakhstan traceability system is called IS MPT.
However, by order of the Ministry of Health of the Republic of Kazakhstan dated 1 February 2023, the Rules for labeling and traceability of medicinal products have been suspended. The introduction of traceability has been postponed until 1 July 2025. According to the latest data, the timeframe of serialization and aggregation implementation are as follows:
- Stage 1 – Until July 1, 2024 – Mandatory labelling of 100% of drugs)
- Stage 2 – From July 1, 2024 – Serialization of drugs purchased by single distributor (for government procurement – about 40%)
- Stage 3 – From January 1, 2025 – Prescription drugs (about 30%) – have to be traceable and labeled
- Stage 4 – From July 1, 2025 – Serialization of non- prescription drugs (about 30%)
Kazakh market is marking significant progress and modernization towards traceability and transparency, taking strategic actions:
- Methodical implementation of Track & Trace Directive
- Advanced Regulatory Compliance Mechanism
- Comprehensive Plan for the Development 2025
- Active Investment Policy of Kazakhstan attracting profitable fundings
- Establishing environment feasible for diversification based on improved production capabilities
The Republic of Kyrgyzstan is the next EAEU country that is introducing mandatory serialization. In September 2022, the government published Order No. 1110/09.20.2022 – Traceability system for medicines and medical devices identification of the Kyrgyz Republic that specifies the track and trace requirements for pharmaceuticals. The supply chain participants must comply with the requirements for the developed Kyrgyz platform – Teksher.
The process of implementation of serialization is divided into four stages:
- Stage 1 – Preparing of guidelines, Introduction of traceability for drugs from the List No. 1, Training of healthcare organizations (turnover participants), Equipment for work in the traceability system, Registration in the ИС ЭБД of a healthcare organization as a participant in the turnover – until 1 July 2023
- Stage 2 – Implementation of traceability for drugs from the List No. 2 – From July 1, 2023 – November 1, 2023
- Stage 3 – Implementation of traceability for medicines included in the traceability system, List No. 3 and not included in Lists No. 1 and No. 2 – From November 1, 2023 – March 1, 2024
- Stage 4 – Implementation of traceability for all medicinal products in circulation in the territory of the Kyrgyz Republic – From March 1, 2024 – June 30, 2024
The aggregation requirements and deadlines are expected to be confirmed.
Medicines consumption data collected through the traceability system will be used to develop a national healthcare strategy.