Stages of medicine labeling in Kazakhstan
The decision to conduct a pilot drug labeling project was made in December 2018. And since September 2019, it has been launched, for which methodological recommendations for this procedure were approved, a list of participants in the pilot project and medicines subject to labeling within its framework was determined.
At the same time, in October 2020, by order of the Prime Minister, a comprehensive plan for the development of the pharmaceutical and medical industry for 2020– 2025 was approved, which also includes issues of labeling medicines. As for the pilot project, it was completed on July 31, 2021.
According to the Kazakhstan Pharmaceutical Bulletin, 23 representatives of the pharmaceutical industry, including manufacturers, distributors, pharmacy and medical organizations, took part in the pilot.
Based on the results of the pilot project, recommendations were sent to improve the marking and traceability information system.
The first stage of mandatory labeling of 90 types of medicines began on July 1, 2022, of which more than 80% of medicines are produced by 4 domestic manufacturers.
A number of domestic manufacturers managed to purchase equipment for marking, joined the IS MPT, but not all market participants are ready to fully implement the project.
Taking into account the risks of reducing the availability of medicines, the insufficient readiness of the information system, due to the lack of integration of the information system for labeling and traceability of goods, the Ministry of Health of the Republic of Kazakhstan has developed amendments that suspend the mandatory labeling and traceability of medicines until July 1, 2024.
The following sequence is currently defined:
· from July 1, 2024 (stage 2) - drugs purchased by the Single Distributor (about 40%);
· from January 1, 2025 (stage 3) - prescription drugs (about 30%);
· from July 1, 2025 (stage 4) - over-the-counter drugs (about 30%)
Full traceability from July 1, 2025.
According to a government update on September 11, 2026, the system has processed approximately 1.1 billion medicine packs since mandatory marking began in July 2024.