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Government approves monthly control of medicines to ensure safety and compliance

The government of Uzbekistan has introduced a new regulation to enhance the post-market surveillance of pharmaceutical products, ensuring that drugs and medical supplies in circulation meet safety and quality standards. The Cabinet of Ministers approved the regulation, which will come into effect on January 1, 2025, according to a document published on Lex.uz.

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The regulation outlines a comprehensive system for monitoring pharmaceuticals after they enter the market, aiming to assess their compliance with technical standards. The post-marketing control will be managed by the Center for Pharmaceutical Safety, operating under the Ministry of Health. The center will conduct regular product assessments through control purchases and laboratory tests.

As part of the process, the Center will implement monthly control purchases of drugs and medical goods. By the 25th of each month, the center will develop a plan for post-market surveillance, with the selection of drugs based on their international non-proprietary names (INN) through an electronic system that performs risk analysis.

In addition to planned checks, the center will also respond to citizen complaints or information regarding product quality, safety issues, illegal distribution, or side effects. In such cases, the control purchases will be based on the product’s trade name rather than its generic equivalent.

Control purchases will be conducted by specialized staff from the center, using official bank cards. For products not available in pharmacies, such as medical equipment or drugs stored in manufacturers' warehouses, samples will be taken directly from the producers.

The collected samples must be delivered to a laboratory within two days of purchase, where testing will be completed within five business days. If necessary, this testing period can be extended to 15 business days. The laboratory will produce reports and send them to the relevant authorities.

Following the laboratory's assessment, the working body will issue a formal conclusion within three working days. The Center for Pharmaceutical Safety will then have up to three additional days to determine what actions are needed based on the findings, which may include recalling unsafe products, issuing warnings, or taking other corrective measures.

This new regulatory framework will help improve oversight of the pharmaceutical market in Uzbekistan and ensure that only safe, effective products remain available to consumers.

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