Trazabilidad MEA

Central Hub for the Commonwealth of Independent States

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Navegando por el panorama regulatorio

Esta página proporciona una descripción general consolidada de las regulaciones farmacéuticas en Oriente Medio y África. Cada país incluido en la lista presenta una breve descripción de su marco regulatorio, con acceso directo a detalles más detallados. El centro está diseñado para aclarar las diversas expectativas de cumplimiento en los MEA, destacando tanto los requisitos emergentes como los estándares establecidos en la región.

Todos los reglamentos

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Armenia

Armenia has implemented pharmaceutical serialization requirements to strengthen medicine safety and improve supply chain transparency. The framework is overseen by the Ministry of Health of the Republic of Armenia and the Scientific Centre of Drug and Medical Technology Expertise (SCDMTE).

The system requires unique identification of pharmaceutical products using standardized barcode technology and electronic reporting of serialized product data. Serialization allows regulators and supply chain participants to verify medicine authenticity and monitor product movement across the distribution chain.

Manufacturers, importers, wholesalers, and pharmacies must ensure serialized identification of pharmaceutical products placed on the Armenian market and maintain traceability records throughout the supply chain.

Azerbaiyán

Azerbaijan operates a national pharmaceutical traceability system known as the Drug Tracking and Monitoring System (DTMS). The system is managed by the Analytical Expertise Center of the Ministry of Health and is designed to improve supply chain transparency, prevent counterfeit medicines, and ensure patient safety.

The system requires pharmaceutical products to be uniquely identified and tracked across the supply chain from manufacturer or importer to pharmacies and healthcare institutions. Serialization and electronic reporting of product movements allow regulators to monitor medicine circulation and investigate suspicious products.

Manufacturers, importers, distributors, and pharmacies must participate in the DTMS platform and report relevant supply chain operations.

Cadena de suministro farmacéutico de Kazajstán

Kazakhstan requires all medicines to be tracked through a national system called ISMPT. The objective is to protect patients, reduce counterfeit medicines, and improve visibility across the pharmaceutical supply chain. All medicines sold or imported into Kazakhstan must carry a secure serialized code and must be reported as they move from manufacturing to pharmacies. Serialization, aggregation, and movement reporting are mandatory.

Kyrgyzstan

Kyrgyzstan has implemented a national pharmaceutical serialization and traceability framework as part of the Eurasian Economic Union (EAEU) digital marking initiative. The system is designed to improve medicine supply chain transparency, prevent counterfeit medicines, and enable regulatory monitoring of pharmaceutical distribution.

The national system requires medicines to carry serialized DataMatrix codes that allow regulators and supply chain participants to track pharmaceutical products from manufacturing or import through distribution and dispensing.

Kyrgyzstan operates its digital marking system through the State Tax Service marking platform, which forms part of the broader national digital product labeling program. Pharmaceutical products must be registered in the marking system, and serialized identifiers must be applied before products are placed on the market.

The framework is aligned with international identification standards and supports electronic reporting of supply chain events across the pharmaceutical distribution network.

Uzbekistan

Uzbekistan enforces pharmaceutical serialization through its national system called XTrace, managed by CRPT Turon. All human medicines must carry serialized GS1 DataMatrix codes issued by the government. The country recently introduced significant changes to serial number format and reporting rules, including removal of the UZF0 segment and the introduction of a mandatory 7 prefix for serial numbers.

Manufacturers, importers and distributors must generate compliant serial numbers, report all movements and ensure strict alignment between printed codes and submitted data for customs clearance.

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