Europe

Navigating the Regulatory Landscape: Central Hub for Europe's Regulations and Related Links

Navigating the Regulatory Landscape

This page serves as a centralized resource for exploring pharmaceutical regulatory requirements across EU member states. Each country listed below features a summary of its compliance landscape along with a link to more detailed information. This hub supports visibility into region-wide mandates such as the Falsified Medicines Directive (FMD), offering a clear view of how regulations are structured and enforced across Europe.

All Regulations

EU FMD

LSPedia's EU FMD resources guide you through the complexities of the European Falsified Medicines Directive. Stay compliant with our insights, ensuring your pharmaceutical operations align with European regulatory standards.

Russia

In Russia, the Chestny ZNAK system represents a comprehensive national track and trace framework designed to ensure pharmaceutical authenticity and combat counterfeit medications. Established under Federal Law No. 425-FZ in December 2017, this robust regulatory system has undergone phased implementation since 2019, creating one of the world's most stringent pharmaceutical traceability networks aimed at protecting public health and ensuring supply chain integrity.

Kazakhstan

In Kazakhstan, the Information System for Marking and Traceability of Goods (IS MPT) serves as the country's comprehensive framework for ensuring pharmaceutical integrity. Operated by Kazakhtelecom JSC, this centralized digital system employs advanced tracking technologies to combat counterfeit medications, enhance supply chain transparency, and safeguard public health across the nation's pharmaceutical landscape.

Armenia

Armenia stands at the forefront of pharmaceutical supply chain modernization through its comprehensive e-Mark electronic marking system. As a member of the Eurasian Economic Union (EAEU), Armenia is strategically developing its track and trace regulatory framework to align with international standards while ensuring robust protection against counterfeit medicines. The country's phased approach to implementation demonstrates a commitment to building a transparent and secure pharmaceutical ecosystem that safeguards public health through advanced digital oversight mechanisms.

Serbia

Serbia has established a sophisticated pharmaceutical regulation system that prioritizes patient safety through advanced traceability measures and anti-counterfeiting protocols. Built upon the foundation of the Serbian Drugs Law of 1993 and aligned with European standards, Serbia's regulatory framework ensures comprehensive monitoring of pharmaceutical products from manufacturer to patient, creating a robust defense against falsified medicines while enabling rapid response capabilities.

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