Name: Russia Pharmaceuticals
Brand: TraceLink

Products

Advanced compliance data management and reporting solutions to meet pharmaceutical traceability requirements in Russia

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Product overview

Comply with Russia pharmaceutical serialization and reporting requirements

TraceLink Russia Pharmaceuticals enables pharmaceutical manufacturers to manage pharmaceutical compliance data and reporting requirements established by Russia Federal Law 425-FZ. This includes the reporting of supply chain events for domestic and foreign pharmaceuticals and their related distribution.

With Russia Pharmaceuticals, you can:

Confidently meet Russia pharmaceutical compliance requirements

Streamline regional compliance operations and processes

Insulate internal enterprise systems from regional compliance demands

Industry challenges

New compliance requirements demand new compliance solutions

Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges managing regulatory compliance and navigating evolving pharmaceutical requirements in Russia. These challenges include:

Complex track and trace regulatory requirements

Russian Federal Law No. 425-FZ covers all pharmaceutical and over-the-counter medicines. This law introduced some of the most complex product identification demands, cryptographic coding requirements, and government reporting regulations.

Complex track and trace regulatory requirements

Extensive reporting requirements for specific supply chain events

Companies must report more than 35 compliance events to the Russia Drug Circulation Monitoring System (MDLP), such as product commission and decommission, aggregation and disaggregation, quality sampling and quality control release testing, and more.

Extensive reporting requirements for specific supply chain events

High configuration barriers for compiling compliance reports

Each of the compliance reports submitted to the MDLP is highly dependent upon a company's unique supply network configuration, requires the capture of extensive business and operational data, and specifies reporting of such data using XML transactions and electronic signatures.

High configuration barriers for compiling compliance reports

Product benefits

Access configuration flexibility & extensive reporting capabilities

The Russia Pharmaceuticals solution provides the configuration flexibility and extensive reporting capabilities to help companies model their supply ecosystems and ensure that the right product and transaction reports are configured and submitted when and where required from product packaging to sale in the supply chain.

Product benefits

Reduce compliance risk

Leverage built-in business rules designed to meet the complex data and event choreography defined in the Russian regulations. The extensive TraceLink network also streamlines partner integration and data exchange without requiring modification of core underlying enterprise systems.

Product benefits

Automate and streamline compliance reporting

Russia Pharmaceuticals delivers a flexible reporting solution that can be tightly integrated to internal serialization/packaging, distribution, and other systems, and to external CMO or 3PL partner systems, to automate Russian compliance as part of normal day-to-day business operations.

Product benefits

Achieve operational scale and performance

Russia Pharmaceuticals provides the operational scale and performance needed to track and report the movement of the highest volume, highest velocity product portfolios through internal distribution networks and external supply chain channels while meeting complex compliance transaction reporting requirements.

Capabilities

TraceLink’s OPUS Compliance Platform

Russia Compliance helps create a comprehensive and flexible compliance platform for meeting Russia’s complex compliance data management and reporting requirements.

Manage workflows and data

Automate and customize reports

Submit reports

Leverage extensive business rules to configure product and company master data and transaction information based on specific report requirements.

Capture system response messages from the Russia MDLP system to verify correct submission/processing or to enable quick response on negative responses or issues.

Receive inbound messages from the Russia MDLP system for movements or transactions triggered by supply or trade partners.