Name: Russia Biologically Active Food Supplements (BAFS)
Brand: TraceLink

Products

Advanced compliance data management and reporting solutions to meet traceability compliance requirements for biologically active food supplements in Russia

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Product overview

Comply with Russia food supplement requirements

The TraceLink Russia BAFS solution enables pharmaceutical manufacturers distributing products in Russia to meet new track-and-trace requirements covering biologically active food supplements (BAFS), such as vitamins and minerals.

With Russia BAFS, you can:

Confidently meet Russia food supplement compliance requirements.

Streamline regional compliance operations and processes.

Insulate internal enterprise systems from country-specific 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 food supplement requirements in Russia. These challenges include:

Crypto code acquisition and management

To achieve compliance, manufacturers must be able to request and receive crypto codes from the OMS government system, as well as provide crypto codes to line management systems and CMOs using existing integrations.

Crypto code acquisition and management

Extensive compliance event reporting requirements

Companies must generate reports when regulated supply chain events are detected, and connect to TT GIS to submit reports and capture government acknowledgments.

Extensive compliance event reporting requirements

Unique business use cases

In addition to the new reporting protocol, companies must also support various manufacturer, importer, and wholesale distributor use cases.

Unique business use cases

Product benefits

Shorten time to compliance

The TraceLink Russia BAFS solution is deployed on the TraceLink Global Compliance Platform, which greatly speeds initial configuration and minimizes reliance on IT for maintenance.

Product benefits

Lower total cost of ownership

The TraceLink Russia BAFS solution capitalizes on the TraceLink platform’s “Integrate Once, Interoperate with Everyone™” capability, which enables manufacturers to connect with partners without configuring costly point-to-point integrations.

Product benefits

Utilize proven compliance expertise

TraceLink has been developing compliance solutions for Russia since 2019, with more than 130 manufacturers and CMOs relying on TraceLink to meet regional track-and-trace requirements.

Product benefits

Ensure continuous compliance

With regulatory requirements, standards, and technical guidelines constantly evolving, TraceLink continually updates our global solutions to ensure you’re always in compliance. TraceLink also provides 24x7 global support to troubleshoot any issues.

Product benefits

Capabilities

TraceLink Russia BAFS

Natively integrated into the TraceLink Global Compliance Platform, the BAFS solution enables customers to meet the complex food supplements compliance requirements by providing them with several key capabilities.

Manage serial numbers and crypto codes

Integrate with government and partner systems

Optimize compliance processes and operations

Automate report generation and submission

Simplify and automate the creation of secure serial numbers for food supplement products and allocate serial numbers to internal packaging lines and contract packaging partners.

Request and receive crypto codes from the OMS government system, and provide crypto codes to line management systems and CMOs using existing integrations.

A single integration to the TraceLink network connects you with all trading partners and government systems.

Securely request and retrieve crypto codes from the OMS system and submit required compliance reports to TT GIS.

Receive commissioning and aggregation information.

Manage changes to packaging hierarchies and corresponding aggregation.

Capture serial numbers of decommissioned products.

Automate compliance event reporting through easy-to-configure triggers.

Ensure the creation of properly formatted reports and maintain an audit trail of reports submitted to TT GIS with predefined business logic designed for specific compliance events.