Name: Uzbekistan Pharmaceuticals
Brand: TraceLink

Products

Intelligent data management and reporting solutions to meet traceability compliance requirements in Uzbekistan

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Product overview

Ensuring regulatory compliance in Uzbekistan

TraceLink’s Uzbekistan Pharmaceuticals solution enables pharmaceutical manufacturers or MAHs who want to commercialize products within Uzbekistan to comply with labeling requirements for serialization and reporting certain events to a central system.

The solution includes the request and retrieval of crypto codes and reporting to the ASL Belgisi system, which is operated by CRPT Turon.

With this product, you can access:

Core compliance solutions

Software validation

Staff training

Industry challenges

Understanding the need for new compliance solutions

Pharmaceutical companies that distribute products within Uzbekistan must comply with labeling and marking requirements for serialization and reporting events to a central system. Some challenges include:

Generating & managing serial numbers

Generate and manage serial numbers for products destined for Uzbekistan and request and retrieve crypto codes from the national system operator.

Generating & managing serial numbers

Managing data across markets

Manage and monitor serial numbers and crypto codes that are distributed to internal packaging lines and contract manufacturers that may also be serializing products for other markets.

Managing data across markets

Obtaining electronic digital signatures

Companies may be required to obtain electronic digital signatures to access the government traceability system and to acquire crypto codes.

Obtaining electronic digital signatures

Adapting to evolving requirements

There is significant uncertainty as compliance and reporting requirements for Uzbekistan continue to evolve, requiring companies to start early, yet ensure system and operational flexibility and scale.

Adapting to evolving requirements

Product benefits

Meet compliance requirements securely

TraceLink’s Uzbekistan Pharmaceuticals solution provides comprehensive capabilities to meet Uzbekistan's emerging regulations for the management of master data, serialized product information, and government reporting of compliance information. The solution and its supporting applications take the burden off of the internal business by continually monitoring business and regulatory requirements, updating the solution as required on a standardized compliance platform.

Product benefits

Reduce time & cost for compliance

Uzbekistan Pharmaceuticals eliminates the need to develop and maintain a custom, one-off compliance solution in-house, and reduces the internal time and costs requirement to initially validate and re-validate as systems and processes evolve. The solution supports electronic submission of compliance transactions to the Uzbekistan Order Management System (OMS) and maintains a record of transactions sent to the government system to support record retention requirements. It provides the ability to report on historical interactions with the government system.

Product benefits

Redirect scarce operational & validation resources

Business and operational teams can be more efficient by relying on TraceLink's purpose-built compliance solution instead of needing to manually capture, configure, and share/report serialization and compliance information, while relying on TraceLink's validated solutions and platform to take the burden off of teams typically faced with continually validating custom internal systems.

Product benefits

Focus on the business, not compliance

Outsource the risk and work to monitor, evaluate, and implement validated compliance solutions to a company dedicated to secure compliance.

Product benefits

Improve budget & cost predictability

Control and confidently predict compliance and validation costs by leveraging an efficient, high-performance compliance and validation solution with a clear to understand subscription model.

Capabilities

TraceLink’s OPUS Compliance Platform

TraceLink's Uzbekistan Compliance helps create a comprehensive and flexible compliance platform for meeting Uzbekistan's complex compliance data management and reporting requirements.

Access crypto codes

Configure reports

Optimize operations

Leverage our network

Request and retrieve crypto codes, and ensure secure compliance reporting to Uzbekistan government systems.

Solutions are continuously updated as market requirements evolve and change.

TraceLink provides proven functionality to retrieve and manage crypto code for serialization exchange processes with CMOs and LMS.

Generate, submit, and manage compliance reports to the ASL Belgisi system.

Use a modular approach to apply business logic to detect and trigger reporting events.

Keep core serialization functionality and integrations with CMOs and internal packaging lines intact.

Leverage critical scalability and operational performance designed to handle vast serialization and event data requirements.

Rapidly process the massive, variable serialization information, event data, and transactions required by Uzbekistan regulations.

TraceLink's network-tenant architecture rapidly onboards new CMOs who package products for Uzbekistan, and simplifies enhancements to existing CMO integrations.

TraceLink customers enjoy exclusive access to our TraceLink Community, where they can engage in detailed discussions on Uzbekistan other EAEU serialization requirements, use cases, and product requirements.