Table of contents
Overview
The SOM Country Clearance transaction is an XML-based message used to confirm that serialized pharmaceutical products are authorized for distribution into a specific country. This transaction ensures that each shipment complies with the destination country’s customs and import/export regulatory rules before leaving the facility.
The TL XML – SOM Country Clearance transaction provides a traceable, auditable record of the country-specific clearance decision. It enables secure, rules-based control over international distribution and supports compliance with global track and trace and product distribution regulations.
Key Use Cases
- Digitally authorize serialized product shipments for distribution into a specific country.
- Apply and document country-specific customs rule compliance.
- Prevent unauthorized or non-compliant product movement across borders.
- Trigger downstream actions such as shipment release, customs processing, or invoicing.
- Provide traceable documentation of customs clearance decisions by market.
- Integrate with ERP, WMS, and compliance systems for global distribution control.
Data Elements Included
A TL XML – SOM Country Clearance transaction includes:
- Transaction Type: SOMCountryClearance
- Serialized Product Identifiers (EPCs): SGTINs or SSCCs of the serialized units being cleared.
- Destination Country Code: ISO 3166-1 alpha-2 code (e.g., “US”, “DE”, “IN”) representing the target market.
- Event Timestamp: Date and time when the clearance was granted.
- Business Location: GLN or internal code of the releasing facility.
- Disposition: Typically "cleared_for_country".
- Shipment or Sales Order Reference (optional): Link to the related transaction.
- Clearance Reason Code (optional): Code indicating why the shipment was approved.
- Transaction ID (optional): Unique identifier for the clearance transaction.
- Digital Signature (optional): Ensures data integrity and non-repudiation.
- Comments or Notes (optional): Free-text for additional QA or other notes.
Benefits of TL XML – SOM Country Clearance
- Ensures compliance with destination-specific customs and regulatory rules.
- Digitally confirms market authorization before product movement.
- Prevents unauthorized international shipments and controlled substance violations.
- Provides traceable, auditable records for customs clearance decisions.
- Automates downstream workflows tied to export or domestic shipment readiness.
Business Process: TL XML – SOM Country Clearance
The SOM Country Clearance transaction supports:
- Order Management & Fulfillment: Authorizes product release based on country-specific customs rules.
- Track and Trace & Government Compliance: Ensures regulatory compliance for global distribution.
- Product Serialization & Traceability: Maintains serialized records of country-level clearance.
- Quality, Risk, and Recall Management: Provides documentation for customs decisions and export control.
- Inventory Management: Updates product status to reflect readiness for market-specific distribution.
How TraceLink Supports TL XML – SOM Country Clearance
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, supports secure and compliant SOM Country Clearance by:
- Applying configurable rule sets based on destination country.
- Generating TL XML-compliant clearance messages with serialization context.
- Transmitting clearance data to internal systems and external partners.
- Logging clearance decisions for audit readiness and regulatory reporting.
- Triggering downstream actions such as shipment release or customs documentation.
- Ensuring secure communication with optional digital signatures.
Explore More Serialization & Compliance Capabilities
- TL XML – SOM Product Release: Digitally authorize product movement.
- TL XML – SOM ESM Sales Shipment: Record serialized shipments.
- TL XML – SOM ESM Receipt: Confirm serialized product receipt and verification.
- EPCIS 1.2 – SOM ESM Void Shipment: Cancel previously approved shipments.
- TL XML – SOM Product Release: Digitally authorize product movement.
Need Help Implementing TL XML Transactions?
Contact Us to learn how our OPUS Platform and B2N Integrate-Once™ model can help you automate country clearance, ensure regulatory compliance, and enable secure, global product distribution across your life sciences and healthcare supply chain.
