Orchestration Integration & Transactions ## Breadcrumb 1. [Home](/) 2. [Orchestration Integration & Transactions](/orchestration-integration-transactions) # EPCIS 1.2 – SOM Country Clearance ![banner-image](https://www.tracelink.com/sites/default/files/2024-03/For%20Internal%2081.png) #### 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. This transaction follows the GS1 EPCIS 1.2 standard and 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 - Authorize serialized product movement into a specific country after clearance. - Enforce country-specific compliance rules before product distribution. - Digitally confirm country clearance by destination market. - Trigger downstream processes such as shipment release, customs documentation, or export approval. - Provide audit-ready documentation of country clearance decisions. - Integrate with ERP, WMS, and compliance systems for global distribution control. ### Data Elements Included An EPCIS 1.2 – SOM Country Clearance transaction includes: - **Event Type:** ObjectEvent with business step "country\_clearance" and action "observe" to indicate regulatory release. - **Serialized Product Identifiers (EPCs):** SGTINs or SSCCs of the serialized units being cleared. - **Event Time and Time Zone:** Timestamp of the clearance event, including time zone offset. - **Read Point:** Location where the clearance was recorded (e.g., QA system, serialization server). - **Business Location:** GLN or internal site code of the releasing facility. - **Destination Country Code:** ISO 3166-1 alpha-2 code (e.g., “US”, “DE”, “BR”) representing the approved market. - **Disposition:** Typically "cleared\_for\_country", or "approved\_for\_export". - **Clearance Reason Code (optional):** Code indicating the reason the shipment was approved. - **Transaction ID (optional):** Unique identifier for the clearance event. - **Digital Signature (optional):** Ensures data integrity and regulatory compliance. - **Comments or Notes (optional):** Free-text field for reviewer notes or exception context. ### Benefits of EPCIS 1.2 – SOM Country Clearance - Digitally confirms country-specific customs clearance before shipment. - Ensures compliance with global controlled substance regulations. - Prevents unauthorized product movement across borders. - Supports audit readiness with traceable clearance records. - Automates downstream processes tied to export and distribution readiness. ### Business Process: EPCIS 1.2 – SOM Country Clearance The SOM Country Clearance transaction supports: - Order Management & Fulfillment: Authorizes shipment release based on country-specific country clearance rules. - Track and Trace & Government Compliance: Ensures regulatory compliance for international distribution. - Product Serialization & Traceability: Maintains a serialized record of country-level clearance decisions. - Quality, Risk, and Recall Management: Provides traceable documentation of clearance decisions for audit and recall readiness. - Inventory Management: Updates product status to reflect clearance for export or market-specific distribution. ### How TraceLink Supports EPCIS 1.2 – SOM Country Clearance TraceLink’s Opus Platform, powered by B2N Integrate-Once™, supports SOM Country Clearance by: - Applying destination-specific country compliance rules to evaluate compliance. - Capturing EPCIS 1.2-compliant clearance events with full serialization context. - Transmitting clearance status to downstream systems and partners. - Logging all clearance transactions for traceability and audit readiness. - Enabling automated workflows for shipment release and export processing. ### Explore More Serialization & Compliance Capabilities - [**EPCIS 1.2 – SOM ESM Sales Shipment**](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/epcis-12-som-esm-sales-shipment): Record serialized shipments. - [**EPCIS 1.2 – SOM ESM Receipt**](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/epcis-12-som-esm-receipt): Confirm serialized product receipt and verification. - [**EPCIS 1.2 – SOM ESM Void Shipment**](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/epcis-12-som-esm-void-shipment): Cancel previously approved product shipments. - [**TL XML – SOM Product Release**](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/tl-xml-som-product-release): Digitally authorize product movement. [See All Serialization and EPCIS Capabilities](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration) ### Need Help Implementing EPCIS 1.2? [**Contact Us**](/contact-us) to learn how our OPUS Platform and B2N Integrate-Once™ model can help you automate country-specific customs clearance, ensure regulatory compliance, and enable secure global distribution across your life sciences and healthcare supply chain. #### Table of contents Contact us to learn more about B2B Integration. 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[View More](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/epcis-12-hda-advance-ship-notice) [ ![CMO](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2024-02/LifeScience-CMO8%20%281%29.png.webp?itok=3ZnAZMLd) ](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/epcis-12-dscsa-advance-ship-notice) ##### EPCIS 1.2 – DSCSA Advance Ship Notice The EPCIS 1.2 – DSCSA ASN (Advance Ship Notice) is an XML-based electronic message used to transmit serialized product shipment data in compliance with the Drug Supply Chain Security Act (DSCSA). [View More](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/epcis-12-dscsa-advance-ship-notice) [ ![Wholesale-Distributor](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2024-02/For%20Internal%2055.png.webp?itok=0K8agZX1) ](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/epcis-12-serialization) ##### EPCIS 1.2 – Serialization The EPCIS 1.2 – Serialization transaction is an XML-based message used to capture and share commissioning (serialization) events for pharmaceutical products. [View More](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/epcis-12-serialization) [ ![Brazil Pharmaceuticals](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2024-02/LifeScience%20CMO-1.png.webp?itok=8qEXci20) ](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/epcis-12-som-esm-update-lot-information) ##### EPCIS 1.2 – SOM ESM Update Lot Information The EPCIS 1.2 – SOM ESM Update Lot Information transaction is an XML-based message used to update or correct lot-level information for serialized pharmaceutical products. [View More](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/epcis-12-som-esm-update-lot-information) [ ![crypto code](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2024-02/crypto%20code.png.webp?itok=hDYDa49u) ](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/tl-xml-som-receipt) ##### TL XML – SOM Receipt The SOM Receipt transaction is an XML-based message used to record the receipt and transfer serialized products between warehouses and trading partners. [View More](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/tl-xml-som-receipt) [ ![digitalising order management](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2025-04/GettyImages-1299660112.jpg.webp?itok=qNA8FTp4) ](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/tl-xml-som-product-release) ##### TL XML – SOM Product Release The SOM Product Release transaction is an XML-based message used to indicate that a serialized pharmaceutical product or batch has successfully passed quality review and other product release processes and is now authorized for downstream processing—such as shipment, aggregation, or inventory movement. [View More](/orchestration-integration-transactions/accelerate-digital-supply-chain-collboration-with-b2b-integration/tl-xml-som-product-release)