Table of contents
Overview
The SOM Market Release transaction is an XML-based message used to confirm that serialized pharmaceutical product(s) are authorized for release into a specific market. This transaction ensures that all regulatory, compliance, and internal controls have been met before product distribution begins.
The SOM Market Release transaction acts as a digital approval checkpoint, signaling that the product is cleared for commercial movement into a designated market.
This transaction adheres to the TL XML schema and integrates with downstream systems to automate release workflows and maintain compliance with DSCSA and other global track and trace regulatory frameworks.
Key Use Cases
- Authorize serialized product movement into a specific country or market.
- Enforce market-specific compliance controls before product distribution.
- Digitally confirm that products meet regulatory and internal release criteria.
- Trigger downstream actions such as shipment creation, customs documentation, or invoicing.
- Support audit readiness with traceable, system-generated market release records.
- Enable secure, rules-based release automation across global supply chains.
Data Elements Included
A TL XML – SOM Market Release transaction includes:
- Serialized Product Identifiers (EPCs): SGTINs or SSCCs of the serialized units being released.
- Market Code: ISO 3166-1 alpha-2 code (e.g., "US", "DE", "BR") indicating the country of release.
- Release Timestamp: Date and time when the market release was approved.
- Business Location: GLN or internal code of the releasing facility.
- Disposition: Typically set to "market_released", "ready_for_distribution", or "SOM_cleared".
- Sales Order or Shipment Reference: Link to the order or shipment being released.
- Release Reason Code (optional): Coded reason for approval (e.g., “REGULATORY_APPROVAL_GRANTED”).
- Transaction ID (optional): Unique identifier for traceability and audit.
- Digital Signature (optional): Ensures data integrity and compliance in regulated environments.
- Comments or Notes (optional): Free-text field for reviewer notes or exception handling.
Benefits of TL XML – SOM Market Release
- Ensures compliance with country-specific SOM and regulatory requirements.
- Prevents unauthorized or non-compliant product movement into restricted markets.
- Digitally documents SOM clearance and market authorization.
- Triggers automated workflows for logistics, finance, and regulatory reporting.
- Improves audit readiness with traceable, system-generated release events.
- Scales globally with TraceLink’s B2N Integrate-Once™ model.
Business Process: TL XML – SOM Market Release
The SOM Market Release transaction may fit into the global compliance and distribution workflow as follows:
- A customer order or shipment is created and the destination country is identified.
- SOM Market Release (TL XML) is triggered.
- Released serialized units are authorized for downstream actions such as shipment, customs clearance, or invoicing.
- TraceLink logs the market release event for full traceability, audit readiness, and regulatory reporting.
- Downstream systems (ERP, WMS, QA) are updated to proceed with fulfillment into the approved market.
How TraceLink Supports TL XML – SOM Market Release
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, enables secure and compliant SOM Market Release workflows by:
- Applying market-specific rules to evaluate compliance by destination country.
- Generating TL XML-compliant release messages to authorize market entry.
- Supporting multi-country operations with configurable rule sets.
- Triggering downstream actions like customs clearance or invoicing based on release status.
- Logging all events for market-level traceability and audit readiness.
Explore More Serialization & Compliance Capabilities
- TL XML – SOM Product Release: Authorize serialized product movement.
- TL XML – SOM Sales Shipment: Record serialized shipments.
- TL XML – SOM Country Clearance: Approve product movement by destination country.
- TL XML – SOM Void Shipment: Cancel shipments which have identified issues.
Need Help Implementing TL XML Transactions?
Contact Us to learn how our OPUS Platform and B2N Integrate-Once™ model can help you automate market releases, ensure global compliance, and scale secure product distribution across your life sciences and healthcare supply chain.
