Event Triggers

European Union (EU) Compliance Reports generate based off certain events that occur in TraceLink. When these events are triggered:

  1. TraceLink generates the EU message directly to the EU Compliance app.
  2. The EU Compliance app then delivers the message directly to the EU Hub.

If the report fails to generate due to insufficient data, an Info Exchange error generates in the EU Compliance app and email alerts are sent to users who have opted in to receive them.

Select the report types below for more information regarding these event triggers:

The following events trigger Active - Update Product Pack State reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions

Status Update - Available

 Generates a message to the EU Compliance app to create the Active - Update Product Pack State report.
  • A Serial Number Status Update message is received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • Item Status changed from "Under Investigation" to "Available".

  • Items have been previously reported to the EU Hub as "Locked".

Status Update - Available

 Generates a message to the EU Compliance app to create the Active - Update Product Pack State report.
  • A Void Delivery message is received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • Items have been previously reported to the EU Hub as "Supplied".

Status Update - Available

 Generates a message to the EU Compliance app to create the Active - Update Product Pack State report.
  • A Void Delivery message is received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • Items have been previously reported to the EU Hub as "Export".

Status Update - Available

 Generates a message to the EU Compliance app to create the Active - Update Product Pack State report.
  • A Void Delivery message is received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • Items have been previously reported to the EU Hub as "Free Sample".

Status Update - Available

 Generates a message to the EU Compliance app to create the Active - Update Product Pack State report.
  • A Serial Number Status Update message is received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • Item Status changed from "Decommissioned" to "Commissioned" and Item Status changed from "Government Sampled" to "Available".

  • Items have been previously reported to the EU Hub as "Sample".

ESM Status Update - Available

 Generates a message to the EU Compliance app to create the Active - Update Product Pack State report.
  • An ESM Serial Number Status Update message is received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • Item Status changed from "Under Investigation" to "Available".

  • Items have been previously reported to the EU Hub as "Locked".
ESM Status Update - Available Generates a message to the EU Compliance app to create the Active - Update Product Pack State report.
  • A Void Delivery message is received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • Items have been previously reported to the EU Hub as "Supplied".
ESM Status Update - Available Generates a message to the EU Compliance app to create the Active - Update Product Pack State report.
  • A Void Delivery message is received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • Items have been previously reported to the EU Hub as "Export".
ESM Status Update - Available Generates a message to the EU Compliance app to create the Active - Update Product Pack State report.
  • A Void Delivery message is received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • Items have been previously reported to the EU Hub as "Free Sample".
ESM

Status Update - Available

 Generates a message to the EU Compliance app to create the Active - Update Product Pack State report.
  • A Serial Number Status Update message is received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • Item Status changed from "Decommissioned" to "Commissioned" and Item Status changed from "Government Sampled" to "Available".

  • Items have been previously reported to the EU Hub as "Sample".

The following events trigger Batch Recall reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
Batch Recall Generates a message to the EU Compliance app to create the Batch Recall report.
  • TraceLink processes a Serialized Operations Manager Batch Recall UI event.
  • The Target Market is an EU FMD country.
    If the product's Target Market is GB (United Kingdom), the Traceability Required drop-down must be set to Required in product master data for the report to generate.
ESM Batch Recall Generates a message to the EU Compliance app to create the Batch Recall report.
  • TraceLink processes a Serialized Operations Manager ESM Batch Recall message.
  • The Target Market is an EU FMD country.
    If the product's Target Market is GB (United Kingdom), the Traceability Required drop-down must be set to Required in product master data for the report to generate.

The following events trigger Checked Out - Update Product Pack State reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
Disposition Updated - Decommission Generates a message to the EU Compliance app to create the Checked-Out - Update Product Pack State report.
  • TraceLink processes the receipt for a Serial Number Exchange Disposition Update message or a Repackage Numbers UI event.
  • The State is Decommissioned.
  • The Reason Code is Repackaged.
  • The Target Market is an EU FMD country.
    If the product's Target Market is GB (United Kingdom), the Traceability Required drop-down must be set to Required in product master data for the report to generate.

The following events trigger Commission Product Pack reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
Product Status Set to "Released" Generates a message to the EU Compliance app to create the Commission - Product Pack report.
  • A SOM_PRODUCT_RELEASE message, SOM_PRODUCT_RELEASE_EVENT_IB message, Serialized Operations Manager Product Release UI, or Serialized Operations Manager Product Release API has been received by TraceLink.
  • Serial numbers associated with the Item Code and Lot Number must have the Country Market Code set to an "EU" country in Product Master Data.
    If the product's Target Market is GB (United Kingdom), the Traceability Required drop-down must be set to Required in product master data for the report to generate.
  • The Packaging Code Type of the serialized item is GTIN-14 or NTIN.

  • The product's Target Market information changes.

Product Shipped - Sale Generates a message to the EU Compliance app to create the Commission - Product Pack report.
  • A SOM_SALES_SHIPMENT message, SOM_SHIPMENT_EVENT_IB message, Serialized Operations Manager UI Shipment message, or the Serialized Operations Manager UpdateOrderShipment API has been received by TraceLink.
  • Sales Distribution Type is "In Country Sale" or "Export Sale."
  • Ship To Country is an EU Country.
  • The serialized item:
    • Is associated with an Item Code and Lot Number where the country market code is to EU country in the EMVS Target Market list.
    • Has a Packaging Code Type of GTIN-14 or NTIN and the Unit of Measure is "EA" (each).
    • Is an AI (01) (21) formatted serial number for GTINs or NTINs.
  • The product's Target Market information changes.
    • If the product's Target Market is GB (United Kingdom) and the Ship to Country Code in the Shipment message is GB (United Kingdom), for the report to generate:
    • The Traceability Required drop-down must be set to Required in product master data.
    • The Sale Type must be Sale - In Country in the Shipment message.
Product Shipped - Transfer Generates a message to the EU Compliance app to create the Commission - Product Pack report.
  • A SOM_SALES_SHIPMENT message, SOM_SHIPMENT_EVENT_IB message, Serialized Operations Manager UI Shipment message, or the Serialized Operations Manager UpdateOrderShipment API has been received by TraceLink.
  • Sales Distribution Type is "In Country Transfer" or "Export Transfer."
  • Ship To Country is an EU Country.
  • The product's Target Market information changes.
    • If the product's Target Market is GB (United Kingdom) and the Ship to Country Code in the Shipment message is GB (United Kingdom), for the report to generate:
    • The Traceability Required drop-down must be set to Required in product master data.
    • The Sale Type must be Transfer - In Country in the Shipment message.
ESM Product Shipped - Sale Generates a message to the EU Compliance app to create the Commission - Product Pack report.
  • A SOM_ESM_SHIPMENT message has been received by TraceLink.
  • Sales Distribution Type is "In Country Sale" or "Export Sale."
  • Ship To Country is an EU Country.
  • The product's Target Market information changes.
    • If the product's Target Market is GB (United Kingdom) and the Ship to Country Code in the Shipment message is GB (United Kingdom), for the report to generate:
    • The Traceability Required drop-down must be set to Required in product master data.
    • The Sale Type must be Sale - In Country in the Shipment message.
ESM Product Shipped - Transfer Generates a message to the EU Compliance app to create the Commission - Product Pack report.
  • A SOM_ESM_SHIPMENT message has been received by TraceLink.
  • Sales Distribution Type is "In Country Transfer" or "Export Transfer."
  • Ship To Country is an EU Country.
  • The product's Target Market information changes.
    • If the product's Target Market is GB (United Kingdom) and the Ship to Country Code in the Sales Shipment message is GB (United Kingdom), for the report to generate:
    • The Traceability Required drop-down must be set to Required in product master data.
    • The Sale Type must be Transfer - In Country in the Shipment message.
End of Batch Message Processed Successfully Generates a message to the EU Compliance app to create the Commission - Product Pack report.
  • A Serial Number Exchange EOB UI, SNX_END_OF_BATCH, or SOM_END_OF_BATCH_EVENT_IB message has been received by TraceLink.
  • Target Market is an EU FMD Country.
    If the product's Target Market is GB (United Kingdom), the Traceability Required drop-down must be set to Required in product master data for the report to generate.
  • The reconciliation quantity matches at the each level.
  • The product's Target Market information changes.

The following events trigger Destruction - Update Product Pack State reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
ESM Product Decommission Generates a message to the EU Compliance app to create the Destruction - Update Product Pack State report.
  • A SOM_ESM_DECOMMISSION message has been recieved by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • The serial number(s) must:

    • Be previously reported to the EU Hub with a status of Active.
    • Currently in the Commissioned state.
    • Have no Item Attribute set, or a Damaged, Disposed, Misplaced, or Sampled Item Attribute set.
Product Decommission Generates a message to the EU Compliance app to create the Destruction - Update Product Pack State report.
  • A SOM_DECOMMISSION_EVENT_IB message, Serialized Operations Manager Decommission UI, or Serialized Operations Manager Decommission API has been received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • The serial number(s) must:

    • Be previously reported to the EU Hub with a status of Active.
    • Currently in the Commissioned state.
    • Have no Item Attribute set, or a Damaged, Disposed, Misplaced, or Sampled Item Attribute set.
ESM Product Destroy Generates a message to the EU Compliance app to create the Destruction - Update Product Pack State report.
  • A SOM_ESM_DESTROY message has been received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • The serial number(s) must:

    • Be previously reported to the EU Hub with a status of Active.
    • Currently in the Commissioned state.
    • Have no Item Attribute set, or a Damaged, Disposed, Misplaced, or Sampled Item Attribute set.
Product Destroy Generates a message to the EU Compliance app to create the Destruction - Update Product Pack State report.
  • A SOM_DECOMMISSION_Event_IB, Serialized Operations Manager Destroy UI, or Serialized Operations Manager Destroy API has been received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 

  • The serial number(s) must:

    • Be previously reported to the EU Hub with a status of Active.
    • Currently in the Commissioned state.
    • Have no Item Attribute set, or a Damaged, Disposed, Misplaced, or Sampled Item Attribute set.

The following events trigger Export - Update Product Pack State reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
ESM Product Shipped - Exported Generates a message to the EU Compliance app to create the Export - Update Product Pack State report.
  • A SOM_ESM_SHIPMENT message has been received by TraceLink.
  • Sales Distribution Type is "Export Sale" or "Export Transfer."
  • Ship To Country is not within the EU.
  • The serial number(s) must:
    • Be previously reported to the EU Hub with a status of Active.
    • Currently in the Commissioned state.
    • If the product's Target Market is GB (United Kingdom) and the Ship to Country Code in the Shipment message is GB (United Kingdom), for the report to generate:
    • The Traceability Required drop-down must be set to Required in product master data.
    • The Supply Type in the Shipment message must not be:
      • Civil Protection Emergency
      • Sample Distribution
      • Dental Practitioner Distribution
      • Emergency Medical Practitioner Distribution
      • Medical Practitioner Distribution
      • Optical Practitioner Distribution
      • Prison Distribution
      • Research University Distribution
      • School Distribution
      • Special Medical Care Distribution
      • Veterinary Distribution
Product Shipped - Exported Generates a message to the EU Compliance app to create the Export - Update Product Pack State report.
  • A SOM_SALES_SHIPMENT message, SOM_SHIPMENT_EVENT_IB message, Serialized Operations Manager Shipment UI, or Serialized Operations Manager Update Order Shipment API has been received by TraceLink.
  • Sales Distribution Type is "Export Sale" or "Export Transfer."
  • Ship To Country is not within the EU.
  • The serial number(s) must:
    • Be previously reported to the EU Hub with a status of Active.
    • Currently in the Commissioned state.
      • If the product's Target Market is GB (United Kingdom) and the Ship to Country Code in the Shipment message is GB (United Kingdom), for the report to generate:
      • The Traceability Required drop-down must be set to Required in product master data.
      • The Supply Type in the Sales Shipment message must not be:
        • Civil Protection Emergency
        • Sample Distribution
        • Dental Practitioner Distribution
        • Emergency Medical Practitioner Distribution
        • Medical Practitioner Distribution
        • Optical Practitioner Distribution
        • Prison Distribution
        • Research University Distribution
        • School Distribution
        • Special Medical Care Distribution
        • Veterinary Distribution

The following events trigger Free Sample - Update Product Pack State reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
ESM Product Shipped - Free Sample Generates a message to the EU Compliance app to create the Free Sample - Update Product Pack State report.
  • A SOM_ESM_SHIPMENT message has been received by TraceLink.
  • Sales Distribution Type is "In Country Sale" or "Export Sale."
  • Ship To Country is an EU Country.
  • Supply Type is Sample Distribution.
  • The serial number(s) must:
    • Be previously reported to the EU Hub with a status of Active.
    • Currently in the Commissioned state.
Product Shipped - Free Sample Generates a message to the EU Compliance app to create the Free Sample - Update Product Pack State report.
  • A SOM_SALES_SHIPMENT message, SOM_SHIPMENT_EVENT_IB message, Serialized Operations Manager Shipment UI, or Serialized Operations Manager Update Order Shipment API has been received by TraceLink.
  • Sales Distribution Type is "In Country Sale" or "Export Sale."
  • Ship To Country is an EU Country.
  • Supply Type is Sample Distribution.
  • The serial number(s) must:
    • Be previously reported to the EU Hub with a status of Active.
    • Currently in the Commissioned state.

The following events trigger Locked - Update Product Pack State reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
Status Updated - Under Investigation Generates a message to the EU Compliance app to create the Locked - Update Product Pack State report.
  • A Serialized Operations Manager Update Serial Number Status UI or Serialized Operations Manager Serial Number Status API message has been received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 
  • Item Status is "Under Investigation".
  • The serial number(s) must be previously reported to the EU Hub with a Status of "Active".
ESM Status Updated - Under Investigation Generates a message to the EU Compliance app to create the Locked - Update Product Pack State report.
  • A Serialized Operations Manager ESM Update Serial Number Status message has been received by TraceLink.
  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 
  • Item Status is "Under Investigation".
  • The serial number(s) must be previously reported to the EU Hub with a Status of "Active".

The following events trigger Product Master Data reports:

Event Event Description Conditions
Product Master Data Created / Updated Generates a message to the EU Compliance app to create the EU Product Master Data report after the system has created or updated a Product Master Data record for any product with an EU Country Market. Once the report is triggered, only the following serial numbers display:
  • The Packaging Code type of the serialized item is a GTIN-14 or NTIN, and the Packaging Code Unit of Measure (UOM) is "EA."
  • Includes only AI (01) (21) formatted serial number for GTINs or NTINs.
  • A MDX_PRODUCT_MASTER message, Product Master Data UI, Product Master Data CSV import has been received by TraceLink.

    Multiple products will be included in the same message if multiple products were submitted to TraceLink to be created or updated.

  • Target Market must be set to a country in Product Master Data that is on the EMVS Target Market list. 
    If the product's Target Market is GB (United Kingdom), the Traceability Required drop-down must be set to Required in product master data for the report to generate.

    See Troubleshooting for more information.

  • Item Data Status is "Active."
  • One or more of the following fields in Product Master Data must have changed:
    • Product Code and Type
    • Product Name
    • Common Name (a.k.a Generic Name)
    • Dosage Form
    • Strength
    • Package Size / Spec
    • Packaging Type
    • Target Market
      • Market
      • Item Code - National Code
      • Reporting Item Code
      • PCID (Article 57 Code)
      • MAH (Marketing Authorized Holder) ID and Type
      • Authorized Distributor(s) (Wholesaler) ID and Type

The following events trigger Sample - Update Product Pack State reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
Product Decommission – Sample Generates a message to the EU Compliance app to create the Sample - Update Product Pack State report.
  • A SOM_DECOMMISSION_Event_IB, Serialized Operations Manager Decommission UI, or Serialized Operations Manager Decommission API has been received by TraceLink.
  • Reason Code is Sampled by Authorities.
  • The serial number(s) must:
    • Be previously reported to the EU Hub with a status of Active.
ESM Product Decommission – Sample Generates a message to the EU Compliance app to create the Sample - Update Product Pack State report.
  • A SOM_ESM_DECOMMISSION message has been received by TraceLink.
  • Reason Code is Sampled by Authorities.
  • The serial number(s) must:
    • Be previously reported to the EU Hub with a status of Active.

The following events trigger Stolen - Update Product Pack State reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
Product Decommission – Stolen Generates a message to the EU Compliance app to create the Stolen - Update Product Pack State report.
  • A SOM_DECOMMISSION_Event_IB, Serialized Operations Manager Decommission UI, or Serialized Operations Manager Decommission API has been received by TraceLink.
  • Reason Code is Stolen.
  • The serial number(s) must:
    • Be previously reported to the EU Hub with a status of Active.
ESM Product Decommission – Stolen Generates a message to the EU Compliance app to create the Stolen - Update Product Pack State report.
  • A SOM_ESM_DECOMMISSION message has been received by TraceLink.
  • Reason Code is Stolen.
  • The serial number(s) must:
    • Be previously reported to the EU Hub with a status of Active.

The following events trigger Supplied - Update Product Pack State reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
Product Shipped – Supplied Generates a message to the EU Compliance app to create the Supplied - Update Product Pack State report.
  • A Serialized Operations Manager UI, Serialized Operations Manager UpdateOrderShipment API or SOM_SALES_SHIPMENT has been received by TraceLink.
  • Sales Distribution Type is "In Country Sale" or "Export Sale."

  • Supply Type is:

    • Civil Protection Emergency Distribution
    • Dental Practitioner Distribution
    • Emergency Medical Practitioner Distribution
    • Medical Practitioner Distribution
    • Optical Practitioner Distribution
    • Prison Distribution
    • Research University Distribution
    • School Distribution
    • Special Medical Care Distribution
    • Veterinary Distribution
    • Special Medical Care Distribution
  • The serial number(s) must be previously reported to the EU Hub.
ESM Product Shipped – Supplied Generates a message to the EU Compliance app to create the Supplied - Update Product Pack State report.
  • A SOM_ESM_SHIPMENT message has been received by TraceLink.
  • Sales Distribution Type is "In Country Sale" or "Export Sale."
  • Supply Type is:
    • Civil Protection Emergency Distribution
    • Dental Practitioner Distribution
    • Emergency Medical Practitioner Distribution
    • Medical Practitioner Distribution
    • Optical Practitioner Distribution
    • Prison Distribution
    • Research University Distribution
    • School Distribution
    • Veterinary Distribution
    • Special Medical Care Facility Distribution
  • The serial number(s) must be previously reported to the EU Hub.

The following events trigger Update Product Pack Data reports:

Each report contains up to 250,000 serial numbers. If the event consists of more than 250,000 numbers, multiple reports generate.

Event Event Description Conditions
Update Lot Generates a message to the EU Compliance app to create the Update Product Pack report.
  • TraceLink processes a Serialized Operations Manager Update Lot UI event.

    If a Barcode Expiration Date is specified in the Update Lot event, TraceLink reports this value instead of the Expiration Date. The Barcode Expiration Date indicates that the expiration date on the lot's packaging is different from the Expiration Date on record in TraceLink.

  • The Target Market is an EU FMD country.
    If the product's Target Market is GB (United Kingdom), the Traceability Required drop-down must be set to Required in product master data for the report to generate.
ESM Update Lot Generates a message to the EU Compliance app to create the Update Product Pack report.
  • TraceLink processes a Serialized Operations Manager ESM Update Lot message.

    If a Barcode Expiration Date is specified in the Update Lot event, TraceLink reports this value instead of the Expiration Date. The Barcode Expiration Date indicates that the expiration date on the lot's packaging is different from the Expiration Date on record in TraceLink.

  • The Target Market is an EU FMD country.
    If the product's Target Market is GB (United Kingdom), the Traceability Required drop-down must be set to Required in product master data for the report to generate.