Withdrawal from Circulation

MAHs and Importers that own Russia Health Products Compliance can generate a Withdrawal from Circulation report to capture the withdrawal of products that were imported into Russia and previously approved by customs for distribution. The reports are submitted to the Track & Trace Government Information System (TT GIS).

Configure the report

The report for a product is generated when its product type is set to the corresponding product group in Product Master Data:

  • Product type as Food Supplement for BAFS

  • Product type as Medical Device for Medical Products

The event triggers (i.e. workflow subscriptions) for the report can be set in Administer for Russia Health Products Compliance. Make sure one of the following event triggers are enabled:

Source Application Event Action Description
Serialized Operations Manager Product Decommissioned Generates Withdrawal from Circulation Report for Decommission from Core Integration

TraceLink generates a Withdrawal from Circulation report for the decommission events that contain serial numbers with a target market of Russia in Product Master Data when they are submitted via core integration or the Web UI, as long as all of the event trigger conditions are met.
Serialized Operations Manager ESM Product Decommissioned Generates Withdrawal from Circulation Report for Decommission from ESM Integration TraceLink generates a Withdrawal from Circulation report for the decommission events that contain serial numbers with a target market of Russia in Product Master Data when they are submitted via ESM integration as long as all of the event trigger conditions are met.
Serialized Operations Manager Product Destroyed Generates Withdrawal from Circulation Report for Destruction from Core Integration TraceLink generates a Withdrawal from Circulation report for the destruction events that contain serial numbers with a target market of Russia in Product Master Data when they are submitted via core integration or the Web UI, as long as all of the event trigger conditions are met.
Serialized Operations Manager ESM Product Destroyed Generates Withdrawal from Circulation Report for Destruction from ESM Integration TraceLink generates a Withdrawal from Circulation report for the destruction events that contain serial numbers with a target market of Russia in Product Master Data when they are submitted via ESM integration as long as all of the event trigger conditions are met.

For more information on how to enable the event triggers, see the Administer Help Center.

Russia Health Products Compliance generates the Withdrawal from Circulation report when TraceLink processes a SOM Decommission, ESM Decommission, SOM Destroy, or ESM Destroy event and the following conditions are met:

  • In Product Master Data, the serialized item is associated with an Item Code that has a Target Market of Russia.
  • In Product Master Data, the Product Type of the serialized item is Food Supplement for Biologically Active Food Supplements or Medical Devices for Medical Products.
  • The products have a Packaging Code Type of GTIN-14 with a Packaging UOM (unit of measure) of Each.
  • The Reason Code for the decommission or destruction is Damaged, Defective, Misplaced, or Sampled.

  • In Serialized Operations Manager, the Destruction Method is not set.

Generate the report

To generate the Withdrawal from Circulation report automatically, enable the appropriate event triggers and ensure that the relevant event trigger conditions are met in Master Data Exchange. When configured, Russia Health Products Compliance generates the Withdrawal from Circulation report automatically when Tracelink processes a decommission or destruction workflow event in one of the following interfaces:

Use any of the following Serialized Operations Manager APIs to trigger the Withdrawal from Circulation report:

Decommission Event (EPCIS v1.2)

Complete the elements required for the report as follows. See the Serialized Operations Manager Trade Partner Event Exchange API Guide for more information.

Element Values
bizLocation Specify the location in Russia where the decommission or destruction takes place.
bizTransactionList Specify the transaction identifier type and date associated with the decommissioned or destroyed product.
tl:businessPartyInfo Specify the reporting party responsible for the decommission or destruction.
tl:decommissionReasonCode

Must be one of the following:

  • Damaged (reported as DESTRUCTION).
  • Defective (reported as DESTRUCTION).
  • Misplaced (reported as LOSS).
  • Sampled (reported as OWN_USE).

Destroy Event (EPCIS v1.2)

Complete the elements required for the report as follows. See the Serialized Operations Manager Trade Partner Event Exchange API Guide for more information.

Element Values
bizLocation Specify the location in Russia where the decommission or destruction takes place.
bizTransactionList Specify the transaction identifier type and date associated with the decommissioned or destroyed product.

tl:businessPartyInfo

Specify the reporting party responsible for the decommission or destruction.
tl:decommissionReasonCode

Must be one of the following:

  • Damaged (reported as DESTRUCTION).
  • Defective (reported as DESTRUCTION).
  • Misplaced (reported as LOSS).
  • Sampled (reported as OWN_USE).

ESM Decommission (EPCIS v1.2)

Complete the elements required for the report as follows. See the Serialized Operations Manager Enterprise Serialization Management API Guide for more information.

Element Values
bizLocation Specify the location in Russia where the decommission or destruction takes place.
bizTransactionList Specify the transaction identifier type and date associated with the decommissioned or destroyed product.
tl:businessPartyInfo Specify the reporting party responsible for the decommission or destruction.
tl:decommissionReasonCode

Must be one of the following:

  • Damaged (reported as DESTRUCTION).
  • Defective (reported as DESTRUCTION).
  • Misplaced (reported as LOSS).
  • Sampled (reported as OWN_USE).

ESM Destroy (EPCIS v1.2)

Complete the elements required for the report as follows. See the Serialized Operations Manager Enterprise Serialization Management API Guide for more information.

Element Values
bizLocation Specify the location in Russia where the decommission or destruction takes place.
bizTransactionList Specify the transaction identifier type and date associated with the decommissioned or destroyed product.
tl:businessPartyInfo Specify the reporting party responsible for the decommission or destruction.
tl:decommissionReasonCode

Must be one of the following:

  • Damaged (reported as DESTRUCTION).
  • Defective (reported as DESTRUCTION).
  • Misplaced (reported as LOSS).
  • Sampled (reported as OWN_USE).

Use Serialized Operations Manager to trigger the Withdrawal from Circulation report from the Web UI. See the Serialized Operations Manager Online Help for more information.

Decommission

  1. In Track & Trace Services (TTS), hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Status Update drop-down and then select Decommission Serial Numbers.
  3. Select the location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Complete the fields required for the report as follows:
    FieldValues
    Reporting PartySpecify the reporting party responsible for the decommission or destruction.
    Reason Code

    Must be one of the following:

    • Damaged (reported as DESTRUCTION).
    • Defective (reported as DESTRUCTION).
    • Misplaced (reported as LOSS).
    • Sampled (reported as OWN_USE).
    LocationSpecify the location in Russia where the decommission takes place.
    Transaction IDs

    Specify the identifier type and value. Add the document date that is printed on the corresponding transaction document.

  5. Complete any other fields that are required in the UI or that your company uses for a specific purpose.

  6. Select Submit.

    A confirmation dialog box displays.

  7. Select Confirm.

Destruction

  1. In Track & Trace Services (TTS), hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Status Update drop-down and then select Destroy Product.
  3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Complete the fields required for the report as follows:
    FieldValues
    Reporting PartySpecify the reporting party responsible for the decommission or destruction.
    Reason Code

    Must be one of the following:

    • Damaged (reported as DESTRUCTION).
    • Defective (reported as DESTRUCTION).
    • Misplaced (reported as LOSS).
    • Sampled (reported as OWN_USE).
    LocationSpecify the location in Russia where the destruction takes place.
    Transaction IDs

    Specify the identifier and value. Add the document date that is printed on the corresponding transaction document.

  5. Complete any other fields that are required in the UI or that your company uses for a specific purpose.

  6. Select Submit.

    A confirmation dialog box displays.

  7. Select Confirm.

To generate the Withdrawal from Circulation report manually, use the Russia Health Products Compliance Compliance Web UI. This option is useful if a report failed to generate automatically, and the information must still be submitted to the Track & Trace Government Information System (TT GIS).

  1. Select the Main Menu icon .
  2. Select Russia Health Products Compliance.

    A new tab opens and displays information for the Russia Health Products Compliance app.

  3. Select the Generate Report icon.
  4. Select Withdrawal from Circulation as the Report Type to generate.
  5. Select Specify Serial Numbers. The serial numbers should be the same that were used to trigger decommission or destruction events in Serialized Operations Manager.
    • Enter the Serial Numbers in the text field.

      or

    • Scan the Serial Numbers in the text field with an external scanner.

  6. Select Generate.

    The panel closes, and TraceLink begins generating the report. Filter to find the new report.

Report details

Field Description Sourced From TT GIS Report Element
Report Type Displays as Withdrawal from Circulation. The type of report. Not reported
Status

The status of the report:

  • Generated – The report is generated in TraceLink but not yet submitted to the TT GIS.
  • Generation Failed – The report failed to generate in TraceLink.
  • Submitted – The report is generated and successfully submitted to the TT GIS.
  • Submission Failed – The report is generated but was not successfully submitted to the TT GIS.
  • Failed – The TT GIS received the report successfully but failed to provide a response.
  • Accepted – The TT GIS received the report successfully and accepted the information.
  • Partially Accepted – The event has multiple reports, and all of them are successfully submitted to the TT GIS, but the TT GIS did not accept all of the reports.
  • Rejected – The TT GIS received the report successfully but rejected the information.

The status of the report.

Not reported
Participant INN The Tax Identification Number (INN). Tax identification number of the reporter. inn
Product Group

The product group:

  • Biologically Active Food Supplements

  • Medical Products

The product group. Not reported
Event Type

The event type:

  • Decommission
  • Destroy
The type of event. Not reported
Date Reported The date and time that the report is generated. The system date and time when the report is generated. Not reported
Trigger Type

Indicates whether the report is generated automatically from an event trigger or manually from the Web UI.

  • System Generated – The report is generated automatically from an event trigger.
  • User Generated – The report is generated manually from the Web UI.
 Indicates whether the report is generated automatically from an event trigger or manually from the Web UI. Not reported
Field Description Sourced From TT GIS Report Element
Withdrawal Reason

The reason for withdrawing the product:

  • Damaged
  • Defective
  • Misplaced
  • Sampled

The withdrawal reason for the event in Serialized Operations Manager.

action

Withdrawal Party Name The company or location reporting the event. The company or location reporting the event from both Company and Partner Master Data.

Not reported
Document Type

The type of document:

  • Damaged
  • Defective
  • Misplaced
  • Sampled

The Reason Code for decommissioning or destruction in Serialized Operations Manager.

document_type

Document Date

The date printed on the corresponding transaction document in the DD Mmm YYYY format.

This date must be always within 5 years from the current date.

 The transaction identifier date attribute in YYYY-MM-DD format in Serialized Operations Manager. document_date

 
Document Number The number printed on the transaction document. The value of the identifier for the transaction in Serialized Operations Manager. document_number

 
Document Name The name of the transaction document. Description why the product is decommissioned or destroyed in Serial Operations Manager. primary_document_custom_name
Field Description Sourced From TT GIS Report Element
Packaging Code The packaging code for the product. The Packaging Code of the serialized item in the shipment.

Not reported
Product Description The name of the product. The description associated with the Packaging Code in Product Master Data.

Not reported
Lot Number The lot number associated with the packaging code used to report the serial numbers. The lot number associated with the Packaging Code in Serialized Operations Manager for this product's serialized items.

Not reported

 
Expiration Date The expiration date for the serialized items. The expiration date associated with the Expiration Date in Serialized Operations Manager for the serial numbers in this lot.

Not reported

 
Quantity The quantity of serial numbers for the Packaging Code and Lot Number. The quantity of serial numbers in the shipment for the Packaging Code and Lot Number.

Not reported

Tips

  • Select the Export icon to export the serial numbers for a Packaging Code and Lot Number to a CSV file.

Response information when using the message status query service:

  • Report ID – The unique ID returned by the TT GIS for the submitted compliance report.
  • Report Name – The name of the compliance report submitted to the TT GIS.
  • Response Date – The date the response is received from the TT GIS.
  • Status – The status returned by the TT GIS for the submitted compliance report.
  • Status Code – The HTTPS code returned by the TT GIS for the submitted compliance report.
  • Description – The description returned by the TT GIS for the submitted compliance report.

Tips

  • Select the Action icon, and then select View Report File to export the report file submitted to the TT GIS.
  • Select the Action icon, and then select View Response File to export the response file received from the TT GIS.