552 - Withdrawal

Russia Compliance Owners generate the 552 - Withdrawal report to capture information about serialized items that are removed from supply chain circulation as the result of a quality sample, decommissioning, or destruction in a warehouse.

Configuring the report

  1. Hover over Company Administration on the User Profile drop-down in the top right of any screen, and then select Workflow.
  2. Configure the event workflows for take sample events:
    • Select the Generate 552 - Withdrawal Report Resulting Actions checkbox for the Take Sample workflow Event.

      or

    • Select the Generate 552 - Withdrawal Report Resulting Actions checkbox for the ESM Take Sample workflow Event (required if sending and receiving ESM integration messages).
  3. Configure the event workflows for decommissioning events:
    • Select the Generate 552 - Withdrawal Report Resulting Actions checkbox for the Product Decommissioned workflow Event.

      or

    • Select the Generate 552 - Withdrawal Report Resulting Actions checkbox for the ESM Product Decommissioned workflow Event (required if sending and receiving ESM integration messages).
  4. Configure the event workflows for destruction events:
    • Select the Generate 552 - Withdrawal Report Resulting Actions checkbox for the Product Destroyed workflow Event.

      or

    • Select the Generate 552 - Withdrawal Report Resulting Actions checkbox for the ESM Product Destroyed workflow Event (required if sending and receiving ESM integration messages).
  5. Select Save in the top left of the screen, above the results table.

    The screen refreshes, and the workflow is enabled.

The Russia Compliance application generates the 552 - Withdrawal report when TraceLink processes a Take Sample or ESM Take Sample event and the following conditions are met in the interface where the event occurred:

  • The products have a Packaging Code Type of GTIN-14 with a Packaging UOM of Each.
  • The products have a Target Market of Russia.
  • The Inspection Country Code is Russia.
  • The products have a Packaging Code Type of GTIN-14 with a Packaging UOM of Each.
  • The products have a Target Market of Russia.
  • The Inspection Country Code is Russia.
  • In Product Master Data, the products must:
    • Have a PackagingCodeType of GTIN-14 with a PackagingUOM (unit of measure) of each.
    • Have a TargetMarket of RU.
  • The cmn:InspectionCountryCode is RU.

Use any of the following messages to generate the 552 - Withdrawal report:

  • In Product Master Data, the products must:
    • Have a PackagingCodeType of GTIN-14 with a PackagingUOM (unit of measure) of each.
    • Have a TargetMarket of RU.
  • The tl:inspectionCountryCode is RU.

Use any of the following messages to generate the 552 - Withdrawal report:

  • In Product Master Data, the products must:
    • Have a PackagingCodeType of GTIN-14 with a PackagingUOM (unit of measure) of each.
    • Have a TargetMarket of RU.
  • The InspectionCountryCode is RU.

Use any of the following messages to generate the 552 - Withdrawal report:

The Russia Compliance application generates the 552 - Withdrawal report when TraceLink processes a Product Decommissioned, ESM Product Decommissioned, Product Destroyed, or ESM Product Destroyed event and the following conditions are met in the interface where the event occurred:

  • The products have a Packaging Code Type of GTIN-14 with a Packaging UOM of Each.
  • The products have a Target Market of Russia.
  • The Reason Code is one of the following:
    • Damaged
    • Defective
    • Misplaced
    • Sampled - Archival
    • Sampled - Clinical Study
    • Sampled - Customs Control
    • Sampled - Federal Inspection
    • Sampled - Marketing Demonstration
    • Sampled - Pharmaceutical Study
    • Sampled - Selective Control
    • Sampled By Authorities
    • Stolen
    • Withdrawn - Experiment
  • A Destruction Method is not specified.
  • The products have a Packaging Code Type of GTIN-14 with a Packaging UOM of Each.
  • The products have a Target Market of Russia.
  • The Reason Code is one of the following:
    • Damaged
    • Defective
    • Misplaced
    • Sampled - Archival
    • Sampled - Clinical Study
    • Sampled - Customs Control
    • Sampled - Federal Inspection
    • Sampled - Marketing Demonstration
    • Sampled - Pharmaceutical Study
    • Sampled - Selective Control
    • Sampled By Authorities
    • Stolen
    • Withdrawn - Experiment
  • A Destruction Method is not specified.

Generating the report in the Web UI

  1. Hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Status Update drop-down and then select Take Product Sample.
  3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Enter RU (Russian Federation) as the Inspection Country Code.
  5. Enter the company or location sampling the product in the Sampling Entity field.
  6. Select one of the following reasons the product is sampled from the Sampling Reason Code drop-down:
    • Archival Sample – The product is sampled to store as a record.
    • Conformity Control – The product is sampled by health authorities when imported to ensure quality standards.
    • Selective Control – The product is sampled by health authorities at random to ensure quality standards.
  7. Enter the reason for the product sample (maximum 100 characters) in the Reason Description field (optional).
  8. Enter the each-level Serial Numbers to sample by selecting one of the following:
    • Select Upload Serial Numbers from File:
      1. Select Choose File.
      2. Browse for and select the desired CSV file.
        3. The CSV file must be smaller than 50MB and cannot contain headers. Only 1 file can be uploaded per session.

      or

    • Select Scan Serial Numbers:
      • Enter the serial numbers (limit of 30,000 characters).

        or

      • Scan the serial numbers (limit of 30,000 characters) with an external scanner.
  9. Select Submit.

    The product is marked as sampled.

    TraceLink disaggregates the sampled product if the serial numbers are aggregated to parent containers, which prompts a disaggregation event and initiates the 913 - Unit Extract report.

  1. 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 manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Enter the identifier of the company or location reporting the event in the Reporting Party field, as entered in Product Master Data (optional).
  5. Enter the identifier of the company or location decommissioning the serial numbers in the Location field.
  6. Ensure that a Destruction Method is not selected.
  7. Select the Reason Code to apply to the decommissioned serial numbers and include in the report:
    • Damaged – The product is damaged.
    • Defective – The product does not function as intended.
    • Misplaced – The product is missing (reported as 11 - Stolen or Misplaced).
    • Sampled - Archival – The product is sampled to store as a record.
    • Sampled - Clinical Study – The product is sampled for a clinical study.
    • Sampled - Customs Control – The product is sampled for inspection control by customs authorities.
    • Sampled - Federal Inspection – The product is sampled for federal inspection.
    • Sampled - Marketing Demonstration – The product is used in a marketing demonstration.
    • Sampled - Pharmaceutical Study – The product is sampled for a post-registration pharmaceutical study, to support submitted changes to a dossier.
    • Sampled By Authorities – The product is sampled by government authorities.
    • Sampled - Selective Control – The product is sampled by health authorities as needed to ensure quality standards.
    • Stolen – The product is stolen (reported as 11 - Stolen or Misplaced).
    • Withdrawn - Experiment – The product is withdrawn from the market during the course of an experiment.
  8. Enter the Reason Description for the decommissioning (optional, maximum 100 characters).
  9. Specify the Transaction IDs for the decommissioning:
    1. Specify a Removal From Circulation document:
      1. Select Add Another in the Transaction IDs table header.
      2. Select Removal From Circulation as the Identifier Type.
      3. Enter the Identifier Value of the Destruction document.
      4. Enter the Document Date printed on the Destruction document.
    2. Specify additional Transaction IDs (optional):
      1. Select Add Another in the Transaction IDs table header.
      2. Select an Identifier Type from the drop-down.
      3. Enter the Identifier Value in the text field.
      4. Select the Document Date from the date picker.
  10. Enter the Serial Numbers to be decommissioned by selecting one of the following:
    • Select Upload Serial Numbers from File:
      1. Select Choose File.
      2. Browse for and select the desired CSV file.
        3. The CSV file must be smaller than 50MB and cannot contain headers. Only 1 file can be uploaded per session.

      or

    • Select Scan Serial Numbers:
      • Enter the serial numbers (limit of 30,000 characters).

        or

      • Scan the serial numbers (limit of 30,000 characters) with an external scanner.
  11. Select Automatically Disaggregate Items From Parent Container to disaggregate all decommissioned child items from their parent containers when the decommission event is submitted (optional).

    If selected, the disaggregation event initiates the 913 - Unit Extract report.

  12. Select Submit.

    The serial numbers are decommissioned and updated with the selected reason code.

  1. 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. Enter the identifier of the company or location reporting the event in the Reporting Party field, as entered in Product Master Data (optional).
  5. Enter the identifier of the company or location destroying the product in the Location field.
  6. Ensure that a Destruction Method is not selected.
  7. Select the Reason Code to apply to the destroyed items and include in the report:
    • Damaged – The product is damaged.
    • Defective – The product does not function as intended.
    • Misplaced – The product is missing (reported as 11 - Stolen or Misplaced).
    • Sampled - Archival – The product is sampled to store as a record.
    • Sampled - Clinical Study – The product is sampled for a clinical study.
    • Sampled - Customs Control – The product is sampled for inspection control by customs authorities.
    • Sampled - Federal Inspection – The product is sampled for federal inspection.
    • Sampled - Marketing Demonstration – The product is used in a marketing demonstration.
    • Sampled - Pharmaceutical Study – The product is sampled for a post-registration pharmaceutical study, to support submitted changes to a dossier.
    • Sampled By Authorities – The product is sampled by government authorities.
    • Sampled - Selective Control – The product is sampled by health authorities as needed to ensure quality standards.
    • Stolen – The product is stolen (reported as 11 - Stolen or Misplaced).
    • Withdrawn - Experiment – The product is withdrawn from the market during the course of an experiment.
  8. Enter the Reason Description for the destruction (optional, maximum 100 characters).
  9. Specify the Transaction IDs for the destruction:
    1. Specify a Removal From Circulation document:
      1. Select Add Another in the Transaction IDs table header.
      2. Select Removal From Circulation as the Identifier Type.
      3. Enter the Identifier Value of the Destruction document.
      4. Enter the Document Date printed on the Destruction document.
    2. Specify additional Transaction IDs (optional):
      1. Select Add Another in the Transaction IDs table header.
      2. Select an Identifier Type from the drop-down.
      3. Enter the Identifier Value in the text field.
      4. Select the Document Date from the date picker.
  10. Enter the Serial Numbers whose items are destroyed by selecting one of the following:
    • Select Upload Serial Numbers from File:
      1. Select Choose File.
      2. Browse for and select the desired CSV file.
        3. The CSV file must be smaller than 50MB and cannot contain headers. Only 1 file can be uploaded per session.

      or

    • Select Scan Serial Numbers:
      • Enter the serial numbers (limit of 30,000 characters).

        or

      • Scan the serial numbers (limit of 30,000 characters) with an external scanner.
  11. Select Automatically Disaggregate Items From Parent Container to disaggregate all destroyed child items from their parent containers when the destruction event is submitted (optional).

    If selected, the disaggregation event initiates the 913 - Unit Extract report.

  12. Select Submit.

    The items are destroyed and updated with the selected reason code.

Generating the report on a mobile device

  1. Open the Smart Inventory Tracker app on the mobile device.
  2. Select the Options icon at the top of any screen.
  3. Select Update Number Status.
  4. Select Sample.

  5. Enter RU (Russian Federation) as the Inspection Country Code.

  6. Enter the identifier of the company or location sampling the product in the Sampling Entity field.

  7.  Select one of the following reasons the product is sampled from the Reason Code drop-down:

    • Archival – The product is sampled to store as a record. Serialized Operations Manager records this Reason Code as Sampled. Archival will be reported to Russia in the future.
    • Conformity Control – The product is sampled by health authorities when imported to ensure quality standards. Serialized Operations Manager records this Reason Code as Sampled by Authorities. Conformity Control will be reported to Russia in the future.
    • Selective Control – The product is sampled by health authorities as needed to ensure quality standards. Serialized Operations Manager records this Reason Code as Sampled by Authorities. Selective Control will be reported to Russia in the future.

  8. Enter the Serial Number:

    • Scan the barcode.

      or

    • Enter the serial number manually and select the Submit icon.
    • SN Status – The current serialization state of the serial number.
      • Commissioned – The serial number is associated with a particular product and lot number.
      • Registered – The serial number came to the company without serial number information and was registered upon receipt or repackaging.
    • Item Status – The state of the product associated with the serial number.
      • Available – Item is available for picking.
  9. Repeat the previous step for any other serial numbers that must be sampled.
  10. Select Submit.
  11. Select Yes in the confirmation dialog box.

    Smart Inventory Tracker sends all serial numbers in the update queue to Serialized Operations Manager, which then associates the appropriate Reason Code to them.

    TraceLink disaggregates the sampled product if the serial numbers are aggregated to parent containers, which prompts a disaggregation event and initiates the 913 - Unit Extract report

Tips

  • To remove a serial number from the update queue, scan or enter it a second time, and select Yes in the dialog box.
    • If the Don't show me this message again checkbox in this dialog box was previously selected during the current update, the serial number is automatically removed from the queue without confirmation.
  • To view all serial numbers in the update queue, select Serial Numbers.
  • To cancel the update, select the Cancel icon in the upper right, and select Yes in the dialog box. Smart Inventory Tracker removes all serial numbers from the update queue.
  • For smartphone users, Smart Inventory Tracker automatically opens the camera to scan barcodes.
    • Select the Close icon to disable the camera.
    • Select the Open icon to enable the camera.
  1. Open the Smart Inventory Tracker app on the mobile device.
  2. Select the Options icon at the top of any screen.
  3. Select Update Number Status.
  4. Select Decommission.

  5. Select the Reason Code to apply to the decommissioned serial numbers and include in the report:

    • Damaged – The product is damaged.
    • Defective – The product does not function as intended.
    • Misplaced – The product is missing.
    • Sampled – The product is sampled for quality testing.
    • Sampled - Clinical Study – The product is sampled for a clinical study.
    • Sampled - Customs Control – The product is sampled for inspection control by customs authorities.
    • Sampled - Federal Inspection – The product is sampled for federal inspection.
    • Sampled - Marketing Demonstration – The product is used in a marketing demonstration.
    • Sampled - Pharmaceutical Study – The product is sampled for a post-registration pharmaceutical study, to support submitted changes to a dossier.
    • Sampled by Authorities – The product is sampled by government authorities.
    • Stolen – The product is stolen.
    • Withdrawn - Experiment – The product is withdrawn from the market during the course of an experiment.

  6. Enter the Serial Number:

    • Scan the barcode.

      or

    • Enter the serial number manually and select the Submit icon.
    • SN Status – The current serialization state of the serial number.
      • Commissioned – The serial number is associated with a particular product and lot number.
      • Encoded – The serial number is encoded. This state typically applies to label or carton pre-printing. This state comes after Reserved and before Commissioned.
      • Reserved – An assignment of the serial number's packaging location.
      • Unreserved – The removal of the serial number's packaging location assignment.
      • Registered – The serial number came to the company without serial number information and was registered upon receipt or repackaging.
    • Item Status – The state of the product associated with the serial number.
      • Available – Item is available for picking.
      • Blocked – Item is unavailable for picking.
      • Pending Receipt – The transfer of ownership is in an interim state because the shipment awaits receipt confirmation at the receiving location.
      • Picked – There is an item reservation against a specific outbound delivery indicating item picking is complete.
      • Received – There is an item reservation against a specific outbound delivery indicating items are received.
      • Shipped – The transfer of ownership is in an interim state, as the shipment is en route to the receiving location.
      • Under Investigation – The item is quarantined or in a holding state due to a product investigation. The serial number cannot be included in a sales shipment.
  7. Repeat the previous step for any other serial numbers that must be decommissioned.

  8. Select the Operational Facility decommissioning the serial numbers.

  9. Ensure that a Destruction Method is not selected.

  10. Enter the Transaction ID to associate with the event:

    • Scan the barcode.

      or

    • Enter the transaction identifier manually, and select the Submit icon.

    The Removal from Circulation Transaction ID Type displays.

  11. Enter the Transaction Date associated with the Removal from Circulation document.
  12. Select Submit.

  13. Select Yes in the confirmation dialog box.

    Smart Inventory Tracker sends all serial numbers in the update queue to Serialized Operations Manager, which then updates their Serial Number Status to Decommissioned. If any serial numbers are aggregated, Serialized Operations Manager:

    • Decommissions all child serial numbers associated with a decommissioned parent container.
    • Disaggregates decommissioned child numbers from their parents and decommissions any containers left empty.
      The disaggregation event initiates the 913 - Unit Extract report.

Tips

  • To remove a serial number from the update queue, scan or enter it a second time, and select Yes in the dialog box.
    • If the Don't show me this message again checkbox in this dialog box was previously selected during the current update, the serial number is automatically removed from the queue without confirmation. .
  • To view all serial numbers in the update queue, select Serial Numbers.
  • To cancel the update, select the Cancel icon in the upper right, and select Yes in the dialog box. Smart Inventory Tracker removes all serial numbers from the update queue.
  • For smartphone users, Smart Inventory Tracker automatically opens the camera to scan barcodes.
    • Select the Close icon to disable the camera.
    • Select the Open icon to enable the camera.
  1. Open the Smart Inventory Tracker app on the mobile device.
  2. Select the Options icon at the top of any screen.
  3. Select Update Number Status.
  4. Select Destroy.
  5. Select a Reason Code to describe why the product is being destroyed:
    • Damaged – The product is damaged.
    • Defective – The product does not function as intended.
    • Misplaced – The product is missing.
    • Sampled - Clinical Study – The product is sampled for a clinical study.
    • Sampled - Customs Control – The product is sampled for inspection control by customs authorities.
    • Sampled - Federal Inspection – The product is sampled for federal inspection.
    • Sampled - Marketing Demonstration – The product is used in a marketing demonstration.
    • Sampled - Pharmaceutical Study – The product is sampled for a post-registration pharmaceutical study, to support submitted changes to a dossier.
    • Sampled by Authorities – The product is sampled by government authorities.
    • Stolen – The product is stolen.
    • Withdrawn - Experiment – The product is withdrawn from the market during the course of an experiment.

  6. Enter the Serial Number:

    • Scan the barcode.

      or

    • Enter the serial number manually and select the Submit icon.
    • SN Status – The current serialization state of the serial number.
      • Commissioned – The serial number is associated with a particular product and lot number.
      • Decommissioned – The serial number is no longer associated with a particular product and lot number.
      • Encoded – The serial number is encoded. This state typically applies to label or carton pre-printing. This state comes after Reserved and before Commissioned.
      • Reserved – An assignment of the serial number's packaging location.
      • Unreserved – The removal of the serial number's packaging location assignment.
      • Registered – The serial number came to the company without serial number information and was registered upon receipt or repackaging.
    • Item Status – The state of the product associated with the serial number.
      • Available – Item is available for picking.
      • Blocked – Item is unavailable for picking.
      • Pending Receipt – The transfer of ownership is in an interim state because the shipment awaits receipt confirmation at the receiving location.
      • Picked – There is an item reservation against a specific outbound delivery indicating item picking is complete.
      • Received – There is an item reservation against a specific outbound delivery indicating items are received.
      • Shipped – The transfer of ownership is in an interim state, as the shipment is en route to the receiving location.
      • Under Investigation – The item is quarantined or in a holding state due to a product investigation. The serial number cannot be included in a sales shipment.
  7. Repeat the previous step for any other serial numbers that must be destroyed.

  8. Select the Operational Facility destroying the serial numbers.

  9. Ensure that a Destruction Method is not selected.

  10. Enter the Transaction ID to associate with the event:

    • Scan the barcode.

      or

    • Enter the transaction identifier manually, and select the Submit icon.

    The Removal from Circulation Transaction ID Type displays.

  11. Select Submit.

  12. Select Yes in the confirmation dialog box.

    Smart Inventory Tracker sends all serial numbers in the update queue to Serialized Operations Manager, which then updates their Serial Number Status to Destroyed. If any serial numbers are aggregated, Serialized Operations Manager:

    • Destroys all child serial numbers associated with a destroyed parent container.
    • Disaggregates destroyed child numbers from their parents and destroys any containers left empty.
      • The disaggregation event initiates the 913 - Unit Extract report.

Tips

  • To remove a serial number from the update queue, scan or enter it a second time, and select Yes in the dialog box.
    • If the Don't show me this message again checkbox in this dialog box was previously selected during the current update, the serial number is automatically removed from the queue without confirmation.
  • To view all serial numbers in the update queue, select Serial Numbers.
  • To cancel the update, select the Cancel icon in the upper right, and select Yes in the dialog box. Smart Inventory Tracker removes all serial numbers from the update queue.
  • For smartphone users, Smart Inventory Tracker automatically opens the camera to scan barcodes.
    • Select the Close icon to disable the camera.
    • Select the Open icon to enable the camera.

Compliance report details

  • Report Date – The date and time that the report generated.
  • Report ID – The report's MDLP document ID.
  • Report Type – 552 - Withdrawal.

This section displays only if the report generated from a Take Sample or ESM Take Sample event.

  • Sampling Party ID – The identifier of the company or location that sampled the product.
  • Sampling Party Name – The name of the company or location that sampled the product, sourced from Company Master Data (this information displays but is not reported).
  • Sampling Type – The reason that the product is sampled, sourced from the Sampling Reason Code in Serialized Operations Manager:
    • 19 - Quality Control – The product is sampled by health authorities as needed to ensure quality standards.
    • 20 - Archival – The product is sampled to store as a record.

This section displays only if the report generated from a Product Decommissioned, ESM Product Decommissioned, Product Destroyed, or ESM Product Destroyed event.

Field Description Sourced From MDLP Report Element
Withdrawal Party ID

The identifier of:

  • The product's MAH if the decommissioning or destruction takes place outside of Russia.
  • The location that completed the decommissioning or destruction if the event takes place in Russia.
  • The company that owns Serialized Operations Manager if a Location is not specified in the decommissioning or destruction event.

Location in the decommissioning or destruction event:

  • If the Location where the decommissioning or destruction takes place is outside of Russia, value is the 36-character Russia Account Number associated with the product's MAH.
  • If the Location where the decommissioning or destruction takes place is inside of Russia, value is the 14-character Russia Account Number.
  • If a Location is not specified, value is the 36-character Russia Account Number associated with the Serialized Operations Manager Owner.
 subject_id
Withdrawal Party Name

The name of the company or location that completes the decommissioning or destruction.

Company or Partner Master Data, the name associated with the identifier of the Location. Not reported
Withdrawal Type

The reason for the decommissioning or destruction.

Displays as one of the following:

  • 6 - Sampled By Authorities – The product is sampled by government authorities.
  • 7 - Sampled - Customs Control – The product is sampled for inspection control by customs authorities.
  • 8 - Sampled - Federal Inspection – The product is sampled for federal inspection.
  • 9 - Sampled - Clinical Study – The product is sampled for a clinical study.
  • 10 - Sampled - Pharmaceutical Study – The product is sampled for a post-registration pharmaceutical study, to support submitted changes to a dossier.
  • 11 - Stolen or Misplaced – The product is stolen or missing.
  • 12 - Sampled - Marketing Demonstration – The product is used in a marketing demonstration.
  • 13 - Damaged – The product is damaged.
  • 14 - Withdrawn - Experiment – The product is withdrawn from the market during the course of an experiment.
  • 15 - Defective – The product does not function as intended.
  • 19 - Quality Control – The product is sampled by health authorities as needed to ensure quality standards.
  • 20 - Archival – The product is sampled to store as a record.

Reason Code in the decommissioning or destruction event.

 withdrawal_type
Withdrawal Document Number The number on the contract service agreement to decommission or destroy the items. Identifier Value of the Removal From Circulation Transaction ID in the decommissioning or destruction event. doc_num
Withdrawal Document Date The date on the contract service agreement to decommission or destroy the items. Document Date of the Removal From Circulation Transaction ID in the decommissioning or destruction event. doc_date
  • Response Received – The date and time that TraceLink received a response message from MDLP.
  • Response Type – The response code from MDLP.
  • Status – The status of the report with MDLP.
  • Error Code – The error code returned by MDLP, if applicable.
  • Error Description – The description of the associated Error Code.