Finalization

Brazil Compliance Owners generate the Finalization report to capture the decommission or destruction of items in Brazil.

A decommission event terminates the use of a serial number with the intention of later re-commissioning the serial number with updated information. A destruction event permanently terminates the use of a serial number that is affixed to a product or container. A destroy event is appropriate if a product is damaged or expired, as this results in the physical elimination of the product.

The Finalization report currently supports a maximum of 800,000 serial numbers.

Configure the report

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

Source Application Event Action Description
Serialized Operations Manager Decommissioned Generate Finalization Report for Decommission from Core Integration

Tracelink generates a Finalization Report for the decommission events that contain serial numbers with a target market of Brazil 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 Decommissioned Generate Finalization Report for Decommission from ESM Integration

Tracelink generates a Finalization Report for the decommission event that contain serial numbers with a target market of Brazil when they are submitted via ESM integration as long as all of the event trigger conditions are met.
Serialized Operations Manager Destroy Generate Finalization Report from Core Integration Tracelink generates a Finalization Report for the destruction event that contain serial numbers with a target market of Brazil 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 Destroy Generate Finalization Report for Destruction from ESM Integration Tracelink generates a Finalization Report for the destruction event that contain serial numbers with a target market of Brazil 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.

Brazil Compliance generates the Finalization report when TraceLink processes a SOM Decommission, ESM Decommission, SOM Destroy, or ESM Destroy event and all of the following conditions are met:

  • The products have a Target Market of Brazil.
  • The products have a Packaging Code Type of GTIN-14 with a Packaging UOM (unit of measure) of Each.
  • The Location of the decommission or destruction is in Brazil.
  • The Reporting Party in the decommission or destruction event has the same CNPJ root as the Owner in Company or Partner Master Data (i.e. the first 8 digits of the CNPJ numbers are the same).
  • The Reason Code for the decommission or destruction is Defective, Disposed, Damaged, Misplaced, Stolen, Sampled - Federal Inspection, or Sample.
  • If the Reason Code is Disposed, the product's Pharmaceutical Manufacturer, which is identified by the MAH ID for the Brazil Target Market in Product Master Data, exists in Company or Partner Master Data at the company or location level.

Generate the report

To generate the Finalization report automatically, work with TraceLink to enable the appropriate event triggers and ensure that the relevant event trigger conditions are met. When configured, Brazil Compliance generates the Finalization report automatically when a decommission or destruction event occurs in one of the following interfaces:

Use any of the following Serialized Operations Manager APIs to trigger the Finalization report:

Decommission Event (EPCIS v1.0)

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

Use this message only if reporting Reason Code as a value other than Defective (sealBrk) or Sampled - Federal Inspection (snvs).

Element Values
bizLocation Specify the location in Brazil where the decommission or destruction takes place.
tl:businessPartyInfo Specify the reporting party responsible for the decommission or destruction.
tl:decommissionReasonCode

Must be one of the following:

  • DAMAGED (reported as damaged).
  • DISPOSED (reported as destroy).
  • MISPLACED (reported as disapp).
  • SAMPLED (reported as quality).
  • STOLEN (reported as robry).
tl:reasonDescription Specify a reason for the decommission or destruction.

Destroy Event (EPCIS v1.0)

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

Use this message only if reporting Reason Code as Damaged (damaged) or Defective (sealBrk).

Element Values
readPoint Specify the location in Brazil where the decommission or destruction takes place.
tl:businessPartyInfo Specify the reporting party responsible for the decommission or destruction.
tl:decommissionReasonCode

Must be one of the following:

  • DESTROY_DAMAGED (reported as damaged).
  • PRODUCTION_DEFECT (reported as sealBrk).
tl:reasonDescription Specify a reason for the decommission or destruction.

Decommission Event (EPCIS v1.2)

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

Element Values
bizLocation Specify the location in Brazil where the decommission or destruction takes place.
tl:businessPartyInfo Specify the reporting party responsible for the decommission or destruction.
tl:decommissionReasonCode

Must be one of the following:

  • DAMAGED (reported as damaged).
  • DEFECTIVE (reported as sealBrk).
  • DISPOSED (reported as destroy).
  • MISPLACED (reported as disapp).
  • SAMPLED (reported as quality).

  • SAMPLED_FEDERAL_INSPECTION (reported as snvs).

  • STOLEN (reported as robry).
tl:reasonDescription Specify a reason for the decommission or destruction.

Destroy Event (EPCIS v1.2)

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

Element Values
bizLocation Specify the location in Brazil where the decommission or destruction takes place.

tl:businessPartyInfo

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

Must be one of the following:

  • DAMAGED (reported as damaged).
  • DEFECTIVE (reported as sealBrk).
  • DISPOSED (reported as destroy).
  • MISPLACED (reported as disapp).
  • SAMPLED (reported as quality).

  • SAMPLED_FEDERAL_INSPECTION (reported as snvs).

  • STOLEN (reported as robry).
tl:reasonDescription Specify a reason for the decommission or destruction.

ESM Decommission (EPCIS v1.2)

Complete the elements required for the message. See the Serialized Operations Manager ESM Synchronization API Guide for more information.

Element Values
bizLocation Specify the location in Brazil where the decommission or destruction takes place.
tl:businessPartyInfo Specify the reporting party responsible for the decommission or destruction.
tl:decommissionReasonCode

Must be one of the following:

  • DAMAGED (reported as damaged).
  • DEFECTIVE (reported as sealBrk).
  • DISPOSED (reported as destroy).
  • MISPLACED (reported as disapp).
  • SAMPLED (reported as quality).

  • SAMPLED_FEDERAL_INSPECTION (reported as snvs).

  • STOLEN (reported as robry).
tl:reasonDescription Specify a reason for the decommission or destruction.

ESM Destroy (EPCIS v1.2)

Complete the elements required for the message. See the Serialized Operations Manager ESM Synchronization API Guide for more information.

Element Values
bizLocation Specify the location in Brazil where the decommission or destruction takes place.
tl:businessPartyInfo Specify the reporting party responsible for the decommission or destruction.
tl:decommissionReasonCode

Must be one of the following:

  • DAMAGED (reported as damaged).
  • DEFECTIVE (reported as sealBrk).
  • DISPOSED (reported as destroy).
  • MISPLACED (reported as disapp).
  • SAMPLED (reported as quality).

  • SAMPLED_FEDERAL_INSPECTION (reported as snvs).

  • STOLEN (reported as robry).
tl:reasonDescription Specify a reason for the decommission or destruction.

Decommission (SOAP)

Complete the elements required for the message. See the Serialized Operations Manager SOAP API Guide for more information.

Element Values
Sampled Must be present to report a Reason Code of quality.
Damaged Must be present to report a Reason Code of damaged.
Misplaced Must be present to report a Reason Code of disapp.
Disposed Must be present to report a Reason Code of destroy.
Stolen Must be present to report a Reason Code of robry.
SampledFederalInspection Must be present to report a Reason Code of snvs.
Defective Must be present to report a Reason Code of sealBrk.
ReasonDescription Specify a reason for the decommission or destruction.
ReportingPartyIdentifier Specify the reporting party responsible for the decommission or destruction.
Location Specify the location in Brazil where the decommission or destruction takes place.

Destroy (SOAP)

Complete the elements required for the message. See the Serialized Operations Manager SOAP API Guide for more information.

Element Values
Sampled Must be present to report a Reason Code of quality.
Damaged Must be present to report a Reason Code of damaged.
Misplaced Must be present to report a Reason Code of disapp.
Disposed Must be present to report a Reason Code of destroy.
Stolen Must be present to report a Reason Code of robry.
SampledFederalInspection Must be present to report a Reason Code of snvs.
Defective Must be present to report a Reason Code of sealBrk.
ReasonDescription Specify a reason for the decommission or destruction.
ReportingPartyIdentifier Specify the reporting party responsible for the decommission or destruction.
Location Specify the location in Brazil where the decommission or destruction takes place.

Use Serialized Operations Manager to trigger the Finalization report from the Web UI. Decommission or destroy a product, completing all fields required in the Web UI or that your company uses for a specific purpose. See the Serialized Operations Manager Online Help for more information.

Decommission

  1. In Track & Trace Services, 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. Complete the fields required for the report as follows:
    FieldValues
    Reason Code

    Must be one of the following:

    • Damaged (reported as damaged).
    • Defective (reported as sealBrk).
    • Disposed (reported as destroy).
    • Misplaced (reported as disapp).
    • Sampled (reported as quality).

    • Sampled - Federal Inspection (reported as snvs).

    • Stolen (reported as robry).
    Reporting EntitySpecify the reporting party responsible for the decommission or destruction.
    Reason DescriptionSpecify a reason for the decommission or destruction.
    LocationSpecify the location in Brazil where the decommission or destruction takes place.
  5. Complete any other fields that are required in the UI or that your company uses for a specific purpose.
  6. Select Submit.

    The Decommission Serial Numbers screen displays, and Brazil Compliance begins automatically generating the report from the event trigger.

Destruction

  1. In Track & Trace Services, 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
    Reason Code

    Must be one of the following:

    • Damaged (reported as damaged).
    • Defective (reported as sealBrk).
    • Disposed (reported as destroy).
    • Misplaced (reported as disapp).
    • Sampled (reported as quality).

    • Sampled – Federal Inspection (reported as snvs).

    • Stolen (reported as robry).
    Reporting EntitySpecify the reporting party responsible for the decommission or destruction.
    Reason DescriptionSpecify a reason for the decommission or destruction.
    LocationSpecify the location in Brazil where the decommission or destruction takes place.
  5. Complete any other fields that are required in the UI or that your company uses for a specific purpose.
  6. Select Submit.

    The Destroy Product screen displays, and Brazil Compliance begins automatically generating the report from the event trigger.

Use the Brazil Compliance Web UI to manually generate the Finalization report. This option is useful if a report failed to generate automatically and the information must still be submitted to the SNCM.

  1. Select [Company Name] Brazil Compliance Network from the Network drop-down in the header.
  2. Select the Go button in the header.
  3. Select the Generate Report icon.
  4. Select Finalization as Report Type to generate.
  5. Select one of the following to specify the Serial Numbers to generate the report for:
    • Select Import Serial Numbers:
      1. Select Choose File.
      2. Select the CSV file with the serial numbers to import.
    • Select Enter Serial Numbers:
      • 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.

    Go to the Table View to locate the new report.

Report details

  Description Sourced From SNCM Report Element
Report Type Displays as Finalization. The type of report. final
Status The status of the report:
  • Generated – The report is generated in TraceLink but not yet submitted to the SNCM.
  • Generation Failed – The report failed to generate in TraceLink.
  • Submitted – The report is generated and successfully submitted to the SNCM.
  • Submitted with Warning – The report is generated and successfully submitted to the SNCM, but the SNCM issued a warning.
  • Submission Failed – The report is generated but was not successfully submitted to the SNCM.
  • Processed with Warning – The SNCM received and processed the report successfully but issued a warning during processing.
  • Processing Failed – The SNCM received the report successfully but failed to process the report.
  • Accepted – The SNCM received the report successfully and accepted the information.
  • Accepted with Warning – The SNCM received the report successfully and accepted the information but issued a warning.
  • Rejected – The SNCM received the report successfully but rejected the information.

At this time, this field does not capture the status response from the SNCM (e.g. Accepted, Partial, Warning).

 The status of the report. Not reported
Date Reported The date and time that the report is generated. The system date and time when the report is generated. ccTime
Document ID The unique report identifier generated by TraceLink. The unique identifier generated by TraceLink. docId
Reporting Entity The company or location that is responsible for reporting the event to the SNCM. The decommission or destruction event location provided in the Serialized Operations Manager message. declarant
Reporting Proxy This field is reserved for a future release. The company, internal location, or Partner that reports to the SNCM on behalf of the reporting entity, if the reporting entity does not submit the report.

-

 mbrAgt
Reporting System The contact information for the reporting system (i.e. TraceLink) required by the SNCM. Displays as TraceLink Brazil Compliance application, Email - case@tracelink.com, Phone +1 (781) 914-4900. The default contact information value provided by TraceLink. usrAgt
Layout Version The layout version of the SNCM API used to submit reports. The default value provided by TraceLink. ver
Environment

The SNCM environment:

  • 0 – Production.
  • 1 – Testing.
 The default value provided by TraceLink. env
Language The language required by the SNCM. Displays as Pt-BR. The default value provided by TraceLink. lc

Tips

  • Select the name of the Report File to export the report file generated for the SNCM.
  • Select the name of the Response File to export the response file received from the SNCM.
Field Description Sourced From SNCM Report Element
Event ID The unique ID of the decommission or destruction event. The unique identifier generated by TraceLink for the event. evtNotifId
Real-Time Report Indicates whether the report is in real time. Displays as True. The default value provided by TraceLink. realTime
Termination Type

The SNCM termination type:

  • damaged
  • sealBrk
  • destroy
  • disapp
  • quality
  • snvs
  • robry
The Reason Code for the decommission or destruction in Serialized Operation Manager.
  • damaged (Damaged)
  • sealBrk (Defective)
  • destroy (Disposed)
  • disapp (Misplaced)
  • quality (Sampled)
  • snvs (Sampled – Federal Inspection)
  • robry (Stolen)
Reason Code The reason code for the decommission or destruction.
  • Damaged – The product is damaged.
  • Defective – The product does not function as intended.
  • Disposed – The product is disposed.
  • Misplaced – The product is missing.
  • Sampled – The product is sampled for quality testing.
  • Sampled – Federal Inspection – The product is sampled for federal inspection.
  • Stolen – The product is stolen.
 The Reason Code for the decommission or destruction in Serialized Operation Manager.
  • damaged (Damaged)
  • sealBrk (Defective)
  • destroy (Disposed)
  • disapp (Misplaced)
  • quality (Sampled)
  • snvs (Sampled – Federal Inspection)
  • robry (Stolen)
Description The decommission or destruction description. Decommission or destruction Reason Description.

desc

Tips

  • Select the file name below Download Serial Numbers to export the serial numbers in the report to a CSV file.
Field Description Sourced From SNCM Report Element
Packaging Code The packaging code for the product. The Packaging Code of the serialized item in the decommission or destruction. gtin
Product Description The description of the product. The description associated with the Packaging Code in Product Master Data. Not reported
Lot Number The lot number for the serialized items. The lot number associated with the Packaging Code for the decommission or destruction in Serialized Operations Manager. lot
Expiration Date The expiration date associated with the Lot Number. The expiration date associated with the lot number of the serial numbers in the decommission or destruction. exp
Quantity The quantity of serial numbers in the report. The quantity of serial numbers in the decommission or destruction for the Packaging Code and Lot Number. Not reported

Tips

  • Select the Export icon to export the serial numbers in the report to a CSV file.

Report Files – The report files to be submitted to the SNCM.

After generating compliance reports in TraceLink, Owners can submit reports manually or automatically to the National Drug Control System (SNCM) to ensure compliance with Brazil regulations.

By default, reports are submitted automatically to the SNCM. If a report fails submission to the SNCM (e.g. if the SNCM is not available), Owners can submit the reports manually.

Tips

  • To submit the report manually, selectSelect the Submit to SNCM icon for each Report File to manually submit to the SNCM.
    • Status – Indicates whether the SNCM successfully received the report.

      This status reflects successful submission or failure only. It does not reflect the status response from the SNCM (e.g. Accepted, Partial, Warning).

      This status reflects successful submission, failure, or the status response from the SNCM.

    • Status Description – The description of the Status.
    • Response Details – The complete details of the response from the SNCM, including the SNCM status response.

    Note the following:

    • If multiple Report Files display, each file must be submitted individually for the SNCM to receive the full report. For large reports, TraceLink generates multiple report files to accommodate the SNCM file size limit.
    • Before submitting compliance reports to the SNCM, Brazil Compliance owners must inform ANVISA that TraceLink is acting as their reporting proxy and provide ANVISA with TraceLink's Brazil CNPJ number.
    • Before closing the panel, save the Response Information for your records (e.g. by pasting this information in an Excel file). After the panel is closed, this information is retrievable only by contacting TraceLink Support.