Shipment

Brazil Compliance Owners generate the Shipment report to capture the sale or transfer of products in Brazil.

The Shipment 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 Shipped Generate Shipment Report for In Country Sales from Core Integration

Tracelink generates a Shipment Report for in-country sales shipments within 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 Shipped Generate Shipment Report for In Country Sales from ESM Integration

Tracelink generates a Shipment Report for in-country sales shipments within Brazil when they are submitted via ESM integration as long as all of the event trigger conditions are met.
Serialized Operations Manager Shipped Generate Shipment Report for In Country Transfers from Core Integration Tracelink generates a Shipment Report for in-country transfers within 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 Shipped Generate Shipment Report for In Country Transfers from ESM Integration Tracelink generates a Shipment Report for in-country transfers within 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 Shipment report when TraceLink processes a Product Shipped - In-Country Transfer, ESM Product Shipped - In-Country Transfer, Product Shipped - In-Country Sale, or ESM Product Shipped - In-Country Sale 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 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.
  • The shipment's Sale Type is Transfer - In Country or Sale - In Country.
  • The Ship From Country Code is Brazil.
  • The Ship To Country Code is Brazil.
  • The Ship From Location and shipping company associated with the location in Company Master Data have the same CNPJ root (i.e. the first 8 digits of the CNPJ numbers are the same).

Generate the report

To generate the Shipment 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 Shipment report automatically when a shipment occurs in one of the following interfaces:

To generate the Shipment report successfully, the packaging level for all SSCC serial numbers should be provided in the shipment message to SOM.

Use any of the following Serialized Operations Manager API messages to trigger the Shipment report:

ESM Shipment (EPCIS v1.2)

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

Element Values
VocabularyElement

Must include:

  • A ship from location that has the same CNPJ root as the shipping company in Company Master Data (i.e. the first 8 digits of the CNPJ numbers are the same).
  • A ship to location.
  • At least one transportation carrier with a CNPJ number.

The locations can also be specified in the sourceList or destinationList for the shipment event as a master data lookup.

bizTransactionList Must include at least one Nota Fiscal Eletronica transaction identifier. Valid value is http://epcis.tracelink.com/hc/btt/notafiscaleletronica.
tl:shipToCountryCode BR.
tl:shipFromCountryCode BR.
tl:salesDistributionType INCOUNTRYTRANSFER or INCOUNTRYSALE.
tl:removalFromCirculation
  • To report Fit for Consumption as False, specify UNFITFORCONSUMPTION.

    or

  • To report Fit for Consumption as True, leave blank, or specify a value other than UNFITFORCONSUMPTION.
tl:aggregationInspection
  • To report Unverified Payload as True, specify UNVERIFIED.

    or

  • To report Unverified Payload as False, leave this field blank, or specify a value other than UNVERIFIED or IMPLIED.

ESM Shipment (XML)

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

Element Values
cmn:TransactionIdentifier Must include at least one NOTAFISCALELETRONICA transaction identifier.
cmn:ShipToCountryCode BR.
cmn:ShipFromCountryCode BR.
cmn:SalesDistributionType INCOUNTRYTRANSFER or INCOUNTRYSALE.
cmn:RemovalFromCirculation
  • To report Fit for Consumption as False, specify UNFITFORCONSUMPTION.

    or

  • To report Fit for Consumption as True, leave blank, or specify a value other than UNFITFORCONSUMPTION.
cmn:AggregationInspection
  • To report Unverified Payload as True, specify UNVERIFIED or IMPLIED.

    or

  • To report Unverified Payload as False, leave blank, or specify a value other than UNVERIFIED or IMPLIED.
cmn:ShipFromLocationLookupId or cmn:ShipFromLocationInfo Specify a ship from location that has the same CNPJ root as the shipping company in Company Master Data (i.e. the first 8 digits of the CNPJ numbers are the same). For cmn:ShipFromLocationInfo, include the name and address.
cmn:ShipToLocationLookupId or cmn:ShipToLocationInfo Specify a ship to location. For cmn:ShipToLocationInfo, include the name and address.
cmn:CarrierInfo Must include at least one transportation carrier with a CNPJ number.

Sales Shipment (EPCIS v1.2)

Complete the elements required for the report as follows. See the Serialized Operations Manager Core Integration API Guide for more information.

Element Values
VocabularyElement

Must include:

  • A ship from location that has the same CNPJ root as the shipping company in Company Master Data (i.e. the first 8 digits of the CNPJ numbers are the same).
  • A ship to location.
  • At least one transportation carrier with a CNPJ number.

The locations can also be specified in the sourceList or destinationList for the shipment event as a master data lookup.

tl:shipToCountryCode BR.
tl:salesDistributionType EXPORTTRANSFER or INCOUNTRYSALE.

Sales Shipment (XML)

Complete the elements required for the report as follows. See the Serialized Operations Manager Core Integration API Guide for more information.

Element Values
cmn:TransactionIdentifier Must include at least one NOTAFISCALELETRONICA transaction identifier.
cmn:ShipToCountryCode BR.
cmn:ShipFromCountryCode BR.
cmn:SalesDistributionType INCOUNTRYTRANSFER or INCOUNTRYSALE.
cmn:RemovalFromCirculation
  • To report Fit for Consumption as False, specify UNFITFORCONSUMPTION.

    or

  • To report Fit for Consumption as True, leave blank, or specify a value other than UNFITFORCONSUMPTION.
cmn:AggregationInspection
  • To report Unverified Payload as True, specify UNVERIFIED or IMPLIED.

    or

  • To report Unverified Payload as False, leave blank, or specify a value other than UNVERIFIED or IMPLIED.
cmn:ShipFromLocationLookupId or cmn:ShipFromLocationInfo Specify a ship from location that has the same CNPJ root as the shipping company in Company Master Data (i.e. the first 8 digits of the CNPJ numbers are the same). For cmn:ShipFromLocationInfo, include the name and address.
cmn:ShipToLocationLookupId or cmn:ShipToLocationInfo Specify a ship to location. For cmn:ShipToLocationInfo, include the name and address.
cmn:CarrierInfo Must include at least one transportation carrier with a CNPJ number.

Shipment 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
VocabularyElement

Must include:

  • A ship from location that has the same CNPJ root as the shipping company in Company Master Data (i.e. the first 8 digits of the CNPJ numbers are the same).
  • A ship to location.
  • At least one transportation carrier with a CNPJ number.

The locations can also be specified in the sourceList or destinationList for the shipment event as a master data lookup.

bizTransactionList

Must include at least one Nota Fiscal Eletronica identifier type. Valid value is http://epcis.tracelink.com/hc/btt/notafiscaleletronica.
tl:shipToCountryCode BR.
tl:shipFromCountryCode BR.
tl:salesDistributionType INCOUNTRYTRANSFER or INCOUNTRYSALE.
tl:removalFromCirculation
  • To report Fit for Consumption as False, specify UNFITFORCONSUMPTION.

    or

  • To report Fit for Consumption as True, leave blank, or specify a value other than UNFITFORCONSUMPTION.
tl:aggregationInspection
  • To report Unverified Payload as True, select UNVERIFIED or IMPLIED.

    or

  • To report Unverified Payload as False, leave blank, or select a value other than UNVERIFIED or IMPLIED.

Update Order Shipment (SOAP)

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

Element Values
ShipToCountryCode BR.
ShipFromCountryCode BR.
SaleType INCOUNTRYTRANSFER or INCOUNTRYSALE.
RemovalFromCirculation
  • To report Fit for Consumption as False, specify UNFITFORCONSUMPTION.

    or

  • To report Fit for Consumption as True, leave blank, or specify a value other than UNFITFORCONSUMPTION.
ShipFromLocation Specify a ship from location that has the same CNPJ root as the shipping company in Company Master Data (i.e. the first 8 digits of the CNPJ numbers are the same).
ShipToLocation Specify a ship to location.
TransportationCarrier Must include at least one transportation carrier with a CNPJ number.
Transactions Must include at least one NOTA_FISCAL_ELETRONICA identifier type.
AggregationInspection
  • To report Unverified Payload as True, specify UNVERIFIED or IMPLIED.

    or

  • To report Unverified Payload as False, leave blank, or specify a value other than UNVERIFIED or IMPLIED.

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

  1. In Track & Trace Services, hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Outbound Movement drop-down, and then select Create Delivery.
  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
    Sale TypeTransfer - In Country or Sale - In Country.
    Ship From Country CodeBrazil.
    Ship To Country CodeBrazil.
    Ship From LocationSpecify a Ship From Location that has the same CNPJ root as the shipping company in Company Master Data (i.e. the first 8 digits of the CNPJ numbers are the same).
    Ship To LocationSpecify a Ship To Location.
    Transportation CarrierMust include at least one transportation carrier with a CNPJ number.
    Transaction IDMust include at least one Nota Fiscal Eletronica Identifier Type and Value.
    Removal From Circulation Reason Code

    • To report Fit for Consumption as True, leave this field blank, or select a value other than Unfit for Consumption.

    • To report Fit for Consumption as False, select Unfit for Consumption.

    Aggregation Inspection

    • To report Unverified Payload as True, select Unverified or Implied.

    • To report Unverified Payload as False, leave this field blank, or select a value other than Unverified or Implied.

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

    The View Deliveries screen displays, the shipment is added, and Brazil Compliance begins automatically generating the report from the event trigger.

Use Smart Inventory Tracker to trigger the Shipment report from a mobile device. See the Smart Inventory Tracker Help Center for more information.

  1. In the Smart Inventory Tracker mobile app, do one of the following:
    • Ship product with an existing delivery number. The delivery number must already exist in Serialized Operations Manager with the fields required for the report.
    • Create a new delivery to ship product.
  2. If creating a new delivery in Smart Inventory Tracker, complete the following steps:

    Create a new delivery in Smart Inventory Tracker only if reporting Fit for Consumption as True.

    1. Complete the fields required for the report as follows:
      FieldValues
      Sale TypeTransfer - In Country or Sale - In Country.
      Ship From CountryBrazil.
      Ship To CountryBrazil.
      Ship From LocationSpecify a Ship From Location that has the same CNPJ root as the shipping company in Company Master Data (i.e. the first 8 digits of the CNPJ numbers are the same).
      Ship To LocationSpecify a Ship To Location.
      Transportation CarrierMust include at least one transportation carrier with a CNPJ number.
      Transaction IDMust include at least one Nota Fiscal Eletronica Transaction ID Type and Value.
      Aggregation Inspection

      • To report Unverified Payload as True, select Unverified or Implied.

      • To report Unverified Payload as False, leave this field blank, or select a value other than Unverified or Implied.

    2. Complete any other fields that are required in the UI or that your company uses for a specific purpose.
  3. Select Submit.

    Smart Inventory Tracker takes the resulting action, and Brazil Compliance begins automatically generating the report from the event trigger.

Use the Brazil Compliance Web UI to manually generate the Shipment 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. Fill in the following fields:
    • Report Type drop-down – Required. Select Shipment as Report Type.
    • Delivery Number field – Required. The delivery number of the shipment to generate the report for.

  5. Select Generate.

    The panel closes and TraceLink begins generating the report.

    Go to the Table View to locate the new report.

Report details

Field Description Sourced From SNCM Report Element
Report Type Displays as Shipment. The type of report. shpt
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. Company or Partner Master Data, the identifier of the product's Pharmaceutical Manufacturer, identified by the MAH ID in Product Master Data for the Brazil Target Market. 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.
Field Description Sourced From SNCM Report Element
Delivery Number The delivery number associated with the shipment. The Delivery Number for the shipment in Serialized Operations Manager. Not reported
Nota Fiscal Eletronica The Nota Fiscal Eletronica transaction ID associated with the delivery. The Nota Fiscal Eletronica Transaction ID in the shipment. bizTrans
From Business The business that ships the delivery. The From Business for the shipment in Serialized Operation Manager. Not reported
To Business The business that the delivery is shipped to. The To Business for the shipment in Serialized Operation Manager. Not reported
Ship From Location The location that the delivery is shipped from. The Ship From Location for the shipment in Serialized Operation Manager. Not reported
Ship To Location The location that the delivery is shipped to.

The Ship To Location for the shipment in Serialized Operation Manager.

 prtnr
Carrier Information The CNPJ number of the shipment's transportation carrier. Can display multiple values if the shipment has more than one Transportation Carrier with a CNPJ number. The Transportation Carriers with a CNPJ number in the shipment. carrs
Date Shipped The date when the delivery was shipped. The Shipment Date for the delivery in Serialized Operations Manager. Not reported
Event ID The unique ID of the shipment event. The unique identifier generated by TraceLink for the event. evtNotifId
Fit for Consumption

Indicates whether the items in the shipment are fit for consumption:

  • True – Displays if the shipment has a Removal From Circulation Reason Code other than Unfit for Consumption or is blank.
  • False – Displays if the shipment has a Removal From Circulation Reason Code of Unfit for Consumption.

The Removal From Circulation Reason Code for the shipment in Serialized Operation Manager.

 fit
Unverified Payload

Indicates whether the contents of the shipment have been inspected:

  • True – Displays if the shipment's Aggregation Inspection is set to Unverified or Implied.
  • False – Displays if the shipment's Aggregation Inspection is not set to Unverified or Implied, or is blank.
 The Aggregation Inspection for the shipment in Serialized Operation Manager. pld, unvPld, supdPld
Real-Time Report Indicates whether the report is in real time. Displays as True. The default value provided by TraceLink. realTime

Tips

  • Select Export 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 shipment. gtin
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. lot
Expiration Date The expiration date for the serialized items. The expiration date in Serialized Operations Manager for the serial numbers in this lot. exp
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 Export icon in row to export the serial numbers for that Packaging Code and Lot Number to a CSV file.
  • Serial Number – The serial numbers at the top-level of aggregation in the shipment.
  • Packaging Level – The packaging level of the Serial Number (e.g. Case).
  • Child Quantity – The quantity of child serial numbers aggregated to the parent Serial Number. Displays a value only if the Serial Number does not have a Packaging Level of Each.
  • Product Description – The name of the product. Displays a value only if the serial number has a Packaging Level of Each.

Tips

  • Select the Action icon, and then select View Aggregation to view information about the Serial Number and its children.

    Aggregation Information

    • Parent Serial Number – The parent serial number that the child serial numbers are aggregated to.
    • Packaging Level – The packaging level of the Parent Serial Number (e.g. Case).
    • Child Quantity – The number of child serial numbers aggregated to the Parent Serial Number.

    Tips:

    • The parent serial number also displays in the screen title.
    • Select Export Child Serial Numbers to export the child serial numbers aggregated to the Parent Serial Number as CSV file.

    Child Serial Numbers

    • Serial Number – The child serial numbers aggregated to the Parent Serial Number indicated in the Aggregation Information section.
    • Packaging Level – The packaging level of the Serial Number.
    • Child Quantity – The quantity of child serial numbers aggregated to the Serial Number. Displays a value only if the serial number has a Packaging Level of Each.
    • Packaging Code – The packaging code for the product. Displays a value only if the serial number has a Packaging Level of Each.
    • Product Description – The name of the product. Displays a value only if the serial number has a Packaging Level of Each.
    • Lot Number – The lot number that the serial number belongs to. Displays a value only if the serial number has a Packaging Level of Each.
    • Expiration Date – The expiration date associated with the Lot Number. Displays a value only if the serial number has a Packaging Level of Each.

    Tips:

    • Select the Action icon, and then select View Aggregation to view information about the Serial Number and its children.
    • Select the Action icon, and then select Export Aggregation to export the child serial numbers aggregated to the parent Serial Number as a CSV file.
  • Select the Action icon, and then select Export Aggregation to export the child serial numbers aggregated to the parent Serial Number as 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.