Activation

Brazil Compliance Owners generate the Activation report to capture the product release of items manufactured inside of Brazil, or the market release of items manufactured outside of Brazil or end of batch of items manufactured inside of Brazil.

The Activation 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 Released Generate Activation Report for Quality Release from Core Integration

Tracelink generates an Activation Report for the products that are quality released in 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 Released Generate Activation Report for Quality Release from Event Exchange Integration

Tracelink generates an Activation Report for the products that are quality released in Brazil when they are submitted via event exchange integration as long as all of the event trigger conditions are met.
Serialized Operations Manager Released Generate Activation Report for Market Release from Core Integration Tracelink generates an Activation Report for the products that are market released in 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 Batch Completed Generate Activation Report for End of Batch from Core Integration Tracelink generates an Activation Report for End of Batch events in Brazil when they are submitted via core integration or the Web UI, 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 Activation report when TraceLink processes a Product Release Event, Received Product Release Event, or Market Release Event, or End of Batch 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.

Generate the report

To generate the Activation 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 Activation report automatically when a product release, or market release, or end of batch event occurs in one of the following interfaces:

Use any of the following API messages to trigger the Activation report:

End of Batch (XML)

Complete the elements required for the message. See the Serial Number Exchange API Guide for more information.

Element Values
cmn:FileSenderNumber Specify the sender of the message.
cmn:FileReceiverNumber Specify the receiver of the message.

Product Release (XML)

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

Element Values
cmn:LocationId Specify the company or location performing the product release.

Product Release 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 company or location performing the product release.

Release Product (SOAP)

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

Element Values
QualityControlEntityID Specify the company or location performing the product release.

Market Release (XML)

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

Element Values
cmn:EventLocation BR.

Market Product (SOAP)

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

Element Values
EventLocation BR.

Use Serialized Operations Manager (for Product Release and Market Release) and Serial Number Exchange (for End of Batch) to trigger the Activation report from the Web UI. Complete a product release or a market release or an end of batch, completing all fields required in the Web UI or that your company uses for a specific purpose. See the Serialized Operations Manager Online Help and Serial Number Exchange Online Help for more information.

Product Release

  1. In Track & Trace Services, hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Status Update drop-down and then select Set Product Release Status.
  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
    Quality Control EntityThe company or location where the product is tested for quality.
  5. Complete any other fields that are required in the UI or that your company uses for a specific purpose.
  6. Select Submit.

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

Market Release

  1. In Track & Trace Services, hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Status Update drop-down, and then select Set Market Release Status.
  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
    LocationSpecify the company or location performing the market release.
    Target MarketBR.
  5. Complete any other fields that are required in the UI or that your company uses for a specific purpose.
  6. Select Submit.

    The Set Market Release Status screen displays, and Brazil Compliance begins automatically generating the report from the event trigger.

End of Batch

  1. In Track & Trace Services, hover over Modules, and then select Serial Number Exchange.
  2. Select Report End of Batch.
  3. Select the ServiceLink for which the end of batch is being reported.
  4. Complete any other fields that are required in the UI or that your company uses for a specific purpose.
  5. Select Submit.

    The Packaging Events Log screen displays, and on the successful End of Batch transaction, Brazil Compliance begins automatically generating the report from the event trigger.

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

Currently, users can manually generate the Activation report for Product Release and End of Batch events only.
  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 Activation as Report Type.
    • Event Type drop-down – Required. The event type to generate the report for. Select Product Release or End of Batch event type.
    • Packaging Code field – Required. The packaging code of the product to generate the report for.
    • Lot Number field – Required. The lot number associated with the packaging code to determine the serial numbers to report.

  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 Activation. The type of report. activ
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
Event ID The unique ID of the product release, or market release, or end of batch 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
Event Location The location where the product release, or market release, or end of batch event takes place. The location of the product release, or market release, or end of batch event. outsrc
Imported Product

Indicates whether the products were commissioned inside or outside of Brazil:

  • Yes – The products' commissioning location is not in Brazil.

  • No – The products' commissioning location is in Brazil.

 The commissioning location associated with the serial numbers in the report. import
Event Type

Indicates the type of event:

  • Product Release
  • Market Release
  • End of Batch
The type of event from Serialized Operations Manager. Not reported
Field Description Sourced From SNCM Report Element
Packaging Code The packaging code for the product. The packaging code of the serial numbers in the product release or market release. 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 of the serial numbers in the product release or market release. 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 product release or market release. exp
Quantity The quantity of serial numbers for the Packaging Code and Lot Number The quantity of serial numbers in the product release or market release 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.