Register

This Help Center is a preview of a future release. The final Help Center will be available on the Validation date.

Marketing Authorization Holders (MAHs) that own Indonesia Compliance can now generate a Register report to capture the release of products in Indonesia.

Configure the report

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

Source Application Event Action Description
Serialized Operations Manager Product Release Generate Register Report from Core Integration TraceLink generates a Register report for products that are quality released within Indonesia 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 Product Release Generate Register Report from Event Exchange Integration TraceLink generates a Register report for products that are quality released within Indonesia when they are submitted via event exchange integration as long as all of the event trigger conditions are met.
Serialized Operations Manager Market Release Generate Register Report for Market Release from Core Integration TraceLink generates a Register Report for the products that are market released in Indonesia 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.

Indonesia Compliance generates a Register report when TraceLink processes a Product Release, Received Product Release, or Market Release event and all of the following conditions are met:

  • The products have a Target Market of ID.
  • 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 ID Target Market in Product Master Data, exists in Company Master Data at the company or location level.

  • The report generates only when the commissioning location is in Indonesia. This prevents incorrect reporting for imported products released outside Indonesia.

Generate the report

To generate the Register report automatically, enable the appropriate event triggers and ensure that the relevant event trigger conditions are met. When configured, Indonesia Compliance generates the Register report automatically when a product release event occurs in one of the following interfaces:

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

Product Release (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:LocationId Specify the company or location performing the product release.
cmn:InternalMaterialCode Specify the internal material number configured in the Product Master Data.
cmn:LotNumber Specify the lot number associated with the cmn:InternalMaterialCode used to identify the serial numbers to be updated.
cmn:QualityControlEntityId Specify the company or location where the product is tested for quality.

Product Release 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 company or location performing the product release.
tl:internalMaterialCode Specify the internal material number configured in the Product Master Data.
cbvmda:lotNumber Specify the lot number associated with the tl:internalMaterialCode.
tl:qualityControlEntityId Specify the company or location where the product is tested for quality.

Market Release (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:InternalMaterialCode Specify the internal material number configured in the Product Master Data.
cmn:LotNumber Specify the lot number associated with the cmn:InternalMaterialCode used to identify the serial numbers to be updated.
cmn:TransactionIdentifier Specify the transaction identifier associated with the released product. This may be a certificate or declaration of conformity.
cmn:MarketCountryCode Specify the 2 character ISO code for the market country.
cmn:PackagingLevel Specify the packaging level of the commissioned item.
cmn:QuantityReported Specify the quantity reported for the released product.

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

Product Release Status

  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:

    Element Values
    Item Code The Internal Material Number or Country Drug Code from Product Master Data.
    Quality Control Entity The company or location where the product to be released is tested for quality.
    Lot Number The number associated with the Item Code.
  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 Indonesia Compliance begins automatically generating the report from the event trigger. The screen refreshes with a message, "The request to assign the Quality Released Attribute to all serial numbers in Lot [Lot Number] is being processed. A notification displays when the request completes." displays at the top of a blank Set Product Release Status screen.

Market Release Status

Assign the Market Released Attribute to some or all serial numbers within a specific lot.

  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:

    Element Values
    Item Code The Packaging Item Code, Internal Material Number or Country Drug Code from Product Master Data.
    Lot Number The number associated with the Item Code.

    Target Market

    		The market that the product is release into. This field is sourced from the product's master data entry.
    Scope

    Radio buttons defining the type of market release:

    • Full Lot - The entire lot is released into the Target Market.

    • Partial Lot - Only a portion of the serial numbers included in the lot are released into the Target Market.
    Serial Numbers

    Specify the serial numbers (scanned, entered, or uploaded) being released into the Target Market (displays only if the Scope is Partial Lot).

    The serial numbers included in the market release must:

    • Exist in the Serialized Operations Manager repository.

    • Have a Serial Number Status of Commissioned.

    • Be included in the Lot Number.
  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 refreshes with one of the following confirmation messages:

    • If the Scope is Full Lot and Production Quantity is blank, "The request to assign the Market Released Attribute to all serial numbers in Lot [Lot Number] has completed." displays at the top of the screen.

    • If the Scope is Full Lot and Production Quantity is included, "The request to assign the Market Released Attribute to all serial numbers in Lot [Lot Number] is being processed. See Info Exchange for its status." displays at the top of the screen.

To generate the Register report manually, use the Indonesia Compliance Web UI. This option is useful if a report fails to generate automatically and the information must still be submitted to the BPOM.

Currently, only Register Report for Product Release can be generated using Indonesia Compliance UI. To generate Register Report for Market Release, see Market Release Status section.

  1. Select the Main Menu icon .
  2. Select Indonesia Compliance.

    A new tab opens and displays information for the Indonesia Compliance app.

  3. Select the Generate Report icon.
  4. Fill in the following fields:
    • Report Type drop-down – Required. Select Register as Report 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. Filter to find the new report.

Report details

Field Description Sourced From BPOM Report Element
Report Type Displays as Register. 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 BPOM.
  • Generation Failed – The report failed to generate in TraceLink.
  • Accepted – The BPOM received the report successfully and accepted the information.
  • Partially Accepted – The event has multiple reports, and all of them are successfully submitted to the BPOM, but the BPOM did not accept all of the reports.
  • Accepted with Warning – The BPOM received the report successfully and accepted the information but issued a warning.
  • Submission Failed – The report is generated but was not successfully submitted to the BPOM.
  • Rejected – The BPOM received the report successfully but rejected the information.

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. Not reported
Event Type

The event type:

  • Product Release
  • Market Release
The type of event. Not reported

Tips

  • Select the name of the Report File to export the report file generated for the BPOM.
  • Select the name of the Response File to export the response file received from the BPOM.
Field Description Sourced From BPOM Report Element
Packaging Code The packaging code for the product. The Packaging Code of the serialized item. gtin
Expiration Date The expiration date for the serialized items. The expiration date in Serialized Operations Manager for the serial numbers in this lot.. exp_date
Package Size The number of individual doses in the pack. The Package Size associated with the product in Master Data Exchange. id_kemasan
Lot Number The lot number associated with the packaging code to determine the serial numbers to report. The lot number associated with the Packaging Code in Serialized Operations Manager for this product's serialized items. lot_no
Batch Number

The lot number associated with the packaging code to determine the serial numbers to report.

The Lot Number and Batch Number always have the same values. The Indonesia government requires Owners to report both fields.

 The lot number associated with the Packaging Code in Serialized Operations Manager for this product's serialized items. lot_no
Serial Number Status

The current status of the serial number. Displays as Active by default.

 The current status of the serial number.

is_active

Marketing Authorization Number The product’s authorization number issued by a government agency. The Market Authorization Number for the Indonesia target market in Master Data Exchange. nie

Tips

  • Select Export Serial Numbers to export the serial numbers in the report to a CSV file.
Field Description Sourced From BPOM Report Element
Packaging Code The packaging code for the product. The Packaging Code of the serialized item. 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 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_no
Expiration Date The expiration date for the serialized items. The expiration date in Serialized Operations Manager for the serial numbers in this lot. exp_date
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 in a row to export the serial numbers for that Packaging Code and Lot Number to a CSV file.

Response information when using the message status query service:

  • File Name – The name of the file received from the BPOM system.
  • Response Date – The date the response is received from the BPOM system.
  • Status – The status returned by the BPOM system for the submitted compliance report.
  • Status Code – The HTTPS code returned by the BPOM system for the submitted compliance report.
  • Description – The description returned by the BPOM system for the submitted compliance report.