Commission - Create Product Pack Data

If the Manufacturer Information section does not display, refer to Commission - Create Product Pack Data (Legacy) as this topic reflects the newer version of the screen.

The European Medicines Verification System (EMVS) introduced a change in the contents of Commission Product Pack and Product Master Data reports. These changes are not backwards compatible. The original version of the reports (called "Legacy" reports within this documentation) are no longer accepted as of 24 Jul 2017. Any reports that generate after 24 Jul 2017 must comply with the new report content specification. Customers who implemented EU Compliance and were submitting reports prior to this date will have the legacy version and the new version of reports in the TraceLink Network. The "View Report Details" screens will display the appropriate content based on whether report is a legacy or new report.

Overview

Select the View Report Details link for a Commission - Create Product Pack Data report in the Actions column of the table on the Search Compliance Reports screen.

  • View the Product Pack report that was sent to the EU Hub.

    Commission - Create Product Pack Data reports capture information about serialized items that are about to be introduced into the EU supply chain (e.g. when items are released, sold, or transferred within the EU or when an end of batch occurs).

    Reports generate automatically when certain events occur in TraceLink or manually when a user initiates the report through Serialized Operations Manager.

  • Confirm that the EU Hub received the report successfully, and troubleshoot issues.

Getting Started

The entity that submits the report must be the owner of the product. Owners must enable Event Workflows to generate the report.

See Configure Event Workflows and Event Triggers for more information.

Report Information

  • Section Title - "Report Information for [Owner], [Company-Location]"
    • Owner - The Owner that sent the report to the European Union Hub.
    • Company - Location - The Owner's location. Format is [Company Name] or [Company Name] - [Location Name].
  • Report Date - The date that the report is generated. Format is [DD] [Mmm] [YYYY] [HH]:[MM] [AM/PM] GMT by [Name] of [Owner Company Name] via Info Exchange (displays as a link that leads to the corresponding View Transaction Details screen in Info Exchange).
  • Report Type - Displays the type of report.
Report Information for Kendall Pharma, Kendall Pharma-North Reading
Report Date   19 Jan 2017 2016 08:38 PM GMT by Sally Goodwell of Kendall Pharma via Info Exchange
Report Type   Product  Master Data (Create)

Commission Information

This section displays the following information:

Field Field Description Sourced From
Product code The product code value (e.g. 04425678663894). GTIN or NTIN associated with the serial number at the point of commission.
Description The Product Description associated with the Product Code. Product Master Data > Item Information > Product Description where language code is "English."

Not included in the EU report.

Lot Number The lot or batch number associated with the serial numbers being reported.
  • Lot Number included in the commissioning event data associated with the serial number(s).

    or

  • Lot Number specified in a Serialized Operations Manager Update Lot event, if one occurred prior to an additional commissioning event for the lot.
Expiration Date The batch expiration date of the serialized items in the lot. Format reported to the EU is YYMMDD.
  • Expiration Date included in the commissioning event data associated with the serial number(s).

    or

  • Expiration Date or Barcode Expiration Date specified in a Serialized Operations Manager Update Lot event, if one occurred prior to an additional commissioning event for the lot.

    If a Barcode Expiration Date is specified in the Update Lot event, TraceLink reports this value instead of the Expiration Date. The Barcode Expiration Date indicates that the expiration date on the lot's packaging is different from the Expiration Date on record in TraceLink.
Package size / Spec The number of individual doses in the pack. Format is numeric only, e.g. if there are 100 pills in the bottle, the Package Size/Spec is 100. Product Master Data > Item Information > Package Size/Spec where the Item Information language code is "English."
Quantity The quantity of serial numbers included in the EU report. The sum of all the serial numbers at the each packaging level associated with the product code or lot.

Not included in the EU report.

Original Product Code The original product code before the repackaging event.

Displays only if items were repackaged.

 The packaging code specified in the repackage event.
Original Lot Number The product's original lot or batch number before the repackaging event.

Displays only if items were repackaged.

 The Lot Number specified in the repackage event.
Download Serial Numbers A list of serial number components for the serialized product that is reported to the EU Hub. Only the highlighted segments of the following AI(01)(21) formatted serial numbers are reported: 0100882026030229217A15K05FE8207BU2.

The Download Serial Numbers file displays serial number information in the same way as reported to the EU Hub, with just the serial number components.

All serial numbers at the each packaging level in the TraceLink repository associated with the Product Code and the Lot Number that are in the commission/available state.
Product Code GTIN14 0088202030229 Expiration Date 31 Mar 2019
Description ALLERGY MED 90 MG CAPS 30 Quantity 5
Lot Number CT_Lot_EU   Download Serial Numbers
Package Size/Spec 30 Original Product Code --
    Original Lot Number --

Manufacturer Information

This section displays the following information:

Field Field Description Sourced From
ID Manufacturer ID does not populate. See Name and Address fields below for Manufacturer information.  
Name The company name of the Marketing Authorized Holder (MAH) or the Manufacturer (CMO).
  • If a MAH is selected, Company Master Data > Address
  • If a CMO is selected, Partner Master Data > Address
Address The address of the Marketing Authorized Holder (MAH) or the Manufacturer (CMO).
  • If a MAH is selected, Company Master Data > Address
  • If a CMO is selected, Partner Master Data > Address
ID   Address 16 Robinson Way Suite
      Suite 77B West
Name Thomas Stanley Schwartstein, LLC   Boston, MA 02114
      U.S.

Response Information

This section displays the following information:

  • Response Received - The date that a response message was received from the EU Hub. Lists the date and time for each response that is received. Format is [DD] [Mmm] [YYYY] [HH]:[MM] [AM/PM] GMT by Info Exchange ("Info Exchange" displays as a link that leads to the corresponding View Transaction Details screen in Info Exchange).

  • Status - The processing and distribution status of the report from the EU Hub to the National System.

  • Error Code - Displays if the EU Hub finds the report invalid.

    For specific error code descriptions see Troubleshooting.

  • Error Description - Description of the Error Code from the corresponding column.

Response Received Status Error Code Error Description
30 Mar 2016 03:21 PM GMT by Info Exchange DISTRIBUTION_FAILED #A18 Distribution Rejected By National System
30 Mar 2016 03:21 PM GMT byInfo Exchange VALID -- --

Available Actions

  • Select the Download Serial Numbers link in the Commission Information section.

    A CSV file downloads. See Troubleshooting for guidelines on opening TraceLink CSV files.

Supplemental Information

Review the error codes below for troubleshooting information:

Error Code Error Description Troubleshooting Information
#A1 Product Not Found The requester tried to create or update packs for a product that does not exist. The request is rejected.
#A2 Batch Not Found The requester tried to update packs for a product batch that does not exist. The request is rejected.
#A8 Pack Expired The requester tried to create packs with an expiry date in the past or update packs to have an expiry in the past. The request is rejected.
#A16 Data Validation Error The format of the request was invalid. The request is rejected.
#A22 Market Not Found A market for which this product was configured is no longer associated with the EMVO. The pack data can never be delivered.
#A32 Duplicate Serial Number The requester tried to create a pack that already exists. The request is rejected in all markets that where the pack exists.

This may leave the national systems in an inconsistent state. It is the responsibility of the requester to submit the appropriate requests to correct the state.
#A52 Expiry Date Mismatch The update of the product batch supplied an original expiry data that does not cross check with the existing expiry date. The request is rejected.
#A54 Insufficient Randomisation of Serial Numbers The requester tried to upload packs with serial numbers that the EMVO considers insufficiently random. The request will be processed, but the EMVO administrators will be alerted to the issue.
#A64 Pack Level Errors There are errors associated with individual packs.
#S10 Request Not Authorized The requester tried to update data they are not entitled to change. The request is rejected. EMVO administrators will be alerted to the issue.
N/A Commission Product Pack Report can not generated for [PackagingCodeType] [PackagingCode] because manufacturer details was not available in pack commission data and manufacturer information could not obtained from product master data in a deterministic way The Manufacturer Information is not available in Product Master Data. The request is rejected. Error message displays in Info Exchange service.