Generate EU Commission - Product Pack Data Report

Overview

Access this screen from the left panel under Event Workflow.

Manually generate a Commission - Create Product Pack Data report to send information to the EU Hub 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).

Compliance reports capture information about regulated activities, helping companies comply with requirements in the EU. They can be configured to generate automatically when certain events occur in TraceLink (e.g. commissioning serial numbers, updating a serial number's status, raising shipments), but may need to be generated manually if certain reports are incomplete or inaccurate.

If the serial numbers specified were already reported, Serialized Operations Manager generates an additional report only if the EU Hub did not successfully receive the original report (i.e. the report has a status of Submitted, Invalid, or Distribution Failed) or if a Target Market that requires the report was added in Product Master Data after the original report was sent.

Getting Started

When scanning, entering, or uploading a file to populate serial numbers, each number must be:

  • On a separate row.
  • Without any special characters.
  • In one of the formats below:

Used for:

  • Items
  • Innerpacks
  • Bundles
  • Cases and Shippers

The format is the AI(01)(21) serial number in barcode format:

  1. First is the 01 Application Identifier
  2. Followed by the GTIN-14 number
  3. Followed by the 21 Application Identifier
  4. Followed by the serial number

    Example: 010088202401033921725368249416

Used for:

  • Pallets
  • Mixed cases

The format is the AI(00) serial number in barcode format:

  1. First is the 00 Application Identifier
  2. Followed by the SSCC-18 code

    Example: 00008820200000050254

Used for:

  • Items
  • Innerpacks
  • Bundles
  • Cases and Shippers

The format is the full 20-digit China serial number, as in this example: 81102302020117515452

Watch how to preserve leading zeros!

Option 1: Specify Item Code and Lot Number

  • Item Code - Country Drug Codes and/or Internal Material Numbers for products in Master Data. Format of each option is:
    • [Packaging Code Type] [Packaging Code] for China
    • [Item Code Type] [Item Code] for EU and India
  • Lot Number - The number associated with the Packaging Item Code, Country Drug Code, or Internal Material Number, which identifies the serial numbers for the report.

Option 2: Specify Serial Numbers

  • Serial Numbers - The serial numbers of the product included in the report.
    • Scan Serial Numbers – Scan or type the serial numbers in the text box.

      Maximum of 30,000 characters.

    • Upload Serial Numbers From File – Upload a file with the serial numbers.

      The file must include only the serial numbers, no headings. Limit of one file per session. File size limit is 50 MB.

Available Actions

    The Show Data From drop-down does not impact the reports generated under Event Workflow Management.

  1. Select the Option 1 - Specify Item Code and Lot Number radio button.
  2. Enter an Item Code in the type-ahead field.

    The product description displays under the field.

  3. Enter a Lot Number in the text field.
  4. Select the Submit button.

    A confirmation message displays.

    The report displays in the Compliance app once complete. Depending on the size of the report, processing may require a few minutes. Processing errors display in Info Exchange.

    The Show Data From drop-down does not impact the reports generated under Event Workflow Management.

  1. Select the Option 2 - Specify Serial Numbers radio button.
  2. Enter the Serial Numbers by selecting one of the following:

    • Select Upload Serial Numbers from File:
      1. Select the Choose File button.
      2. Browse for and select the desired CSV file.

        The CSV file cannot contain headers.

    • Select Scan Serial Numbers:
      • Enter the serial numbers in the text field.

        or

      • Scan the serial numbers in the text field with an Edge device.

  3. Select the Submit button.

    A confirmation message displays.

    The report displays in the Compliance app once complete. Depending on the size of the report, processing may require a few minutes. Processing errors display in Info Exchange.

Error Messages

Errors either display at the top of the screen or are found in Info Exchange (may vary):

Error Message Description
Lot <lotnumber> for item <item code type> <item code value> does not exist. TraceLink cannot find a matching lot number.
Serial numbers from multiple products/lots were entered. All serial numbers must correspond to the same product lot. The serial numbers belong to more than one lot.