How-Tos

Owners must configure Event Workflows in order for reports to generate and display in the EU Compliance app.

1. Hover over Compliance on the Modules menu in the upper left, and then select European Union.

   The Search Compliance Reports screen displays.

2. Select the blue arrow to the left of the "Search Criteria" section to reveal the search fields.
3. Select one or more of the following search fields:
   • Service Publisher - The Owner that sent the report to the European Union Hub.
   • Report Type - The type of compliance report, indicated by the following options:
     • All (default)
     • Active - Update Product Pack State - Reports that are sent to the EU Hub when a product that has been previously reported as Exported, Supplied, Free Sample, Sample, or Locked is moved to the Active state.
     • Batch Recall - Reports that are sent to the EU Hub and the National System's response when a Batch Recall is submitted.
     • Checked Out - Update Product Pack State - Reports that are sent to the EU Hub when products are decommissioned due to a repackage event.
     • Commission - Create Product Pack Data - Reports that are sent to the EU Hub when a product pack is distributed in the EU market.
     • Update Product Pack Data - Reports that are sent to the EU Hub when the Pharmaceutical Manufacturer amends a previously reported Lot Number or Expiration Date for serialized products.
     • Destruction - Update Product Pack State - Reports that are sent to the EU Hub when a previously commissioned product is destroyed or decommissioned.
     • Export - Update Product Pack State - Reports that are sent to the EU Hub when a previously reported product is shipped to a country outside of the EMVS Target Market country list.
     • Free Sample - Update Product Pack State - Reports that are sent to the EU Hub when a previously reported product is given away as a free sample.
     • Locked - Update Product Pack State - Reports that are sent to the EU Hub when a previously reported product is Under Investigation.
     • Product Master Data (Create) - Reports that are sent to the EU Hub when the Product Master Data for the product is created.
     • Product Master Data (Update) - Reports that are sent to the EU Hub when the Product Master Data for the product is updated in any way.
     • Sample - Update Product Pack State - Reports that are sent to the EU Hub when a previously reported product is sampled by government authorities.
     • Serial Number Verification - The EU Hub's response to the Serial Number Verification Request.
     • Stolen - Update Product Pack State - Reports that are sent to the EU Hub when a previously reported product is stolen.
     • Supplied - Update Product Pack State - Reports that are sent to the EU Hub when a previously reported product is shipped with an Article 23 Supply Type.
   • Status - The status of the compliance report:
     • All (default)
     • Generated - Reports that have been created and sent to the EU Hub.
     • Submitted - Reports that have been submitted and the EU Hub has confirmed as received.
     • Submit Failed - Reports that have been created, sent to the EU Hub, and failed to receive a response.

       TraceLink attempts to send a Generated report to the EU Hub 5 times in a 15-hour period. The report fails and remains in the Submit Failed state if no response is received on the fifth attempt.

     • Valid - Reports to which the EU Hub has responded that the data submitted is valid.
     • Invalid - Reports to which the EU Hub has responded that the data submitted has issues.
     • Loaded - Reports that the EU Hub has processed and accepted.
     • Distributed - Reports in which content has been distributed to the national systems.
     • Distribution Failed - Reports where the EU Hub was unable to distribute data to national systems.
     • Success - Batch Recall and Update Product Pack State reports that have been validated by the EU Hub and successfully distributed to the National System.
     • Failed - Batch Recall and Update Product Pack State reports that have been validated by the EU Hub but failed to be distributed to the National System. See Troubleshooting for more information.
     • Partial - Batch Recall and Update Product Pack State reports that have been validated by the EU Hub but partially failed to be distributed to the National System. See Troubleshooting for more information.
   • Company - Location - An Owner's location (use to refine results).
   • Date Type - The type of date to search for:
     • Report Date - The date on which reports were sent.
     • Response Date - The date on which the EU Hub acknowledged receiving the compliance report.

   • Date On Or After (GMT) - Reports that occurred on or after this date.

     Default value is one day prior to the current GMT date.

   • Date On Or Before - Reports that occurred on or before this date.

     Default value is the current GMT date.

   • Advanced Options - Options to refine results further:
     • Packaging Code and Keywords - The GTIN or NTIN code.
       • Packaging Code - Reports that contain the entered Packaging Code.
       • Keywords - Reports that contain the entered Keywords, including Lot Number.
     • Serial Number - Format is AI(01)(21) without the parenthesis.

       Only exchanges that contain that exact serial number display.

     Be aware of the following:

     • The search is not case sensitive.
     • Use an asterisk (*) wildcard only for single terms, rather than quoted phrases.
     • The search results include all entered words by default (i.e. an AND operator is implied).
     • Enter "OR" between words to search for one word or another.
4. Select the Search button.

   The results display in the table.

• Select the View Report Details link in the Actions column of the results table for more report information.

• Select the View Transaction Details link in the Actions column of the results table to view and download the message in Info Exchange.

• Select the Export Results to CSV link to download the results table as a CSV file.

1. Hover over Compliance on the Modules menu in the upper left, and then select European Union.

   The Search Compliance Reports screen displays.

2. Select the Request Verification button.

   The Request Serial Number Verification screen displays.

3. Specify Product Identifier Information by selecting one of the following:
   • Select Scan Data Matrix Bar Codes and scan serial numbers into the text field.

     Barcode must include [GTIN] [Serial Number] [Lot Number] [Expiration Date], and the scanner must support the ASCII-232 character as well as the ASCII-29 or ASCII-173 characters.

   • Select Upload From File:
     1. Select the Choose File button.
     2. Browse for and select the desired CSV file. Format is the human-readable barcode, including the delimiter ASCII characters (e.g. [Delimiter] [Product Code] [Serial Number] [Delimiter] [Lot Number] [Delimiter] [Expiration Date]).

        The file type must be .csv or .txt, cannot contain headers, and product information must be in a single column, one per row with no commas.

   • Select Enter Information and enter the following product information:

     Enter the product information only, omitting any delimiter ASCII characters.

     1. Product Code - The product code value (e.g. 04425678663894).
     2. Serial Number - The serial number associated with the product.
     3. Lot Number - The lot or batch number associated with the serial numbers.
     4. Expiration Date - The batch expiration date of the serialized items in the lot.
4. Select the Submit button.

   The Search Compliance Reports screen displays with the confirmation message "Your request for serial number verification has been submitted to the EU Hub."

Search for the response on the Search Compliance Reports screen.

1. Hover over Compliance on the Modules menu in the upper left, and then select European Union.

   The Search Compliance Reports screen displays.

2. Select Search Information Requests from the Go To: drop-down in the upper right.

   The Search Information Requests screen displays.

3. Select the blue arrow to the left of the "Search Criteria" section to reveal the search fields.
4. Select one or more of the following search fields:
   • Report Type - The type of report.
     • Product Master Data Report - View the product and response information associated with the specific Master Data Report.
     • Pack Disclosure Report - View information about a specific EU Hub alert and its cause.
     • EU Alert Report - View a list of EU Hub alerts received during a certain time period.
   • Created On Or After (GMT) - Reports that occurred on or after this date.

     Default value is one week prior to the current GMT date.

   • Created On Or Before - Reports that occurred on or before this date.

     Default value is the current GMT date.

5. Select the Search button.

   The results display in the table.

Request a Pack Disclosure report to receive information about a specific EU Hub alert and its cause.

1. Hover over Compliance on the Modules menu in the upper left, and then select European Union.

   The Search Compliance Reports screen displays.

2. Select Search Information Requests from the Go To: drop-down in the upper right.

   The Search Information Requests screen displays.

3. Select the Request Information Report button.

   The Request Information Report screen displays.

4. Select Pack Disclosure from the Report Type drop-down.
5. Enter the Alert ID from the EU Hub Alert report in the text field.
6. Select the Submit button.

   The Search Information Requests screen displays with the confirmation message "Your information request has been submitted to the EU Hub. You will be able to download it from the table below when it is available."

Request a Product Master Data report to receive product and response information from the EU Hub.

1. Hover over Compliance on the Modules menu in the upper left, and then select European Union.

   The Search Compliance Reports screen displays.

2. Select Search Information Requests from the Go To: drop-down in the upper right.

   The Search Information Requests screen displays.

3. Select the Request Information Report button.

   The Request Information Report screen displays.

4. Select Product Master Data from the Report Type drop-down.
5. Select a Data Scope from the radio buttons.
   • All Products - Request data from all products that have been reported to the EU by the user's company.
   • Specific Product - Request data about a specific Packaging Code or Internal Material Number.
6. Enter the Country Drug Code or Internal Material Number for the product in the Item Code type-ahead field (required if requesting the report for a Specific Product).
7. Select the Submit button.

   The Search Information Requests screen displays with the confirmation message "Your information request has been submitted to the EU Hub. You will be able to download it from the table below when it is available."

Search for the submitted Information Request on the Search Information Requests screen.

Create an EU Alert Report to view alerts sent from the EU Hub during a certain time period. EU Hub alerts notify recipients to potential issues with serialized products, raised by the NMVS.

1. Hover over Compliance on the Modules menu in the upper left, and then select European Union.

   The Search Compliance Reports screen displays.

2. Select Search Information Requests from the Go To: drop-down in the upper right.

   The Search Information Requests screen displays.

3. Select the Request EU Alert Report button.

   The Request EU Alert Report screen displays.

4. Select the Date On Or After (GMT) from the date picker to specify the start date for the alerts.

   Default value is one day prior to the current GMT date. Maximum date range is 31 days.

5. Select the Date On Or Before (GMT) from the date picker to specify the end date for the alerts.

   Default value is the current GMT date. Maximum date range is 31 days.

6. Select the following fields to narrow the alerts included in the report (optional):
   • Product Code - The product specified in the alerts.
   • Lot Number - The lot or batch specified in the alerts.
   • Target Market - The country whose national system raised the alert.

     Enter "Hub" to include alerts that were raised by the EU Hub, rather than the NMVS for a specific country.

7. Select the Submit button.

   The Search Information Requests screen displays with the confirmation message "Your report is being created. You will be able to download it from the table below when it is available."

Search for the generated EU Alert report on the Search Information Requests screen.