EU Certification Conformance Test

• Select EU Certification Conformance Test from the Management landing page.
• Expand the Management Navigation in the header of any screen, and select EU Certification Conformance Test.

To help TraceLink customers facilitate their EU Certification, this screen offers a simple way for Managers to send reports with test data to the European Medicines Verification Organisation's (EMVO) Quality Environment (IQE) where the data is verified for EU Certification. The EU Certification Conformation test can be run for initial certification or, in the event EMVO updates the requirements, for re-certification conformance testing.

The IQE Hub Portal displays the received reports as either Passed or Failed indicating if the data they received complies (i.e. conforms) to the EMVO standard:

• If the data displays as Passed, submit the results for EMVO approval.
• If the data displays as Failed, then follow-up action may be necessary to obtain certification.

• The TraceLink iTest account must be configured to point to the IQE environment in the EU Hub for the test to succeed. Test this connection to the EU Hub by selecting the Test Hub Connectivity icon on the on the Applications screen.

Contact a TraceLink representative for help with this configuration.

• The TraceLink user running the test must be a Manager.

• Product Code 1 – The unique GTIN or NTIN value (including the valid check digit) that identifies the product (e.g. NTIN 04425678663894).
• Product Code 2 – The unique GTIN or NTIN value (including the valid check digit) that identifies the product (e.g. NTIN 04425678663895).
• My company is registered as a Parallel Distributor with EMVO – Includes additional data in the reports, required for Parallel Distributors in the EU.

  Select this checkbox only if the company is a Parallel Distributor.

1. Ensure connectivity to the EU Hub by selecting the Test Hub Connectivity icon on the Applications screen before running the Conformance test.
2. Select EU Certification Conformance Test on the Management landing page.

The EU Certification Conformance Test screen displays.

3. Enter the 14-digit unique Product Code 1 in the first text field.
4. Enter the 14-digit unique Product Code 2 in the second text field.
5. Select the My company is registered as a Parallel Distributor with EMVO checkbox if the company is a Parallel Distributor.
6. Select Submit.

   The test messages may take several minutes to process.

   The following confirmation message displays, "Your Product Codes have been submitted to the EU Hub for conformance testing. Navigate to Info Exchange to confirm that you received the response messages from the EU Hub."

7. Go to Info Exchange to confirm 4 successful Batch Recall Responses display Success-Processed, which indicates that all of the test messages were successfully accepted by EMVO.

   Go to the IQE Test Status Metrics in the OBP (On Boarding Partner) Portal within 30 minutes of running the tests.

8. View the testing results in the EMVO IQE Hub.
   • If the data displays as Passed, submit the results for EMVO approval.
   • If the data displays as Failed, then follow-up action may be necessary to obtain certification.