Ennov InSight Registrations 7.3

Create an XEVPRM ZIP File

You can use the XEVMPD Submission wizard to create the XEVPRM .zip file for submission to the EMA.

The XEVMPD Submission wizard is available only for users with xEVMPD license, and Write permissions for RPT (Registration Planning and Tracking), Product Detail Management (PDM), and Data Administration rights set to Yes or NO (both options are acceptable since Calyx RIM 7.0.1 release) and Write permission for XEVMPD Wizards.
You can access the XEVMPD Submission wizard from the Wizards menu or from I Am Looking To > Create New > XEVMPD Submission.
To create your XEVPRM .zip file:
  1. Select the Wizards > XEVMPD Submission.
  2. On the Select Sender/Receiver Information page:
    1. Select a Sender (menu with active values from Data Administration > Message Sender Values).
    2. Select a Receiver (menu with two predefined by system values - EVTEST and EVHUMAN).
  3. Click Next.
  4. On the Authrorized Product Selection page, select or enter the search criteria and click Next.
    Click Next to show all the authorized products without the search criteria selection.
  5. Make a selection on the Authrorized Product Search Results page.
  6. Click Next.
  7. On the Authrorized Product Attachment Results page, see the list of attachments if exist.
  8. Click Next.
  9. On the Create XEVPRM Confirmation page, select the location where your XML file is saved.

    The system can save your file to the predefined location. If the Location for XEVMPD Submission field is set correctly during the server setup, then after selecting Next on the Create XEVPRM Confirmation page, the generated Submission XML file will be saved to that location. The predefined location is selected by default on the Create XEVPRM Confirmation page. The information about the predefined location must be included in insight.var file. If you need to save your file to a folder other than the default, you can change the location manually.

    This option is applicable to the following DMS repositories:
    • File System
    • Documentum

    Use Browse to chose the location. Use Clear to clear the location.

    Note: If your predefined location is other than File System and you are logging on to the DMS, you will be required to enter your DMS credentials.
  10. Click Next.
  11. On the Create XEVPRM Summary page:
    1. A message to confirm the generation of XEVPRM .zip file is displayed.
    2. Click the hyperlink to save the XEVPRM .zip file to your desktop.
    3. After the XEVPRM .zip file is saved, click Finish.
    You can now submit the XEVPRM .zip file to EMA.