Creating an XEVPRM ZIP File

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

1. Choose WIZARDS > XEVMPD Submission (or Create a New - XEVMPD Submission).
2. On the Select Sender/Receiver Information page:
   1. Select a Sender (drop-down menu with Active Message Sender Name Values from Data Administration).
      The Authorised Product section is filtered by Sender value. The value is automatically filled by the system with the Full Product Presentation entity Message Sender field the first time it is used in the wizard. Values with a blank Message Sender field, and Marketing Authorisation values with the Sender field selected in the Full Product Presentation entity, are available when you select the Authorised Product section.
   2. Select a Receiver (drop down menu with two predefined by system values - EVTEST and EVHUMAN).
3. To proceed, click Next.
4. On the Select XEVPRM Sections page, select one or more of the available XEVMPD sections:
   • Organisation
   • Source
   • Master File Location
   • ATC
   • Pharmaceutical Form
   • Route of Administration
   • Authorised Product
   If there are validation errors associated with your selected XEVPRM Sections, the system displays messages describing the errors.
5. To proceed, click Next.
6. Do the following:
   1. Specify search criteria for the selected XEVPRM properties.
      Depending on the XEVPRM properties selected, additional filters may appear for defining your search.
   2. The wizard guides you through criteria selection according to the XEVPRM properties you selected.
      Display Columns is the only required search criteria field for all section properties. All other criteria are optional.
7. To proceed, click Next.
8. On the Search Results page:
   • Organisation name, Source name, Master File Location Company, ATC Code, Pharmaceutical Form name, Route of Administration name, and Authorisation Number are hyperlinks. You can click on the name and modify the data in the pop-up window.
   • The columns can be sorted, refreshed, and exported to Excel.
   • You can correct the errors by clicking on the hyperlinked name of the section and correct the fields that resulted in validation errors. After correcting the field, refresh the pop-up window. If there are errors with Attached data for Authorised Product, you need to exit the wizard and fix the data.
9. To proceed, click Next.
10. On the Create XEVPRM Confirmation page:
    1. Please enter a name: You can accept the system-generated name in this field, or enter a new name for XEVPRM message to be saved.
       In the following image, XEVPRM_20141210085118 is a system-generated name.

       Warning: Avoid using special characters in the name field, such as: \ or / or &
    2. Output location: Specify the location where the message will be saved. Select the document management system or file share from the list and browse to choose the specific location in your system. Select the location, and then click OK.
       
       Note: The system has an ability to automatically save a file to a predefined location during the server setup, then after selecting Next button on the Create XEVPRM Confirmation screen generated Submission XML file will be saved to that location. You can change the location using the Browse button. If your predefined location is other than File System and you are logging on to a DMS, a pop-up message will prompt you to enter your credentials.
11. To proceed click Next.
12. On the Create XEVPRM Summary page:
    1. You can see the confirmation that the XEVPRM .zip file was generated successfully.
    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.