Ennov InSight Registrations 7.3

XEVMPD Acknowledgement Wizard

The XEVMPD Acknowledgement wizard enables you to upload the Acknowledgement XML file, received from the EMA, to Calyx RIM. The file contains EudraVigilance (EV) codes for updating the XEVMPD values.

Note: The file can be uploaded automatically if all the settings required for this process were configured during installation of the application server.

The XEVMPD Acknowledgement wizard can be invoked from the Calyx RIM Home Page menu bar or from the Update - XEVMPD Acknowledgement section in the I Am Looking To pane. The wizard is available only for users with XEVMPD License, RPT (Registration Planning and Tracking) and Product Detail Management (PDM) with at least Write permissions, Data Administration rights set to Yes or No (both options are acceptable since Calyx RIM 7.0.1 release), and at least Write permission for the XEVMPD Wizards.

Note: For the Registration FPP Attachment, the Validity Declaration field is automatically updated once the XEVMPD Acknowledgement wizard passes. If the Registration FPP Attachment is associated to the acknowledged Authorised Product, or the Registration FPP Attachment is created from a Registration Attachment that was previously acknowledged, the value assigned is Previous Copy was sent (1).

The XEVMPD Acknowledgement wizard enables you to upload XEVPRM files that were exported by an external system, using the Force XEVPRM Acknowledgement Import functionality.

Note: When a Message Sender from the XEVPRM file that you are uploading using the Force XEVPRM Acknowledgement Import functionality does not exist in the Calyx RIM system, then it is automatically created during the wizard execution. The Message Sender Name with a prefix [Inserted] and the Message Sender ID are added to the Data Administration section (Message Sender Values under Other Maintenance).

For 3rd Acknowledgement type files only, the system automatically checks EV codes that have been entered by the EMA into the <operationresultdesc> tag of the XML Acknowledgement File and puts the corresponding Entity Name in braces near it in the OPERATION_RESULT_DESCRIPTION database column, if the entity with such EV code exists in the system. Otherwise, the EV code is followed by Not Defined in braces. For example:

  • Added: Authorised Pharmaceutical Form [PHF00010MIG { Collodion} ]
  • Added: Authorised Pharmaceutical Form [PHF00001MIG { Not Defined } ]

The XEVMPD Acknowledgement wizard enables you to automate the inactivation of registration attachments once the corresponding acknowledgment has been received.

Note: Verify that the following value exists in the insight.var file: xevmpd.message.import.inactivate.attachment=true.