Copy Full Product Presentations

In the Copy Full Product Presentation wizard, you can copy a Full Product Presentation under the same Registration, or under different Registration(s).

Note: You must have at least Write permissions for the Full Product Presentation (FPP) in Entity Security section to copy Full Product Presentations.Some fields of the source Full Product Presentation (FPP) are not copied:

Full Product Presentation under the same Registration flow Full Product Presentation under different Registration(s) flow
The XEVMPD Marketing Authorisation Number, XEVMPD MAH/Organisatiom, and Date Submitted to EMA values are automatically assigned once the XEVMPD Submission wizard is completed. The XEVMPD Marketing Authorisation Number, XEVMPD MAH/Organisatiom, and Date Submitted to EMA values are automatically assigned once the XEVMPD Submission wizard is completed.
The EV Code value is not copied. The Previous EV Code value from the FPP Previous EV Codes tab and EV Code values are not copied.
The Local Code value that is hidden on the Full Product Presentation Attributes page. The Local Code value is not copied. This attribute is hidden on the Full Product Presentation Attributes page.
Full Product Presentation under the same Registration flow Full Product Presentation under different Registration(s) flow
The Message Sender field is read only and is automatically updated with data when the XEVMPD Submission Wizard passed. Not available on the Create page. The Message Sender field is read only and is automatically updated with data when the XEVMPD Submission Wizard passed. Not available on the Create page.

The following features apply to the copied full product presentation (FPP):

Full Product Presentation under the same Registration flow Full Product Presentation under different Registration(s) flow
The Last Updated Date value is populated with the date of the copy action. The Last Updated Date value is populated with the date of the copy action.
The Previous EV Code value is copied and appears on the FPP Previous EV Codes tab with the data from source Full Product Presentation. The Package Sets and Package Set Description fields will have the Package Set Name values of the selected Registration.

The following features apply to the copied Registration FPP Attachment, if the Full Product Presentation you are copying has it assigned and you have selected Yes on the Copy Registration FPP Attachment page of the Full Product Presentation under different Registration(s) flow:

  • The Attachment and Validity Declaration values are populated with the appropriate Registration FPP Attachment values of the source Full Product Presentation.
  • The Registration FPP Attachment Concerned Parties and Registration FPP Attachment Comments values are not copied.

Wizard NavigationThe Copy Full Product Presentation wizard consists of:

  • Select wizard flow > Select the flow for the Full Product Presentation copy you would like to perform:

◦ Full Product Presentation under different Registration(s)

◦ Full Product Presentation under the same Registration

  • Copy Full Product Presentation:

◦ Select Registration(s) under which you would like to copy Full Product PresentationNote: Available only for the Full Product Presentation under different Registration(s) flow.

◦ Copy Full Product Presentation Attributes

◦ Copy Registration FPP AttachmentNote: Available only for the Full Product Presentation under different Registration(s) flow.

  • Summary