Copied Full Product Presentations and Registration FPP Attachments

You can copy a Full Product Presentation assigned to the Registration being copied, if the security permissions are set correctly in the Security Administration > Entity Security Section and you select Yes for the Copy Full Product Presentation field in the wizard.

The following table describes the copied Full Product Presentation fields that are copied, populated with specific values, and not copied from the source Full Product Presentation:

Fields that are populated with values from the source Full Product Presentation Fields that appear blank Fields that are populated with specific values
  • EEA Country
  • Full Product Name
  • Full Product Short Name
  • Product INN/Common Name
  • Product Company Name
  • Product Strength
  • Product Form
  • Formulation Part
  • Intended Use Part
  • Target Population Part
  • Container or Pack Part
  • Device Part
  • Time Period Part
  • Flavour Part
  • Language
  • CountriesNote: For the applications of

National, Mutual Recognition (MRP), or Decentralised (DCP) Procedure types.

  • Authorisation Status
  • Authorised Pharmaceutical Form
  • Authorisation/Renewal Date
  • Withdrawn/Invalidated Date
  • Information Date
  • XEVMPD Comments
  • Special Measures
  • XEVMPD

Marketing Authorisation Number

  • XEVMPD MAH/Or­

ganisation

  • Previous EV Code
  • Local Code
  • EV Code
  • Date Submitted to

EMA

  • Message Sender
  • Full Product Presentation Concerned Parties
  • Full Product Presentation Keywords
  • Full Product Presentation Description
  • Full Product Presentation Comments
  • Package Sets field is set to the value selected in the Select Package Set(s) > Package Set field.
  • Package Description field is set to the value selected in the Select Package Set(s) > Package Set field.
  • Last Updated Date field is set to today's date

If there is at least one Registration FPP Attachment under Full Product Presentation assigned to the Registration being copied, and you selected Yes for the Copy Full Product Presentation field, it is copied as well:

  • Attachment Name and Validity Declaration fields appear with the value from the source Registration FPP Attachment
  • Registration FPP Attachment Concerned Parties and Registration FPP Attachment Comments fields appear blank