Full Product Presentation Criteria

Ennov InSight presents detailed criteria about the Full Product Presentation.

• If Full Product Presentation required properties are not populated with valid data, the entity is not created.
• Full Product Short Name, Product INN/Common Name, Product Company Name, Product Strength, Product Form are case sensitive fields.
• The only required field is Full Product Name. Other fields are optional.
• Application Code, Application Name, and License Code are already populated by the system in display mode.
• The concatenation of Full Product Name, EEA Country, Language, Package Description, Authorisation Status, Authorisation/Renewal Date, and EV Code must be unique within a Registration.
• EV Code and Date Submitted to EMA remain blank during the Full Product Presentation creation process. These fields are populated automatically when the XEVMPD Acknowledgement Wizard is completed. The Last Updated Date appears when all changes are made.
• Message Sender field remains blank during the creation process. When the XEVMPD Submission Wizard passes, this field is updated automatically.
• For the XEVMPD Submission Wizard, in the Authorised Product XEVMPD section, when an Application has one of the EU CP (Centralised Procedure) Types (e.g. EU CP Bio) selected, you can send the XEVMPD submission specific for EEA Countries, such as Norway, Iceland, or Liechtenstein. To be included in the XML file, Norway, Iceland, or Liechtenstein should also be selected in the EEA Country field. Otherwise, the Country from the PSet (Package Set) Registration is added to the XML file.

Note: The Package Sets multi-select field will not display package sets with the status Withdrawn. It displays the full list of assigned to the Registration Product Sets for each Full Product Presentation creation. The Package

Description field is not displayed until the value for the PSet field is chosen. The value can be modified manually.