Calyx RIM for Registrations

Full Product Presentation Creation Features

  • If Full Product Presentation required properties are not populated with valid data, a message is displayed and 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.
  • Family Code, Family Name, 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 withing a Registration.
  • Use Reference Ingredient for XEVMPD provides you with an ability to choose if you want the reference active ingredient attached to active ingredient information or reference strain data (for a Flu Vaccine) attached to strain to be placed to the XML file instead of active ingredient information or strain (for a Flu Vaccine). The default value is No when active ingredient does not have references or strain (for a Flu Vaccine) does not have reference strains data, and Yes if active ingredient or strain (for a Flu Vaccine) do have at least one reference active ingredient or reference strain (for a Flu Vaccine).
  • EV Code and Date Submitted to EMA remain blank during the Full Product Presentation creation process. These fields will be populated automatically when the XEVMPD Acknowledgement Wizard is completed. The Last Updated Date will appear 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, like Norway, Iceland, or Liechtenstein. To be included to 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Note: The Package Sets multi-select field will not display package sets with the status Withdrawn.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 on the create screen until the value for the PSet field is chosen. The value still can be modified manually.