Pending Changes

Track pending changes specific to attributes for the Application, Medicinal Product and Registration.

You can enable or disable the Pending Changes functionality through a configuration file located at \InSightManager \server\all\conf\insight\PendingChanges.json. Please contact our support representatives for configuration assistance.

You must have at least Write privileges for both RPT and PDM licenses to read, create, apply and remove Pending Changes.

Pending Changes tab is available on the Event Attributes page only for the following:

Procedure types: all EU procedure types.Note: Pending Changes are not available for EU CTR Procedure type. • Application types: Marketing Authorisation Application and the Marketing Authorisation Application - Animal Health.
Registration types: Package Set Registration.

You can delete or apply the pending changes from the Pending Changes tab before closing an event.

Once you close an event, Create, Apply and Delete Pending Changes options will be disabled.

If you choose Withdrawn or Not Approved status when closing an event, the changes will not apply and the associated attributes will no longer appear on the Pending Changes tab. The selected entity type will remain with the current values without any updates.

The following are the Pending Changes properties:


Entity	Description
Ap plication	To successfully apply all your selected changes in the Pending Changes wizard, you must close the Event with the Approved status. This will update the Procedure Type and Legal Status of Supply attributes for the Application and the Pending Change item list will disappear from the Pending Changes tab. The Procedure Type attribute is available only for EU National applications, allowing to change from EU National to EU MRP. For applications with other than EU National procedure type, the only pending change available is Legal Status of Supply.
Med icinal Product	To successfully apply all your selected changes in the Pending Changes wizard, you must close the Event with the Approved status. This will update the Pediatric Use Indicator and Full Indication Text attributes for the Medicinal Product and the Pending Change item list will no longer appear on the Pending Changes tab.
Full Product Presentation	To successfully apply all your selected changes in the Pending Changes wizard, you must close the Event with the Approved status. This updates the Full Product Presentation, Authorised Pharmaceutical Form, Authorization/ Renewal Date, Authorization Status, Full Product Name, Full Product Short Name, Information Date, Product Company Name, Product Form, Product INN/Common Name, Product Strength, XEVMPD Comments, Withdrawn/ Invalidated Date attributes and the Pending Change item list will no longer appear on the Pending Changes tab.Note: It is impossible to apply FPP using the Pending Changes tab if the following fields are populated with the same values as the other FPPs applied to the same registration: Concatenation of Full Product Name, EEA Country, Language, Package Description, Authorisation Status, Authorisation/Renewal Date, EVCode.
Entity	Description
Reg istration	To successfully apply all your selected changes in the Pending Changes wizard, you must close the Event with the Approved status. This will update the MAH/Organisation, QPPV, MFL, Subject to Additional Monitoring, Next Renewal Date, Last Renewal Date, License Status, License Status Date, Enquiry Email, Enquiry Phone Number, License Issue Date, Expiration Date/Registration Valid Until, Registered RTC attributes and the Pending Change item list will no longer appear on the Pending Changes tab.
Reg istration Package Set	To successfully apply all your selected changes in the Pending Changes wizard, you must close the Event with the Approved status. This will update the MAH/Organisation, Authrorisation Status, Authrorisation Status Date and Withdrawn Date attributes for the and the Registration Package Set and the Pending Change item list will no longer appear on the Pending Changes tab.
Reg istration Package Set Coun try	To successfully apply all your selected changes in the Pending Changes wizard, you must close the Event with the Approved status. This will update the Legal Status of Supply attributes for the selected entity type and the Pending Change item list will no longer appear on the Pending Changes tab.Note: This option is available for MRP or DCP applications only.