Post-Migration Script Updates for Calyx RIM 6.2 CHF 3

The migration script will perform multiple changes to the Data Administration. Following are the set of changes:

  • JO-1-0 Assembly DTD /Schema type will be added to the Assembly > Assembly DTD/Schema Types section in Data Administration section, if it does not already exist.
  • The Application Maintenance > Country Values section of Data Administration will be updated to set the value for the eCTD Code for the Jordan country.
  • A procedure type value JO-National will be created in the Application Maintenance - Procedure Type Values section.
  • Existing associations to application procedure type will be deleted for each of the Jordan country and will be associated to JO-National procedure type.
  • Existing associations to application types for Jordan country will be deleted and will be associated to the CTA and NDA application types.
  • Filing Type Values will be added to the Sequence Maintenance > Filing Type Values section in Data Administration, if they do not already exist.
    • ASMF Filing
    • Biological Allergen
    • Biological Bio-similar
    • Biological Blood Product
    • Biological Drug
    • Biological Vaccine
    • CEP Submission
    • Extension Filing
    • Generics
    • Generic Narcotics
    • Generic Vitamin Drug
    • Herbal Drug
    • MAA - Originator Drug
    • MAA - Originator Vitamin Drug
    • New Drug
    • New Narcotics
    • New Vitamin Drug
    • None
    • Notification with pricing
    • Notification without pricing
    • Originator Narcotics
    • Periodic Safety Update Report
    • Plasma Master File
    • PSUR single assessment procedure
    • Radiopharmaceutical Non-Radioactive Components (kits)
    • Radiopharmaceutical Ready-for-use Radioactive Product
    • Registration Department approval
    • Renewal Filing
    • Risk Management Plan Filing
    • Technical committee approval
    • Transfer MA Filing
    • USR Filing
    • Value added medicine
    • Veterinary drug
    • Withdrawal Filing