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 section in Data Administration section, if it does not already exist.
- The 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
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