Calyx RIM 6.1 CHF 4 Data Administration Tables
Data Administration changes to support AU eCTD Module 1 specification v3.1 and NeeS specification v2.0
If the AU-3-1 Assembly DTD/Schema Type already exists in the section in Data Administration, it will be activated if inactive and updated to have the internal code value AU-3-1. Otherwise, AU-3-1 Assembly DTD/Schema Type will be added.
Filing Type Values
Under the
Sequence Maintenance, the
Filing Type Values table will be updated with the following new sequence types:
- Provisional Registration - TGA initiated variation
- Notification
- CN
- Extension of Provisional Registration
- Duplicate
Under the
table, the following sequence type will be updated:
- Withdrawal filing type will be updated to be Product Withdrawal
Sequence Description Values
Under the
Submission Maintenance, the
Sequence Type Values table will be updated with the following new Sequence Description:
- Provisional approval - rolling data submission - {date: d} (with eCTD code seq-desc-26)
Regulatory Activity Lead Values
Under the
Submission Maintenance, the
Regulatory Activity Lead Values table will be updated with the following new Regulatory Activity Lead:
- Prescription meds-chemical (with eCTD code reg-act-lead-7)