Calyx RIM 6.2 CHF 3 Data Administration Tables
Data Administration Updates: Region
If the JO region already exists in the Values section in Data Administration, it will be updated to have the code value JO in the database. Otherwise, an error message will be generated and the script will exit.
The country value 'Jordan' will be updated to belong to the Jordan region, if it does not belong to it already.
Data Administration Updates: Assembly DTD/Schema Type
If the JO-1-0 Assembly DTD /Schema type already exists in the section in Data Administration, it will be activated (if inactive) and updated to have the code value JO-1-0. Otherwise, the JO-1-0 Assembly DTD /Schema will be added.
Data Administration Updates: Filing Type Values
Filing Type Values are added to the
section in Data Administration, if they do not already exist. If they already exist, they will be updated with an eCTD Code for the JO-1-0 DTD/Schema. The following list shows the added Filing Types with their eCTD Codes:
- ASMF Filing: asmf
- Biological Allergen: bla
- Biological Bio-similar: bls
- Biological Blood Product: blb
- Biological Drug: bld
- Biological Vaccine: blv
- CEP Submission: cep
- Extension Filing: extension
- Generics: bgd
- Generic Narcotics: bgn
- Generic Vitamin Drug: bgv
- Herbal Drug: hrd
- MAA - Originator Drug: ord
- MAA - Originator Vitamin Drug: orv
- New Drug: mnd
- New Narcotics: nnd
- New Vitamin Drug: nvd
- None: none
- Notification with pricing: var-n2
- Notification without pricing: var-n1
- Originator Narcotics: orn
- Periodic Safety Update Report: psur
- Plasma Master File: pmf
- PSUR single assessment procedure: psusa
- Radiopharmaceutical Non-Radioactive Components (kits): rnr
- Radiopharmaceutical Ready-for-use Radioactive Product: rrp
- Registration Department approval: var-ra
- Renewal Filing: renevar
- Risk Management Plan Filing: risk
- Technical committee approval: var-tca
- Transfer MA Filing: transfer-ma
- USR Filing: usr
- Value added medicine: vam
- Veterinary drug: vrt
- Withdrawal Filing: withdrawal