Modify Filing Type Values
To support a country implementation by the database upgrade from Calyx RIM6.2 CHF 6 to Calyx RIM 6.2 CHF 7, the filing type values must be modified in your Calyx RIM Data Administration configuration section before executing the migration.
- On the Calyx RIM home page, click Go To > Data Administration.
- Under Sequence Maintenance, click Filing Type Values.
- Find the ASMF Filing and click the ASMF Filing link.
-
On the
Filing Type eCTD Code tab, click
Create
.
-
Enter the following:
Field Name Value Applicable DTD/Schema eu-3-0-1 Countries Great Britain -
Save.
The filing type eCTD code is created.
-
To modify other filing type values, perform the steps above and in step 3, use a different filing type from the table below each time. Do this for Great Britain and Northern Ireland.
For Great Britain:
Filing Type Display Name Countries ASMF Filing ASMF Filing Great Britain Follow-Up Measures Follow-Up Measures Great Britain Notification 61-3 Filing Notification 61-3 Filing Great Britain Original Filing Original Filing Great Britain PAED Article 46 PAED Article 46 Great Britain Plasma Master File Plasma Master File Great Britain Renewal Filing Renewal Filing Great Britain Transfer MA Filing Transfer MA Filing Great Britain Variation 1A Filing Variation 1A Filing Great Britain Variation 1B Filing Variation 1B Filing Great Britain Variation 2 Filing Variation 2 Filing Great Britain Withdrawal Filing Withdrawal Filing Great Britain For Northern Ireland:
Filing Type Display Name Countries Additional PV Activity in the RMP Related to PAM Additional PV Activity in the RMP Related to PAM Northern Ireland Annex II Condition Related to PAM Annex II Condition Related to PAM Northern Ireland Annual Reassessment Filing Annual Reassessment Filing Northern Ireland Arbitration Filing Arbitration Filing Northern Ireland Article 107i Referral Article 107i Referral Northern Ireland Article 16c (1c)i Referral Article 16c (1c)i Referral Northern Ireland Article 16c(4) Referral Article 16c(4) Referral Northern Ireland Article 20 Referral Article 20 Referral Northern Ireland Article 29 Paediatric Referral Article 29 Paediatric Referral Northern Ireland Article 29(4) Referral Article 29(4) Referral Northern Ireland Article 30 Referral Article 30 Referral Northern Ireland Article 31 Referral Article 31 Referral Northern Ireland Article 35 Referral Article 35 Referral Northern Ireland Article 5(3) Referral Article 5(3) Referral Northern Ireland Article 58 Filing Article 58 Filing Northern Ireland Clinical Data for Publication - Final Version Clinical Data for Publication - Final Version Northern Ireland Clinical Data for Publication - Redacted Proposal Clinical Data for Publication - Redacted Proposal Northern Ireland Conditional Specific Obligation Filing Conditional Specific Obligation Filing Northern Ireland Corrective/Preventative Action Related to PAM Corrective/Preventative Action Related to PAM Northern Ireland DMF Filing DMF Filing Northern Ireland Extension Filing Extension Filing Northern Ireland Follow-up Filing Follow-up Filing Northern Ireland Follow-up Measures Follow-up Measures Northern Ireland Legally Binding Measure Related to PAM Legally Binding Measure Related to PAM Northern Ireland Lifting Suspension Filing Lifting Suspension Filing Northern Ireland Marketing Authorisation Application Marketing Authorisation Application Northern Ireland National Variation Filing National Variation Filing Northern Ireland Notification 61-3 Filing Notification 61-3 Filing Northern Ireland Original filing Original filing Northern Ireland PAED Article 29 Filing PAED Article 29 Filing Northern Ireland PAED Article 45 PAED Article 45 Northern Ireland PAED Article 46 PAED Article 46 Northern Ireland PAED Related to PIP (Article 7, 8, 30) PAED Related to PIP (Article 7, 8, 30) Northern Ireland Paediatric Submission Related to PAM (Article 45) Paediatric Submission Related to PAM (Article 45) Northern Ireland Paediatric Submission Related to PAM (Article 46) Paediatric Submission Related to PAM (Article 46) Northern Ireland PAES Submission Related to PAM PAES Submission Related to PAM Northern Ireland PASS Protocol Submission (Article 107n) PASS Protocol Submission (Article 107n) Northern Ireland PASS Report Submission (Article 107q) PASS Report Submission (Article 107q) Northern Ireland Plasma Master File Plasma Master File Northern Ireland Periodic Safety Update Report PSUR Filing Northern Ireland PSUR single assessment procedure PSUR single assessment procedure Northern Ireland Recommendation Related to PAM Recommendation Related to PAM Northern Ireland Referral Filing Referral Filing Northern Ireland Reformat Filing Reformat Filing Northern Ireland Renewal Filing Renewal Filing Northern Ireland Repeat Use Procedure Repeat Use Procedure Northern Ireland Safety Filing Safety Filing Northern Ireland SDA Submission Related Filing SDA Submission Related Filing Northern Ireland Specific Obligation Filing Specific Obligation Filing Northern Ireland Specific Obligation Related to PAM Specific Obligation Related to PAM Northern Ireland Supplement Filing Supplement Filing Northern Ireland Transfer MA Filing Transfer MA Filing Northern Ireland USR Filing USR Filing Northern Ireland Variation 1A Filing Variation 1A Filing Northern Ireland Variation 1AIN Filing Variation 1AIN Filing Northern Ireland Variation 1B Filing Variation 1B Filing Northern Ireland Variation 2 Filing Variation 2 Filing Northern Ireland Withdrawal Filing Withdrawal Filing Northern Ireland