Data Migration Documentation

Calyx RIM 6.2 CHF 2 Data Administration Tables

Data Administration Updates: Region

If the CH region already exists in the Application Maintenance - Region Values section in Data Administration, it will be updated to have the code value CH in the database. Otherwise, an error message will be generated and script will exit.

The country value 'Switzerland' will be updated to belong to Switzerland region, if it does not belong to it already.

Data Administration Updates: Assembly DTD/Schema Type

If the CH-1-4 Assembly DTD /Schema type already exists in the Assembly > Assembly DTD/Schema Types section in Data Administration, it will be activated (if inactive) and updated to have the code value CH-1-4. Otherwise, CH-1-4 Assembly DTD /Schema will be added.

Data Administration Updates: Filing Type Values

Filing Type Values are added to the Sequence Maintenance > Filing Type Values section in Data Administration, if they do not already exist. If they already exist, they will be updated with an eCTD Code for CH-1-4 DTD/Schema Following are the list of Filing Types added with their eCTD Codes:
  • Application for 5 years Data Protection: eas
  • Co-Marketing Medicinal Product: co-marketing
  • Corrigendum Filing: corrigendum
  • DMF Filing: dmf
  • Follow-Up Measures: fum
  • Known Active Substance: na-bws
  • New Active Substance: na-nas
  • Orphan Fast Track Filing: orphan-fasttrack
  • Parallel Import: pi
  • Periodic Safety Update Report: psur
  • Plasma Master File: pmf
  • Reformat Filing: reformat
  • Renewal Filing: renewal
  • Supplement Filing: supplemental-info
  • Transfer MA Filing: transfer
  • Variation Requiring Product information Authorisation: var-pi
  • Withdrawal Filing: withdrawal
  • Used for meeting: advice
  • New Application- Co-Marketing: na-co-marketing
  • New Application- Parallel Import: na-pi
  • Variation 1A Filing- var-type1a
  • Variation 1AIN Filing: var-type1ain
  • variation 1B Filing: var-type1b
  • Variation 2 Filing: var-type2
  • Extension Filing: extension

Data Administration Updates: Valid Values 5.0

The new STF-2-2-5-0 entry has been added to the Assembly DTD/Schema Types section in Data Administration with the Region and Country details. The following regions are added to the list:
  • Canada
  • European Union
  • Switzerland
  • United States