Verify Migration Script Updates: Ennov InSight 7.1.15
After the migration script is run, changes must be verified and updated to the Data Administration data.
WHO Updates
- Creates or updates the WHO region to have the code value WHO in the database.
- Creates or updates the WHO country and associates it with the WHO region.
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Updates Health Authority Name to World Health Organization, Health Authority Abbreviation to WHO, Health Authority eCTD Code to whopqt and Health Authority Website to https://extranet.who.int/prequal/ in Application Maintenance > Country values.
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Adds the WHO-1-0 assembly DTD type in the Assembly - Assembly DTD/Schema Types section in Data Administration, if it does not already exist.
- Updates National Procedure Type in the Application Maintenance-Procedure Type Values section in Data Administration values to make it activate (if inactive) and updates to include the WHO country.
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Updates Application Maintenance > Application Type values with the following values and assigns the corresponding eCTD codes:
- Finished Pharmaceutical Product
- Finished Vaccine Product
- Active Pharmaceutical Ingredient
- Active Pharmaceutical Ingredient Master File
- The Finished Pharmaceutical Product Application Type will have Default Flag set to Yes upon associating it with WHO country.
- Updates Sequence Maintenance > Filing Type values with the following values and assigns the corresponding eCTD codes:
- Annual Report (FVP)
- APIMF Procedure
- New Emergency Use Listing (EUL) Application (FPP,FVP)
- Post-PQ Change (API, FFP, FVP)
- New Prequalification Application (API, FFP, FVP)
- Reassessment (FVP)
- Requalification Application (FPP)
- Updates Submission Maintenance > Sub Filing Type values with the following values and assigns the corresponding eCTD codes:
- Annual Notification (FPP)
- Abridged
- Immediate Notification (API)
- Annual Notification (API)
- Conversion
- eCTD Baseline
- EUL-Full (Emergency Use Listing)
- Full
- Immediate Notification (FPP)
- Major
- Minor
- Parallel
- Product Extension
- Standard
- Type A (Approval Before Implementation)(Major)(FVP)
- Type N (Immediate Notification)(Minor) (FVP)
- Update
- no Application Sub Type
- EUL- Abridged (Emergency Use Listing)
- Updates Submission Maintenance > Regulatory Activity Lead values with the following values and assigns the corresponding eCTD codes:
- Initial
- Validation Response
- Response
- Additional Info
- Reformat
- Updates Submission Maintenance > Submission Product Type values with the following values and assigns the corresponding eCTD codes:
- Biotherapeutic Product
- Finished Pharmaceutical Product
EU 3.1 Updates
The migration script will perform multiple changes to Data Administration data related to EU 3.1. These should be verified, and where necessary, updated. The script does the following:
- Adds the country Northern Ireland to the Application Maintenance - Country Values section in Data Administration if it does not already exist.
- Updates EU County-Health Authority values in the Application Maintenance – Country values section in Data Administration if they do not already exist. The list of new or updated values can be found below:
- AT-BASG
- BE-FAMHP
- HR-HALMED
- CY-PHS
- CZ-SUKL
- DK-DKMA
- EE-SAM
- DK-DKMA
- EE-SAM
- FR-ANSM
- DE-BFARM
- EL-EOF
- HU-OGYI
- IS-IMCA
- IE-HPRA
- IT-AIFA
- LV-ZVA
- LI-LLV
- LT-SMCA
- LU-MINSANT
- MT-MEDAUTH
- NL-MEB
- NO-NOMA
- PL-URPL
- PT-INFARMED
- SK-SIDC
- SI-JAZMP
- ES-AEMPS
- SE-MPA
- Adds the 'EU-3-1' Assembly DTD/Schema type in the Assembly - Assembly DTD/Schema Types section in Data Administration. If the 'EU-3-1' Assembly DTD/Schema already exists, it will be activated (if inactive) and updated to have the code value 'EU-3-1'. Otherwise, the 'EU-3-1' Assembly DTD/Schema will be added.
- Updates Sequence Maintenance – Filing Type values with the following values:
- Article 18 Filing
- Updates Submission Maintenance – Sub Filing Type values with the following values:
- Initial
- Validation Response
- Response
- Additional Information
- Closing Information
- Consolidating
- Corrigendum
- Reformat
- Re-examination