TGA use only This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: provided to the TGA at <https://www.tga.gov.au/treatment-information-provided-tga>. COR report-based process prescription medicines – COR-A and COR-B application checklist You must complete and submit this checklist as part of your Module 1.2.1 application form. This will enable the TGA to assess whether the application is eligible for the COR-A or COR-B process. If certain criteria are not met, the application can then only be submitted as a Category 1. See for further information. Criteria Checklist General The assessment package is from a comparable Yes overseas regulator (COR), as published on the Name of COR: TGA website. Date of approval: Note: Overseas approval older than 1 year is only eligible for COR-B. The application meets the following general Yes eligible for COR-A or COR-B application criteria: No not eligible for the COR report-based The COR assessment package relates to a de process. novo evaluation for full marketing approval of the medicine (i.e. not provisionally approved). The COR assessment package is complete, in English and unredacted. An application for marketing approval for the medicine that is the subject of this application has not been delayed, deferred, rejected, refused or withdrawn in any country. Nomenclature: Yes Does the COR report use Australian approved No include further information: terminology (e.g. AANs, ABNs, dosage forms)?
TGA use only This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: provided to the TGA at <https://www.tga.gov.au/treatment-information-provided-tga>. COR report-based process – prescription medicines COR-A and COR-B application checklist You must complete and submit this checklist as part of your Module 1.2.1 application form. This will enable the TGA to assess whether the application is eligible for the COR-A or COR-B process. If certain criteria are not met, the application can then only be submitted as a Category 1. See for further information. Criteria Checklist General The assessment package is from a comparable overseas regulator (COR), as published on the TGA website. Note: Overseas approval older than 1 year is only eligible for COR-B. Yes Name of COR: Date of approval: The application meets the following general application criteria: The COR assessment package relates to a de novo evaluation for full marketing approval of the medicine (i.e. not provisionally approved). The COR assessment package is complete, in English and unredacted. An application for marketing approval for the medicine that is the subject of this application has not been delayed, deferred, rejected, refused or withdrawn in any country. Yes eligible for COR-A or COR-B No not eligible for the COR report-based process. Nomenclature: Does the COR report use Australian approved terminology (e.g. AANs, ABNs, dosage forms)? Yes No include further information:
application-checklist-for-cor-report-based-process.docx