Elements not previously evaluated by the TGA: No Does the application contain elements to Yes please include further details of novel Australia (first in class, incorporating novel or elements: emerging technologies or containing active Note: Additional evaluation may be required ingredients or excipients not previously registered in Australia). Third party proprietary information - e.g. Drug Master Files (DMFs) For dossiers that include proprietary information N/A skip to next section from a third party, evidence to confirm that all Yes eligible for COR-A or COR-B. Include proprietary information, including the COR DMF number evaluation and relevant communication between the third party and the COR, has been provided to No not eligible for the COR report-based the TGA. process. Will a Certificate of Suitability (CEP) be provided to N/A skip to next section the TGA? Yes No provide the full DMF and COR assessment. Was the CEP also provided to the COR? Yes No provide the full DMF and COR assessment. Indications and Directions for Use The proposed indications are equivalent to that No not eligible for the COR report-based approved by the COR, including equivalent dosing process. and administration details (directions for use). Yes include hyperlink to approved indication in COR report. Hyperlink For generics and biosimilars Yes The proposed indications are identical to the No not eligible for the COR report-based indications for the Australian originator product. process. Medicine characteristics The proposed medicine is identical to that Yes eligible for COR-A or COR-B evaluated and approved within the COR No not eligible for the COR report-based assessment package with regard to all of the process. below: Dosage form Strength or size (disregarding pack size) Formulations (active substance and excipients)
Elements not previously evaluated by the TGA: Does the application contain elements to Australia (first in class, incorporating novel or emerging technologies or containing active ingredients or excipients not previously registered in Australia). No Yes please include further details of novel elements: Note: Additional evaluation may be required Third party proprietary information - e.g. Drug Master Files (DMFs) For dossiers that include proprietary information from a third party, evidence to confirm that all proprietary information, including the COR evaluation and relevant communication between the third party and the COR, has been provided to the TGA. N/A skip to next section Yes eligible for COR-A or COR-B. Include DMF number No not eligible for the COR report-based process. Will a Certificate of Suitability (CEP) be provided to the TGA? N/A skip to next section Yes No provide the full DMF and COR assessment. Was the CEP also provided to the COR? Yes No provide the full DMF and COR assessment. Indications and Directions for Use The proposed indications are equivalent to that approved by the COR, including equivalent dosing and administration details (directions for use). No not eligible for the COR report-based process. Yes include hyperlink to approved indication in COR report. Hyperlink For generics and biosimilars The proposed indications are identical to the indications for the Australian originator product. Yes No not eligible for the COR report-based process. Medicine characteristics The proposed medicine is identical to that evaluated and approved within the COR assessment package with regard to all of the below: Dosage form Strength or size (disregarding pack size) Formulations (active substance and excipients) Yes eligible for COR-A or COR-B No not eligible for the COR report-based process.
application-checklist-for-cor-report-based-process.docx