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General Eligibility for COR Application

There are currently two approaches under the COR report-based process, namely COR approach A (COR-A) and COR approach B (COR-B). The approach used will depend on what extent is the product data available, which the TGA needs to evaluate. (refer below)
The eligibility of COR-A or COR-B can be identified through the COR application checklist available from the TGA website.

Flowchart on Eligibility for COR report-based process

Flowchart on Eligibility for COR report-based process