Information in Information in Information in Information in Brief discussion of noted application to be application to be application to be application to be differences filed with the filed with the CRA filed with the CRA filed with the CRA proposed RRA (please specify (please specify (please specify (please specify TGA, HC, SMC or TGA, HC, SMC or TGA, HC, SMC or TGA, HC, SMC or HSA): HSA): HSA): HSA): Synopsis of Biostudy(ies) Reference Product Used Indications approved for the reference product Approved strengths of reference product
Information in application to be filed with the proposed RRA (please specify TGA, HC, SMC or HSA): Information in application to be filed with the CRA (please specify TGA, HC, SMC or HSA): Information in application to be filed with the CRA (please specify TGA, HC, SMC or HSA): Information in application to be filed with the CRA (please specify TGA, HC, SMC or HSA): Brief discussion of noted differences Synopsis of Biostudy(ies) Reference Product Used Indications approved for the reference product Approved strengths of reference product
acss-generic-medicine-work-sharing-trial-eoi-form.docx