b. I undertake to remain up to date in relation to knowledge about potential future approved goods that may be entered on the ARTG that could be used instead of the unapproved good, and where a suitable alternative good becomes available on the ARTG, stop using the unapproved good. Where there is a good reason to continue using the unapproved good, I undertake to reapply for approval, submitting a clinical justification to the HREC on why you want to use the unapproved good instead of the now approved good. c. I undertake to provide the HREC with regular reports as required by the TGA (detailed in Section 7) d. I agree to abide by any conditions set by the HREC and/or TGA in relation to approval to use the unapproved good. e. I certify that the information I have provided in this application is true and accurate Full Name Signature Date
b. I undertake to remain up to date in relation to knowledge about potential future approved goods that may be entered on the ARTG that could be used instead of the unapproved good, and where a suitable alternative good becomes available on the ARTG, stop using the unapproved good. Where there is a good reason to continue using the unapproved good, I undertake to reapply for approval, submitting a clinical justification to the HREC on why you want to use the unapproved good instead of the now approved good. c. I undertake to provide the HREC with regular reports as required by the TGA (detailed in Section 7) d. I agree to abide by any conditions set by the HREC and/or TGA in relation to approval to use the unapproved good. e. I certify that the information I have provided in this application is true and accurate Full Name Signature Date
NIIM-AUTHORISED-PRESCRIBER-SCHEME-APPLICATION-FORM_V2_17-July-2018.docx