N/A (a) Is the therapeutic good to be used in the service exempt from the regulatory requirements of the Therapeutic Goods Act 1989? Yes (If yes, please provide supporting documentation as an attachment to this application form) No If no, has it been listed or registered or included in the Australian Register of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration (TGA)? Yes (if yes, please provide details below) No ARTG listing, registration or inclusion number: Insert ARTG number here TGA approved indication(s), if applicable: Insert approved indication(s) here TGA approved purpose(s), if applicable: Insert approved purpose(s) here If the therapeutic good has not been listed, registered or included in the ARTG, is the therapeutic good in the process of being considered for inclusion by the TGA? Yes (please provide details below) No Date of submission to TGA: Insert date of submission here Estimated date by which TGA approval can be expected: Insert estimated date here TGA Application ID: Insert TGA Application ID here TGA approved indication(s), if applicable: If applicable, insert description of TGA approved indication(s) here TGA approved purpose(s), if applicable: If applicable, insert description of TGA approved purpose(s) here If the therapeutic good is not in the process of being considered for listing, registration or inclusion by the TGA, is an application to the TGA being prepared? Yes (please provide details below) No Estimated date of submission to TGA: Insert date of submission here Proposed indication(s), if applicable: If applicable, insert description of proposed indication(s) Proposed purpose(s), if applicable: If applicable, insert description of proposed purpose(s) here
N/A (a) Is the therapeutic good to be used in the service exempt from the regulatory requirements of the Therapeutic Goods Act 1989? Yes (If yes, please provide supporting documentation as an attachment to this application form) No If no, has it been listed or registered or included in the Australian Register of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration (TGA)? Yes (if yes, please provide details below) No ARTG listing, registration or inclusion number: Insert ARTG number here TGA approved indication(s), if applicable: Insert approved indication(s) here TGA approved purpose(s), if applicable: Insert approved purpose(s) here If the therapeutic good has not been listed, registered or included in the ARTG, is the therapeutic good in the process of being considered for inclusion by the TGA? Yes (please provide details below) No Date of submission to TGA: Insert date of submission here Estimated date by which TGA approval can be expected: Insert estimated date here TGA Application ID: Insert TGA Application ID here TGA approved indication(s), if applicable: If applicable, insert description of TGA approved indication(s) here TGA approved purpose(s), if applicable: If applicable, insert description of TGA approved purpose(s) here If the therapeutic good is not in the process of being considered for listing, registration or inclusion by the TGA, is an application to the TGA being prepared? Yes (please provide details below) No Estimated date of submission to TGA: Insert date of submission here Proposed indication(s), if applicable: If applicable, insert description of proposed indication(s) Proposed purpose(s), if applicable: If applicable, insert description of proposed purpose(s) here
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