Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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35 result(s) found, displaying 26 to 35
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GuidanceGuidance for sponsors on how and when to use a boxed warning in PI or a CMI.
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GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
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GuidanceGuidance clarifying the interaction between our requirements and AHPRA advertising guidelines.
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GuidanceGuidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.
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GuidanceGuidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules for advertising off-label uses.
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GuidanceGuidance for new sponsors on how to supply, import, and export disinfectant products.
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GuidanceGuidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.
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GuidanceThis guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.
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GuidanceTips for sponsors, distributors and retailers on creating prescription medicine labels that are compliant with Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
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GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.