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Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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292 result(s) found, displaying 201 to 225
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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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 for sponsors and manufacturers about regulatory requirements for exempt therapeutic goods.
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GuidanceThis guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.
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GuidanceGuidance on the requirements that specifically apply to active medical devices.
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GuidanceAustralian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.
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GuidanceGuidance for industry on how to apply for consent to supply therapeutic goods that do not comply with subsection 9(2) of TGO 92.
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GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
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GuidanceGuidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.
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GuidanceThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.
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GuidanceGuidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).
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GuidanceGuidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance on when software is classified as an in vitro medical device and how it is regulated.
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GuidanceGuidance clarifying the interaction between our requirements and AHPRA advertising guidelines.
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GuidanceGuidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
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GuidanceGuidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.
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GuidanceGuidance on advertising services that involve therapeutic goods.
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GuidanceGuidance for sponsors of certain medical devices who are required to submit annual reports.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceThis guidance assists providers of IV drips to understand how to comply with the therapeutic goods advertising requirements in Australia.
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GuidanceGuidance for importation, supply and wholesale requirements for medicinal cannabis.
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GuidanceGuidance about how to promote your business and service, without advertising biologicals to the public.
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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 relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.
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GuidanceGuidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.