Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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309 result(s) found, displaying 276 to 300
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GuidanceAn outline of the regulatory process and a summary of the requirements to successfully submit a biologicals application.
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GuidanceThis guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
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GuidanceGuidance for holding acceptable evidence to support indications and claims made about your listed medicine.
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GuidanceGuidance on submitting an effective prescription medicines application.
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GuidanceGuidance on the process and regulatory requirements to register prescription medicines.
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GuidanceGuidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications.
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GuidanceGuidance on submitting an effective application to register an over-the-counter (OTC) medicine.
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GuidanceGuidance on information required for an effective application to register a complementary medicine and proceed to evaluation.
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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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GuidanceGuidance on clinical performance requirements and risk mitigation for in vitro diagnostic medical devices intended to be used as self-tests for seasonal influenza.
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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.
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GuidanceGuidance on obligations during provisional registration period, process for applying for extension of provisional registration and transition to full registration.
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GuidanceThis guidance explains the administrative and prescribing (dossier) information you need to support the registration or variation of a prescription medicine.
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GuidanceGuidance to help sponsors and manufacturers of therapeutic goods to understand and use the Poisons Standard to determine if any restrictions apply to their product.
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GuidanceGuidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.
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GuidanceGuidance about the administrative information to support assessed listed medicine applications.
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GuidanceGuidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
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GuidanceGuidance for applicants on information required for Module 1 in dossiers for applications for registered complementary medicines to be consistent with the Common Technical Document (CTD) format.
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GuidanceGuidance on our approved terminology for medicines.
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GuidanceGuidance on how the Poisons Standard is amended and the processes that underpin scheduling policy
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GuidanceRisk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form.
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GuidanceThis guidance outlines the information needed in your dossier for us to be able to effectively review your application for a biological therapeutic good.
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GuidanceGuidance to help you understand the different types of complementary medicines.
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GuidanceGuidance on the use of permitted indications in listed medicines.