Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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11 result(s) found, displaying 1 to 11
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GuidanceProvides guidance on the regulatory requirements for labels and other medicine presentation.
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GuidanceGuidance for data requirements for microorganisms used as active ingredients in listed or registered complementary medicines. These are generally referred to as probiotics or postbiotics.
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GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
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GuidanceAn overview of the Data Protection Scheme for assessed listed medicines, and the criteria that must be met for information to be considered protected under the Scheme.
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GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
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GuidanceGuidance on changing information in the ARTG for listed or assessed listed medicines.
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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 on our approved terminology for medicines.
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GuidanceGuidance about information required for an assessed listed medicine application to pass preliminary assessment and proceed to evaluation.