Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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50 result(s) found, displaying 1 to 25
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GuidanceProvides guidance on the regulatory requirements for labels and other medicine presentation.
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GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.
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GuidanceGuidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.
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GuidanceGuidance to assist sponsors to understand the process for submitting a priority registration application.
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GuidanceGuidance on when and how to provide Product Information to us.
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GuidanceGuidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
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GuidanceGuidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.
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GuidanceGuidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).
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GuidanceGuidance on provisional registration process for prescription medicines with provisional determination.
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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 about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
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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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GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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GuidanceGuidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.
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GuidanceThis guidance explains requirements for registering a non-prescription OTC medicine on the Australian Register of Therapeutic Goods (ARTG).
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GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
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GuidanceGuidance for sponsors about how to apply for orphan drug designation for a prescription medicine.
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GuidanceGuidance on submitting the CPD for prescription medicines.
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GuidanceGuidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.
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GuidanceGuidance about the process of applying for a priority determination, which is the first step of the priority review registration pathway.
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GuidanceGuidance for the deletion of commercially confidential and personal information in an Australian Public Assessment Report (AusPAR).