Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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- (-) Over the counter (OTC) medicines (36)
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74 result(s) found, displaying 1 to 25
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GuidanceThis Guidance describe the requirements and standards for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia
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GuidanceGuidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.
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GuidanceGuidance to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.
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GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
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GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.
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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 to assist sponsors to understand the process for submitting a priority registration application.
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GuidanceGuidance on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.
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GuidanceGuidance on when and how to provide Product Information to us.
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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 on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
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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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GuidanceThis guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.
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GuidanceGuidance on provisional registration process for prescription medicines with provisional determination.
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GuidanceGuidance to change an ARTG registered over-the-counter (OTC) medicine.
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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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GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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GuidanceGuidance about application pathways and data requirements for new generic medicines, and variations to existing 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 will help you understand our pharmacovigilance inspection program (PVIP).
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GuidanceThis guidance explains requirements for registering a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance for sponsors about how to apply for orphan drug designation for a prescription medicine.