Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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42 result(s) found, displaying 1 to 25
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GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
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GuidanceTimeframes for supplying UDI compliant medical devices in Australia
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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 to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.
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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 to change an ARTG registered over-the-counter (OTC) medicine.
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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 application pathways and data requirements for new generic medicines, and variations to existing medicines.
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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 on requirements for Australian market authorisation of preparations containing bromhexine hydrochloride, for an OTC new medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of topical nasal decongestant medicines, for an OTC new medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of tablets containing aspirin, for an OTC new medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of topical imidazole antifungal medicines for dermal use, containing clotrimazole or miconazole nitrate, for an OTC New Medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of oral medicines containing ranitidine hydrochloride, for an OTC new medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of oral medicines containing paracetamol, for an OTC New Medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of oral medicines containing loperamide hydrochloride, for an OTC New Medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of oral laxative medicines containing docusate sodium and/or sennosides, for an OTC new medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of oral preparations containing dextromethorphan hydrobromide, for an OTC new medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of a cough expectorant containing guaifenesin, for an OTC new medicine N2 application.
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GuidanceGuidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).
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GuidanceThis guidance provides for a nationally uniform approach to retail storage of Schedule 6 and Schedule 7 poisons.
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GuidanceGuidance explaining how to find out which statements (if any) are required by the RASML for a particular over-the-counter (OTC) or complementary medicine.