Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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313 result(s) found, displaying 126 to 150
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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 the types of notifications and variations for biological medicines.
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GuidanceGuidance on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).
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GuidanceGuidance for sponsors on the process for including IVD medical devices in the ARTG.
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GuidanceGuidance on reclassifying active medical devices with diagnostic functions in Australia, including transition arrangements, Class III requirements, and sponsor obligations for ARTG inclusion.
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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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GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).
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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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GuidanceGuidance to understand if your medical device product should be in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance on the use of modified unprocessed herbal materials in complementary medicines
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GuidanceGuidance on using literature based submissions for applications for listed, assessed listed and registered complementary medicines.
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GuidanceGuidance for making an offer of enforceable undertaking to us.
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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 preparations containing bromhexine hydrochloride, for an OTC new medicine N2 application.
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GuidanceGuidance on the application process and information required for a substance to be evaluated for use in listed medicines.
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GuidanceGuidance for sponsors about how to apply for orphan drug designation for a prescription medicine.
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GuidanceGuidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.
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GuidanceGuidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.
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GuidanceGuidance for biological sponsors on the eligibility criteria and supporting documents required for priority determination applications
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GuidanceGuidance on submitting the CPD for prescription medicines.
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GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
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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 complying with therapeutic goods advertising requirements.
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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.