Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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310 result(s) found, displaying 201 to 225
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GuidanceThis guidance helps providers of digital mental health services or products to understand their regulatory obligations.
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GuidanceGuidance on clinical performance and risk mitigation requirements for self‑test IVDs for chlamydia, gonorrhoea and syphilis.
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GuidanceGuidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13.
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GuidanceGuidance for sponsors of COVID-19 IVDs about their ongoing obligations
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GuidanceGuidance on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising.
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GuidanceGuidance to help you understand which therapeutic goods will be regulated as a biological.
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GuidanceGuidance for the requirements applicable to medical devices containing poisons.
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GuidanceGuidance to determine the level of regulation of PRP, PRF or conditioned serum products for therapeutic use.
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GuidanceGuidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.
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GuidanceGuidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.
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GuidanceGuidance on the priority applicant determination criteria and process for medical devices including in vitro diagnostics (IVDs).
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GuidanceGuidance for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
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GuidanceGuidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.
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GuidanceGuidance on mandatory warning statements for labels of medicines containing neuromuscular blocking agents.
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GuidanceGuidance to assist sponsors with the reclassification of surgical mesh devices.
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GuidanceGuidance on generic and originator medicines in the context of over-the-counter (OTC) non-prescription medicine applications.
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GuidanceGuidance for manufacturers and sponsors on the product standards that apply to haematopoietic progenitor cells (HPCs).
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GuidanceGuidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.
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GuidanceGuidance about the Annual Charge Exemption (ACE) scheme waiver process.
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GuidanceGuidance for sponsors and manufacturers about medical device definitions and requirements for system or procedure packs.
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GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceThis guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.
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GuidanceGuidance for sponsors and manufacturers about regulatory requirements for exempt therapeutic goods.
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GuidanceGuidance for sponsors on how and when to use a boxed warning in PI or a CMI.