Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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292 result(s) found, displaying 176 to 200
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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.
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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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GuidanceThis guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.
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GuidanceGuidance for the requirements applicable to medical devices containing poisons.
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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 manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.
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GuidanceGuidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.
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GuidanceGuidance for sponsors and manufacturers on regulatory responsibilities associated with first aid kits supplied using the special Conformity Assessment procedure.
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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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GuidanceHow to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.
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GuidanceGuidance to understand how we interpret regulations and how manufacturers can comply with them.
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GuidanceGuidance on our expectations concerning clinical performance requirements and risk mitigations for in vitro diagnostic medical devices intended to be used as self-tests for chlamydia, gonorrhoea and syphilis.
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GuidanceGuidance for sponsors of COVID-19 IVDs about their ongoing obligations
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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 the priority applicant determination criteria and process for medical devices including in vitro diagnostics (IVDs).
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GuidanceGuidance on mandatory warning statements for labels of medicines containing neuromuscular blocking agents.
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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 to assist sponsors with the reclassification of surgical mesh devices.
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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 on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.
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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 mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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GuidanceGuidance for sponsors and manufacturers about medical device definitions and requirements for system or procedure packs.