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 76 to 100
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.
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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 on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.
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GuidanceGuidance to assist sponsors to understand the process for submitting a priority registration application.
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GuidanceGuidance on when and how to provide Product Information to us.
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GuidanceGuidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.
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GuidanceGuidance on the evaluation process and information required for new registered complementary medicines.
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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 on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.
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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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GuidanceGuidance on provisional registration process for prescription medicines with provisional determination.
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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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GuidanceAustralian recommendations and requirements
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GuidanceGuidance for data requirements for microorganisms used as active ingredients in listed or registered complementary medicines. These are generally referred to as probiotics or postbiotics.
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GuidanceClassifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.
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GuidanceGuidance for preparing a technical file review, as part of your application to include an in-vitro medical device (IVD) in the Australian Register of Therapeutic Goods.
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GuidanceGuidance on the regulation of system or procedure packs and using the special conformity assessment procedure.
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GuidanceGuidance to change an OTC medicine, listed in the Australian Register of Therapeutic Goods (ARTG), using the Changes Table.
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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 manufacturers outlining the procedures for submitting Conformity Assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
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GuidanceGuidance on TGO 109: Standards for Biologicals - General and Specific Requirements.
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GuidanceGuidance on TGO 108: Requirements around the minimisation of transmission of communicable diseases for therapeutic goods containing biologicals and human cell or tissue (HCT).
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GuidanceThis guidance is for manufacturers of registered medicinal gases to understand our interpretation of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to GMP for medicinal products.