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Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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61 result(s) found, displaying 51 to 61
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GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
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GuidanceGuidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications.
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GuidanceGuidance on submitting an effective application to register an over-the-counter (OTC) medicine.
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GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
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GuidanceGuidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.
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GuidanceGuidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
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GuidanceGuidance about information required for an assessed listed medicine application to pass preliminary assessment and proceed to evaluation.
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GuidanceThis guidance describes the safety and efficacy data you will need for Common Technical Document (CTD) Module 4 and Module 5 to support applications for over-the-counter (OTC) medicines.
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GuidanceGuidance providing an overview of the Common Technical Document (CTD), modules 1-5. The CTD is a set of dossier specifications for the registration of medicines.
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GuidanceGuidance to assist you with submitting acceptable applications for registration of over-the-counter (OTC) medicines.
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GuidanceGuidance for manufacturers in the development of Technical Master Files (TMF) relevant to blood, blood components and haematopoietic progenitor cells.