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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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- Advanced therapies (2)
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265 result(s) found, displaying 251 to 265
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GuidanceGuidance on the process and regulatory requirements to register prescription medicines.
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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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GuidanceThis guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.
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GuidanceTips for sponsors, distributors and retailers on creating prescription medicine labels that are compliant with Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
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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 what to do if the sponsor of a therapeutic good changes.
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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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GuidanceInformation required to establish quality for listed medicines
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GuidanceGuidance for applicants on information required for Module 1 in dossiers for applications for registered complementary medicines to be consistent with the Common Technical Document (CTD) format
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GuidanceGuidance to help you understand the different types of complementary medicines.
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GuidanceFor applications lodged from March 2018.
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GuidanceThis guidance describes the safety and efficacy data you will need for CTD Module 4 and Module 5 to support applications to either register an OTC medicine in the ARTG or vary the safety and/or efficacy aspects of a registered OTC medicine. (Formerly ARGOM Appendix 1)
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GuidanceGuidance on the two mechanisms to provide information about a drug substance sourced from a third-party manufacturer.
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GuidanceGuidance to assist you with submitting acceptable applications for registration of over-the-counter (OTC) medicines.