Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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32 result(s) found, displaying 26 to 32
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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 to help sponsors and manufacturers of therapeutic goods to understand and use the Poisons Standard to determine if any restrictions apply to their product.
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GuidanceGuidance on our approved terminology for medicines.
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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.