Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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28 result(s) found, displaying 26 to 28
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GuidanceGuidance to assist sponsors and manufacturers when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) and selecting a GMDN term.
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GuidanceRisk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form.
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GuidanceGuidance on the two mechanisms to provide information about a drug substance sourced from a third-party manufacturer.