Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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54 result(s) found, displaying 51 to 54
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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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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 manufacturers in the development of Technical Master Files (TMF) relevant to blood, blood components and haematopoietic progenitor cells.