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114 result(s) found, displaying 61 to 70
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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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PageInformation on colourings in medicines for topical and oral use.
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PageThe Scheduling Policy Framework (Scheduling Policy) sets out the national policy for applying access restrictions on medicines and chemicals.
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PageFind out about our clinical evaluation streams and the functions each unit provides.
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PageThis information explains your responsibilities when obtaining Good Manufacturing Practice (GMP) clearance by any pathway, or by GMP certification following our inspection.
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PageA new version of the code of practice for tamper-evident packaging of therapeutic goods is now available.
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PageInformation for sponsors on demonstrating stability of medicines under Australian conditions.
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PageWe provide transparency of the prescription medicines registration process via the online publication of Australian Public Assessment Reports (AusPARs). Explore questions and answers about AusPARs.
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PageHow to submit nonclinical studies in Module 4 of the Common Technical Document (CTD).
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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.