The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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758 result(s) found, displaying 601 to 625
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FormsInformation on when a manufacturer's statutory declaration is required.
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N2 application
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N1 application
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Compositional guidelinesCompositional guideline for 'Ribose' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Calcium pyruvate' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Choline dihydrogen citrate' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Dimethylglycine hydrochloride' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Lepidium meyenii (dried tuber)' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Magnesium pyruvate' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Polaprezinc' permitted for use in listed medicines
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User guideQuestions and answers for administrators
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User guideQuestions and answers for financials.
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Reference materialThe Regulator Performance Framework was developed to measure the performance of regulators and will apply from 1 July 2015
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User guideUpdated information for registered users of the Australian Adverse Drug Reaction Reporting System
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Reference materialEach year, approximately 40 new prescription medicines containing new active substances are registered.
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User guideQuestions and answers for drafters/submitters
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Compositional guidelinesCompositional guideline for 'Squid oil' permitted for use in listed medicines
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Reference materialReview of cardiovascular safety of non-steroidal anti-inflammatory drugs.
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Compositional guidelinesCompositional guideline for 'Hydroxycitrate complex' permitted for use in listed medicines
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FormsUse this form to apply for an Australian Approved Name (AAN).
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FormsUse this form to propose updates to the Required Advisory Statements for Medicine Labels (RASML)