Resources
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637 result(s) found, displaying 526 to 550
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User guideThe OTC application categorisation framework defines the different OTC medicine application levels and identifies the key application criteria
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Compositional guidelinesCompositional guideline for 'Sugar cane wax alcohols (SCWA)' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Palmitoleic acid-rich fatty acid ethyl esters' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Alginate-konjac-xanthan polysaccharide complex' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Poliglusam derived from Aspergillus niger' permitted for use in listed medicines
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FormsWe are redeveloping the Conformity Assessment application form to enable applicants to provide all the required information at the time of submitting their application.
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FormsA revised CPD template for Biological medicines and vaccines is now available for sponsors
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User guideInformation on quality for the medicine/finished product
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Compositional guidelinesCompositional guideline for 'D-Ribose-L-Cysteine' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Levomefolate glucosamine' permitted for use in listed medicines
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FormsInformation on completing and submitting an OTC analytical validation summary form
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User guideThe cover letter (letter of application) needs to provide useful information regarding the nature and scope of the application
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FormsInformation on when a manufacturer's statutory declaration is required.
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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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User guideUpdated information for registered users of the Australian Adverse Drug Reaction Reporting System