Resources
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629 result(s) found, displaying 501 to 525
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FormsYou must complete and submit the relevant checklist as part of your dossier submission
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FormsProposal form for a new Approved Cell and Tissue Name (ACN)
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User guideUser guide for sponsors that provides the pilot specification and guidance information relevant for preparation of an electronic Common Technical Document (eCTD) sequence to the TGA.
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User guideFinished product (medicine) analytical procedure validations for complementary medicines.
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Compositional guidelinesCompositional guideline Sorbitan Distearate permitted for use in listed medicines.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/HMPC/104613/2005 Rev. 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/341363/2014.
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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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FormsThe Module 1.2.1: Assessed listed medicine general application information form must be completed in conjunction with the Assessed listed medicines application form.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/500825/2016
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Compositional guidelinesCompositional guideline for 'Dimethylglycine hydrochloride' permitted for use in listed medicines
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User guideQuestions and answers for drafters/submitters
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/600958/2010/Corr.*
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Compositional guidelinesCompositional guideline for 'Lipase' 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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FormsFind further information about inspection and audit feedback forms.
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Compositional guidelinesCompositional guideline for 'Calcified Lithothamnion species' 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 'Magnesium pyruvate' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Molybdenum trioxide' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Hesperidin' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Amylase' permitted for use in listed medicines
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Compositional guidelinesCompositional guideline for 'Cellulase' permitted for use in listed medicines
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User guideThis form is used to include a new biological or vary an existing biological on the ARTG
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FormsUse this form to make a freedom of information (FOI) request for a document held by the Therapeutic Goods Administration (TGA).