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623 result(s) found, displaying 576 to 600
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Reference materialA new version of the code of practice for tamper-evident packaging of therapeutic goods is now available
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User guideSteps to register a new fixed combination medicine.
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Compositional guidelinesCompositional guideline for 'Galactooligosaccharides' permitted for use in listed medicines
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Reference materialThe new Therapeutic Goods (Medicines Advisory Statements) Specification 2021 commences 1 January 2022
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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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Compositional guidelinesCompositional Guideline for D-glucose, polymer with xylitol permitted for use in listed medicines.
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Reference materialWatch this video to learn about creating and submitting a Clinical Trial Notification (CTN) using the online form
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FormsInformation on when a manufacturer's statutory declaration is required.
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Reference materialComplying with therapeutic goods advertising restrictions.
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User guideHow to search TGA business services for approved ingredients and accepted TGA terminology.
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Reference materialLabelling Order. This guidance is no longer in use and has been replaced by ARGB Appendix 11 - Guidance on TGO 107: Standard for Biologicals – Labelling Requirements.
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Compositional guidelinesCompositional guideline for '3-Fucosyllactose' permitted for use in listed medicines
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Reference materialAdditional Q&A's on use of market authorisation evidence from overseas regulatory bodies for medical devices
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FormsPrescription medicines Minor Variation E-form now available
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Compositional guidelinesCompositional guideline for 'Hemp Seed Oil' permitted for use in listed medicines
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Compositional guidelinesCompositional Guideline for Cyclocarya paliurus leaf extract dry.
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Reference materialAll surgical procedures carry risk. A page for consumers considering getting implants.
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Compositional guidelinesCompositional guideline for 'Calanus finmarchicus oil' permitted for use in listed medicines
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Reference materialGuidance on colourings in medicines for topical and oral use
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Reference materialThe Scheduling Policy Framework (Scheduling Policy) sets out the national policy for applying access restrictions on medicines and chemicals.
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Reference materialUpdate to the six clinical evaluation streams and the functions each unit provides
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FormsTGA is 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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Compositional guidelinesCompositional guidelines for 'Chicken Sternum Cartilage Powder' permitted for use in listed medicines.
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Compositional guidelinesCompositional guideline for 'Shea Butter Ethyl Esters' permitted for use in listed medicines
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Reference material