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 551 to 575
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User guideA how to fill in a device incident report
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Compositional guidelinesCompositional guideline for 'Streptococcus salivarius M18' permitted for use in listed medicines
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Reference materialIn addition to the legislated requirements, there are other features of leaflet and card design that can be very helpful for patients
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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 'Resveratrol' permitted for use in listed medicines
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Reference materialThings to keep in mind when you see the ‘TGA assessed’ symbol or statement
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Reference materialThe TGA has published a list of FAQs on issues raised by industry in relation to permitted indications
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User guideUser guide on the Adverse Event Management System (AEMS) for health professionals.
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Reference materialImportant information about potential impact of regulation changes that came in force on 1 July 2018
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Reference materialEffective 1 October 2018 TGA has made a new determination which excludes certain goods from the operation of the Act
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Reference materialGuidance on colourings in medicines for topical and oral use
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FormsChecklist to assist in a priority review designation application
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FormsThis checklist is to be used by sponsors to apply for priority review determination
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Compositional guidelinesCompositional guideline for 'Streptococcus salivarius K12' permitted for use in listed medicines
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Reference materialApplication phases for a new registered complementary medicine
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Reference material
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Reference materialThe new assessed listed medicines pathway is now available.
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User guideThis is a step-by-step guide for agents and sponsors who wish to apply for Priority review, Provisional determination or Orphan drug designation of a prescription medicine.
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Reference materials23 instruments supporting the new COR process have been updated.
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