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889 result(s) found, displaying 451 to 475
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Reference materialThis guidance helps sponsors and manufacturers of therapeutic goods to understand and use the Poisons Standard to determine if any restrictions apply to their product
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Reference materialSME Assist's 'Meeting Your Obligations' workshop - Live stream - 22 October 2020 has now been published.
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Reference materialGuidance for applicants on how to request and prepare for pre-submission meetings.
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Reference materialGuidance for applicants (sponsors, manufacturers and agents) preparing for pre-submission meetings related to applications
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User guideUser guide for sponsors converting their dossier format from paper, CTD or NeeS to eCTD
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User guideUser guide for sponsors who need to withdraw information from their eCTD dossiers and can be used as best practice for NeeS withdrawals
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Reference materialCase studies can provide advertisers with valuable insight to how the TGA uses enforcement tools to address non-compliant advertising of therapeutic goods
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Reference materialAn outline of the regulatory process and a summary of the requirements to successfully submit a biologicals application
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Reference materialWebinar presentation, recordings and frequently asked questions
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Reference materialQuestions and answers from the information webinars held on 8 and 9 October 2020
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Reference materialThe TGA has initiated compliance reviews of a selection of listed medicines at risk of containing safrole
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Reference materialGuidance on how to change sponsor details in PI and labels
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User guideThis user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
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Reference materialIf sponsorship is transferred to you, you need to notify the TGA
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ChecklistsA compliance checklist for advertisers applying to use a restricted representation.
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User guideQuestions and answers about submitting an application for approval to use a restricted representation.
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Reference materialThe Government has agreed to provide a 50 per cent reduction in annual charges for certain medical devices for the 2020-21 financial year.
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Reference materialFrom 30 November 2020 certain sports supplements are regulated as therapeutic goods (medicines)
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Reference materialThe TGA has made a section 7 declaration to declare that certain sports supplemenst are therapeutic goods
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FormsUse this form to seek TGA advice on a biowaiver justification proposed for inclusion in an application to register a new medicine for oral ingestion