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889 result(s) found, displaying 876 to 889
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Reference materialThis guidance intends to outline for sponsors and manufacturers the types of RWE relevant in the Australian context.
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FormsWe are asking all vendors to identify whether they should be considered as a small business in relation to their dealings with us.
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FormsUse this form to report defects that you think have arisen during manufacture, storage or handling of a medicine or vaccine.
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Reference materialThe new Therapeutic Goods (Medicines Advisory Statements) Specification 2021 commences 1 January 2022
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User guideHow to search TGA business services for approved ingredients and accepted TGA terminology.
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Reference materialoverview of stability testing of Listed complementary medicines
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ChecklistsA checklist for sponsor intending to supply a therapeutic vaping device
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Reference materialThe Australian medical devices legislation creates a system of non-mandatory medical device standards orders (MDSO) and conformity assessment standards orders (CASO) that can be used to demonstrate compliance.
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Reference materialTest procedures for starting materials used in complementary medicines must use analytical methods that are validated for that purpose.
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Reference materialApplications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal.
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User guideUser guide for sponsors and manufacturers wanting to submit data in the NeeS format.
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Reference materialWhat has been updated?