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- Prescription medicines (20)
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41 result(s) found, displaying 26 to 41
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Reference materialStandards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products
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User guideThe system now allows equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the ARTG
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User guideInstructions for applicants on how to organise and fill out a pre-submission planning form (PPF).
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Reference materialImproved CMI templates and resources
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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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User guideThis document replaces AU eCTD specification - Module 1 and regional information Version 3.0 and contains updated information.
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Reference materialThe Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines.
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Reference materialUpdate about the transitionary arrangements for reformatting Product Information, including accessing a fee waiver
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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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User guideFinished product (medicine) analytical procedure validations for complementary medicines.
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Reference materialOverview of stability testing of Listed complementary medicines
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Reference materialThe conformity assessment certification and audit requirements for certain medical devices have changed.
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User guideInformation on quality for the medicine/finished product
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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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Reference materialExternal evaluators are required to use their expertise to review the data provided by sponsors and prepare an assessment report.
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Reference materialThis document will assist applicants completing the Bioequivalence Study Information Form (BSIF) for inclusion in an application for a new prescription generic medicine.