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758 result(s) found, displaying 676 to 700
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Reference materialGuidance on European Union guidelines for complementary medicine sponsors in Australia.
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User guideFinished product (medicine) analytical procedure validations for complementary medicines.
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FormsA list of TGA forms for prescription medicine sponsors.
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Reference materialSearch the Code Tables for codes needed to apply for good manufacturing practice (GMP) clearance.
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FormsUse this form to apply for an Approved Biological Name.
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FormsUse this form to report suspected adverse reactions to vaccines and prescription, over-the-counter and complementary medicines.
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Reference materialThis document will assist applicants completing biowaiver templates for inclusion in an application for a new prescription generic medicine.
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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.
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Reference material
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Reference materialDocuments released under Section 11C of the Freedom of Information Act 1982, Jul 2014 to Jun 2015
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Reference materialWe may decide to seek advice from an expert advisory committee during the evaluation of an application to register or change an over-the-counter (OTC) medicine
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User guideThe cover letter (letter of application) needs to provide useful information regarding the nature and scope of the application
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User guideHow to search TGA business services for approved ingredients and accepted TGA terminology.
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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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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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FormsComplete this form when submitting a new DMF to TGA, or when updating an existing DMF already held by the TGA.
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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 TGA will be initiating targeted compliance reviews of selected listed medicines to evaluate evidence held to support indications related to exercise performance.
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FormsApplication form to apply for biologicals (priority applicant) determination
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/INS/GCP/856758/2018
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International scientific guidelines adopted in AustraliaCOMP/431/01 adopted by the Therapeutic Goods Administration (TGA)