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630 result(s) found, displaying 51 to 75
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User guideA step-by-step guide for Australian manufacturers of therapeutic goods.
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FormsThis form collects information about the legal entity making applications under the Therapeutic Goods Act 1989.
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User guideInformation to assist medical practitioners in submitting AP applications via the online system
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E1; CPMP/ICH/375/95
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User guideFrom 14 September 2020, we will publish all notifications of shortages for reportable medicines on the Medicine Shortages Reports Database
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/EWP/2330/99
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User guideThe Special Access Scheme (SAS) & Authorised Prescriber (AP) scheme Online System (SAS & AP online system) is the preferred method of submission for SAS applications and notifications.
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Compositional guidelinesCompositional guideline for 'Conifer phytosterol complex' permitted for use in listed medicines
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FormsTransfers of conformity assessment certificates.
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International scientific guidelines adopted in AustraliaAccess European Union guidelines adopted in Australia that are related to complementary medicines.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/BPWG/2220/99
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User guideNotifying us of any medical device Conformity Assessment certification lapse is a legal requirement.
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User guideStep by step guide to submitting a Custom-Made Medical Device (CMMD) notification.
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FormsApplication form to apply for biologicals (priority applicant) determination
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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 guideThis user guide is for sponsors wanting to submit GMP clearance application by the TGA Business services (TBS) portal.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - CPMP/QWP/159/01; EMEA/CVMP/271/01
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FormsInformation and links to the application to import or export a therapeutic good that is mercury form.
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FormsThe completed assurances form is required in Module 1.5 of your OTC new medicine N1 application
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/CPWP/83508/2009
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FormsThe Pre-submission Planning Form (PPF) provides the TGA with the necessary information on the scope and scale of application to arrange appropriate resourcing for the processing and evaluation of an application.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BMWP/403543/2010
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMEA/CHMP/VWP/164653/2005.
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FormsThis form is to be submitted with the expression of interest when applying for membership to a TGA expert committee.