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889 result(s) found, displaying 476 to 500
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Reference materialProvides guidance for sponsors on the regulatory requirements for medicine presentation for listed medicines
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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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Reference materialUpdated information on using and buying hand sanitisers
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User guideThis user guide outlines how to communicate effectively with consumers using the revised Consumer Medicine Information (CMI) template
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User guideThis user guide provides guidance about preparing the summary page for Consumer Medicine Information (CMI) documents.
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Reference materialWe have identified disinfectants as being critical in preventing the spread of COVID-19
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Reference materialThere is significant interest from potential sponsors and manufacturers to understand how disinfectants are regulated and how to supply them
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User guideA user guide for evaluations of substance for use in listed medicines and assessed listed medicines.
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Reference materialTGA approves reduction of the deferral period for blood and plasma donors with sexual activity risk factors
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Reference materialAll collection swabs are medical devices and must be included in the ARTG
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Reference materialThis is the first package of regulatory changes for the broader medical device reforms
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User guideCheck out our user guide to assist sponsors when using the code tables for GMP Clearance applications.
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ChecklistsComplete this questionnaire prior to submitting your GMP clearance application and upload it as part of your evidence package on your TGA ebusiness services portal
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User guideStep by step user guide on submitting applications to register a complementary medicine (RCM) or over the counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG) in the TGA Business services (TBS).
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FormsSponsors should note that the Bioequivalence Study Information Form (BSIF) has been amended
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Reference materialIf an ingredient name is not on the approved list, you can submit a proposal for it to be included
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Reference materialCovers the general principles of advertising requirements for therapeutic goods and includes two case studies
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Reference materialCovers the general principles of post-market monitoring requirements for therapeutic goods and includes a case study
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Reference materialProvides an overview of therapeutic goods regulation, TGA's role and sponsor responsibilities when supplying therapeutic goods in Australia
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Reference materialCovers the general principles of manufacturing requirements for therapeutic goods and includes a case study
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Reference materialCovers the general principles of market authorisation and the process of getting approval to supply a therapeutic good
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FormsThis form guides you through the classification of biologicals and captures sufficient information about your product for us to provide advice
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Reference materialGuidance for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines