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Reference materialThe TGA has published updated Australian Regulatory Guidelines for Sunscreens
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/600958/2010/Corr.*
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User guideFinished product (medicine) analytical procedure validations for complementary medicines.
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Reference materialUpdate to TGA's conditions and advertising requirements for COVID-19 rapid point-of-care tests.
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Reference materialSME Assist's 'Meeting Your Obligations' workshop - Live stream - 22 October 2020 has now been published.
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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 guideInstructions for applicants on how to organise and fill out a pre-submission planning form (PPF).
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Reference materialWe have published updated guidance for OTC medicines to better assist applicants to register or make a change to a registered 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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Reference materialDefinitions of terms and links to other information about the regulation of IVDs.
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Reference materialUpdate about the transitionary arrangements for reformatting Product Information, including accessing a fee waiver
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FormsInformation and forms about applications for TGA conformity assessment certificates.
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Reference materialTo enable timely distribution of COVID-19 vaccines, international labels are being used during the initial global rollout, including in Australia.
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Reference materialAnswers to frequently asked questions in relation to rapid antigen point-of-care tests.
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Reference materialThe purpose of this guidance is to assist applicants compile a literature based submission (including mixed applications), and replaces the previous TGA guidance: Literature-Based Submissions - Points to consider (2003).
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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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FormsPlease include this form in CTD Module 1.5 of your application dossier.
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Compositional guidelinesCompositional Guideline for Theanine permitted for use in listed medicines.
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Compositional guidelinesCompositional Guideline for calcium fructoborate tetrahydrate permitted for use in listed medicines.
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Reference materialGuidance for advertising - claims such as 'TGA approved' must not be used in advertisements for therapeutic goods.
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Reference materialThe standards have been remade and revised guidance published.
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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 materialUpdated questions and answers