COVID
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307 result(s) found, displaying 1 to 10
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PageTo enable timely distribution of COVID-19 treatments, international labels may be used during initial supply in Australia.
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PageInformation for sponsors and manufacturers wishing to make label claims of efficacy against COVID-19 for products that are either hard surface disinfectants or disinfectants that are medical devices.
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PageBatch release testing of biological medicines (excluding vaccines) is no longer required.
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PageCOVID-19 treatments that have provisional approval for use in Australia.
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PageCOVID-19 treatments undergoing evaluation for provisional registration by the TGA.
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PageCOVID-19 vaccines undergo evaluation for provisional and full registration by the TGA.
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PageCOVID-19 vaccine batch release information is now available
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GuidanceGuidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.
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GuidanceInformation to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.
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GuidanceGuidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.