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334 result(s) found, displaying 51 to 75
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Regulatory decision noticesThis instrument is made under subsections 19(5AA), 32CM(1A) and 41HC(1A) of the Therapeutic Goods Act 1989.
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Therapeutic Goods (Special Access Scheme - Application and Notification Forms) Approval (No. 2) 2024
Regulatory decision noticesThis instrument is made under the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Act 1989. -
Safety updatesTCMs sold in Australia are carefully regulated to ensure safety and quality.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Regulatory decision noticesMRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.
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Regulatory decision noticesThis instrument is made under section 39 of the current Poisons Standard.
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Regulatory decision noticesThis instrument is made under section 39 of the current Poisons Standard.
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Regulatory decision noticesWe are providing a 12-month period of labelling exemptions for signal words for certain Pharmacy medicine and Pharmacist Only medicine products.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Safety updatesHealth professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age.
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Safety updatesWe have received Australian reports of Guillain-Barré Syndrome (GBS) following Shingrix vaccination.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Regulatory decision noticesFind out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) which commenced on 27 September 2024.
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Regulatory decision noticesThis instrument is made under section 39 of the current Poisons Standard.
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Regulatory decision noticesSummary of Changes made to transition eCTD AU Module-1 v3.1 to eCTD AU Module-1 v3.2
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Regulatory decision noticesThis instrument is made under the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Regulatory decision noticesThis instrument is made under regulations 10AC, 10FA and 10HA of the Therapeutic Goods Regulations 1990.
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Regulatory decision noticesThis instrument is made under regulations 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990.
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Regulatory decision noticesFind out about our position on Messenger RNA (mRNA) technology.
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Safety updatesAn updated warning about the risk of sudden cardiovascular death has been added to the Product Information and Consumer Medicine Information documents for azithromycin.
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Regulatory decision noticesInformation for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates.
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Safety updatesInformation for health professionals about medicines with safety related updates to their Product Information.
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Regulatory decision noticesSix monthly report – supply of unapproved therapeutic goods by a sponsor.