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What's new
114 result(s) found, displaying 51 to 75
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PageYou can access unapproved therapeutic goods in certain circumstances. Find out who can apply, what you can access and what to do before you apply.
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Advertising permissionApproval under section 42DF for use of restricted representations by Boston Scientific Pty Ltd
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PageSearch for infringement notices whereby a financial penalty may be issued in response to certain breaches of the Therapeutic Goods Act 1989 (the Act).
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Market actionsMedifab is conducting a product correction for the KayserBetten Safe Surround Genie Bed.
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Media releasesWe have issued 12 infringement notices totalling $126,720 to 2 companies and 5 individuals for the alleged unlawful importation and advertising of prescription-only medicines.
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PageHow to submit data in the Electronic Common Technical Document (eCTD) format.
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PageHow to submit applications, reports and documentation in the electronic common technical document (eCTD) and non-eCTD electronic submission (NeeS) formats.
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DatasetView annual charge exemptions (ACE) based on a sponsor declaring $0 turnover.
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ConsultationWe would like your feedback on our proposal to improve information sharing about the safety, quality and performance of medical devices.
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PageThis page contains a list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia. Healthcare practitioners can use this list when prescribing and supplying unapproved therapeutic vaping goods as they have been notified as complying with applicable standards.
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DatasetRefer to our database of consents to import, supply or export therapeutic goods that do not comply with standards.
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PageKey information and updates about the shortage of Creon (pancreatic extract) capsules.
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Market actionsConsumers are advised that the medicines listed below containing Andrographis paniculata (Andrographis) are being recalled due to the risk of severe allergic reactions.
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Regulatory decision noticesThis consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.
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Medicine shortage alertsSerious Scarcity Substitution Instrument allows pharmacists to dispense 180 mg capsules without a new prescription.
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PageHow we work with other regulators and organisations.
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PageThis document supports UDI awareness and adoption in Australian healthcare settings.
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PageSerious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.
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PageThe Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories.
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Advertising permissionThis instrument is made under section 42DK of the Therapeutic Goods Act 1989.
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PageUnderstand the benefits of UDI in healthcare and how healthcare organisations can prepare for and adopt UDI.
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PageUnique Device Identification (UDI) webinars cover a range of topics including introductory UDI information, adoption in healthcare and software support for UDI.
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PageKey information about the shortage for patients, carers and health care professionals
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PageYou can access unapproved therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG) in limited circumstances. You must speak to a health practitioner first.
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Prescription medicine decision summaryAujemflu (influenza virus haemagglutinin) has been approved for active immunisation against influenza in persons 50 years of age and older.