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716 result(s) found, displaying 1 to 25
- PublicationsCost Recovery Implementation Statement, 2022-2023Updated Cost recovery implementation statement for 2022-2023
- PublicationsMedicines Safety UpdateMedicines Safety Update (MSU) provides health professionals with practical information and advice on drug safety and information about emerging safety issues.
- PublicationsReference guide for managing conflicts of interest – for TGA advisory committee membersHow TGA advisory committees manage members conflicts of interests.
- Scheduling decisions (final)Notification of amendments to the Poisons Standard in relation to Delegate-only final decisions and New Chemical Entities (NCEs), September 2022Notification of amendments to the Poisons Standard in relation to Delegate-only final decisions and New Chemical Entities (NCEs), September 2022
- PublicationsIndependent expert panel reportThis report was commissioned by the TGA in response to concerns of increasing prevalence of intentional paracetamol poisoning, especially among young people, and involving paracetamol obtained via general sale in supermarkets and convenience stores.
- Meeting statementsACMD meeting statement, Meeting 67, 9 June 2022Advisory Committee on Medical Devices (ACMD) meeting statement, Meeting 67, 9 June 2022
- PublicationsManufacturing principles for medicinal productsPIC/S Guide to Good Manufacturing Practice for Medicinal Products
- Meeting statementsACMD meeting statement, Meeting 68, 11 August 2022Advisory Committee on Medical Devices meeting statement, Meeting 68, 11 August 2022
- Meeting statementsACV Meeting Statement, Meeting 33, 20 May 2022Advisory Committee on Vaccines, Meeting 33, 20 May 2022
- Meeting statementsACV Meeting Statement, Meeting 32, 22 March 2022Advisory Committee on Vaccines, Meeting 32, 22 March 2022
- Scheduling decisions (interim)Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS #37 ACCS #33 Joint ACMS-ACCS #30 - March 2022Public notice of interim decisions in response to advice received from the March 2022, ACMS #37 , ACCS #33 , Joint ACMS-ACCS #30. Closing date: 15 September 2022
- PublicationsTherapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran) Labelling Exemption 2022This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- PublicationsTherapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2022This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- PublicationsTherapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2022This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- PublicationsApplication audit (technical file review) of IVD medical device applicationsPrepare for a technical file review as part of your application to include an in vitro medical device in the Australian Register of Therapeutic Goods.
- PublicationsDirection about advertisements: 13 Vape Pty LtdThe TGA has issued a direction notice to 13 Vape Pty Ltd and an executive officer to cease promoting the use and supply of nicotine vaping products to Australian consumers.
- PublicationsTherapeutic Goods (Poisons Standard) (Benzylpenicillin - Seqirus) Exemption 2022This labelling exemption is granted under section 1.1(3) of Part 2 of the current Poisons Standard.
- PublicationsCost Recovery Implementation Statement, V1.0 July 2022This Cost Recovery Implementation Statement (CRIS) provides information on how the TGA, within the Department of Health, implements and cost recovers its regulatory activities.
- Meeting statementsMedical device reforms: Consumer Working Group meeting statement, Meeting 7, 4 May 2022Meeting statement from meeting 7 of the MDCWG.
- PublicationsAustralian Dental Sector Working Group, Meeting statement, Meeting 4, 31 March 2022A meeting statement from the fourth meeting of the Dental Sector Working Group is now available.
- PublicationsDirection about advertisements: Precision Pharmaceuticals Pty LtdDirection Notice issued to cease advertisement of prescription and illegal products
- Meeting statementsACCM meeting statement, Meeting 29, 17 March 2022Advisory Committee on Complementary Medicines meeting statement for 17 March 2022
- Scheduling decisions (final)Notice of final decisions to amend (or not amend) the current Poisons Standard - ACMS #36, Joint ACMS-ACCS #29, ACCS #32Notification of final decisions in relation to matters considered at ACMS #36, ACCS #32 and Joint ACMS-ACCS #29 (November 2021).
- Scheduling decisions (final)Notice of final decision to amend (or not amend) the current Poisons Standard in relation to isothiazolinones, methylisothiazolinone and methylchloroisothiazolinoneFinal decision on proposed amendments to the Poisons Standard relating to isothiazolinones, methylisothiazolinone and methylchloroisothiazolinone