Robuta

https://www.tga.gov.au/resources/resources/forms/application-amend-poisons-standard Application to amend the Poisons Standard | Therapeutic Goods Administration (TGA) Apr 17, 2026 - The application form to amend the current Poisons Standard. therapeutic goodsapplicationamendpoisonsstandard https://www.tga.gov.au/resources/plant-preparations Plant preparations | Therapeutic Goods Administration (TGA) Feb 2, 2026 - Find approved terminology for herbal ingredient plant preparations. therapeutic goodsplantpreparationsadministrationtga https://apps.tga.gov.au/Prod/msi/Search/Details/pemetrexed%20disodium?sort=tradename Medicine Shortages Information Initiative | Therapeutic Goods Administration (TGA) The Medicine Shortages Information Initiative provides information about prescription medicine shortagestherapeutic goodsinformationinitiativeadministration https://www.legislation.gov.au/F2022L00100/latest/text Therapeutic Goods (Advisory Committee Meetings) (Information) Specification 2022 - Federal Register... advisory committee meetingstherapeutic goodsinformationspecificationfederal https://www.legislation.gov.au/F2002B00237/2025-03-25/text Therapeutic Goods (Medical Devices) Regulations 2002 - Federal Register of Legislation therapeutic goodsmedical devicesfederal registerregulationslegislation https://www.tga.gov.au/news/committee-meetings/joint-acms-accs-meeting-25-june-2020 Joint ACMS-ACCS meeting #25, June 2020 | Therapeutic Goods Administration (TGA) Oct 24, 2025 - The 25th meeting of the Advisory Committees on Medicines Scheduling and Chemicals Scheduling (Joint ACMS-ACCS #25), June 2020. therapeutic goodsjointacmsaccsmeeting https://www.tga.gov.au/products/medicines/assessed-listed-medicines/monitoring-and-compliance Monitoring and compliance for assessed listed medicines | Therapeutic Goods Administration (TGA) Oct 29, 2025 - Understand your ongoing post-market responsibilities for assessed listed medicines. monitoring and compliancetherapeutic goodsassessed https://www.tga.gov.au/resources/explore-topic/cosmetics Cosmetics | Therapeutic Goods Administration (TGA) May 15, 2026 - We do not assess cosmetics unless they make therapeutic claims. The ingredients in cosmetics are regulated as industrial chemicals. therapeutic goodscosmeticsadministrationtga https://soterixmedical.com/newsroom/press/2017/07/soterix-medical-receives-therapeutic-goods/29 Soterix Medical receives Therapeutic Goods Administration Approval for Major Depression Treatment... Soterix Medical is the world leader in non-invasive neuromodulation and brain stimulation technology. Researchers and clinicians choose Soterix Medical devices... therapeutic goodsmajor depressionmedicalreceives https://consultations.tga.gov.au/tga/gmp-forum-survey/consult_view/ GMP Forum 2018 - Survey - Therapeutic Goods Administration - Citizen Space This site lists consultations that are run by the Therapeutic Goods Administration and the Office of Drug Control. On this site you can find, share or take... therapeutic goodsgmpforumsurveyadministration https://www.legislation.gov.au/F2019L01352/2020-11-30/details Therapeutic Goods (Declared Goods) Order 2019 - Federal Register of Legislation therapeutic goodsfederal registerdeclaredorderlegislation https://www.legislation.gov.au/F1999B00330/asmade/downloads Therapeutic Goods Amendment Regulations 1999 (No. 3) - Federal Register of Legislation therapeutic goodsfederal registeramendmentregulations https://www.tga.gov.au/about-us/using-our-website Using our website | Therapeutic Goods Administration (TGA) Oct 18, 2025 - Find out how you can use our web content and how we handle your information. using our websitetherapeutic goodsadministrationtga https://www.tga.gov.au/resources/auspmd/trikafta Trikafta | Therapeutic Goods Administration (TGA) Nov 28, 2025 - Australian prescription medicine decision summary therapeutic goodstrikaftaadministrationtga https://www.tga.gov.au/news/media-releases/therapeutic-goods-administration-new-website Therapeutic Goods Administration - new website | Therapeutic Goods Administration (TGA) Jan 28, 2026 - Therapeutic Goods Administration therapeutic goodsnew websiteadministrationtga https://www.legislation.gov.au/F2019L00050/latest/text Therapeutic Goods (Advertising Complaints and Investigations Information) Specification 2019 -... complaints and investigationstherapeutic goodsadvertisinginformationspecification https://www.legislation.gov.au/F2021L01661/latest/text Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 - Federal Register of... therapeutic goodsfederal registeradvertisingcodeinstrument https://ablis.business.gov.au/service/ag/therapeutic-goods-advertising-code-tgac-/30930 Therapeutic Goods Advertising Code (TGAC) - AG - Australian Business Licence and Information Service ABLIS helps you find the government licences, permits, approvals, registrations, codes of practice, standards and guidelines you need to know about to meet... therapeutic goods https://www.legislation.gov.au/F2002B00237/2020-02-01/text Therapeutic Goods (Medical Devices) Regulations 2002 - Federal Register of Legislation therapeutic goodsmedical devicesfederal registerregulationslegislation https://www.legislation.gov.au/F2024L01453/latest/versions Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Instrument 2024 -... therapeutic goodsseriousscarcitymedicineestradiol https://www.tga.gov.au/news/safety-updates/new-safety-warnings-isotretinoin-roaccutane New safety warnings for isotretinoin (Roaccutane) | Therapeutic Goods Administration (TGA) Nov 5, 2025 - Updates further highlight potential risks of mood-related changes and sexual disorders. safety warningstherapeutic goodsnewisotretinoinroaccutane https://www.legislation.gov.au/F2002B00237/latest/text Therapeutic Goods (Medical Devices) Regulations 2002 - Federal Register of Legislation therapeutic goodsmedical devicesfederal registerregulationslegislation https://www.tga.gov.au/resources/sponsor?page=36 Sponsors | Therapeutic Goods Administration (TGA) Nov 11, 2025 - Search our sponsor database to view the regulatory activities for each sponsor. therapeutic goodssponsorsadministrationtga https://www.tga.gov.au/resources/industry-guidance-and-resources/tga-learn/online-education-events/webinars/gmp-clearance-common-deficiencies GMP clearance - Common deficiencies | Therapeutic Goods Administration (TGA) Jan 25, 2025 - Examples of GMP clearance applications common deficiencies. therapeutic goodsgmpclearancecommondeficiencies https://www.tga.gov.au/safety/safety-monitoring-and-information/medicine-monitoring-guidelines-and-safety-reviews/pharmacovigilance-inspection-program Pharmacovigilance Inspection Program | Therapeutic Goods Administration (TGA) Apr 23, 2026 - An initiative to help sponsors of medicines meet their pharmacovigilance obligations. inspection programtherapeutic goodspharmacovigilanceadministrationtga https://paperform.co/templates/australian-therapeutic-goods-advertising-complaint-form/ Australian Therapeutic Goods Advertising Complaint Form Template | TGA Submission | Paperform Professional TGA complaint form for reporting non-compliant therapeutic goods advertising in Australia. Capture product details, evidence, and regulatory... therapeutic goodscomplaint formaustralianadvertisingtemplate https://www.legislation.gov.au/F2010L02771/asmade/downloads Therapeutic Goods Amendment Regulations 2010 (No. 4) - Federal Register of Legislation therapeutic goodsfederal registeramendmentregulations https://legislation.act.gov.au/di/2021-207/ Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2021 (No 3) |... therapeutic goods https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub Unique Device Identification (UDI) hub | Therapeutic Goods Administration (TGA) May 4, 2026 - A collection of information about the implementation of medical devices Unique Device Identification (UDI). unique device identificationudi hubtherapeutic goodsadministrationtga https://www.tga.gov.au/about-us/international-engagements/australia-canada-singapore-switzerland-united-kingdom-access-consortium/access-consortium-biosimilars-work-sharing-initiative Access Consortium Biosimilars work-sharing initiative | Therapeutic Goods Administration (TGA) Oct 20, 2025 - New Biosimilars work sharing initiative through Access Consortium. work sharingtherapeutic goodsaccessconsortiumbiosimilars https://www.tga.gov.au/news/committee-meetings/joint-acms-accs-meeting-18-march-2018 Joint ACMS-ACCS meeting #18, March 2018 | Therapeutic Goods Administration (TGA) Oct 24, 2025 - The 18th joint meeting of the Advisory Committees on Medicines Scheduling and Chemicals Scheduling (Joint ACMS-ACCS #18), March 2018. therapeutic goodsjointacmsaccsmeeting https://simple.wikipedia.org/wiki/Regulation_of_therapeutic_goods?action=edit&redlink=1 Creating Regulation of therapeutic goods - Simple English Wikipedia, the free encyclopedia therapeutic goodssimple englishcreatingregulation https://www.tga.gov.au/resources/auspmd/abrysvo-rsv-vaccine Abrysvo (RSV vaccine) | Therapeutic Goods Administration (TGA) Nov 27, 2025 - Abrysvo (recombinant respiratory syncytial virus pre-fusion F protein bivalent vaccine) was approved for the prevention of lower respiratory tract disease... rsv vaccinetherapeutic goodsadministrationtga https://www.legislation.gov.au/F2023L00122/asmade Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023 - Federal Register of... therapeutic goodsfederal registeringredientsdetermination https://www.tga.gov.au/resources/artg/484717 BRIVARACETAM DR REDDY'S brivaracetam 50 mg tablet blister pack (484717) | Therapeutic Goods... Apr 22, 2026 - Australian Register of Therapeutic Goods (ARTG) information for BRIVARACETAM DR REDDY'S brivaracetam 50 mg tablet blister pack. dr reddy https://www.tga.gov.au/resources/publication/scheduling-decisions-final/final-decisions-and-reasons-nces-medicines-and-chemicals-november-2018 Final decisions and reasons for NCEs, medicines and chemicals, November 2018 | Therapeutic Goods... Oct 24, 2025 - Final decisions and reasons for NCEs and medicines and chemicals referred to the November 2018 scheduling meetings (ACMS #25, ACCS #23 and Joint ACMS-ACCS #20). final decisions https://www.legislation.gov.au/F2011L01492/latest/versions Therapeutic Goods Order No. 86 Standards for human skin (08/07/2011) - Federal Register of... https://www.tga.gov.au/safety/recalls-and-other-market-actions/procedure-recalls-product-alerts-and-product-corrections-prac Procedure for recalls, product alerts and product corrections (PRAC) | Therapeutic Goods... Feb 24, 2026 - Information for sponsors conducting market actions for therapeutic goods in Australia. product alertsprocedurerecallscorrectionsprac https://www.tga.gov.au/resources/resources/forms/module-121-assessed-listed-medicine-general-application-information-form Module 1.2.1: Assessed listed medicine general application information form | Therapeutic Goods... Oct 10, 2025 - The Module 1.2.1: Assessed listed medicine general application information form must be completed in conjunction with the Assessed listed medicines application... medicine general https://www.tga.gov.au/resources/guidance/understanding-regulation-autologous-human-cell-and-tissue-hct-products Understanding regulation of autologous human cell and tissue (HCT) products | Therapeutic Goods... Oct 22, 2025 - Guidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation. cell and tissue https://www.tga.gov.au/news/blog/what-do-i-need-do-if-my-medicine-or-medical-device-recalled What do I need to do if my medicine or medical device is recalled? | Therapeutic Goods... Feb 27, 2026 - Therapeutic goods can sometimes have problems. When they do, we decide if a market action is needed to fix the issue. There are four types of market actions. what do i need https://www.tga.gov.au/products/regulations-all-products/tga-reforms/medical-devices-reforms/medical-device-reforms-comparable-overseas-regulator-marketing-approvals Medical device reforms: comparable overseas regulator marketing approvals | Therapeutic Goods... Mar 17, 2026 - Marketing approvals and certificates from comparable overseas regulators can be considered for TGA approvals. medical devicereformscomparableoverseasregulator https://www.tga.gov.au/resources/artg/66962 RELENZA ROTADISKS zanamivir 5mg insufflation blister pack (66962) | Therapeutic Goods... Dec 12, 2025 - Australian Register of Therapeutic Goods (ARTG) information for RELENZA ROTADISKS zanamivir 5mg insufflation blister pack. blister packzanamivirinsufflationtherapeuticgoods https://www.legislation.gov.au/F2023L01088/latest/details Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 - Federal Register of... https://www.legislation.gov.au/Series/F2017L00286 Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 - Federal Register of...