Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
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TGA Commences Evaluation Moderna Covid 19 Vaccine Spikevax Potential Transition Full Registration
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TGA Grants Provisional Approval Pfizers Covid 19 Bivalent Comirnaty Originalomicron BA4 5 Covid 19 Vaccine Booster Dose Vaccine
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Covid 19 Vaccine Safety Report 27 01 2023
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Changes Applying Evaluation NEW Substances Listed Medicines
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Product Information Safety Updates January 2023
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Mode Medical PTY LTD AND Executive Officer Fined Almost 160000 Alleged Unlawful Advertising Intravenous Infusion Products
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Caveman Nutrition PTY LTD Cave Nutrition Store PTY LTD AND Their Director Fined 208000 Alleged Unlawful Advertising Sports Supplements Containing Dangerous Substances
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Jshealth Vitamins PTY LTD Fined 13320 Alleged Unlawful Supply Complementary Medicine
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TGA Confirms Performance Australian Approved Rapid Antigen Tests Covid 19 Variants
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TGA Makes Interim Decision Reduce Maximum Paracetamol Pack Sizes
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Change Classification Psilocybin AND Mdma Enable Prescribing Authorised Psychiatrists
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Direction About Advertisements Melbourne Based Individual
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Avoid Prescribing Pregabalin Pregnancy IF Possible
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Covid 19 Vaccine Safety Report 09 02 23
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Daen Medicines Update
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Sport Supplement Suppliers Check Products Latest Wada Banned Substances
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TGA Grants Provisional Approval Modernas Covid 19 Bivalent Spikevax Bivalent Originalomicron BA4 5 Booster Dose Vaccine
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Covid 19 Vaccine Safety Report 23 02 2023
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Pholcodine Cough Medicines Cancelled TGA AND Recalled Pharmacies Safety Reasons
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Consumers Warned About Ozempic Scams
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Update Effectiveness Monoclonal Antibodies Against Covid Variants
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Product Information Safety Updates February 2023
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TGA Seizes More 55000 Potentially Dangerous Products Assistance NSW Police
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Covid 19 Vaccine Safety Report 09 03 2023
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Australian Manufacturer Fined Almost 160000 Allegedly Breaching Conditions ITS Medicines Manufacturing Licence
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Jshealth Vitamins Fined 13320 Alleged Unlawful Supply Complementary Medicine
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Check Pholcodine USE General Anaesthesia
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GMP Clearance Additional Countries Added MRA Pathway
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Lapse Provisional Registration Tecentriq Atezolizumab Treatment Locally Advanced OR Metastatic Triple Negative Breast Cancer Mtnbc
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Covid 19 Vaccine Safety Report 23 03 2023
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Update Listed Medicine Ingredients March 2023
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Update Listed Medicine Ingredients November 2022
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Update Listed Medicine Ingredients January 2022
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Update Listed Medicine Ingredients April 2022
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Update Listed Medicine Ingredients November 2019
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Update Listed Medicine Ingredients October 2021
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Update Listed Medicine Ingredients March 2022
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Update Listed Medicine Ingredients August 2022
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Update Listed Medicine Ingredients August 2021
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Update Listed Medicine Ingredients March 2021
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Update Listed Medicine Ingredients December 2020
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Update Listed Medicine Ingredients August 2020
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Update Listed Medicine Ingredients June 2020
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Update Listed Medicine Ingredients March 2020
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Update Listed Medicine Ingredients June 2019
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Tgas NEW Powers Will Help Reduce Impact Medicine Shortages Patients
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Product Information Safety Updates March 2023
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Company Director Sentenced 2 Years Imprisonment Personal AND Company Fines Over 25 Million Selling Illegal Sarms
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Understanding Changes Mdma AND Psilocybin Access
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Update Listed Medicine Ingredients December 2019
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Changes Medical Device Essential Principles Nanomaterials
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Dual Labelled Medicines Begin Transition Sole Medicine Ingredient Names Soon
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Covid 19 Vaccine Safety Report 06 04 23
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First Mpox Monkeypox Test KIT Approved Australia
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Update Listed Medicine Ingredients MAY 2023
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Therapeutic Goods Poisons Standard Covid 19 Vaccine Moderna Elasomeran AND Davesomeran Labelling Exemption 2023
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Therapeutic Goods Biologicals Application Form Priority Applicant Determinations Approval 2022
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Covid 19 Vaccine Safety Report 20 04 23
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Therapeutic Goods Medical Devices Application Form Priority Applicant Determinations Approval 2020
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Therapeutic Goods Poisons Standard Covid 19 Vaccine Pfizer Tozinameran AND Famtozinameran Labelling Exemption 2023
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Therapeutic Goods Poisons Standard Benzylpenicillin Seqirus Exemption 2022
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Therapeutic Goods Application Form Conformity Assessment Body Determination Approval 2021
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Therapeutic Goods Poisons Standard Covid 19 Vaccine Moderna Labelling Exemption 2021
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Therapeutic Goods Poisons Standard Covid 19 Treatment Glaxosmithkline Sotrovimab Labelling Exemption 2021
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Approval Forms Requests Under Subsection 9D3 Therapeutic Goods ACT 1989 Vary Entry Australian Register Therapeutic Goods Registered Therapeutic Goods
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Therapeutic Goods Poisons Standard Covid 19 Treatment Gilead Remdesivir Labelling Exemption 2021
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Therapeutic Goods Poisons Standard Covid 19 Vaccine Moderna Elasomeran Labelling Exemption 2022
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Therapeutic Goods Poisons Standard Covid 19 Treatment Glaxosmithkline Sotrovimab Labelling Exemption 2022
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Therapeutic Goods Poisons Standard Covid 19 Treatment Gilead Remdesivir Labelling Exemption 2022
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Therapeutic Goods Poisons Standard Covid 19 Vaccine Pfizer Labelling Exemption 2021
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Therapeutic Goods Provisional AND Priority Determinations AND Orphan Drug Designations Approval Application Form
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Infringement Notices Totalling 66600 Given Three Sydney Based Companies AND TWO Individuals Alleged Unlawful Importation Nicotine Vaping Products
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Therapeutic Goods Complementary Medicines Section 26ae Listing Approval Application Form AND Specification Office Which Application Must BE Delivered
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Therapeutic Goods Provisional Determinations AND Orphan Drug Designations Extension Approval Application Form
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Therapeutic Goods Medicines Listing Approval Application Forms AND Specification Office Which Application Must BE Delivered
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Therapeutic Goods Complementary Medicines Registration Approval Application Forms AND Specification Office Which Application Must BE Delivered
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Therapeutic Goods Microbiological Standards Medicines TGO 100 Order 2018
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Therapeutic Goods Orders Repeal Instrument 2019
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Therapeutic Goods Materials OR Articles ARE NOT Medical Devices Order 2019
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Therapeutic Goods Groups Order NO 1 2001
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Therapeutic Goods Poisons Standard Covid 19 Vaccine Astrazeneca Labelling Exemption 2021
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Direction About Advertisements 13 Vape PTY LTD
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Instrument Arrangement USE Computer Program Make Decisions November 2017
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Direction About Advertisements Precision Pharmaceuticals PTY LTD
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Therapeutic Goods Adverse Events Management System Adverse Events Following Immunisation Arrangement Computer Programs Instrument 2022
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Direction About Advertisements Evolution Supplements
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Therapeutic Goods Medical Devices Arrangement Computer Programs Instrument 2020
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Direction About Advertisements Auzsupps PTY LTD
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Therapeutic Goods International Agreements Notice Prohibition Minamata Convention Mercury Instrument 2021
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Therapeutic Goods Permissible Ingredients Application Variation Approval 2023
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Direction About Advertisements ESR YOU PTY LTD
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Direction About Advertisements MR David Leyonhjelm
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Direction About Advertisements Peter Daryl Evans AND Peter Evans Chef PTY LTD
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Therapeutic Goods Foreign Countries AND Foreign Jurisdictions Determination 2019
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Approval Form Which Information Sufficient Determination Applications Made Under Section 23 Therapeutic Goods ACT 1989 Registration Therapeutic Goods
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Therapeutic Goods Articles ARE NOT Medical Devices Order NO 1 2010
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Therapeutic Goods Groups Order NO 1 1992
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Therapeutic Goods Articles ARE NOT Medical Devices Order NO 2 2004
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Therapeutic Goods Single Therapeutic Goods Order NO 1 1991
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Modernas Covid 19 Vaccine Spikevax Receives Approval Full Registration
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Surveys Medical Devices Manufactured Point Care
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TGA Makes Final Decision Reduce Paracetamol Pack Sizes
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Removal Prescribing Restrictions Ivermectin
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Covid 19 Vaccine Safety Report 04 05 23
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Live Vaccines What ARE Contraindications
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Direction About Advertisements CAT Media PTY LTD
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EU MDR Transition Extension
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TGA Publishes Updated Guidelines Sunscreens
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Important Safety Information Janus Kinase JAK Inhibitors
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TGA Targets Unlawful Importation Prescription Medicines
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Updates Prescribing Medicines Pregnancy Database MAY 2023
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GMP Clearance Extension Processing Times
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Covid 19 Vaccine Safety Report 18 05 2023
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Update Listed Medicines Indications November 2019
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Update Listed Medicines Indications January 2021
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Instrument Arrangement USE Computer Program Make Decisions July 2018
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Therapeutic Goods Adverse Event Management System Sponsors Arrangement Computer Programs Instrument 2023
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Queensland Individual Fined Nearly 16000 After Allegedly Importing Unregistered Nicotine Vaping Products
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Phase OUT ISO 13485 Certificates IVD Medical Devices
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Lifeblood Sexual Activity AND Prep Deferrals
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HOW Find OUT Whats Your Medicine
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Covid 19 Vaccine Safety Report 01 06 2023
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2023 Seasonal Influenza Vaccines
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Oral Anticoagulants CAN Cause Serious Kidney Damage Rare Circumstances
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TGA Supports Mhras NEW International Recognition Framework Medicines
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DO YOU Read Label Every Time
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Product Information Safety Updates April AND MAY 2023
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Affinity Corp Australia PTY LTD Fined 66600 Alleged Unlawful Advertising Medicinal Cannabis Products
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Infringement Notices Totalling 588840 Issued Three Sydney Based TSG Stores AND Jaradat AND Sabbagh Group PTY LTD
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Pracmed Healthcare PTY LTD Fined 39960 Alleged Unlawful Advertising
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Covid 19 Vaccine Safety Report 15 06 2023
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NEW Guidance Published Manufacturer Evidence IVD Medical Devices
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Product Information Safety Updates June 2023
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Update Listed Medicine Ingredients July 2023
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Covid 19 Vaccine Safety Report 29 06 2023
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Update Mdma AND Psilocybin Access AND Safeguards 1 July 2023
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Deadline Certain Medical Device Reforms BE Extended
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Nitrosamine Risk Assessment Category 1 Prescription Medicine Registration Applications
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Icmra Statement Safety Covid 19 Vaccines
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Amendments Restrictions Prescribing MS 2 Step Mifepristone AND Misoprostol
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Natures Puff PTY LTD AND Director Fined 105600 Alleged Unlawful Advertising Nicotine Vaping Products
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Covid 19 Vaccine Safety Report 13 07 2023
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Vaping Products Medicinal Cannabis AND Wellness Industry Included 2023 24 Compliance AND Enforcement Priorities
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Product Information Safety Updates July 2023
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Covid 19 Vaccine Safety Report 27 07 2023
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Trava Health PTY LTD Fined Alleged Unlawful Advertising Medicinal Cannabis
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Covid 19 Vaccine Safety Report 10 08 2023
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NEW Reporting Requirements Medicine Shortages
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Covid 19 Vaccine Safety Report 24 08 2023
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Empirelabz Australia PTY LTD Fined 115500 Alleged Unlawful Advertising AND Supply Sport Supplements
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Nius Development PTY LTD Fined 26640 Allegedly Importing Unapproved Cosmetic Injectable Products
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Product Information Inserts ARE NO Longer Required Injectable Medicines Administered Health Professionals
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Changes Regulation Sports Supplements Medicinal Dosage Forms
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Product Information Safety Updates August 2023
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Post Market Review Facemasks Closed
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Changes Choline Salicylate Access Start 1 October 2023
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TGA Seizes 40000 Vapes Part Multi Agency Operation Queensland
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Scam Alert
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Covid 19 Vaccine Safety Report 07 09 2023
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Therapeutic Goods Mercury Form Application Import OR Export Approval 2023
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Medical Devices Vigilance Program Pilot
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Product Information Safety Updates September 2023
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Naturally Elevated PTY LTD AND Individual Fined 138600 Alleged Unlawful Advertising Medicinal Cannabis
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Covid 19 Vaccine Safety Report 21 09 2023
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Therapeutic Goods Database Adverse Event Notifications Arrangement Computer Programs Instrument 2023
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Covid 19 Vaccine Safety Report 05 10 2023
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TGA Seizes 70000 Vapes NSW
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Product Information Safety Updates October 2023
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Covid 19 Vaccine Safety Report 19 10 2023
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Warnings Supply AND Advertising Haytox
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USE Caution When Prescribing Baclofen Label
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Update Listed Medicine Ingredients October 2023
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Ovira PTY LTD Fined Alleged Unlawful Advertising Health Product
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Vapor Kings PTY LTD AND Director Penalised Total 5 Million Advertising Nicotine Vaping Products
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Therapeutic Goods Poisons Standard Covid 19 Vaccine Pfizer Raxtozinameran Labelling Exemption 2023
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Covid 19 Vaccine Safety Report 02 11 23
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Global Event Promotes Side Effect Reporting
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Product Information Safety Updates November 2023
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Withdrawn Instantscripts PTY LTD Fined 742500 Alleged Unlawful Advertising Therapeutic Goods
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NEW Medicine Adverse Event Search Sponsors
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Joint Operation Seizes 2 Million Worth Unlawfully Imported Therapeutic Goods
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DO YOU Know What TGA Does AND Doesnt Regulate
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NEW Regulations Place Stronger Controls Importation Manufacture AND Supply Vapes
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Court Proceedings Initiated Against CDA Clinics QLD PTY LTD AND ITS Former Director Alleged Unlawful Advertising Medicinal Cannabis
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NEW Warnings Romosozumab Evenity Cardiovascular Risks
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Create Content Plays Rules
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Philips Recall Action Sleep Apnoea AND Respiratory Care Machines Final Chance Register Replacement Device
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GMP Clearance Sponsor Information Dashboard AND Guidance Updates
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GMP Clearance Bulgaria Added MRA Pathway
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GMP Clearance Mutual Recognition Agreement MRA AND Compliance Verification CV Pathway Updates
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Promise Pilot Pathway Access Work Sharing Priority Prescription Medicine Applications
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Direction About Advertisements Pracmed Healthcare PTY LTD
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NEW Regulation Vapes Starting January 2024
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Updated Medicinal Cannabis Guidance
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TWO Nurses Fined Allegedly Importing Unapproved Cosmetic Injectables
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Aussie Mega Supplements Operator Fined AND Undertakes Comply Rules Supply AND Advertising Therapeutic Goods
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Enforceable Undertaking Yossef Wahib Trading Aussie Mega Supplements
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TGA Seizes Black Salve AND Amygdalin During Search Warrant Brisbane
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Therapeutic Goods Medicines AND OTG Authorised Supply Notification Form Approval 2023
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Therapeutic Goods Therapeutic Vaping Goods Sponsor Notice Form Approval 2023