Resources
Regulator resource library
56,398 indexed Australian government compliance resources across 11 federal regulators.
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Medical Devices Safety Update Volume 6 Number 1 January 2018
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Medical Devices Safety Update Volume 6 Number 2 March 2018
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Medicines Safety Update Volume 9 Number 1 February March 2018
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Medical Devices Safety Update Volume 6 Number 3 MAY 2018
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Medicines Safety Update Volume 9 Number 2 June 2018
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Medical Devices Safety Update Volume 6 Number 4 July 2018
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Medicines Safety Update Volume 9 Number 3 August September 2018
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Medical Devices Safety Update Volume 6 Number 5 September 2018
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Medical Devices Safety Update Volume 6 Number 6 November 2018
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Medicines Safety Update Volume 9 Number 4 December 2018
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Fluoroquinolone Antibiotics AND Risk Aortic Aneurysmdissection
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Tocilizumab AND Hepatotoxicity
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Paclitaxel Coated Products Used Peripheral Arteries
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Direct Acting Oral Anticoagulants AND Risk Recurrent Thrombotic Events
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Update Tocilizumab AND Hepatotoxicity
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Update Fluoroquinolone Antibiotics AND Adverse Events
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Ferric Carboxymaltose AND LOW Blood Phosphorous
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Acrylonitrile Butadiene Styrene Incompatible Anaesthetic Spray
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Updated Cleaning Instructions Long Term Nasogastric Tubes
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Planning Vital When Using Patient Handling Slings
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Surgical Staplers TGA Reviews Device Incident Reports
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Consider Whole Picture When Testing Troponin Levels
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Programmable VT Detection Cardiac Resynchronisation Therapy Defibrillator CRT D Devices
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Water Injection AND Haemolysis
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Clonidine Importance Dosing Compliance AND Safe Storage
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TGA Response Accc Safety AND Information Standards
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Update Dienogest AND Risk Venous Thromboembolism
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Sertraline AND Microscopic Colitis
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Updated Contraception Advice Tamoxifen
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Bupropion AND Serotonin Syndrome
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Methylphenidate USE Pregnancy
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Parenteral Iron Products Fetal Bradycardia AND Kounis Syndrome
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Nifedipine AND Pulmonary Oedema When Used Pregnancy
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Ocrelizumab AND Late Onset Neutropenia
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Erenumab AND Hypertension
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Propylthiouracil AND Carbimazole USE Pregnancy
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Pentosan Polysulfate Sodium AND Pigmentary Maculopathy
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Octreotide AND Atrioventricular Block
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Ceftriaxone AND Risk Hepatitis AND Encephalopathy
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Tenofovir Alafenamide AND Renal Adverse Effects
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Limitations Pulse Oximeters AND Effect Skin Pigmentation
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Acellular Dermal Matrix Products Used Breast Reconstruction
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Antidepressant USE AND Youth Suicide
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Clindamycin Capsules AND Injections Acute Kidney Injury
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Ipilimumab AND Serous Retinal Detachment
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Administer Vinca Alkaloids Intravenous Infusion Only
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Donepezil AND Cardiac Conduction Disorders
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Clozapine AND Gastrointestinal Hypomotility Severe Complications
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Product Information Safety Updates April 2022
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Scheduling News
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Australian Government Response Review Medicines AND Medical Devices Regulation
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Codeine RE Scheduling Regulation Impact Statement RIS
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Medicines Advisory Statements Specification Updates
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SME Assist Workshops AND Events
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Outcomes Consultation Draft List Permitted Indications
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Labelling Changes Information Health Professionals
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Changes Nappy Rash Products
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Update Developing Alternative Quality Standard Sunscreen Excipients
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High Moderate Risk Changes Permissible Ingredients Caffeine
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Update Listed Medicine Ingredients September 2019
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N Nitroso Compounds Sartan Blood Pressure Medicines
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NEW Science Strategy Prepares Regulatory Scientists Future
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TGA Expand Quality Audits Medicinal Cannabis
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Ventilators Covid 19 USE Australia
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Recall Notifications TGA OR GS1 Australias Recall Health Platform
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TGA Permit Conditional Substitution Ease Serious Shortages
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Access Consortium Regulators Pledge Support Tackle Covid 19
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Critical Medicines Supply Modelling Supports Return Elective Surgery
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Childrens Paracetamol Liquid Returns Front Counter Supply Limits Remain
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Delays Commencement Certain Medical Device Regulatory Changes
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Independent Review Reforms Therapeutic Goods Advertising Framework Complete
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TGA Grants Provisional Determination Covid 19 Vaccine
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Acss Consortium Welcomes UK ITS Newest Member
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NEW Compliance Dashboard Post Market Medical Device Reviews
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TGA Grants Second Provisional Determination Covid 19 Vaccine
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Regulation Impact Statement Unique Device Identification System Medical Devices
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TGA Grants Third Provisional Determination Covid 19 Vaccine
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Covid 19 Vaccine Provisional Determinations
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Updates Electronic Application TGA Conformity Assessment Certificate
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TGA Statement UK Government Emergency USE Authorisation Related Covid 19 Vaccine Bnt162b2 Supplied Pfizer AND Biontech
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TGA Grants Additional Provisional Determination Covid 19 Vaccine
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Icmra Statement Healthcare Professionals HOW Covid 19 Vaccines Will BE Regulated Safety AND Effectiveness
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NMI Mask Testing Forum 20
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TGA Adopts Access Consortium Guidance Fast Tracking Authorisations Modified Covid 19 Vaccines Variants
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NEW Standard Serialisation AND Data Matrix Codes Medicines
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Sunscreen Testing AMA Laboratories Condition Listing
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Update Psilocybin AND Mdma Scheduling
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TGA Grants Provisional Determination Glaxo Smithkline Australia PTY LTD Covid 19 Monoclonal Antibody Treatment Sotrovimab
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Important Information About Aspen Medical PTY LTD Respirators Face Masks Batches
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Update Special Access Scheme SAS Authorised Prescriber AP Online System
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Important Information About Aspen Medical PTY LTD Respirators Face Masks
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Provisional Determination Granted Pfizer Relation Covid 19 Vaccine Comirnaty USE Individuals 12 Years AGE AND Older
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TGA Evaluating First Monoclonal Antibody Treatment Covid 19 Sotrovimab Glaxosmithkline Australia PTY LTD
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Communication Stakeholders Remaking Standards AND Legislative Instruments Human Cell AND Tissue HCT Products Blood AND Blood Components
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Changes Medicine Shortage Reporting System
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Covid 19 Vaccine Janssen
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TGA Provisional Approval Pfizer Biontech Covid 19 Vaccine Include 12 15 Years AGE Group
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Covid 19 Vaccine Spikevax Elasomeran
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Covid 19 Treatment Gilead Sciences PTY LTD Remdesivir Veklury
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Covid 19 Treatment Glaxosmithkline Australia PTY LTD Sotrovimab Xevudy
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Influenza Vaccine Batch Release 2022 Season
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Antiepileptic Medicines Updated Precautions Pregnancy AND Women Childbearing Potential
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TGA Provisionally Approves Moderna Covid 19 Vaccine Spikevax USE Children 6 Months
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TGA Grants Provisional Determinations Pfizer Covid 19 Vaccines Target Omicron Variant
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Provisional Determination Granted Pfizer Relation Covid 19 Vaccine Comirnaty USE Individuals 6 Months 5 Years
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Covid 19 Vaccine Weekly Safety Report 02 06 2022
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Person Fined 31698 Alleged Unlawful Advertising Disposable Nicotine Vaping Products
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13 Vape PTY LTD Directed Cease Alleged Unlawful Advertising Nicotine Vaping Products
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Precision Pharmaceuticals PTY LTD Fined AND Directed Cease Alleged Unlawful Advertising Nicotine Vaping Products
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TGA Provisionally Approves Biocelect PTY LTD Novavax Covid 19 Vaccine Nuvaxovid USE Individuals Aged 12 17 Years
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Court Proceedings Initiated Against Vapor Kings PTY LTD AND ITS Director Alleged Unlawful Advertising Nicotine Vaping Products
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Court Proceedings Initiated Against Prefixx PTY LTD AND ITS Director Alleged Unlawful Advertising Nicotine Vaping Products
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TGA Approval Change Blood Donation Rules Relating Vcjd Deferral
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Covid 19 Vaccine Safety Report 28 07 2022
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Rapid Antigen Test Cancellations NOT DUE Failure Detect Covid 19 Omicron Variant
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TGA Commences Evaluation Pfizers Covid 19 Vaccine Comirnaty Children Aged 6 Months Less 5 Years
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Surrogate Viruses USE Disinfectant Efficacy Tests Justify Claims Against Monkeypox
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Enviro Tech Holdings AND Company Officers Ordered Federal Court PAY 96000 Unlawful Importation Surgical Face Masks
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2san PTY LTD Fined 66600 Allegedly Failing Provide Ongoing Evidence Support Performance ITS Covid 19 Rapid Antigen Tests
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Covid 19 Vaccine Safety Report 11 08 2022
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Enforceable Undertaking Strapit Medical AND Sports Supplies PTY LTD
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Covid 19 Vaccine Weekly Safety Report 26 05 2022
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Strapit Medical AND Sports Supplies PTY LTD Undertakes Comply Advertising Rules Therapeutic Goods
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Covid 19 Vaccine Weekly Safety Report 23 06 2022
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WA Individual Fined 2664 Alleged Unlawful Importation AND False Declaration Nicotine Vaping Products
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Transition Period 2018 2021 Advertising Code Ends 30 June 2022
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Individual Fined 2664 Alleged Unlawful Advertising Relation Covid 19
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Individual Fined 10664 Alleged Unlawful Importation Covid 19 Rapid Antigen Tests
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Individual Fined 2664 Allegedly Advertising Unapproved Therapeutic Goods
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NSW Individual Fined 2664 Alleged Unlawful Advertising Nicotine Vaping Products
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Phenix Health PTY LTD Directed Cease Alleged Unlawful Advertising Nicotine Vaping Products
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Hough Pharma PTY LTD Fined 106560 Allegedly Failing Provide Information Demonstrate Adequate Performance Three Covid 19 Rapid Antigen Tests AND Allegedly Failing Provide Appropriate Customer Support
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Philips Electronics Australia LTD Fined 133200 Alleged Breaches Therapeutic Goods Legislation
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Covid 19 Vaccine Weekly Safety Report 16 06 2022
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TGA Grants Provisional Determination Sabizabulin Treatment Covid 19
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First Generation Oral Sedating Antihistamines DO NOT USE Children
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TGA Participates Global Operation Tackling Illicit AND Counterfeit Therapeutic Goods
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Enforceable Undertaking Doughbot Enterprises PTY LTD AND Stuart Singleton
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Doughbot Enterprises AND Officer Fined 87312 AND Company AND ITS Director Undertake Comply Advertising Rules Nicotine Vaping Products
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Covid 19 Vaccine Safety Report 25 08 2022
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Update Manufacturing Principles Medicines Apis Sunscreens
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Covid 19 Vaccine Safety Report 30 06 2022
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Product Information Safety Updates July 2022
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TGA Provisionally Approves Moderna Bivalent Covid 19 Vaccine USE Booster Dose Adults
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World Environmental Technologies Fined 13320 Alleged Unlawful Importation Ivermectin
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Cyclotek Queensland Fined 93240 Allegedly Breaching Conditions ITS Manufacturing Licence
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International Work Sharing First Medicines Approved ALL Five Access Consortium Regulators
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First Combination Covid 19 AND Influenza Self Tests Approved Australia
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Covid 19 Vaccine Safety Report 08 09 2022
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Covid 19 Vaccine Safety Report 14 07 2022
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Product Information Safety Updates MAY 2022
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Product Information Safety Updates August 2022
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Independent Review Paracetamol Overdose
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Fluorouracil AND Capecitabine DPD Deficiency
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Jshealth Vitamins PTY LTD Fined 26640 Alleged Unlawful Advertising
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TGA Provisionally Approves Pfizers Covid 19 Vaccine Comirnaty Tozinameran USE Booster Dose Individuals 5 Years AND Older
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Covid 19 Vaccine Safety Report 23 09 2022
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Mdne Enterprises AND Executive Officer Fined AND Directed Cease Alleged Unlawful Advertising Nicotine Vaping Products
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Direction About Advertisements Mdne Enterprises PTY LTD
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Best Body Industries PTY LTD AND Executive Officer Fined Almost 130000 Alleged Unlawful Advertising Sports Supplements
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Three Medicinal Cannabis Companies Fined Almost 1 Million Alleged Unlawful Advertising
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TGA Provisionally Approves Pfizers Covid 19 Vaccine Comirnaty Tozinameran USE Children Aged 6 Months Less 5 Years
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TGA Grants Provisional Determination Modernas Covid 19 Bivalent Original Plus Omicron Ba4ba5 Booster Dose Vaccine
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User Experience Survey Daen Medicines Beta Version
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Peripheral Neuropathy Supplementary Vitamin B6 Pyridoxine
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Covid 19 Vaccine Safety Report 06 10 2022
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Queensland Individual Fined 5328 Alleged Unlawful Advertising Complementary Medicine
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Pharmacovigilance Inspection Program Risk Assessment Survey
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Inspire Cosmetology PTY LTD Fined 26640 Alleged Unlawful Import Therapeutic Goods
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NSW Person Fined 2664 Alleged Unlawful Import Prescription Medicines
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Covid 19 Vaccine Safety Report 20 10 2022
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TGA Provisionally Approves Modernas Covid 19 Vaccine USE Booster Dose Individuals 12 Years AND Older
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TGA Provisionally Approves Pfizer Bivalent Covid 19 Vaccine USE Booster Dose Adults
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Standard Serialisation AND Data Matrix Codes Commences 1 January 2023
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West Australian Health Practitioner Fined 13320 Alleged Unlawful Advertising Medicinal Cannabis
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TWO Medicinal Cannabis Clinics Fined 239760 Alleged Unlawful Advertising
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Covid 19 Vaccine Weekly Safety Report 09 06 2022
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Imuni PTY LTD Fined 13320 Alleged Unlawful Advertising Complementary Medicine
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Product Information Safety Updates September AND October 2022
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Covid 19 Vaccine Safety Report 03 11 2022
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Philips Recall Action Sleep Apnoea AND Respiratory Care Machines Have YOU Registered Replacement
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AUS Labs Smart Labs Isarms AND Director Christopher Ramsey Plead Guilty Over 200 Charges Illegal Manufacture Supply AND Advertising Sarms AND Nootropics
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TGA Grants Provisional Determination Pfizers Covid 19 Bivalent Comirnaty Bivalent Omicron Ba4ba5 Booster Dose Vaccine
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Covid 19 Vaccine Safety Report 17 11 2022
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Medical Practitioner Fined 2664 Alleged Unlawful Advertising Nicotine Vaping Products
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TGA Consults Potential Nicotine Vaping Product Regulatory Reforms
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Warning Advertising Ozempic Semaglutide Prohibited
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Covid 19 Vaccine Safety Report 01 12 2022
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Prevent Paracetamol Poisoning Your Home
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Product Information Safety Updates November 2022
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Reminder About Weight Loss Products
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Covid 19 Vaccine Safety Report 15 12 2022
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Product Information Safety Updates December 2022
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Updates Prescribing Medicines Pregnancy Database MAY 2022
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Updates Prescribing Medicines Pregnancy Database December 2022
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Access Generic Medicines Work Sharing Initiative Update
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Covid 19 Vaccine Safety Report 22 12 2022
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Travellers Injectable Medicines Containing Ingredients Derived Animal OR Human Origin NO Longer Require TGA Approval Enter Australia
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Antibiotics Shortage Australia
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Covid 19 Vaccine Safety Report 12 01 23