Media releases & statements

July

Australia's first COVID treatment approved

10 July 2020

The TGA has granted provisional approval to remdesivir ("Veklury", Gilead Sciences Pty Ltd) as the first treatment option for COVID-19.
Regulation of thermometers and other temperature measuring medical devices and products for COVID-19

10 July 2020

This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations
Nature's Way Kids Smart Vita Gummies Omega 3 DHA Fish Oil

9 July 2020

Update - Recall of all affected batches of the 120 pastille pack size
TGA issues fines of nearly $1.8 million for alleged illegal activity in 2019-20

8 July 2020

TGA compliance and enforcement in 2019-20
The Original 3 Bullets capsules

7 July 2020

The Original 3 Bullets capsules pose a serious risk to your health and should not be taken.
Zostavax vaccine

6 July 2020

Safety advisory - not to be used in people with compromised immune function
Pre-approval no longer required for ads in specified media

1 July 2020

From 1 July 2020 medicine ads in specified media no longer require pre-approval

June

Arborvitae Health and Wellbeing fined $12,600 for alleged advertising breaches in relation to COVID-19

30 June 2020

The TGA has issued an infringement notice for $12,600 to Sydney-based company Arborvitae Health and Wellbeing for alleged unlawful advertising in relation to COVID-19.
Pfeffer Contracting fined $25,200 for alleged advertising breaches in relation to COVID-19

30 June 2020

The TGA has issued two infringement notices totalling $25,200 to Sydney-based company Pfeffer Contracting for alleged unlawful advertising in relation to COVID-19.
Counterfeit Alprazolam 2mg and Kalma 2 tablets

29 June 2020

Counterfeit Alprazolam 2mg tablets and counterfeit Kalma 2 tablets pose a serious risk to your health and should not be taken
Prohibition on importing e-cigarettes containing vaporiser nicotine

29 June 2020

Implementation timeframe extended to 1 January 2021
Phenelzine (Nardil) discontinuation

29 June 2020

Joint statement on accessing alternatives and patient management
Australian Chemical Research fined $25,200 for alleged breaches in relation to hand sanitiser

29 June 2020

The TGA has issued two infringement notices totalling $25,200 to Sydney-based company Australian Chemical Research
Queensland woman fined $7,560 for alleged unlawful advertising in relation to COVID-19

29 June 2020

The TGA has issued three infringement notices totalling $7,560 to a woman based in Brisbane
Country of origin and medicine quality

25 June 2020

There is no requirement for a medicine to display the country of origin on the label.
High-dose codeine

24 June 2020

No lasting increase in consumption following up-scheduling of low-dose products
Reminder: pre-approval for ads in specified media ends 30 June 2020

23 June 2020

Reminder of changes for those who advertise medicines to the public using television, radio, print media, cinema, billboards or other public displays
TGA to review complaints of alleged non-compliant advertising of medicinal cannabis products to the public

23 June 2020

The TGA has commenced a review of complaints received alleging non-compliant advertising of medicinal cannabis products to the public
ICMRA statement about confidence in vaccine safety and effectiveness (for healthcare professionals)

18 June 2020

The International Coalition of Medicines Regulatory Authorities aims to provide healthcare professionals with important messages regarding vaccines
ICMRA statement about confidence in vaccines (for the general public)

18 June 2020

The International Coalition of Medicines Regulatory Authorities highlights the importance of vaccines for consumers
Inskin Cosmedics Group fined $25,200 for alleged unlawful importation of cosmetic medical devices

17 June 2020

The TGA has issued two infringement notices to Sydney-based company Inskin Cosmedics Group Pty Ltd
Chemforce fined $63,000 for alleged unlawful advertising in relation to COVID-19

17 June 2020

The TGA has issued five infringement notices to Sydney-based company Chemforce Pty Ltd
Pharmacist fined $30,240 for alleged unlawful advertising

17 June 2020

The TGA has issued twelve infringement notices to a Victorian-based pharmacist for alleged unlawful advertising of therapeutic goods
Net Pharmacy fined $214,200 for alleged unlawful advertising

17 June 2020

Net Pharmacy fined $214,200 for alleged unlawful advertising
Counterfeit Cialis 20mg tablets

17 June 2020

Counterfeit Cialis 20mg tablets pose a serious risk to your health and should not be taken.
Sunscreen SPF testing by AMA Laboratories

15 June 2020

TGA taking action on sunscreens tested by AMA Laboratories
Hydrogen Technologies fined $50,400 for alleged advertising breaches including reference to COVID-19

15 June 2020

The TGA has issued four infringement notices totalling $50,400 to Cairns based company Hydrogen Technologies Pty Ltd for alleged advertising breaches including reference to COVID-19
Herbal Blue capsules

15 June 2020

Herbal Blue capsules pose a serious risk to your health and should not be taken.
Federal Court restrains MMS Australia from advertising and supplying MMS and DMSO

4 June 2020

The Federal Court of Australia has made orders restraining MMS Australia from advertising and supplying goods containing certain potentially dangerous substances until a further hearing next week
Further changes to reduce opioid harm

2 June 2020

The reforms will enable the safe and effective prescribing and use of opioids while maintaining access for patients who need them.

May

TGA initiates court proceedings against MMS Australia and director Charles Barton for alleged unlawful advertising

29 May 2020

The TGA has initiated proceedings in the Federal Court of Australia in response to the alleged unlawful advertising of Miracle Mineral Supplement (MMS), dimethyl sulfoxide (DMSO) and other medicines by Southern Cross Directories Pty Ltd trading as MMS Australia
Regulation of Personal Protective Equipment and COVID-19

29 May 2020

An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves
Allpulse Technologies fined $50,400 for alleged advertising breaches

28 May 2020

The TGA has issued four infringement notices totalling $50,400 to Brisbane based company Allpulse Technologies Pty Ltd
Warning about advertising that conflicts with stay at home when sick advice

28 May 2020

The TGA is reminding advertisers that therapeutic goods advertising must not undermine public health campaigns, as the cold and flu season begins in Australia and COVID-19 restrictions are eased
Super Slim Green Lean Body capsules

27 May 2020

Super Slim Green Lean Body capsules pose a serious risk to your health and should not be taken.
Company issued $12,600 infringement notice for alleged COVID-19 advertising breach

22 May 2020

The TGA has issued a $12,600 infringement notice to Melbourne based company NutriPATH Pty Ltd for the alleged unlawful advertising of a COVID-19 Polymerase Chain Reaction (PCR) test collection kit.
Reuse of face masks and gowns during the COVID-19 pandemic

21 May 2020

Updated to include new section on Reprocessing of PPE by Healthcare facilities
Doctor fined $37,800 for alleged advertising breaches including references to COVID-19

21 May 2020

The TGA has issued fifteen infringement notices totalling $37,800 to a doctor in Perth
Andrographis paniculata

20 May 2020

Safety advisory – potential to change sense of taste
Gold Max Pink capsules

19 May 2020

Gold Max Pink capsules pose a serious risk to your health and should not be taken.
2020 seasonal influenza vaccines

15 May 2020

Updated with information about ingredients
How to spot a dodgy health product ad

14 May 2020

Ads for health products are everywhere, but don't believe everything you read
Shortage of metformin modified-release 500 mg (multiple brands)

13 May 2020

Serious shortage substitution notice - Metformin modified-release 500 mg tablets
End of pre-approval process for ads in specified media

13 May 2020

From 1 July 2020, medicine advertisements in specified media do not need pre-approval from the TGA
Blackmores Professional Duo Celloids S.C.F. tablets

13 May 2020

Recall - potential for mould contamination
MMS Australia fined $151,200 for alleged unlawful advertising

13 May 2020

The TGA has issued twelve infringement notices totalling $151,200 for the alleged unlawful advertising of Miracle Mineral Supplement and other medicines
Influenza vaccines released for 2020 season

8 May 2020

Information updated
Miracle Mineral Solution (MMS)

8 May 2020

Safety advisory - false and misleading claims relating to COVID-19
Amendments to the new restrictions on prescribing hydroxychloroquine for COVID-19

8 May 2020

Update - PBS changes and supplier letter reinforce prescribing guidance
Breast implants and anaplastic large cell lymphoma

8 May 2020

Update - Further suspension of breast implant devices
Chinese Family in Hong Kong tablets

7 May 2020

Chinese Family in Hong Kong tablets pose a serious risk to your health and should not be taken.
Promedical Equipment fined $63,000 for alleged unlawful advertising of a COVID-19 Rapid Test kit

7 May 2020

The TGA has issued five infringement notices totalling $63,000 to a Queensland company for alleged breaches relating to COVID-19 test kits
WA woman fined $2,520 for alleged breaches in relation to COVID-19 test kits

7 May 2020

The TGA has issued an infringement notice for $2,520 to a woman in Western Australia for alleged breaches relating to COVID-19 test kits
Muses Coffee (Magic Thin) sachets

6 May 2020

Muses Coffee (Magic Thin) sachets pose a serious risk to your health and should not be taken.
Vitamin B6 (pyridoxine)

5 May 2020

Vitamin B6 - potential for dose-related adverse events
Ventilators and other devices intended for respiratory support for COVID-19

4 May 2020

Guidance for healthcare facilities to assist with sourcing additional equipment to treat patients in the event of a shortage of ventilators and other respiratory support devices

April

TGA publishes more information about medicine formulations

30 April 2020

To improve access to important ingredient information, TGA publishes the names of excipients in medicines and biologicals on its website
Additional safety protections relating to COVID-19 for faecal microbiota transplant (FMT) products

28 April 2020

Advice for FMT providers on safety protections related to COVID-19
Woman fined $2,520 for alleged breaches in relation to COVID-19 test kits

24 April 2020

The TGA has issued an infringement notice for $2,520 to a woman in Western Australia for alleged breaches relating to COVID-19 test kits
Labtest Direct issued with a $12,600 infringement notice for alleged advertising of COVID-19 test kits

24 April 2020

The TGA has issued an infringement notice for $12,600 to Labtest Direct for the alleged advertising of COVID-19 Rapid Test kits
CK Surgitech issued $25,200 in infringement notices for alleged breaches in relation to COVID-19 test kits

24 April 2020

The TGA has issued infringement notices totalling $25,200 to Queensland company CK Surgitech for alleged breaches relating to COVID-19 test kits
Pete Evans' company fined for alleged COVID-19 advertising breaches

24 April 2020

The TGA has issued two infringement notices to Peter Evans' company totalling $25,200 for alleged breaches of therapeutic goods legislation in relation to the promotion of a 'BioCharger' device
Domestic Good Manufacturing Practice (GMP) inspections during the COVID-19 pandemic

24 April 2020

Conducting domestic inspections during the Coronavirus (COVID-19) pandemic
Review on the safety of low dose cannabidiol

24 April 2020

The TGA has published the safety review of low does cannabidiol
Force G Men's Power tablets

23 April 2020

Force G Men's Power tablets pose a serious risk to your health and should not be taken
Dark Horse capsules

21 April 2020

Dark Horse capsules pose a serious risk to your health and should not be taken.
Federal Court of Australia grants interim injunction to prevent advertising by Evolution Supplements Australia

16 April 2020

The Federal Court granted the interim injunction on 3 April 2020
Gentamicin Injection USP 10 mg/mL (20 mg/2 mL) (Teligent OU)

14 April 2020

Safety advisory - alternative product filling shortage may cause airway constriction if administered via inhalation
Expedited recall system for faulty or unauthorised COVID-19 devices

11 April 2020

The TGA has established an expedited recall pathway for faulty or unauthorised COVID-19 devices.
Seven Day Slim Capsules

8 April 2020

Seven Day Slim capsules pose a serious risk to your health and should not be taken.
Vigour 800 tablets

8 April 2020

Vigour 800 tablets pose a serious risk to your health and should not be taken.
Coronavirus (COVID-19): Information on medicines and medical devices

7 April 2020

The TGA is publishing the latest information about medicines and medical devices as it relates to COVID-19 on this page
Mojo Black capsules

3 April 2020

Mojo Black capsules pose a serious risk to your health and should not be taken
ATP Science issued infringement notices for $302,400 for alleged advertising breaches

3 April 2020

The TGA has issued ATP Science Pty Ltd with 24 infringement notices
Ranitidine

2 April 2020

Update 2 - contamination with N-nitrosodimethylamine
Warning to consumers and advertisers about COVID-19 test kits

1 April 2020

COVID-19 tests must be done under the direction of a health professional
Seasonal flu vaccine (all alerts)

1 April 2020

Information about seasonal flu vaccines
Gentamicin 40 mg/mL Injection (Hospira UK Limited)

1 April 2020

Safety advisory - alternative product filling shortage may cause airway irritation if administered via inhalation

March

Oxymed Australia Pty Ltd fined $63,000 for alleged advertising breaches

27 March 2020

The TGA has issued Oxymed Australia Pty Ltd five infringement notices for alleged advertising breaches
No evidence to support intravenous high-dose vitamin C in the management of COVID-19

27 March 2020

We have investigated a report that intravenous high-dose vitamin C may be beneficial in the management of COVID-19
TGA issues warning about illegal advertising relating to COVID-19

24 March 2020

The TGA will take action in relation to the illegal advertising of therapeutic goods, including those that make false and misleading claims about preventing or curing COVID-19
New restrictions on prescribing hydroxychloroquine for COVID-19

24 March 2020

Only certain types of specialists will be able to prescribe hydroxychloroquine to new patients
No evidence to support claims ibuprofen worsens COVID-19 symptoms

20 March 2020

TGA monitoring
COVID-19 limits on dispensing and sales at pharmacies

19 March 2020

Information for consumers
Limits on dispensing and sales of prescription and over-the-counter medicines

19 March 2020

Community pharmacists to enforce new limits on dispensing and sales of prescription and over-the-counter medicines
TGA suspends overseas GMP inspections and QMS audits until further notice

19 March 2020

Due to changes in travel restrictions, all overseas GMP inspections and QMS audits have now been suspended until further notice
TGA response to coronavirus (COVID-19)

19 March 2020

Information updated to include details about good manufacturing practice for sponsors and manufacturers
TGA cautions against over-buying medicines

16 March 2020

Stockpiling medicines may disrupt access to vital medicines by patients and pharmacies
Dragon 'Wolverine' tablets

13 March 2020

Dragon 'Wolverine' tablets pose a serious risk to your health and should not be taken
Court proceedings commenced against Evolution Supplements Australia and its sole director for alleged advertising breaches

13 March 2020

The Secretary of the Department of Health has commenced proceedings in the Federal Court of Australia (Court) against Evolution Supplements Australia Pty Ltd
Maxman Cialis tablets (Plastic bottle inside cardboard carton)

6 March 2020

Maxman Cialis Tablets pose a serious risk to your health and should not be taken
International work-sharing initiative - Baloxavir marboxil (Xofluza)

5 March 2020

Xofluza approved as part of an international work-sharing initiative between the TGA, Health Canada and Swissmedic

February

Caruso’s Natural Health fined $12,600 for falsely claiming to hold evidence for Caruso’s Kids Eye Care

26 February 2020

Caruso's Natural Health pays $12,600 fine for false certification in relation to therapeutic good
Bling Bling Sister BBS Superman Capsules

26 February 2020

Bling Bling Sister BBS Superman capsules pose a serious risk to your health and should not be taken
Multi-level marketing company fined $37,800 for alleged advertising breaches

18 February 2020

Juice Plus Company Australia Pty Ltd has paid penalties of $37,800 for alleged advertising breaches relating to vitamin products
Palexia SR 100 mg tapentadol sustained release tablets

14 February 2020

Product defect correction - potential for blank labelling to pose risk of accidental misuse
InSkin Cosmedics Group pays $37,800 in penalties for alleged supply and advertising of unapproved dermapen device

10 February 2020

InSkin Cosmedics Group Pty Ltd has paid penalties of $37,800 in regards to the alleged supply and advertising of the Dermapen 4
Warning about products claiming to treat or prevent the novel coronavirus

7 February 2020

The TGA has identified certain therapeutic goods being inappropriately promoted for the prevention or treatment of novel coronavirus (2019-nCoV) infections in Australia
Prescription opioids hub

4 February 2020

New information for industry added

January

Measles vaccines available in Australia continue to meet quality standards

22 January 2020

Measles vaccine testing shows the vaccine meets required standards
No shortage of salbutamol asthma inhalers

10 January 2020

Adequate stock available despite bushfires
Temporary permission granted to advertise puffers and other inhalers with salbutamol

7 January 2020

Pharmacies and others can advertise availability of OTC salbutamol products during the bushfire season

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