TGA Lists Disinfectants for Use Against COVID-19 in the ARTG for Legal Supply in Australia

The Therapeutic Goods Administration (TGA) has recently received many enquiries seeking to know which disinfectants have been entered into the Australian Register of Therapeutic Goods (ARTG) for use against COVID-19. Claims that a disinfectant has an effect against any virus must be expressly permitted by the TGA before being used in consumer advertising (including on the label). In response to the COVID-19 pandemic, the TGA has permitted SARS-CoV-2 and COVID-19 virus claims. The following list is comprised of disinfectant products that have been entered into the ARTG with specific claims against SARS-Cov-2 (COVID 19) or COVID-19 on the product label: Legal anti-viral disinfectants    (Please see related story - Emma Koehn, SMH  'Snake Oil Salesmen': COVID-19 Claims Under Microscope As Disinfectants Boom )

Australian Chemical Research Fined $25,200 for Alleged Breaches in Relation to Hand Sanitiser

The TGA has fined Sydney-based company Australian Chemical Research Pty Ltd $25,200, for alleged breaches of the Therapeutic Goods Act 1989. Australian Chemical Research allegedly manufactured and supplied antibacterial/anti-viral hand sanitiser not included in the Australian Register of Therapeutic Goods (ARTG), and which was neither an exempt good nor a good that is excluded from the operation of the Act The company allegedly claimed the hand sanitiser kills 99.99% of germs, viruses and bacteria on hands, including the flu virus, the common cold virus and HIV. The label also stated that the active ingredients of the hand sanitiser included 80% iso-propanol. However, the product contained a large percentage of n-propanol, which is a less effective and potentially hazardous alcohol. Australian Chemical Research was not licenced to manufacture therapeutic goods and did not have approval to do so.    Source: Hand sanitiser penalty

Presentation: Supplying and Advertising Certain Therapeutic Goods For COVID-19

Information for new sponsors of hand sanitisers, disinfectants and personal protective equipment. This presentation by the TGA was held as a webinar on 28th May 2020 and contains all notes, links and tables of that event, in a PDF document format.    Source: COVID19 webinar notes 

Post-Market Review of Face Masks: Cancelled ARTG Entries

The TGA is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). During the review many face masks have been cancelled from the ARTG with the latest list displayed here: Face-mask cancellations   (Please also see general overview: Post-market face mask review

Warning About Advertising that Conflicts with ‘Stay-at-Home When Sick’ Advice

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. If sponsors advertise cold and flu medicines, they must ensure that the advertising is consistent with the current public health advice about COVID-19. Promoting a product as enabling someone to attend a workplace, school or other activity outside of home while experiencing cold and flu symptoms (even if temporarily controlled) conflicts with the Department of Health's advice to stay home when unwell, ensuring that important public health messages are not undermined. If you are advertising therapeutic goods directly in relation to COVID-19, you should be aware that there are sanctions and penalties for any advertising that does not comply with the current regulations. Claims about COVID-19 are not permitted in consumer advertising, except for certain disinfectants.    Source: COVID-19 advertising

COVID-19: Eligibility to Request Consent to Supply Therapeutic Goods that Do Not Comply with the New Labelling Requirements of TGO 92

The COVID-19 pandemic has placed unprecedented pressures and challenges on the pharmaceutical industry, including difficulty in implementing new medicine labels that comply with the new labelling orders (TGO 91/92) for medicines that come into force on 1 September 2020. In recognition of these challenges, the TGA has established a temporary process for sponsors of listed, registered complementary, and over-the-counter (OTC) medicines to request consent to supply products that do not comply with TGO 92 due to adverse business impacts of COVID-19. The end date for this consent will be 6 March 2021.   Source: Covid-19 impact on TGO 92

Urgent Recall: Gin Bottles Filled with Hand Sanitiser Sold

An Australian liquor distiller has issued an urgent recall on bottles of gin after finding they had been filled with hand sanitiser. The company, Apollo Bay Distillery, says it has sold a number of the bottles with no seal, which have been labelled as gin but actually contain the sanitiser. Hand sanitiser is not safe to drink and should not be consumed.   Source: Gin hand sanitiser

Listed Medicines Referencing Macular Degeneration Reminder

Macular degeneration is a restricted representation and not permitted in listed medicines. In 2017, the TGA initiated targeted compliance reviews for 13 listed medicines that inappropriately referenced macular degeneration. During the reviews, they determined that none of the sponsors of these medicines held sufficient evidence for the indications related to eye health. Sponsors were required to amend the listing of these products on the ARTG to remove any unsupported claims or cancel their product from the ARTG.  Source: Macular degeneration reminder

End of Advertising Pre-Approval Scheme: Q & A

Until 1 July 2020, advertisements for 'designated therapeutic goods' that are to appear in 'specified media' require approval under the Therapeutic Goods Regulations 1990 before they can be published or broadcast. The TGA outsourced the processing of applications for advertising approval to Consumer Healthcare Products Australia until 30 June 2020. Pre-approvals will not be required after 30 June 2020. If sponsors are unsure whether their products’ advertising is compliant, once pre-approvals end and a new more self-regulatory regime begins, then they are recommended to seek advice from a regulatory affairs consultant, a lawyer who specialises in therapeutic goods, or engage the services of an independent vetting service that assesses the advertising of therapeutic goods for compliance.    Source: Pre-approval scheme ends    (Please also see related story: TGA social-media advertising guide )

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How to Spot a Dodgy Health Product Advertisement

Ads for health products are everywhere, but don't believe everything you read. Some ads break the law, whether it's by offering a miracle cure or advertising an unapproved medicine. Other ads just need a little extra scrutiny, such as a fad treatment promoted by a social media influencer. These TGA tips can help you avoid dodgy health products and challenge bogus advertisements when you see them.   Source: Dodgy ad detector

Consultation: Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines

The revised Australian regulatory guidelines for listed medicines and registered complementary medicines (published May 2020) replaces ARGCM V8.0. The new version reflects recent reforms to the regulatory framework and presents guidance in separate documents to facilitate timely updates. This is an interim step towards a new landing page, which will be modelled on that for the Australian Guidelines for Prescription Medicines. The TGA welcome feedback on the revised guidance, using the feedback form on the web-page.    Source: ARGCM consultation

Reminder: Update to Manufacturing Principles for Medicines, APIs & Sunscreens Effective 1 July 2020

The TGA's Manufacturing Quality Branch (MQB) is responsible for the assessment, inspection and licensing/certification of manufacturers of medicines supplied to, or exported from, Australia. The intent of this notice is to provide early notification that the TGA intends to adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-14) issued, 1 July 2018, as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens. The transition to PIC/S GMP PE009-14 will commence 1 July 2020 with a 12-month transition period.   Source: Manufacturing principles

Net Pharmacy Fined $214,200 for Alleged Unlawful Advertising

The TGA has issued seventeen infringement notices totalling $214,200 to Net Pharmacy Pty Ltd, a company based in Victoria, for alleged unlawful advertising of therapeutic goods. The advertisements, published on two websites, were for prescription only therapeutic goods that included peptides, Selective Androgen Receptor Modulators (SARMs) and hormones. Therapeutic Goods Act 1989 prohibits advertising to the general public of prescription only medicine. One of the websites also allegedly promoted the use of stem cells. Stem cells are a type of human cell and tissue product that are regulated as biologicals and cannot be advertised to the general public. It is also alleged that one of the website advertisements included a reference to cardiovascular disease. Under the Act, representations concerning a serious form of a disease, condition, ailment or defect, such as cardiovascular disease, are restricted representations. The use of restricted representations in advertisements for therapeutic goods is unlawful without the express permission of the TGA.    Source: Unlawful advertising

MMS Australia and Director Charles Barton Charged Over Alleged Unlawful Advertising

The TGA has initiated proceedings in the Federal Court of Australia in response to the alleged unlawful advertising of Miracle Mineral Supplement (also referred to as Miracle Mineral Solution) (MMS), dimethyl sulfoxide (DMSO), and other medicines by Southern Cross Directories Pty Ltd trading as MMS Australia. As reported in last month’s issue of this newsletter, the TGA recently issued MMS Australia with twelve infringement notices totalling $151,200 for alleged unlawful advertising. The TGA also informed MMS Australia that it must immediately remove all advertisements in breach of the Therapeutic Goods Act 1989 and warned that court action may be initiated if the advertisements were not removed within two days. MMS Australia did not remove the allegedly unlawful advertising. The TGA has therefore initiated court proceedings to obtain an injunction restraining MMS Australia and its director, Charles Barton, from advertising or supplying the relevant goods. The TGA will also seek orders that MMS Australia and Mr Barton pay penalties for alleged contraventions of the Act.    Source: MMS now in court

Allpulse Technologies Fined $50,400 for Alleged Advertising Breaches

The TGA has issued four infringement notices totalling $50,400 to Brisbane based company Allpulse Technologies Pty Ltd. In May 2020, the company allegedly advertised on its website a medicine containing hydrogen peroxide for internal therapeutic use that was not included in the Australian Register of Therapeutic Goods (ARTG). Hydrogen peroxide is a substance used to bleach human hair and sometimes for topical first aid or dental purposes. However, the TGA is not aware of any accepted clinical or scientific evidence to substantiate therapeutic claims in relation to the ingestion of hydrogen peroxide. The TGA is particularly concerned about potentially harmful effects from internal administration. The company's website also allegedly advertised other unapproved goods using unauthorised representations. These goods included 'Stabilized Electrolytes of Oxygen' (SEO), which was promoted for the treatment of serious conditions such as cancer and Alzheimer's disease. Under the Therapeutic Goods Act 1989, cancer is a prohibited representation and Alzheimer's disease is a restricted representation.  Source: Allpulse breach     (Please see also related story on USA President Trump’s proposal to combat COVID-19 with internal use of disinfectants) .

Queensland Woman Fined $7,560 for Alleged Unlawful Advertising in Relation to COVID-19

The TGA has issued three infringement notices totalling $7,560 to a woman based in Brisbane for alleged unlawful advertising in relation to COVID-19. The woman allegedly advertised, through her website and eBay store, a hydrogen peroxide product for therapeutic use that is not included in the Australian Register of Therapeutic Goods (ARTG). Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully advertised to the general public in Australia.   Source: COVID19 advert penalty

GSK and Novartis to Pay $4.5 Million in Penalties Over Voltaren Osteo Gel Claims

The Federal Court has ordered that the makers of pain relief product Voltaren Osteo Gel pay $4.5 million in penalties for breaches of the Australian Consumer Law. From 2012 to 2017, initially Novartis and then GSK marketed Osteo Gel as being specifically formulated and more effective than Emulgel in treating osteoarthritis related pain and inflammation even though both had the same active ingredients. The recommended retail prices for Osteo Gel were set up to 16% above that of Emulgel, and consumers were potentially misled into paying more for an identical product believing it was more effective.   Source: Voltaren gel penalty  

Recurring Issues in the Importation of Biological Products

The Department of Water, Agriculture and the Environment (DAWE) have published a notice, alerting importers to the requirement to hold valid import permits for a variety of products, including medicines and foods. Importers of most biological products must have a valid import permit before their goods arrive in Australia. If a permit, including documentary requirements, is required and those products arrive without one, then the importer will likely be directed to export or destroy them, or there could be significant delays.   Source: Importing biological products

Planned Prohibition on Importing E-Cigarettes Containing Vaporiser Nicotine

The Australian Government has announced that they intend to amend the Customs (Prohibited Import) Regulations from 1 July 2020 prohibiting the importation of e-cigarettes containing vaporiser nicotine (nicotine in solution or in salt or base form) and nicotine-containing refills unless on prescription from a doctor.   Source: e-cigs import ban  (Please see related story: Accessing e-cigs ) [Late News Update: Health Minister Gives Bows to Backbench Pressure On Vaping Ban  ]

TGA Notice of Interim Decisions on Proposed Amendments to The Poisons Standard

Proposed changes to the Poisons Standard may be of interest to sponsors of products containing any of the ingredients arbutin, melatonin, picramic acid (including its salts), and assorted marker dyes and pigments. This consultation closes on 9 July 2020.   Source: Poisons Standard consultation

ICMRA Community Statement About Confidence in Vaccines

The International Coalition of Medicines Regulatory Authorities has issued a general statement to highlight the importance of vaccines. The public statement reinforces the messages that: Vaccines save lives; Getting vaccinated is an act of responsibility; Vaccines undergo rigorous scientific evaluation by regulatory authorities; Vaccines are medicines of continuously proven pharmaceutical quality; and that, regulators and health authorities continue to rigorously monitor the safety, effectiveness and quality of vaccines after they are approved and released for use.   Source: Public vaccine statement

TGA Reviews Complaints of Alleged Non-Compliant Advertising of Medicinal Cannabis Products

The TGA has commenced a review of complaints received alleging non-compliant advertising of medicinal cannabis products to the public. The TGA has written to a number of entities in relation to non-compliance with the law with instruction to cease unlawful behaviour. The majority of respondents have brought themselves into compliance. For those that have not, further action is being considered.   Source: Cannabis advertising

TGA Publishes Changes to Fees and Charges from 1 July 2020

For a complete list of the new TGA rates please visit: TGA fees and charges summary

USA: AHPA Backs FDA and FTC on COVID19 Marketers

The American Herbal Products Association has supported the warnings sent recently by the Food and Drug Administration, and the Federal Trade Commission to marketers making product claims as to their efficacy related to COVID19. “The regulated dietary supplement industry supports FDA and FTC using their authorities against any company or individual selling products making COVID-19 cure or prevention claims,” said AHPA President Michael McGuffin. “While research supports the use of certain herbs and dietary supplements to maintain healthy immune system responses, AHPA is not aware of evidence that would substantiate a claim that any dietary supplement is effective to prevent or treat COVID-19, and such a claim is not allowed under current U.S. law.”    Source: AHPA USA COVID19 marketers


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