How can you refer to the TGA when you advertise your products?

The TGA has provided further clarification. You cannot use the term “TGA approved” or “TGA registered”, or use the TGA logo or Commonwealth Coat of Arms, in advertising. This even includes statements such as "U.S. Food & Drug Administration (FDA) approved". However the TGA encourages advertisers to provide the product’s AUST L or AUST R number in advertising to the public.    Source: TGA


Compliance enforcement

Caro white and Carotone products have been supplied illegally as cosmetics while they have had a higher than permitted level of hydroquinone making them prescription medicines, but they have not been submitted to the TGA. Products include Caro White Lightening Oil, Caro White Lightening Beauty Lotion, Caro White Lightening Beauty Cream, Carotone Lightening Body Lotion and Carotone Black Spot Corrector. All future shipments into Australia will be destroyed.    Source: TGA

Tianda Pharmaceuticals fined $26,640 for alleged unlawful advertising of Anti-Epidemic Formula 1 in relation to COVID-19. Listed medicines cannot be advertised for treatment of COVID-19 and in an eBay ad Tianda claimed the products were “approved” by the TGA.    Source: TGA

Invigorate Labs fined $18,648 for alleged advertising breaches relating to medicinal cannabis and CBD. The products included vaping products and creams that had not been submitted to the TGA. Along with the illegal claims for CBD there were also claims for treatment of "palindromic rheumatoid arthritis" and cancer.    Source: TGA.

TGA to take action against political party United Australia Party.  TGA's lawyers allege UAP breached copyright and demand distribution of alleged misleading adverse event reports stop.    Source: TGA


Assessed listed medicines: data protection

Assessed listed medicines fall in between the categories of listed medicine, and registered medicine. For an assessed listed medicine, the TGA reviews the evidence forward to support the indications for use. There have bene very few applications for this category. The data protection keeps clinical trial data submitted to the TGA confidential.    Source: TGA


Export-only medicines

The TGA has revised the guidelines for preparing an application for an export-only medicine or medical device.    Source: TGA – medicines, medical devices.


Nicotine vaping products

As of 1st October all nicotine vaping products will be regulated as Schedule 4 (prescription only) medicines. Both personal importation and domestic purchases require a prescription.    Source: TGA


Rapid Antigen Tests (RATs) for Self-Testing (Home Testing) for COVID-19

The regulations are changing rapidly and the tests will soon be available.    Source: TGA – here and here.


Chattanooga Ultrasound Gel Products and Lotions

All batches are being recalled because of the risk of contamination with a bacteria, Burkholderia cepacia complex.    Source: TGA


Improvements to the Therapeutic Goods Advertising Code

The TGA has summarised the feedback from 67 stakeholder submissions. There was broad support for most proposals with differing views on items such as “who should and who should not be allowed to make product endorsements and testimonials”.    Source: TGA


ACCC grants interim authorisation to medicine wholesalers

The purpose is to co-operate in providing fair and efficient access to essential medication and pharmacy products as the COVID-19 pandemic continues.    Source: ACCC


TGA Navigating therapeutic goods regulation podcast now released on Apple podcasts.    Source: TGA news

RFA Breaking News

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Complementary Medicines and Medical Devices:

Therapeutic goods advertising compliance: 2020-21 Annual Report Summarises compliance outcomes including examples, infringements and court actions. 55% of complaints originated from consumers, 18% from other companies. We recommend all suppliers…


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