TGA Website Redevelopment. The TGA is “modernising” its website. Some links will change, and some old pages removed. The TGA is presenting a webinar on 7th and 12th July. To register for the webinar follow this link.

 

New poisons standard published 1st June.    Source: TGA.

 

TGA fees and charges – increase on the 1st of July each year. Summarised here.

 

Post-market review of antigen and rapid antigen tests. A summary of the results of testing on 97 products.    Source: TGA

 

Revised evidence guidelines for listed medicines. How to demonstrate the efficacy of listed complementary medicines is acceptable.    Source: TGA

Also refer to Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines.

 

Links to 15 presentations given by the TGA at the 2022 ARCS Annual Conference.    Source: TGA

 

Supply of unapproved therapeutic goods: a guide to completing the reporting form.    Source: TGA

 

Advice for consumers on purchasing COVID-19 rapid antigen tests. How to ensure you are using an approved test.    Source: TGA

 

Therapeutic Goods Advertising Code: the 6 month transition period from the 2018 code to the 2021 code ends 30th June.    Source: TGA. Also refer to Complying with advertising requirements and Testimonials and endorsements in advertising

 

Product recalls

Multiple Sunscreens Recalled - Low levels of benzene detected. The investigation has finished and no other brands have been affected.    Source: TGA

 

Compliance enforcement

Eight infringement notices totalling $106,560 have been issued to Hough Pharma for allegedly failing to provide information to the TGA to demonstrate the safety and performance of three COVID-19 RATs and failing to provide appropriate customer support.    Source: TGA

HERO Instant Energy for Male products were tested and found to contain undeclared Tadalafil. The Australian Border Force will seize and destroy future shipments as it is intercepted at the Australian border.    Source: TGA

The TGA has commenced court proceedings in the Federal Court of Australia against Prefixx and its sole director, Mr Brad Anthonisz, for alleged unlawful advertising of nicotine vaping products. Several warnings were issued but the advertising and selling of the products continued for some months.    Source: TGA

TGA has issued one infringement notice totalling $2,664 to a Queensland based individual for alleged unlawful advertising of therapeutic goods in relation to COVID-19.    Source: TGA

The TGA has issued one infringement notice of $2,664 to a NSW based individual for the alleged unlawful advertising of a medicine that was not included in the Australian Register of Therapeutic Goods and was not exempt from being on the ARTG.    Source: TGA

The TGA has issued four infringement notices totalling $10,664 to an individual for alleged unlawful importation of 13,500 COVID-19 rapid antigen tests.    Source: TGA

Philips Electronics Australia issued with ten infringement notices totalling $133,200 for failing to provide information on Philips CPAP and bi-level PAP (Continuous or bi-level Positive Airway Pressure) machines used for individuals with sleep apnoea, and mechanical ventilators.    Source: TGA

 

Implementation of the Review of Medicines and Medical Devices Regulation. 9 reviews and reforms listed here.

 

Street sales, online dealers and convenience stores: Inside the thriving black market for nicotine vapes. An interesting article in the press.    Source: Sydney Morning Herald.

And: Vape websites send buyers to ‘easy’ online prescriptions, bypassing local GPs.    Source: Sydney Morning Herald.

Also:

As the Coalition (the former federal government) feuded over vaping, 'personal' donations were made by the pro-vape lobby. A national vaping lobby group donated a total of $44,000 to the Liberal Party but the money was declared as personal gifts from its director on electoral returns.    Source: ABC news.

RFA Breaking News

Cosmetics, Personal Care and TGA Listed Sunscreens:

Melbourne e-commerce business fined $13k for unauthorised imports. Investigators from AICIS have fined a Melbourne e-commerce order fulfilment business more than $13,000 for allegedly importing industrial chemicals without the required…

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Foods:

Review of import policy for mushrooms an trifles. The review will consider permitted and prohibited species, country of origin differences, target and hitchhiker pests, substrates approved for use, sterilisation requirements;…

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Complementary Medicines and Medical Devices:

TGA Website Redevelopment. The TGA is “modernising” its website. Some links will change, and some old pages removed. The TGA is presenting a webinar on 7th and 12th July. To…

Readmore..

Cosmetic, Personal Care and TGA Listed Sunscreens:

Useful resources for labelling of products Label your products.    Source: business.gov.au Labelling, SDS and packaging.    Source: Australian Industrial Chemicals Introduction Scheme (AICIS) Cosmetic labelling.    Source: ACCC Product Safety Australia  …

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Foods:

Research into vitamin D levels in the population A number of FSANZ staff recently contributed to a journal article investigating vitamin D in Australian diets. This study showed that vitamin…

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Complementary Medicines and Medical Devices:

Advertising - testimonials and endorsements. This is a new TGA guidance document that explains the difference between testimonials and endorsements, and which types of each are permitted. For example, testimonials:…

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