New TGA fees now in place

TGA fees rise at the beginning of the financial year i.e. the 1st July. For nonprescription medicines go here. The application fee for a listed complementary medicine has risen by $10 is now AUD$870 and the annual charge has also increased by $10 to $1,170. For all other fees for medicines including complementary medicines and medical devices, go here and select “2021-22”

 

Guidance on regulation of vaping products

For health practitioners, consumers and importers.    Source: TGA

 

Button batteries in medical devices for domestic use

Button batteries continue to be of concern due to the potential for young children to ingest them.    Source: TGA

 

Compliance enforcement

Aidacare fined $26,640 for alleged non-compliance with requests for face masks information TGA

V P & Associates fined $26,640 for alleged unlawful advertising of Liquim in relation to SARS-CoV-2 coronavirus TGA

Queensland man fined $7,992 for alleged unlawful importation of nootropic 'smart drugs'. Three infringement notices have been issued to a Queensland man for the alleged unlawful importation of a medicine containing Armodafinil, which is a prescription only medicine and popularly known as a “smart drug”. TGA. See also TGA alert on “smart drugs”.

Dentist fined $5,328 for alleged unlawful importation of injectables TGA.

 

Compliance reviews of listed complementary medicines

This list published in June summarises the outcomes of 15 medicines compliance reviews. Some products passed, others needed some corrective action, and some were cancelled.    Source: TGA. Search by “Publication date” to see recent entries.

 

Laboratory test results

There is a minimum delay of 6 months between the testing and publication of results, to allow the TGA to undertake any investigations and follow-up action in response to non-complying test results.    Source: TGA. Click on “Release date” for latest entries.

 

More news on regulation of faecal microbiota transplant products

What are FMT products, what are they used or, when does the regulation commence, what action is required, how can you source these products.    Source: TGA

 

Counterfeit human growth hormone products

The TGA, in conjunction with Sandoz and Novartis Australia, has investigated reports of counterfeit Somatropin HGH vials in community circulation. The product is labelled as “Novartis-Bio Somatropin HGH (191 amino acid sequence rDNA origin for injection) 3.7mg per Vial (10x10IU Vials of Somatropin)”.    Source: TGA

RFA Breaking News

Cosmetic, Personal Care and TGA Listed Sunscreens:

New video explains the basics of AICIS registration This 2-minute video explains when you do – and don't – need to register your business with AICIS, and gives a quick…

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Foods:

Applications, approvals and amendments to the Food Standards Code FSANZ has commended assessing applications for: The steviol glycoside, rebaudioside I, produced by enzymatic bioconversion of stevia leaf extract. The bioconversion…

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Complementary Medicines and Medical Devices:

New permitted ingredients for listed medicines The Permissible Ingredients Determination (ingredients that may be use in listed complementary medicines) has been revised. 61 ingredients have been either added to the…

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Cosmetics, Personal Care and TGA Listed Sunscreens:

New sunscreen standard in force New sunscreen standard in forceThe new sunscreen standard, AS/NZS 2604:2021, specifies requirements and test methods for broad spectrum and water resistant sunscreen products. Includes labelling…

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Foods:

New biosecurity website A new website - biosecurity.gov.au - details measures in place to protect Australia from harmful pests, diseases and weeds. This gathers information previously found on different state…

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Complementary Medicines and Medical Devices:

Hemp seed oil - change of status An interim decision has been made to exclude hemp seed oil from Schedule 9 of the poisons schedule whe used for oral consumption…

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