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

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…

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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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