Updated list of ingredients permitted in listed complementary medicines

A revised list has been published. You can find it here: https://www.legislation.gov.au/Details/F2022L00173. There is one new ingredient - Euglena gracilis whole cell dry; an updated name - ‘Cistus ladaniferus’ becomes ‘Cistus ladanifer’; and there are changes to requirements for several ingredients. To see these, open “Explanatory Statement” at https://www.legislation.gov.au/Details/F2022L00173/Download. If your products contain Andrographis paniculata, inorganic magnesium salts, ‘benzalkonium chloride’, mollusc and mollusc-derived ingredients, ‘pyridoxal 5-phosphate’, ‘pyridoxal 5-phosphate monohydrate’, or ‘pyridoxine hydrochloride’, or Artemisia species, you should note these important changes.

 

New Compositional guideline: Euglena gracilis whole cell dry    Source: TGA

 

Compliance enforcement

JMIT Distributors fined $79,920 for alleged advertising breaches involving nicotine vaping products. The company was contacted on multiple occasions but failed to come into compliance and continued to advertise nicotine vaping products for supply.    Source: TGA

NSW based executive officer fined $10,656 for alleged unlawful advertising of nicotine vaping products. The individual failed to bring the company's advertising into compliance with the Act.    Source: TGA

TGA has issued an infringement notice of $13,320 to Victorian-based company TCF Trading for alleged unlawful importation of 70,000 COVID-19 rapid antigen tests that were not included in the Australia Register of Therapeutic Goods (ARTG).    Source: TGA

The TGA has issued two infringement notices totalling $5,328 to a Melbourne-based individual for alleged unlawful importation more than 19kg of nicotine vaping products which were not registered on the ARTG to the individual and were not exempt from being registered.    Source: TGA

 

Should it be mandatory for healthcare facilities to report adverse events/safety problems with medical devices to the TGA? Feedback on discussion paper closed in December 2021. Almost three quarters of respondents were in favour of introducing mandatory reporting of medical device related adverse events.    Source: TGA. You can read responses from stakeholders here.

 

Recall: SFI Australasia, in consultation with the TGA, has initiated a recall for one batch of Ellura capsules (active ingredient: Vaccinium macrocarpon) due to the presence of ethylene oxide.    Source: TGA.

 

Supplying medicinal cannabis in Australia: this is a recording and transcript of a TGA webinar presentation in October 2021.    Source: TGA

 

TGA is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals.    Source: TGA

 

A new Poisons Standard has been published. The changes are detailed in the explanatory statement to SUSMP No. 35 February 2022.    Source: TGA. Explanatory statement is here.

 

Importing COVID-19 rapid antigen tests (RATs) – a fact sheet.    Source: TGA

 

Surgical mesh devices: information for medical practitioners on “up-classification”.    Source: TGA

 

Post-market review of face masks: the latest outcomes and action taken due to product defects.    Source: TGA.

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