Poisons standard: “Interim Decisions” in relation to substances including cannabis and tetrahydrocannabinols, choline salicylate, chromates and chromium trioxide, and other ingredients.    Source: TGA.

 

Listed medicine compliance reviews. Updated 22nd March. Some medicines reviewed can still be supplied. There are issues with others.    Source: TGA

 

Revised guidelines for evidence to support indications for use/claims for listed medicines. Members of our tech team attended a recent TGA webinar. The deadline for comments on the proposed new guidelines is 1st April. Stakeholders affected by the recent floods or disasters may submit a request for a two-week extension to the Complementary and OTC Medicines Branch via email: This email address is being protected from spambots. You need JavaScript enabled to view it.. The TGA presentation is available here.

 

Medicinal cannabis reforms. On the 6th April the TGA is hosting a webinar on changes to the manufacturing, labelling and packaging requirements for medicinal cannabis products. For information and to register go here.

 

Testing of nicotine vaping products. This is an update to the results of TGA testing of 214 vaping products. Products are tested for presence of nicotine, the concentration of nicotine, presence of prohibited ingredients and compliance with labelling regulations.    Source: TGA

 

In the media:

Doctors call for ban on all vaping products including non-nicotine products. Concern is that advertising is designed to appeal to children. The black market is thriving, even though the TGA has commenced 288 investigations and issued 49 infringement notices totalling $450,216.    Source: Sydney Morning Herald.

 

Compliance enforcement

Getafix Café Pty Ltd fined $13,320 for alleged advertising of COVID-19 Rapid Antigen Test Kit on its website. The advertisements did not comply with the advertising requirements. The company was contacted by the TGA multiple times but failed to come into compliance.    Source: TGA

Gold Coast company FuturePro, trading as Inet Herbal has pleaded guilty to seven breaches of the Therapeutic Goods Act 1989 for the unlawful import, export, manufacture, supply, and advertising of herbal medicines with claims relating to the prevention and treatment of illnesses including various types of cancers. The illegally advertised therapeutic products included Zenith Salve with DMSO (a Schedule 4 prescription-only medicine), commonly known as bloodroot salve or black salve, Zenith Gentle Salve with DMSO, bloodroot capsules, Gumby Gumby and others. Black salve is a corrosive topical paste and can burn and destroy layers of skin and surrounding tissue. A sentencing hearing has set for 28 April 2022 at Southport Courthouse in Queensland.    Source: TGA

Melbourne pharmacist fined $7,992 for the alleged unlawful advertising of nicotine vaping products which are Schedule 4 prescription only medicines and cannot be advertised to the Australian public.    Source: TGA

DPD Stores Pty Ltd fined $26,640 for alleged counterfeit nicotine vaping products that did not declare on the labels and packaging that they contained nicotine.    Source: TGA

MEPH Pharmacy fined $39,960 for the alleged unlawful advertising of nicotine vaping products which are prescription only and cannot be advertised to the public.    Source: TGA

Healy World Australia fined $26,640 for alleged unlawful advertising of a TENS device for a purpose not included for the device in the Australian Register of Therapeutic Goods. The advertising contained a prohibited reference to a serious condition, with references to depression, anxiety and associated sleep disturbances, without the relevant regulatory permission from the TGA.    Source: TGA

Herbal medicine practitioner fined $2,664 for making 'miracle' claims. It has long been the case that a medicine cannot be advertised as a “miracle”. In this case the product was advertised as "a miracle covid treatment that no-one is speaking about".    Source: TGA

Vaxine fined $13,320 for alleged unlawful advertising of an unapproved COVID-19 vaccine on Facebook and YouTube. Apparently the TGA communicated with Vaxine by phone and in writing but the concerns were not addressed.    Source: TGA
 

Pharmacovigilance: this is an often overlooked responsibility. RFA offers a 1.5 hour course which includes a full set of documents and procedures. Courses are conducted by via Zoom, by appointment. Contact us for details.

RFA Breaking News

Cosmetic, Personal Care and TGA Listed Sunscreens:

Guide to categorising your chemical importation and manufacture. Updates to the guide.    Source: AICIS   Draft evaluation of a chemical with CAS number 1428963-39-6. Call for comment, deadline 3rd…

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Foods:

Imported kava – update to the definition of permitted kava products and labelling requirements for retail ready packs and bulk imported kava not for immediate retail sale.    Source: Dept…

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Complementary Medicines and Medical Devices:

Pharmacovigilance – important reading for all suppliers/sponsors and manufacturers of complementary medicines! This is an often overlooked responsibility and the TGA is now issuing fines for non-compliance - see next…

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Cosmetic, Personal Care and TGA Listed Sunscreens:

Download a list of chemicals on the inventory. AICIS has published a downloadable spreadsheet containing all the chemicals on their database. However this may not be very useful as it…

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Foods:

Do you import kava for sale or wholesale in NSW? From 1 December last year, commercial imports of kava from Pacific Island nations resumed. From this date, importers have been able…

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Complementary Medicines and Medical Devices:

Poisons standard: “Interim Decisions” in relation to substances including cannabis and tetrahydrocannabinols, choline salicylate, chromates and chromium trioxide, and other ingredients.    Source: TGA.   Listed medicine compliance reviews. Updated…

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