New advertising code

New Therapeutic Goods Advertising Code commences 1 January 2022. Advertisers have until 30 June 2022 to transition to the new code. Key changes include simplifying mandatory statements, clarifying that paid or incentivised testimonials cannot be included in advertisements, expanded list of permitted product samples, various improved definitions, and prohibition of advertisements causing undue alarm, fear or distress.    Source: TGA


Large numbers of illegal nicotine vaping products seized in a joint TGA-ACT Health operation

Dangerous and prohibited ingredients were found in two out of every three nicotine vaping products tested after a joint operation resulting from consumer tip-offs. Six prohibited ingredients were found, including the flavouring agent diacetyl, which when inhaled can cause irreversible lung damage.    Source: TGA


New TGA website searching tool

Search by product name, AUST L or AUST R number, active ingredient, non-active ingredient, product sponsor. Trial version is available now at


Compliance enforcement

In our March 2020 newsletter we reported that the TGA had issued penalty notices to Oxymed Australia and its director Malcom Hooper totalling $63,000 for illegal advertising of hyperbaric oxygen therapy chambers as a cure for serious diseases. The penalty notices were not paid, so the matter was taken to the Federal Court of Australia, which has ordered Malcom Hooper and Oxymed Australia to pay fines totalling $3,000,000. Source: TGA

NSW individual fined $7,992 for alleged unlawful advertising of ivermectin and zinc for COVID-19. TGA

KL4 Pty Ltd (Medcure) fined $106,560 for alleged unlawful importation of Ayurvedic medicines. TGA


Compounded medicines and GMP

TGA has produced a draft updated guidance and is calling for comments.    Source: TGA also here


Warning on importation of counterfeit Ivermecitin

Laboratory testing has confirmed that Iversun-12, Covimectin-12, and Ivilife-12, labelled as containing 12 mg, contain less than what is declared on the labels. It is illegal to advertise the sale of ivermecetin and it is not permitted to be used in the treatment of COVID.    Source: TGA


First aid kits containing medicines and medical devices

First aid kits always contain at least one medical device, and therefore are regulated as medical devices.    Source: TGA


News story: “Inside the TGA”

Subtitled “Fake blood, artificial stomachs and state-of-the-art technology” this article was published in the press and is an interesting overview of the TGA’s activities, including additional testing done 7 days a week on surgical masks during the COVID pandemic. TGA staff includes 750 scientists, medical experts, engineers and pharmacists, former police officers, spies and lawyers!    Source: Sydney Morning Herald


Software based medical devices

A list of FAQ explains if your product comes under TGA regulations, and what your obligations are.    Source: TGA


Australian TGA licensed manufacturers

When can your licence be suspended or revoked? New guidance document.    Source: TGA

How can I apply to vary my manufacturing licence? A step-by-sept guide. TGA


Overseas manufacturers

When can an overseas manufacturer obtain GMP certification, via an application submitted by the Australian sponsor or agent (regulatory consultant). Another “step-by-step” guide. TGA

RFA Breaking News

Cosmetics, Personal Care and TGA Listed Sunscreens:

Recall: 'Banana Boat' Sunscreen Sprays SPF 50+ (aerosol) Benzene was detected in 4 batches of three products supplied. Benzene is classified as a human carcinogen, a substance that could potentially…



Company pays penalties of $36,640 for misleading claim on “pure” vanilla extract HBC Trading labelled the product as “alcohol free pure vanilla extract” and placed an image of vanilla beans…


Complementary Medicines and Medical Devices:

Revised list of ingredients permitted in listed complementary medicines. Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2022, which…


Cosmetics, Personal Care and TGA Listed Sunscreens:

Step by step guide to categorising your chemical importation and manufacture With supporting self-guided decision tools helps you categorise your chemical introduction as listed or exempted or reported or assessed.    Source: AICIS   Infringement notice issued to…



Changes to the inspection of some imported food Kava products are classified as “risk food”. Commercial imports of kava will be inspected to verify compliance with food standards. Other foods…


Complementary Medicines and Medical Devices:

New advertising code New Therapeutic Goods Advertising Code commences 1 January 2022. Advertisers have until 30 June 2022 to transition to the new code. Key changes include simplifying mandatory statements,…


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