A Guide to Understanding the TGA & the ARTG

Over the last few weeks, almost undoubtedly relating to the COVID-19 virus pandemic, we have received many enquiries about products that carry an ARTG ID number, and ultimately, what the purpose of an ARTG ID number is. Unfortunately, government websites typically don’t have the most user-friendly layouts and it often becomes a daunting and time-consuming task to filter through to the right information.

In response, we have decided to create a comprehensive guide to help our customers make more informed decisions for their businesses by understanding the relationship between the TGA and the ARTG, and how products can still be effective without a listing.

The TGA & the ARTG

There seems to be some confusion surrounding what the ARTG is and the importance of having an ARTG ID number, so let’s start from the beginning and get a clear understanding of the organisation that deals with these issues.

What is the TGA?

According to their website, the “Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, and blood-related products.”

“Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.”

Essentially, if a company is making a specific therapeutic claim about how the product benefits its human users, then it is subject to the Therapeutic Goods Act 1989 and must go on the Australian Register of Therapeutic Goods.

What is the ARTG?

The Australian Register of Therapeutic Goods (ARTG) is as its name suggests – a register of therapeutic goods that can be lawfully supplied in Australia, regulated by the Therapeutic Goods Administration (TGA). The ARTG is a searchable database that provides publicly available assurance that the product does what it claims.

Before the end of 2018, disinfectants needed to be registered on the ARTG and subsequently had an ARTG ID number. The rules have now changed such that products need only be registered if there are specific therapeutic claims about a product’s performance. However, if a product is making a more general claim (such as, “kills germs and bacteria”), then it need only adhere to those specific requirements necessary to verify that particular claim.

A little unclear? Read on for further clarification.

General Claims VS Specific Claims

Like all chemical solutions, the product you choose should be dependent on the problem you’d like to solve. As such, it is important to understand the need for a specific therapeutic claim, and how it stacks up against a general claim.

A good set of examples close to home is from two of our very own hospital-grade disinfectants, CounterFlu and Tango.

We currently only have one product that actually needs to be listed on the ARTG and that’s CounterFlu (with an ARTG ID 332361). CounterFlu is a virucidal, hospital-grade disinfectant that has been microbiologically tested and proven to kill various viruses, germs, bacteria, moulds, and fungi, with its most notable capabilities killing coronaviruses including SARS-CoV-2 (COVID-19 virus). When you visit the Product Data Sheet (PDS), you’ll notice CounterFlu has a very specific claim against a range of viruses, bacteria, and germs that must be approved by the TGA before we’re able to advertise accordingly.

With the new changes for the register, Tango was but is no longer listed on the ARTG, nor does it have an ARTG ID number despite still maintaining its powerful disinfecting status. Under previous TGA rules, Tango was listed on the ARTG simply because it qualified as a hospital-grade disinfectant (a general therapeutic claim). Being listed meant it carried the ID number 104423. The rules have since changed such that only disinfectants with claims against specific bacteria or viruses can be listed on the ARTG. Again, this is because claims that a disinfectant has an effect against a specific virus must be expressly permitted by the TGA before being used in consumer advertising – including on the label – to avoid misleading.

Here is where most of the confusion seems to be for our customers: are products still effective if they don’t have an ARTG listing? Since we don’t make specific claims about Tango, it no longer needs to be listed on the ARTG, and thus the listing has lapsed. Tango is still an effective hospital-grade disinfectant, however, and can be advertised as such because it has been successfully tested for a general claim against a range and level of bacteria specified by the TGA for ‘hospital-grade’ disinfection.

Now that we have a better understanding of the relationship between the TGA and the ARTG, as well as the importance of specific claims of therapeutic goods, we can move on to more practical questions.

How does the TGA help protect consumers?

Well, typically when we see therapeutic goods on the shelves of stores, we are oblivious to the verification processes these products must go through before they can be sold in Australia.

The TGA helps stop the spread of misinformation by eliminating misrepresentation of facts (intentional or otherwise) and is intended to help keep consumers safe from wrongful claims.

In the case of our previous example, Tango, this was done by adhering to the stringent criteria of laboratory testing needed for a successful general claim of ‘hospital-grade’ disinfection. Although Tango no longer has an ARTG ID number, it maintains its status of ‘hospital-grade’ as it has passed all necessary tests set forth by the TGA and thus has been granted permission to market the product accordingly.

Contrastingly, although CounterFlu is a hospital-grade disinfectant too, it goes one step further and is listed on the ARTG because it has verified claims that it kills specific viruses like COVID-19 virus or Human Influenza Virus (common flu).

This verification process obliges companies to market products as truthfully as possible to avoid any misrepresentation of facts and mislead Australian consumers.

Final Thoughts

So, what can you do with this information? Well, with over 55 years of experience in manufacturing quality chemical solutions, we want to share our knowledge so we can all make the most informed decisions.

Hopefully, this comprehensive guide to understanding the TGA and the ARTG has helped you identify with confidence that products don’t necessarily need an ARTG ID number to be effective.

However, if you have a specific therapeutic benefit you want to get out of using a product (e.g. killing the COVID-19 virus with a disinfectant), then the publicly searchable ARTG ID number can provide the much-needed assurance that the product has verified its claim to the highest degree set forth by a branch of the Australian Government Department of Health, the Therapeutic Goods Administration.