Tag Archives: COVID19

A Comprehensive 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 (yes, “human” is specified!), 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? Well, that’s bureaucracy for you. 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.

Conclusion

So, what can you do with this information? Well, with over 50 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 COVID-19 virus with a disinfectant or protecting yourself from UV rays with sunscreen), 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.

Coronavirus COVID-19 Crisis – Everything You Need to Know

Agar Update 17.07.2020

As the COVID-19 crisis continues to evolve, our team at Agar is still working hard to ensure the regular supply of trusted high quality products to our clients. Fortunately some consistency has returned to our supply chain and this has been reflected in our improved order fulfilment.

Our warehouses in NSW, QLD & SA along with many distributors have had restrictions eased, but now with the second wave of the virus in Victoria where our main factory is located, we must adhere to the latest higher restrictions. In any case, thanks to the efforts of our amazing team we have been able to keep production running at steady capacity as we continue to play our part in helping Australia work through this by providing supply to essential healthcare and cleaning services.

As always we are very grateful to our loyal clients for their understanding and support during these challenging times. We wish all Australians, and the rest of the world, safety and good health.

We are committed to keeping our clients informed and we’ll keep you posted should the situation change.

Stay safe, be informed.

– Agar Team

Agar Update 31.03.2020

During this COVID-19 crisis, Agar has made an active effort to continue the regular supply of goods to our clients to reduce the negative impact we all face, but as the situation progresses with panic buying, extraordinary demand, and low stocks, we have had to adapt.

Unfortunately in these unpredictable times, the fall of the Australian dollar coupled with the rising scarcity of the raw materials needed to produce our cleaning products has caused production delays, increased expenses, and various limitations.

We have increased our production and will continue to ensure we play our part in helping Australia work through this by prioritising supply to essential services on the frontlines of the pandemic like our hospitals and healthcare facilities. We are working as best we can to ensure we clear our remaining backlog of orders as quickly as possible to get you the products you need.

We are very grateful to our loyal clients for their understanding and support during these challenging times. We wish all Australians, and the rest of the world, safety and good health.

Stay safe, be informed.

“Together we can will get through this.”

– Agar Team

What is the coronavirus (COVID-19)?

COVID-19 is the latest discovery in the coronavirus family. Coronaviruses are part of a large family of viruses that can cause illness in animals or humans. In humans, several coronaviruses can cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).

COVID-19 was discovered after an outbreak began in December 2019 in Wuhan, China.

How does it spread?

On February 7 2020, Chinese researchers said the virus could have spread from an infected animal to humans through illegally trafficked pangolins, sought after in Asia as food and medicine. Scientists have pointed to either bats or snakes as the possible source.

COVID-19 is contagious and can be caught by others who have the virus. The disease can spread by breathing in the contaminated small droplets expelled through coughs or sneezes, or by touching a surface where they have landed and then rubbing your face – your nose, eyes, or mouth. This emphasises the importance of washing your hands regularly with soap (for 20 seconds minimum!) and keeping a distance from others to avoid inhalation of contaminated droplets.

So, how can I stop the spread?

Precautionary & Prevention Measures:
  • Regularly wash your hands with soapy water for a minimum of 20 seconds
    or, if you can’t:
  • Regularly disinfect your hands with an alcohol-based sanitiser such as Agar’s Cool Tide or AS-60 – look for at least 60% ethanol
  • Clean and disinfect highly used surfaces – keyboard, mouse, light switches, telephones, mobiles, steering wheels, etc.
  • Maintain at least 1.5-metre distance between yourself and others
  • Do not shake hands, hug, or kiss as greetings
  • Practice social distancing – avoid crowds and gatherings of people when possible (follow government directives)
  • Avoid touching eyes, nose and mouth
  • Sneeze and cough in a tissue or the bend of your elbow to minimise the spread
  • Stay how if you feel unwell. If you have any of the symptoms outlined below, then seek medical attention – call in advance
  • Limit travel as much as you can except to places deemed essential – supermarkets, work, emergency facilities
  • Limit contact with elderly persons or persons with underlying health issues
  • Keep up to date with Health Alerts from the AUS Government HERE
  • Don’t share drink bottles, crockery and cutlery
  • Get a flu shot as soon as possible (could help reduce the risk of further problems)
Hand Wash How To
9 Steps of Hand Washing
What symptoms should I look out for?
  • Fever
  • Coughing
  • Sore throat
  • Fatigue
  • Shortness of breath

If you have serious symptoms such as difficulty breathing, call 000 for urgent medical help.


What is the difference between COVID-19 and the flu?

The first symptoms of COVID-19 and influenza (flu) infections are often very similar. They both cause fever and similar respiratory symptoms, which can then range from mild through to severe disease, and sometimes can be fatal.

Both viruses are also transmitted in the same way, by coughing or sneezing, or by contact with hands, surfaces or objects contaminated with the virus. As a result, the same public health measures, such as hand hygiene (handwashing), good respiratory etiquette (coughing into your elbow, or tissue and immediately disposing of it) and good household cleaning are important actions to prevent both infections.

The speed of transmission is an important difference between the two viruses. Influenza typically has a shorter incubation period (the time from infection to appearance of symptoms) than COVID-19. This means that influenza can spread faster than COVID-19.

While the range of symptoms for the two viruses is similar, the fraction with severe disease appears to be higher for COVID-19. While most people have mild symptoms, approximately 15% of people have severe infections and 5% require intensive care in a hospital ICU. The proportions of severe and critical COVID-19 infections are higher than for influenza infections.

Agar’s Commitment

To Staff:

Hand sanitisers and facemasks are readily available. Meetings have been limited. Physical cash transactions discontinued. Distancing 1.5m between staff members. Opportunities to work remotely where possible. No face-to-face transactions with customers.

To Public:

Regular updates regarding stock availability and demand. Situation updates in conjunction with legislative lockdown adjustments. Priority service to Healthcare and Hospitals at the forefront of the pandemic. Continuing to supply and develop virus combative products.

To our Clients:

We are working to our maximum capacity to clear the backlog of orders we have received and will keep you informed throughout this process. We want to thank all our clients for their patience and understanding and apologise for the inconvenience.

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For sales, please contact sales@agar.com.au.

Sources & References
Check your symptoms:

*Disclaimer: All above information/sources are accurate to the best of our knowledge at the time of writing. Please reference the above information at your own discretion.