Work to upgrade road barriers along the Tuggeranong Parkway is continuing, with lane closures this weekend to allow the project team to safely complete the remaining barrier replacements.
From 7 pm Friday 14 May, until 5 am Monday 17 May, the Tuggeranong Parkway will be reduced to one lane in each direction between the Heysen Street overpass and the Glenloch Interchange. Speed reductions will be in place for the safety of both workers and road users.
The public are encouraged to avoid the area and take alternate routes where possible.
Due to the wet weather experienced in recent weeks, works will continue until the end of this month (weather permitting).
Electronic road signage will be in place in advance of the closure locations to help motorists in making early decisions to leave the Tuggeranong Parkway and take alternate routes.
These works are jointly funded by the Australian and ACT Governments.
Source: Australian Trade and Investment Commission – Austrade
Canned Australian wine puts fizz into India’s fast-growing wine market
13 May 2021
Victoria-based Barokes Wines has become the first wine-maker to launch canned wine in India, despite the pandemic.
The Australian Senior Trade and Investment Commissioner for South Asia, Stuart Rees, launched the Barokes Wine brand in Mumbai on 18 February. The wine is being imported by Hover Barrell LLP in Mumbai.
Award-winning brand bets on wine retail in India
Barokes Wines is a global leader in canned wine. The company has won over 400 medals and its slim, aluminium cans are sold around the world.
Five varieties of Barokes canned wine are now available in India. These include three sparkling wines (white, rosé and red), as well as a cabernet-shiraz-merlot and a chardonnay-semillon.
The concept of canned wine is new to India. According to sources, the canned wine format is suited to India, where the wine market is comparatively small but aspirational, and dominated by domestic production.
The company’s patented Vinsafe® process is able to preserve wine stability and longevity for up to five years.
India’s wine imports growing at over 10% per year
The key market segment for wine is dominated by the ‘on-trade’ hospitality sector. On-trade sales accounted for 70% of the wine sold in India prior to the pandemic, according to Euromonitor International (2020), Wine in India – Country Report (September 2020), accessed 11 May 2021.
Retail sales of wine were not hit as hard during 2020 than sales from restaurants and other hospitality venues. Restaurants have been closed for protracted periods since the onset of the pandemic.
Meanwhile new opportunities to sell wine have emerged. State governments in Maharashtra, Odisha (Orissa) and West Bengal authorised e-commerce wine and liquor purchasing and home deliveries during 2020.
Source: Euromonitor International (2020), Wine in India – Country Report (September 2020), accessed 11 May 2021.
Overall, wine sales in India are growing fast. Annual growth rates exceeded 10% per year from 2013 to 2019, according to Euromonitor. Sales are expected to grow by approximately 8% per year to 2024.
Austrade helped Barokes Wines into India, including an introduction to Mumbai-based importer, Hover Barrel LLP.
According to local sources, the entry of Barokes canned wines into India should help to redefine wine-drinking for aspirational young consumers in India. It will likely expand Australia’s market share by broadening the market for wine imports.
The Australia–India Business Exchange
Austrade has also launched a program to help increase trade and investment between Australian and India.
The Australia-India Business Exchange provides insights, advice, and business connections to grow two-way trade and investment between Australia and India.
To find out more, please contact Austrade online or call 13 28 78.
Source: Australian Trade and Investment Commission – Austrade
13 May 2021
The Australian Government is introducing a patent box to encourage investment in Australia’s biotechnology and medical technology sectors.
The patent box was announced in the Australian Government’s Budget 2021–22, which details its economic plan for Australia.
What is the patent box?
The A$206 million patent box scheme will reduce taxes on income from innovative research. Its aim is to encourage businesses to undertake their R&D in Australia, keep patents here and manufacture patented technologies onshore.
The patent box will help bridge the gap to commercialisation, and support businesses to keep the development of their IP and the value they create.
Australia joins more than 20 countries with a patent box, including the UK and France.
How will the scheme work?
From 1 July 2022, income derived from Australian medical and biotech patents will be taxed at a concessional corporate tax rate of 17%.
This is lower than the standard corporate income tax rate of 30%, or 25% for small and medium companies.
Which patents are eligible?
Only granted patents, which were applied for after the Budget 2021–22 announcement, will be eligible. The Australian Government will follow the OECD’s guidelines on patent boxes to ensure the patent box meets internationally accepted standards.
Australia’s biotech and medtech sectors
Australia has vibrant biotech and medtech sectors. The country is an attractive destination for R&D because the healthcare system is receptive to innovation, research is well funded, and a strong regulatory system protects intellectual property. Australian universities and institutes undertake world-leading research and seek international collaborations.
See how US biotechnology firm Illumina is collaborating with the University of Melbourne and the Victorian Government to set up a A$60 million Genomics Hub in Melbourne.
Find out more about tax incentives to support Australia’s recovery (PDF, 627KB), including the patent box.
Find out more about investing in Australia or contact Austrade for more information.
Senator the Hon Michaelia Cash Attorney-General Minister for Industrial Relations Deputy Leader of the Government in the Senate
The Morrison Government today announces that it will extend the final reporting date for the Royal Commission into Violence, Abuse, Neglect and Exploitation of People with Disability to 29 September 2023.
This provides an additional 17 months to account for the impact of COVID-19 and recognising the broad issues of inquiry under the Royal Commission’s terms of reference.
“This extension will enable the Government to receive and implement recommendations as expeditiously as possible,” Minister Ruston said.
“This will make meaningful change to the lives of people with disability, while also enabling the Royal Commission to fulfil its terms of reference.
“We remain focused on supporting people with disability, their families and supporters, advocacy groups and the disability community.”
Attorney-General Michaelia Cash said the Government had favourably acted on requests from the Chair since the inquiry started.
“The Government has added a seventh Commissioner, refined the Letters Patent to articulate the Chair’s role and progressed legislative amendments to the Royal Commissions Act 1902 to assist the Commission’s workload,” the Attorney-General said.
The Royal Commission is independent from Government and sets its own processes including how it approaches its terms of reference, informs itself for the inquiry and, importantly, hears directly from people with disability, their families and loved ones.
The Government continues to fund free and independent counselling and advocacy support for people with disability that have experienced violence, abuse, neglect and exploitation, as well as their families and carers, and anyone affected by the Royal Commission.
A national legal advisory service and legal financial assistance scheme are funded and available for people or entities giving evidence or engaging in other ways with the Royal Commission. Additional funding for support services for an extended reporting date will be considered through the ordinary budget processes.
The Government looks forward to receiving the Royal Commission’s final report on 29 September 2023.
Source: New South Wales Department of Primary Industries
Joint media release: NSW Deputy Premier and Minister for Agriculture and Western NSW
13 May 2021
The NSW Government has today announced a $50 million package to offer farmers, households and small businesses assistance to battle the mice plague currently impacting parts of rural and regional NSW.
Deputy Premier John Barilaro and Minister for Agriculture Adam Marshall said free baiting, through free-of-charge grain treatment, would be made available to primary producers, while affected rural and town households and small businesses would be able to apply for rebates to help them meet the cost of purchasing mouse baits.
“We know the financial pressure this mice plague is putting on farmers and household budgets, we have heard the concerns of regional NSW and we are acting on it,” Mr Barilaro said.
“The NSW Government will establish grain treatment facilities at specified locations across rural and regional NSW for farmers to have their grain treated free of charge and we will provide rebates to small businesses and households through Service NSW to help meet the cost of buying bait.
“I am also forming an advisory committee to ensure everyone has access to expert advice, including the latest hot spots, health and food safety advice, information for vets and guidance for keeping children and animals safe.”
Under this package households will be able to apply for rebates of up to $500 and small businesses will be eligible to claim up to $1,000 through Service NSW.
The advisory committee will include representatives from the Department of Regional NSW, Local Land Services, Department of Primary Industries, Resilience NSW, NSW Health, Service NSW, NSW Food Authority, Office of Small Business Commissioner, the Office of Local Government and the CSIRO.
Mr Marshall said farmers would be able to have their grain treated free of charge to protect their hard-sown crops from vermin.
“Today’s announcement of free baits to treat grain almost completely removes the cost burden on our farmers and croppers and complements our popular workshops to arm farmers with the tools needed to build a mice-free fortress to protect their paddocks,” Mr Marshall said.
“I’ve seen first-hand the impact these rodents are having. They are a scourge on our agricultural production so we are giving landholders a fearsome suite of tools to manage mice.
“We’re making this as easy for farmers as we possibly can. No tedious rebate forms to fill out, just bring your grain to have the experts treat it free of charge.
“Free bait is better than any rebate for our farmers, who we continue to stand behind post drought, bushfires and floods.”
In addition to free grain treatment and expert workshops, the NSW Department of Primary Industries will also launch an unprecendented body of research to identify and potentially develop future tools to combat mice plagues, including biological controls.
$500 rebates for eligible households
$1,000 rebates for eligible small businesses
Free mice bait (grain treatment) for farmers
The NSW Government has sought urgent approval from the Commonwealth’s APVMA for the use of bromadiolone in NSW
Expanded workshops to educate farmers on the best eradication strategies
A research project to identify and potentially develop a new mice-killing agent
For the latest information about the mice plague, eligibility, how rebates will be claimed as well as health advice, go to www.nsw.gov.au/mice.
Media contact: Georgina Kentwell | Deputy Premier | 0427 206 308, Luke O’Donnell | Minister Marshall | 0427 837 497
A man has been arrested and charged for allegedly starting bushfires in the southern suburbs in January.
Just after 4pm on Sunday 24 January 2021, bushfires were discovered on Hicks Hill Road at Cherry Gardens, Mathews Road and Mount Bold Road at Bradbury and Dorset Vale and Cut Hill Road at Kangarilla. The fires quickly spread in very hot conditions, burning for over 24 hours.
Following an investigation, today (13/5) Southern District Detectives arrested and charged a 61-year-old man from Hallett Cove with twelve counts of intentionally causing a bush fire and ten counts of property damage.
The man has been refused police bail and will appear in Adelaide Magistrates Court tomorrow.
The investigation is ongoing and police ask anyone who saw people or vehicles in the Cherry Gardens, Dorset Vale, Bradbury, Clarendon and Kangarilla areas who may have witnessed a small white car in those areas between the hours of 3.30 p.m. and 6.00 p.m. to please contact Crime Stoppers on 1800 333 000 or report online www.crimestopperssa.com.au.
Source: Australian Ministers for Regional Development
I’m very pleased right now to be able to welcome the Deputy Prime Minister of Australia, Michael McCormack, he’s joining us live from Canberra. Deputy Prime Minister, thank you so much for being here.
It’s a pleasure.
In terms of the spend that we are seeing on this Budget, though, you know that potentially later tonight we’re going to hear from the Opposition. There’s going to obviously be those people that say we’re spending too much in terms of the $161 billion Australian deficit. But realistically with the impact that we saw from COVID-19 and the hope that we can really get this unemployment rate below five per cent and the recovery back on track, was there really any other alternative?
There was not and that is why John Howard, indeed, former greatly acknowledged Prime Minister of this country said when you do have a situation such as this then you need to throw everything at it, to ensure that those jobless queues which we saw very early in the pandemic, which were reminiscent of the Great Depression, we didn’t want to see those continuing. We wanted to see businesses as best as they could to be able to stay open. And that’s what why we put in place a measure called JobKeeper, which enabled businesses to remain connected with their employees, to remain with their doors open and remain functioning and trading. And that’s why we also extended the JobSeeker allowance, which is our, effectively, unemployment rate, to give those people who suddenly found themselves on the welfare queues – for sometimes the first time in their lives – the dignity of being able to still put bread and butter on the table to still have that ability to be able to finance their lives. We’ve made some tough decisions. We’ve made some big calls, yes, but Australia is the envy of the world when you look at our low case rates. Yes, we’ve lost 910 Australians and that is very, very sad for their families. But if you consider what was being tipped early in the piece with thousands of people dying, with potentially, you know, much of the population being affected by this virus, we’ve done very, very well.
And I wanted to touch on, as well as, because you’re obviously the Minister for Regional Development as part of your many portfolios but we’ve seen a considerable shift, I suppose, when it does come to this investment as well in green technologies, this investment that has been earmarked in terms of really making that shift. And, you know, it all ties into the Biden Summit that we had back in April towards things like green hydrogen, towards things like carbon capture technology. So how important is that going to be? Because you’ve also got to balance the fact that in a lot of these regional areas perhaps the coal-fired plant is the big source or the big employer? So, how do you navigate trying to find that balance and ensuring that we still meet all of our targets moving forward?
Well, you’re totally right and we’ve absolutely done what you’ve just said – we’ve had that balance. That word is very important. So we still use, of course, traditional forms of energy and indeed, two-thirds of our energy supplies come from traditional sources, come from coal. Indeed, it’s also worth $66 billion of exports and employs 55,000 Australians and makes sure that many other countries can be warm in winter and cool in summer and that’s necessary. But we’re meeting and beating what we said we’d do as far as our climate emissions, as far as lowering our emissions are concerned. We’re certainly meeting what we said we’d do in Paris. We’ll continue to do that and we’ll continue to, as we work towards 2050 and of course, meeting future climate targets, of course, we will make sure we do it through technology, not taxes.
Now, the farmers, I suppose, over the past couple of years here in Australia have had a particularly rough trot. We’ve dealt with the bushfires, we’ve dealt with the droughts. We had the floodings earlier this year and also the issues when it does come to China. But how has the Government really been able to try and drive into other export markets in order to make sure that they have somewhere to sell their goods?
Well, Dan Tehan is the new Trade Minister and he wasted no time in getting across to Europe, getting across to the United Kingdom, and I know he’s made himself freely available to American diplomats as well. We’ll make sure that we broaden our trade interests. We’ve got that trans-Pacific partnership agreement – $13.3 trillion opportunity right here in our backyard. And we’re making sure that we do diversify our markets. Of course, China is a big market for us – $149.7 billion of trade with China. And we also understand it’s a big world out there and we’ve got the world’s best food and fibre. Our resources are in great demand and we’ll continue to make sure we diversify our markets. Dan Tehan will continue to make sure that if there’s any other possibilities – we’ve just sent our first shipment of barley indeed, to Mexico. So, that’s something that’s a new and diversifying market example, and that’s what we’ll continue to do.
Sir, it’s Nancy here in Singapore, and as you point out the importance of the relationship with China, your biggest trading partner here, there are concerns that the relationship is not at a very good point right now. And I just wonder how you respond to China when they say that it’s your Government that has caused – taken a series of measures that has been really the disruptive force in this relationship and accusing you of a cold war mentality. How do you respond?
Well, we’ll let the World Trade Organisation sort out any matters or any conflicts so far as trading relations are concerned. We’ll continue to work in a diplomatic and pragmatic and practical way with Chinese officials. We’ll continue to do that. Our phones are always there if they want to talk to us, in a very bilateral fashion. Of course, Dan Tehan, the new Trade Minister – very welcoming and open to any conversations that Beijing wants to have with us as far as making sure that we smooth any relationships, that we get on with continuing to provide China with our resources of course, their steel mills need our metallurgical coal. They still need our other resources, whether it’s food, whether it’s fibre. They understand that we’ve got a great market here and we’ve got a great product and they’ll continue, I know, to support us, as we will them.
I think part of the concern, though, is when China came out and indefinitely suspended the key economic dialogue with Australia they signalled to many that they’re not really in a mood to negotiate. What specifically are you willing to do in the Government to bring China to the negotiating table and improve this relationship?
We’ll be patient. We always are. We’ll be patient. We’re here. We understand that we’ve got the world’s best product and I know that perhaps some of your viewers might think otherwise – we’re all very parochial and we’re all very fiercely proud of what we produce in our own countries – but I know our farmers are the best in world. I know our mining resources are valued right across the world and whether it’s rare earths, whether it’s coal, whether it’s iron ore – you mentioned that at the top of the show, our iron ore price is very strong at the moment and we’ve based our Budget on very conservative estimates about where that iron ore price might go. But, indeed, our resources are greatly valued, greatly in demand around the world and whether it’s China or any other country, we’ll work with them always in a friendly and diplomatic and responsible way.
Good morning, Tanvir Gill joining in this conversation as well. You, India and Japan have come together – Australia, India and Japan have come together to formally launch the supply chain resilience initiative that China’s called unfavourable for the global economy. What is the plan here and how do you go about executing the supply chain lines across these three regions?
Well, resilience is a big thing and whether it’s Japan, whether it’s India or whether it’s Australia, we all need our markets to be more resilient. We all need to bounce back. We’re in the midst of a global pandemic and of course, our hearts go out to India at the moment with what they are suffering through this global pandemic. We want to get through this. We have to get through this and as peoples of the world, we will get through this and resilience is a very, very big thing. We understand just how much we need to broaden our interests with market opportunities. But we also need to have that ability to be able to reach out to our friends, to our neighbours in the Indo-Pacific region and make sure that they know that Australia is here, Australia’s open for business and Australia will continue to trade because we understand as well as anybody that trade equals jobs and more trade means more jobs.
Alright, on that subject, given the crisis that India is facing, how are negotiations going with the Indian authorities on restarting repatriation flights? I believe the flights start the day after. Because your Immigration Minister has said that the whole process will be very complex and will take a lot of time.
And it will take time and we’ll always put our national interest first. But, of course, we are a country which places humanitarian efforts first and foremost and that’s why we’re always first to help when island nations in the Pacific have cyclones and other natural disasters. We’re very much conscious of the fact that we’ve got a number of Australians in India at the moment, and we speak to High Commissioner Barry O’Farrell on a daily basis. I know the Foreign Affairs Minister, Senator Marise Payne, is very aware of the problems and difficulties that India faces and that’s why in the Budget there’s more than 120 government-facilitated flights. We’re going to bring more than 17,000 Australians home over the next 12 months and we’ll continue to do that. Our Prime Minister Scott Morrison said on March 13 last year, he urged and encouraged and implored Australians if they could do so to come home. Not all Australians took advantage of that ability to do it then and of course, with the situation worsening in some countries, there is a great desire to come back to Australia now. So, we’ll continue to facilitate those flights. We’ll continue to work with commercial airlines to make sure that we get as many Australians home, whether they’re in India or anywhere else.
Sir, we very much appreciate you joining us today and weighing in on these important issues. Thank you so much. The Deputy Prime Minister of Australia Michael McCormack with us and Will, thank you for bringing us the interview, as always.
Source: Australian Capital Territory – State Government
Lost doggos will find their way home more easily after the ACT Government today passed new legislation requiring all dog owners to update their details annually, at no additional cost.
Annual dog registration will enable the delivery of a new digital dog database which will provide up to date information on where dogs live and who owns them.
“The new system will improve the information we have about dogs in the ACT, ensuring we can contact owners quickly if lost or roaming dogs need to be returned to their families,” said Minister for City Services, Chris Steel.
“It will also allow the government to deliver better education and services to pet owners and manage dangerous dogs to help prevent and respond to dog attacks.
“The new system will address challenges with the current lifetime registration system, where 95 per cent of roaming dogs that are retrieved have out of date registration information such as an incorrect phone number or address.
“At the moment there are no triggers for owners to update their information when they move, if ownership of the dog has been transferred to someone else, or if the dog has passed away. The new online system will mean we have better, more accurate and up-to-date information about Canberra’s canine community, improving safety for pets and the community.
From 1 July 2021, dog owners will receive an annual registration reminder notice in the form of an email, text or letter from Domestic Animal Services. This will be provided at least 14 days prior to their dog’s renewal date, allowing time for owners to take action.
The notice will contain details on how to quickly and easily confirm or update their dog’s registration details using an ACT Digital Account.
A dog’s annual registration renewal date will be based on the date they were first registered in the ACT. For example, if you registered your dog in the ACT on 1 September 2020, then your annual renewal date will be 1 September each year.
There will be transitional arrangements for owners whose annual registration would fall due within the first month of these new requirements taking effect. This means that if you registered your dog in the ACT on 15 July 2020, then your annual renewal date will be 15 August 2021.
“Importantly, dog owners can update their registration details before the 1 July start date. This will allow us to easily contact you when your dog’s registration falls due in the first 12 months of the system,” Minister Steel said.
“Canberrans love their dogs, and pets make a great contribution to our community’s wellbeing. At the same time, it is vital we continue to strengthen responsible dog ownership and provide education to the community on how to be a responsible dog owner.
“This includes looking after and taking care of your dog, knowing the nature and temperament of your dog, maintaining effective control of your dog in public places, de-sexing, registration and micro-chipping.”
Canberrans can find out more information on the new annual dog registration process, as well as how to update a dog’s registration details now by visiting www.cityservices.act.gov.au/dogrego.
The City will transfer responsibility for its section of Marmion Avenue to the State Government’s Main Roads WA (MRWA) in recognition of the road’s significance as a high traffic transport route
Wanneroo Council approved the transfer at last night’s ordinary council meeting.
Mayor Tracey Roberts thanked the State Government for supporting the improvement of transport infrastructure – a key focus for the City.
“The City continues to invest a large portion of its capital works budget on transport infrastructure, pathways, traffic management and street lighting to improve efficiency and safety for our rapidly growing population,” Mayor Roberts said.
“Wanneroo’s large and diverse region services the greater Perth area and beyond, so it is a priority to ensure local, state and federal governments work together to maintain fit-for-purpose transport routes.”
City of Wanneroo Director Assets, Harminder Singh, said the City would work with MRWA to finalise the transfer.
“We are looking forward to working closely with Main Roads WA to complete the transfer of these roads to positively impact our community,” he said.
Formal proceedings of the transfer will take some months to complete, pending resolution of land tenure.
Since 2010 the City has requested that Marmion Avenue and Ocean Reef Road be reclassified as State Administered Roads under the responsibility of MRWA.
Following the 2018 review of WA’s road classification criteria, MRWA took over the responsibility of Ocean Reef Road from 1 July 2020.
In April 2021, MRWA determined the section of Marmion Avenue between Ocean Reef Road and Yanchep Beach Road fit the criteria for reclassification as a State Administered Road under the Main Roads Act 1930, following completion of the state-funded four-lane dual carriageway.
This instrument amends the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019, principally to incorporate the most recent version of the TGA instructions for disinfectant testing and to clarify a small number of matters.
It is an offence to import and/or supply therapeutic goods in Australia that do not conform with a standard applicable to the goods (refer sections 14 and 14A of the Act).
The following guidance contains information about:
Information required to support your application
Once the TGA has received your application to list your disinfectant product on the ARTG, the TGA will request a copy of labelling. Alternatively you can attach the labelling for all products to the application. Based on the labelling information, further information may be requested to support the assessment of the application, as outlined below.
The TGA recommends that you retain the following information, which may be requested from you during either the pre-market evaluation or post-market review of your product/s:
Information relating to the formulation of ingredients, including fragrance and colourants.
Stability data (for a new ingredient), if requested, to the extent that it is available. If you are asked to provide stability data and this information is not complete, you will need to supply preliminary stability data and indicate the protocol to be used for monitoring product performance, until a final shelf life determination is made. Your approach must be consistent with the TGA Instructions for Disinfectant Testing.
Relevant manufacturing quality control certificates and associated descriptions.
A Safety Data Sheet (SDS).
Name and address for all manufacturers involved in the process of producing the disinfectant.
Details of the manufacturing steps, including the identity of the manufacturer responsible for the process (all disinfectants are exempt from GMP requirements under Item 13 Schedule 7 of the Therapeutic Goods Regulation 1990).
Records of complaints or adverse events.
Every application for a new product listing will be assessed. Data will be requested to support the specific claims on the label. Additional data as outlined above may be requested. A full pre-market review and safety evaluation of listed disinfectants will only be conducted on products that contain a new chemical entity and/or make new specific claims. This may incur an evaluation fee.
All ingredients included in the formulation of therapeutic goods supplied in Australia must be identified using the relevant Australian Approved Names (AANs) or Proprietary ingredients. The Sponsor must include the full formulation of the product within the application prior to approval.
Australian approved names (AANs)
The TGA develops and maintains approved terminology to ensure accuracy and consistency of the information about goods on the ARTG.
These approved terms must be used to identify ingredients in your listed disinfectant:
When applying to list goods on the ARTG via the TGA Business System (TBS).
On labels and packaging for therapeutic goods.
Product Information documents provided with the goods.
Proprietary ingredients are entered into the TGA Business System (TBS) by the TGA, using details submitted by the supplier of the ingredient or by a medicine sponsor (on behalf of the supplier) using the Notification of a new proprietary ingredient form. This allows for the capture of complex formulation details and other relevant information, and the provision of a unique name and number. Sponsors may select proprietary ingredients using the assigned ingredient ID number for use in their application for a listed disinfectant.
Proprietary ingredient formulations for disinfectants are fragrances or colouring ingredients and are considered to be “commercial-in-confidence”.
You will need to adhere to the test requirements as set out in the TGA Instructions for Disinfectant Testing in order to demonstrate microbial efficacy. If requested, you will need to provide all test methodologies and results – a summary will be insufficient. Full test methodologies and results will need to be in English with clear indexing and organisation. A summary of tests and results in English is not acceptable.
Testing as described above may not be applicable to automated airborne disinfectant technologies. These include hydrogen peroxide vapour, hydrogen peroxide + peracetic acid fogging.
Manufacturers must take reasonable steps to ensure the disinfectant product is safe when used as intended, or if there is accidental contact with the product.
There is no expectation that studies will need to be initiated to assemble the necessary data. While a new study might be needed for a new chemical entity, it is expected that this section can be satisfied with information available through a competent search of the available literature and/or databases.
The TGA will accept information generated for other regulatory agencies. It is understood that most available toxicity data will be in relation to the individual components of a formulation rather than the formulation itself.
Toxicity tests on disinfectants used on surfaces should clearly identify any potential hazards of the formulation and risks to the user, through either intended use or accidental body contact. These hazards and risks must be clearly identified on labels and in product information.
Manufacturers should consider the following when determining toxicity of their product:
Acute oral toxicity
Any other known toxicity of an active ingredient or where the basic poisons related safety information suggests other forms of toxicity not mentioned above may be a hazard (e.g. neurotoxicity)
Basic poisons-related safety information is required for all disinfectants. The basic poisons-related safety information is that which would satisfy the Poisons Standard or Safety Data Sheet requirements of:
Additional information should also be supplied for the following, where applicable:
Acute Oral toxicity: Additional information on acute oral toxicity should be collected unless it can be shown that the disinfectant is unlikely to be used in a way that will cause it to contact the digestive tract. The information should relate to tests conducted at concentrations equivalent to those likely to be encountered in use.
Inhalation toxicity, skin irritation, sensitisation and eye irritation: Additional information on residue tests should be collected unless it can be shown that the disinfectants or their residues are unlikely to come into contact with skin, mucous membrane or eyes. The basic poisons related safety information is that which would satisfy the Poisons Standard30 or Material Safety Data Sheet (MSDS) requirements of the Safe Work Australia’s Model Code of Practice: Labelling of workplace hazardous chemicals.
Environmental toxicity: Ecotoxicological information should be held for all listable disinfectants, according to the requirements outlined by any relevant state or federal environmental protection legislation. The information provided should be reflected in appropriate handling, storage, transport, use, disposal, waste management and neutralisation instructions. The potential for reuse or recycling should be considered whenever appropriate.
The container for a disinfectant must:
be impervious to and incapable of reacting with its contents
be sufficiently strong to prevent leakage arising from ordinary risks of handling, storage or transport
have sufficient excess capacity to prevent breakage of the container or leakage of the contents if the contents are likely to expand during handling, storage or transport.
All listed disinfectants must have labelling in place that includes the following:
approved name(s) of all ingredient(s) that are active against pathogenic or food spoilage micro-organisms
acceptable common name of the Disinfectant (Schedule 1 TGO 104)
quantity/proportions of ingredients(s) which result or contribute to the disinfectant action, and proportion of available chlorine/bromine/iodine if applicable (expressed as either % w/w, %w/v, % m/m, % m/v or % v/v)
quantity of disinfectant
expiry date or use by date
the AUST L number (recommended but not compulsory)
clear and adequate instructions for use, including:
details on how to prepare the disinfectant and use it to ensure specifications are met, including details on: type of diluent, the required strength, and any limitations on quality, contact time, allowable temperature range, minimum effective concentration and pH range if significant
installation instructions (if applicable)
limitations of use, including reuse period (if applicable) and managing dilution factor if disinfectant is reused
where reuse is provided for, complete information on how to properly monitor the effectiveness of the reused solution (use of test strips)
limitations on storage conditions for stock solutions and activated solution.
For a disinfectant that contains chlorhexidine, the words:
“Not to be used on skin”.
Household grade disinfectants and commercial grade disinfectants must not be labelled “hospital grade” or use words implying that they are hospital grade.
Labelling must comply with the requirements of the SUSMP.
Many sponsors have a range of listed disinfectants in different presentations, or may sell differently branded versions of the same product. Generally these products are considered to be separate and distinct therapeutic goods under section 16 of the Act and therefore require individual listing on the ARTG.
Listed disinfectants are able to be treated as a single therapeutic good if they have the following common characteristics:
The principal manufacturer
They are a disinfectant with specific claims.
Are not subject to different standards.
Contain the same ingredient that is active in their final formulation.
If your listed disinfectants meet these requirements, you can apply for listing of these products with one application.
If you wish to enter additional products that come within the requirement of the Single Goods Order onto an existing ARTG entry, you can request a variation of the listing of your therapeutic goods. This can be done by submitting a Device Change Request, which will be considered by the Delegate of the Secretary under section 9D of the Act.
One Device Change Request can be submitted for additional products providing the products share common characteristics as defined in the Therapeutic Goods (Single Therapeutic Goods) Order No.1 of 1991, and the only variation is in presentation of the goods and/or packaging/branding.
If the composition of the products has changed (i.e. you are now manufacturing/supplying a listed disinfectant that has a different ingredient that is active), this is not a variation and you will need to submit an application for a separate listing of these goods on the ARTG.
Evidence to demonstrate compliance with regulatory requirements must be held by the manufacturer or sponsor for examination on request by the TGA, in the event of a problem arising with the product, or as part of a routine compliance evaluation.
From the Applications menu, under the Medical Device list, select Device/OTG Application.
Step 3 – Complete the application form and attach all relevant documents
You’ll be taken to Page 1 of the application form to complete/confirm the required details. To begin, select Other Therapeutic Good – Listed disinfectant from the list in the Application for field.
Complete the required details for Page 1, remembering to add a Sponsor’s own reference before continuing. Select the Next button to continue.
Business Services system (TBS)
This application pathway is limited only to disinfectants that make specific claims. If your product does not make specific claims and is considered an exempt product it cannot be listed on the ARTG.
Page 2 requires the relevant manufacturer’s details.
To search for your manufacturer, select the Search button under Manufacturer name which opens the search window.
Enter your search term and select the Search button. This will display a list of possible manufacturers which match (or closely match) your search term.
Once you have selected the correct manufacturer, select the Add to Application button.
To select the correct GMDN code for your application, select the Search button under the GMDN code and description field which will open the GMDN search window.
You can search by the GMDN code, or text in the GMDN description. In the case of a hard surface disinfectant the GMDN code is based on the Common name of the product (i.e. Disinfectant, household/commercial grade or Disinfectant, hospital grade). Once you have found the correct GMDN, select it from the search results, and press OK to add the details to your application. Once you have completed Page 2, select Next to continue.
The final page has a:
summary of the application information for you to review
section to electronically attach supporting information
declaration you need to agree to before you can submit your application.
Disinfectant applications must include the full formulation of the product. To input the formulation ensure that you select “yes” your product is formulated and input the formulation with all relevant AAN and PI’s.
Attaching supporting documents
To attach supporting information, select the Add button in the Function to Attach/Add Supporting Information field which will open the File Upload window.
Select the Document type from the dropdown list. You should attach all relevant documents from your computer. Select the Browse button and then select the relevant file from your computer to attach. Select the Add button to attach this file to your application.
Note: Follow this process for each file you need to attach.
Each attachment will be listed under the Function to Attach/Add Supporting Information field.
If you need to delete any attachments, select Remove next to the attachment you want to delete.
Before you can submit your application, you must agree to the declaration:
When the form has been completed, select Validate. This will ensure that the form has all the required information to allow your form to be submitted.
Validation of your form is only confirming that you have filled out all required fields in the application. Validation is not an approval of your application or a guarantee that all the required information has been submitted to the TGA.
If there are any issues with the form, they will be identified with blue writing near the top of the page that will link you to the incomplete information when you select it.
If you filled in all required fields in the application form, you will be able to submit your application.
Fees and charges
The current application fee for listed disinfectants can be found in our Schedule of fees and charges under ‘Other listed and registered therapeutic goods (OTGs)”. The application fee is specifically stated under ‘Listed OTG fees’ as ‘Application fee’.
Listed disinfectants may attract an evaluation fee in addition to the initial application fee if they contain a new ingredient or make new specific claims. The current evaluation fee can be found in our Schedule of fees and charges under ‘Other listed and registered therapeutic goods (OTGs)’. The fee is specifically stated under ‘Listed OTG fees’ as ‘Fee for evaluating documents and information relating to the safety of a listed therapeutic device’.
Application and evaluation fees are not refundable. For further information refer to the refunds web page.
Once your product is listed on the ARTG, annual charges for maintaining your listing will apply. The current annual charge for listed disinfectants can be found in our Schedule of fees and charges under ‘Other listed and registered therapeutic goods (OTGs)’. The fee is specifically stated under ‘Annual charges’ as ‘Listed OTG: tampons and disinfectants’.
Post-market – ongoing responsibilities
Once a disinfectant has been listed on the ARTG, it must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval.
There are mandatory requirements for all sponsors of disinfectants, including:
telling us about any changes to the composition of your product;
retaining distribution records for five years;
reporting adverse events; and
ensuring the information on your ARTG listing remains current.
The TGA may contact the sponsor to request information to demonstrate that the disinfectant continues to comply with the regulations.
Advertising for disinfectants (including the label) must comply with all applicable therapeutic goods advertising requirements. These include:
If the disinfectant is not included in the ARTG and it is not exempt from the requirement to be included in the ARTG, it cannot be advertised to the public (subsection 42DL (12) of the Act). Claims to be able to supply such a disinfectant to any party are also prohibited (subsection 22(6) of the Act).
Disinfectants included in the ARTG can only be promoted for those purposes included in the ARTG and (where relevant) the label. The promotion of ‘off-label’ use to any audience is prohibited (subsections 22(2) to (5) of the Act).
Note there are particular requirements for ‘other therapeutic goods’ (which includes disinfectants) in sections 12 and 13 of the Code, which prescribe the mandatory information that must appear in advertising.
Disinfectant advertising to the public must comply with all other relevant provisions of the Code.
Before advertising disinfectants to consumers, you should check to see if your advertising material (for example, posters, media and social media advertising) contains restricted and/or prohibited representations, as defined in the Code.
The TGA does not require advertising for disinfectants to appear in specified media to be pre-approved under the Therapeutic Goods Regulations 1990.
Varying a disinfectant entry that is in the ARTG
If your disinfectant product is already listed on the ARTG, and you wish to vary either the labelling, formulation or other aspects of the manufacture of the product, the sponsor must apply to the TGA for approval prior to supplying the product.
You may submit an application to the TGA via a Device Change Request form (DCR) through the TGA Business Services link on the TGA website. Guidance on when an application is required is included in the following table, entitled Notifying TGA of changes to listed disinfectants.
If your disinfectant product is already listed on the ARTG, and you wish to vary the product in a way that does NOT change the formulation or aspects of manufacturer or labelling (i.e. varying the fragrance or colour of a product) the sponsor must submit a Device Change Request as soon as practicable and no later than three months after the implementation of the change. Refer to the following table.
When applying for a variation, you must provide information to validate the variation, as set out in the section below.
Notifying TGA of variations to listed disinfectants in the ARTG
There are two types of changes:
variations to product information in relation to Registered and Listed Disinfectants. This information relates to the quality, safety and effective use of the goods, including information regarding the usefulness and limitations of the goods;
additions of products to grouped listings. All changes must be made in accordance with legislative requirements.
Fees for variations (approvals)
All variations requiring approval attract a processing fee and if approval is required for listed goods, an evaluation fee may also be payable.
denotes the sponsor must receive Approval from the TGA prior to change being made. A Device Change request must be submitted.
denotes that Notification by the sponsor to the TGA is required as soon as practicable, and no later than three months after implementation of the change. A Device Change request must be submitted.
denotes that Notification required directly to the TBS as soon as practicable, and no later than three months after implementation of the change. No fee is required in sponsor address or contact change.
denotes the change may require a new registration or listing.
denotes No Approval or Notification is required. Changes may be made without reference to the TGA.
Replaced references to Safe Work Australia’s National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)] with Safe Work Australia’s Model Code of Practice: Labelling of workplace hazardous chemicals