Engel Hellyer & Partners is one of the most trusted and experienced Pharmaceutical TGA and AICIS Regulatory Affairs consultants.

Since 1982, we have been providing quality regulatory advice to large multinationals and SMEs.

Disinfectants are a specialised group of products which are ‘recommended by its manufacturer for application to an inanimate object to kill micro-organisms’. These products come in different forms including products for household use such as disinfectant sprays, and disinfectant wipes. There are also industrial and hospital grade disinfectants available in bulk quantities

Disinfectants can be marketed for a variety of uses including offices, laboratories, clean-rooms, as well as premises such as medical suites, doctors offices, dentist labs, hospitals,  barbers and hair dressers and other premises wanting to practice infection control.

Disinfectants Exempt from TGA Listing
If products make only generalised claims against bacteria, then they are exempt from TGA listing requirements.  However, the disinfectant is still regulated by the TGA, meaning that there is a legal obligation for it to comply with all other regulatory requirements!

The label must comply with TGO 104 , and you must have satisfactory evidence on file to support disinfectant claims. Usually this will be the TGA Disinfectant Test or European equivalent.

Listed Disinfectants
If products make specific claims such as claims against viruses in general, named bacteria and viruses then the product will need to be listed with the TGA.

Our Expertise
We can assist you with all aspects of disinfectant compliance. We have submitted over 20 disinfectant applications to the TGA and dozens of additional label and claims – that’s just in the last 5 years!

We are well versed with the TGA expectations when it comes to efficacy studies, labelling requirements, and submitting AAN applications for any ingredients not already on the TGA list!

As this is one of our core skills it means that we can confidently review your data and accurately foreseen and deal with any issues BEFORE submitting anything to the TGA!

If there are any regulatory barriers to marketing as a disinfectant, we can also advise you on how to present products for cleaning use only if you do not wish to make claims of disinfection!

COVID-19 Claims:
We have assisted a number of clients to amend their existing disinfectant listings to make successful COVID-19 claims. The TGA will accept Human Coronavirus 229E or Murine Hepatitis Virus as surrogate viruses in lieu of COVID-19.

Documentation requirements
In order to assist you, we will need to see:

  • Product artwork
  • Quantitative Formula – i.e. list of ingredients and percentages
  • Tests already completed

Label Changes
In most cases you will need to make label changes to comply with Australia specific TGA requirements. Some of the required information includes:

  • Common name – e.g. ‘Hospital Grade Disinfectant’ to be stated near the product name
  • Australian Sponsor – name and address
  • List of active ingredients and percentages
  • Statement of dilution – or ‘use undiluted’
  • Statement: “Do not mix with detergents or other chemicals”
  • Statement: ‘”Not to be used on Medical Devices”
  • Statement: “Not to be used on skin”

Further reading:

TGA Disinfectant Landing Page:
Click Here.

TGO 104: Disinfectants – TGA – Hospital Grade & Household Grade
Click Here.

TGA Instructions for Disinfectant Guidance:
Click Here.

TGA Disinfectant Claim Guide:
Click Here.