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Advertising and Labelling

Effective product labelling is not just about squeezing all the technical and legal requirements onto your pack – although that’s often a huge challenge in itself.

Your labels have to give consumers the confidence to choose and use your product correctly.

Labelling and advertising of therapeutic goods are tightly controlled.  The rules are complex and can be difficult to understand.

Find out more about:

Advertising therapeutic products

Getting advice for Advertising therapeutic products

In addition to the normal advertising controls that apply via the ACCC and other regulators, the TGA regulates advertising of therapeutic goods via the Therapeutic Goods Advertising Code (TGAC), the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations.  The definition of advertising in the Act is very broad and covers any form of communication about a product that might be considered top be promotional in nature.

These additional controls mean you need to check what is being said, who is saying it and in what context.  This can include statements made by your customers and others on social media sites and other areas where information is required to be provided, such as announcements to the Australian Stock Exchange (ASX).

In some cases, representations are restricted or prohibited.  Prior approval from the TGA is needed before you use these statements on your labels or in your advertising.

The advertising requirements apply to all forms of advertising that is directed to consumers and this includes information provided on product labels and package inserts.

At Archer Emery & Associates, we can help you by:

  • Providing ad hoc advice verbally and/or in writing on any regulatory issues related to existing or proposed advertising
  • Reviewing proposed advertising for compliance with the TGAC and advising you on any necessary changes
  • Reviewing your websites and social media content for compliance with the TGAC and advising you on any necessary changes
  • Assisting you in dealing with the TGA regarding non-compliant advertising
  • Preparing and submitting application to the TGA for approval to use restricted representations

Labelling therapeutic products

Getting advice for Labelling therapeutic products

We have been closely involved in non-prescription medicine label regulation for many years. We can help you ensure that your labels are legally compliant, and present the necessary information simply and clearly so your customers know how to use it safely and effectively.

Device labels must comply with the Therapeutic Goods Administration’s (TGA) requirements.  What these are will depend on the system under which your device is regulated.

We can help you to ensure your labels meet all the TGA’s requirements.

The labelling requirements are complex and depend on the type of product, its ingredients and its intended use. 

Some of the requirements that may apply are:

Non-prescription Medicines 

  • Therapeutic Goods Order (TGO) 92
  • Medicines Advisory Statements Specification (previously known as RASML)
  • Poisons Standard (previously the SUSMP)
  • Therapeutic Goods Advertising Code 2021 (TGAC)
 

Devices

  • Therapeutic Goods (Medical Devices) Regulations 2002 Essential Principle 13 and regulation 10.2
  • Poisons Standard (previously the SUSMP)
  • Therapeutic Goods Advertising Code 2021 (TGAC)
 

Other Therapeutic Goods (OTG)

  • Therapeutic Goods Order (TGO) 104 (disinfectants)
  • Therapeutic Goods Order (TGO) 103 (tampons)
  • Poisons Standard (previously the SUSMP)
  • Therapeutic Goods Advertising Code 2021 (TGAC)
 

At Archer Emery & Associates, we can help you by:

  • Providing ad hoc advice verbally and/or in writing on any regulatory issues related to existing or proposed labelling
  • Reviewing proposed labels for compliance with the relevant requirements and advising you on any necessary changes
  • Assisting you in dealing with the TGA regarding non-compliant labels
  • If needed, preparing and submitting application to the TGA for approval to make changes to your labels.

Labelling cosmetics

Getting advice for Labelling cosmetics

The wording on a cosmetic label can be critical.

Using the wrong words can make your product a medicine without you realising it! This could then mean a (very scary) letter from the Therapeutic Goods Administration (TGA) requiring you to stop selling your product until it is approved by them.

We can help you to avoid this situation by reviewing your cosmetic labels to position them appropriately.  There are other label requirements for cosmetics and we can make sure your labels comply with these too.

At Archer Emery & Associates, we can help you by:

  • Providing ad hoc advice verbally and/or in writing on any regulatory issues related to existing or proposed labelling
  • Reviewing proposed labels for compliance with the relevant requirements and advising you on any necessary changes
  • Assisting you in dealing with the TGA regarding non-compliant labels

Labelling foods

Getting advice for Labelling foods

Food labelling is very complicated with numerous technical requirements applied by the Food Standards Code (FSC). 

The wording on a food label can also be critical.  As with cosmetics, using the wrong words can make your product a medicine without you realising it! This could then mean a (very scary) letter from the Therapeutic Goods Administration (TGA) requiring you to stop selling your product until it is approved by them.

We can help you to avoid this situation by reviewing your food labels to position them appropriately and comply with the relevant technical requirements of the FSC.

At Archer Emery & Associates, we can help you by:

  • Providing ad hoc advice verbally and/or in writing on any regulatory issues related to existing or proposed labelling
  • Reviewing proposed labels for compliance with the relevant requirements and advising you on any necessary changes
  • Assisting you in dealing with the TGA regarding non-compliant labels

Contact Us

Archer Emery and Associates – the Therapeutic Goods Administration (TGA) Experts. To find out how to enhance your regulatory team and maximize your chances of success – whatever the project. Click here to get in touch >>