Applying to use a restricted representation

• Ensure you have the necessary information and supporting documents prior to commencing your application, as the application form cannot be saved and accessed later. 
• Each application is assigned a unique identification number, use this for queries regarding your application.

You submit an application through the Regulatory and Compliance portal:

Submit an application - external site

Cost

There is no fee to submit a restricted representation application.

Requirements for the goods covered by the application

Approval to use a restricted representation is limited to therapeutic goods that can be lawfully advertised to the public.

See: What can and cannot be advertised to the general public for more information.

Requirements for the proposed restricted representation

Proposed restricted representations must by consistent with:

• accepted indications and intended purposes found in the Australian Register of Therapeutic Goods (ARTG) entry for the goods 
• any mandatory statement, health warning or other information that is required to be included in the product packaging or labelling. 

Wording of your proposed restricted representation

The wording of your proposed restricted representation is required to be accurate, balanced and not misleading or likely to be misleading, with evidence provided in the application to substantiate claims.

Restricted representations that include marketing claims where accuracy cannot be established are unlikely to be approved. 

For example, the claim ‘The best and fastest imaging for anterior cruciate ligament tears’ is subjective and difficult to establish accuracy. Avoid exaggeration and embellishment.

Our guidance on Part 3 of the Code provides more detailed information on the requirements for advertising to be accurate, balanced and not be misleading - see Applying the Advertising Code rules: general requirements. 

Public interest criteria

We use the public interest criteria set out in the Code to help us determine if a restricted representation can be used.

Public interest criteria ask if using the restricted representation would likely:

• Take advantage of consumer vulnerability with or when faced with the serious disease, condition, ailment or defect.
• Result in consumers not seeking advice from a health professional.
• Have a larger negative impact on public health.

We may also consider other aspects of the public interest when appropriate.

Addressing the public interest criteria may also reveal changes in wording or approach you may need to make in your proposed representations.

Proposed advisory statements 

In some circumstances it may be necessary for advisory statements to accompany restricted representations to ensure their use does not compromise individual or public health and/or to ensure the representations are balanced and not misleading.

For example, advisory statements may be appropriate to:  

• ensure that use of the representation appropriately communicates the risks of the goods, e.g. risks associated with surgical procedures needed to use the device. 
• inform consumers about the importance of consulting with a doctor to determine the suitability of treatment with the goods.

Applicants may propose advisory statements in their application to justify that their proposed representations meet the legislative criteria.

Required information for your application

The following information must be provided in your application:

• The name of the business seeking approval.
• Contact details for the primary contact, including an Australian phone number.
• The name of the therapeutic goods that will use the restricted representations.
• The name, or a list of names, of the serious forms of disease(s), condition(s), ailment(s) or defect(s) that will be referred to.
• Wording of the proposed representations. 

Supporting documents

The following supporting information should be provided with your application:

• A detailed written explanation, with supporting evidence to substantiate the proposed representation meets the legislative criteria to be accurate, balanced and not misleading.  
• A detailed written explanation, with supporting evidence to substantiate that using the restricted representation will not raise any concerns in relation to each of the public interest criteria set out in Section 29 of the Code.
• The ARTG certificate or inclusion number for the therapeutic goods (if applicable). 
• A copy of the product labelling and packaging if restricted representations will be used on the label and packaging.
• For a medical device, the instructions for use document or patient information leaflet. 
• A completed Restricted representation application checklist.

There is no requirement to provide specific examples of advertising; however, it may be beneficial to provide specific examples with your application if they will support and give context in relation to the proposed use of the restricted representation.

Approval can only be given to the applicant in relation to the advertising of a specific product/s identified in the application. The scope of your application must be clear, defined and reasonable.

Large and complex applications involving multiple and unrelated diseases, different representations with various sets of evidence to substantiate them require more extensive assessment.

It’s preferable to limit the scope of your application to a single concept and lodge multiple, discrete applications.

Examples of proposed representations suitable for a single application

• A single medicine to be advertised for assisting with multiple related conditions with common supporting evidence.
• Two related devices under a common ARTG entry, assisting with a single condition with common supporting evidence.

Example of proposed representations that would be best split up into multiple applications

• A single device for use in relieving multiple health conditions with various supporting evidence for each condition.

If you are unsure of whether multiple applications may be needed, please contact us for advice.

We give consideration to: 

• the wording of the proposed representations
• the context in which the proposed representation will be used (for example if the advertisement will only appear in certain publications) 
• the supporting information supplied with your application
• any advice provided by subject matter experts within the TGA such as medical officers, scientific evaluators or lawyers
• any advice sought from a relevant advisory committee (see Advisory bodies and committees).
• any other relevant information the decision maker may be aware of
• if the advertisement will be accurate, balanced and not misleading
• the public interest criteria.

Requests for additional information

Following assessment of the application, we may identify issues to be addressed by amending the proposed representation(s), advertising and/or supporting documentation to allow assessment of the application to continue.

Timeframes

We have 60 days after the day of submission to make a decision.

This time can be extended by us. Typically, we will extend the timeframe if we request additional information from you to make an assessment.

The primary contact shown in your application will be notified via email if the time is extended.

The decision to approve, or to refuse to approve, an application is made by the Secretary of the Department of Health and Aged Care (or their delegate). 

An email will be sent to the primary contact shown in your application informing them of the outcome.

When the restricted representation is approved

If the application is approved, the restricted representation(s) as specified in our decision letter can be used in advertisements for the relevant good/s noting the approval may be subject to certain conditions. 

The approval is only for the use of the restricted representations as specified in the decision letter. It is not for the entire advertisement in which the restricted representations will be used. Your advertisement must comply with all other aspects of the Act and the Code. 

We may withdraw an approval where:

• there has been a breach of a condition of approval
• additional information about the safety or efficacy of the goods becomes available.

When the restricted representation is refused

If an application is refused the applicant can seek an internal review. Review rights are detailed in the decision letter.

The decision letter will identify issues that should be addressed before submitting a new application.