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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
Guidance for advertisers
Pre-approvals for advertising
This guidance for advertisers applies to the current Therapeutic Goods Advertising Code 2015 but incorporates amendments to the Therapeutic Goods Act 1989 (the Act) that came into effect on 6 March 2018, and has been further updated to provide specific information on advertising biologicals and to also include more background information on advertising requirements.
The Therapeutic Goods Advertising Code (No.2) 2018 was made on 31 October 2018 to replace the 2018 Code which will come into effect on 1 January 2019. A summary of the changes is available. To assist advertisers with implementation, we have also published guidance material; Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
You must seek pre-approval under the Regulations for advertisements of medicines that are to appear in specified media. This requirement will continue until the pre-approval process is removed on 1 July 2020.
You should be aware that there a range of offences relating to the publication or broadcast of an advertisement for medicines in specified media.
You need to obtain approval for any restricted representations to appear in your advertisement before seeking pre-approval for your advertisement.
Extension of pre-approval process
The Review of Medicines and Medical Devices Regulation (the Review) recommended:
- replacement of the current pre-approval arrangement for advertisers with a more self-regulatory regime
- that requirements for advertising therapeutic goods to the public be made consistent for all medicines and medical devices.
Both of these recommendations could largely be achieved through removing the need for pre-approval. Consumer concerns were raised during consultation of the Bill and the Government has decided to extend the pre-approval process until 1 July 2020. We will work to support advertisers throughout the transition period by providing you with clear guidance and the required information to achieve compliant advertising.
You will continue to be required to obtain prior approval from us for use of restricted representations in advertisements for therapeutic goods when the pre-approval requirements are removed in 2020.
See Advertising therapeutic goods for more information about the removal of pre-approvals for advertising.
You must include the approval number for approved advertisements that appear in mainstream media or are displays about goods.
The approval number must stand alone, be legible and be located in the bottom right hand corner of approved print advertisements. It usually begins with the letters 'ASMI' or 'CHC' followed by a 5-6 digit number and date code.
Approvals are valid for 2 years.
Specified media advertisements require approval
Specified media is defined under section 42B of the Act as:
- mainstream media (this includes any magazine or newspaper for consumers containing a range of news, public interest items, advertorials, advertisements or competitions)
- broadcast media
- cinematograph films
- displays about goods, including posters:
- in shopping malls (except inside an individual shop)
- in or on public transport
- on billboards
For the purposes of pre-approval, the concept of 'specified media' excludes those types of broadcast media specified in Regulation 5BA, including internet, pay television and digital radio.
Offences relating to advertising approvals
Offences relating to the publication or broadcast of an advertisement for medicines in specified media are specified under section 42C of the Act. These include publishing or broadcasting an advertisement:
- without prior approval (subsection 42C(1))
- that differs from the approved advertisement (subsection 42C(2)); and
- that does not comply with any conditions of approval (subsection 42C(6))
Before you lodge an application for pre-approval, you will need to obtain approval from us for any restricted representations that appear in the proposed advertisement.
Application for advertising approval
You must complete an application for advertising approval to seek approval for advertising therapeutic goods in specified media, as described above.
Approval application types
You need to include your advertisement and application type in your application. There are four types of approval applications:
- New advertisement - a completely new advertisement
- Minor change to Approval number - typographical error, changed sponsor contact details or a change in the address/location from where the advertised goods are available
- Variation of Approval number - cut down of an existing advertisement. A variation does not allow for the addition of any new matter, including new claims
- Re-approval of Approval number - re-approval of an identical advertisement whose approval number has expired
Fees for advertising approval applications
Where to send your application for advertising approval
Submit the completed form together with supporting documentation and the prescribed fee to the appropriate Advertising Services Manager. The Advertising Services Manager will then consider the application in accordance with the criteria for approval specified in Regulation 5G.
|Type of advertisement and medicine||Submit application to|
The Office of Advertising Compliance
Phone: 02 6260 4066
Fax: 02 6260 4122
Phone: 02 9955 7205
Minimum requirements for the submission of advertisements for approval
- Typed copy (no smaller than 10 point), black copy on white background.
- Draft layout or clear description of layout.
- For television commercials, copy of script with storyboard.
- For radio, copy of script to include sound-effect descriptions.
- Copies of appropriate documentation:
- Certificate of Listing/Registration, showing the indications for use
- Label (enlarged for legibility)
- Copy of any research/surveys/data referenced in advertisement (Note: further evidence to be provided if requested)
- Copy of documentation supporting any testimonials and/or endorsements(Note: further evidence to be provided if requested).
Applicants should note that:
- evidence to substantiate therapeutic claims needs to be provided to the Advertising Services Manager upon request
- substantiation, in line with levels of evidence required to be held by the sponsor at the time of listing or registration, may be required by the Advertising Services Manager
- notwithstanding the above, further substantiation may also be requested
- a claim / indication entered on the ARTG entry for the medicine will not automatically be approved as an advertising claim
- advertisements should not be booked for publication before advertising approval has been granted or before the medicine has been included in the ARTG.
Review of a decision to refuse to approve an advertisement
You can submit a request to review a decision in relation to advertising approval to the Minister for Health in writing (Regulation 5M of the Regulations). The Advertising Services Manager can provide you further instructions on how to request a review of a decision.
When to request review of a decision
You must make the request within 30 days after notice of the decision is given to the applicant and must be accompanied by information to support the request.
A request for reconsideration given to the Minister outside the statutory 30 day reconsideration period cannot be accepted unless the information is provided in response to a request from the Minister (or the Minister's delegate).
Who reviews a decision
The Minister may either personally undertake a request for reconsideration of an initial decision or delegate to an officer of the Department with the appropriate delegation. The internal review officer can confirm the original decision to refuse to approve the advertisement or substitute a new decision if the decision under review is found to be defective on matters of law, the merits or administrative process.
The Minister (or the Minister's delegate) is not able to consider any information provided after the notification is made of a request for reconsideration of an initial decision (subregulation 5M(4) of the Regulations).
There is no time limit set out in the Regulations within which the Minister (or the Minister's delegate) must make a decision upon reconsideration under regulation 5M.
Further review of a decision
If you are dissatisfied with the internal review of the merits of the decision, you can apply to the Administrative Appeals Tribunal (AAT) for a review of that decision. The AAT can assess the merits of the decision being challenged and decide whether the decision was 'correct and preferable'.
The initial decision remains in effect unless and until it is revoked or revoked and substituted by the Minister (or the Minister's delegate) as a result of a request for reconsideration under regulation 5M of the Regulations OR is set aside, varied or remitted by the AAT or is otherwise overturned or stayed.