Australia: TGA review of labelling and packaging

Life Sciences Spotlight
Last Updated: 8 October 2011
Article by Amanda Turnill and Lisa Haile

Following a Parliamentary review into the transparency of the Therapeutic Goods Administration (TGA), the TGA has initiated its own review into the labelling and packaging framework for all prescription, over-the-counter and complementary medicines. Although the TGA review will examine all packaging and labelling for medicines, a major concern will be the lack of regulation of the use of nanoparticles in both the drug delivery and medical imagery fields.

In June 2011, the TGA released the Review to improve the transparency of the Therapeutic Goods Administration (Review). The purpose of the Review was to investigate the perception that the TGA does not provide the public with sufficient information about its activities and the goods that it regulates. The review panel was created by Parliamentary Secretary for Health and Ageing Catherine King and chaired by DLA Piper Special Counsel Professor Dennis Pearce. In the panel's final report 21 recommendations were made, designed to enhance the TGA's transparency. A key recommendation made by the panel was to improve the labelling and packaging requirements of therapeutic goods.

The recommendation was made after the review panel discovered deficiencies in the current labelling regime. The review panel noted that irregularities, inconsistencies and a general lack of information were being provided under the TGA labelling requirements. Of particular concern was the apparent lack of regulation around the labelling of nanoparticles on medical packaging. At present, there are no requirements to include a statement that a product includes nanoparticles. This is of particular concern given their increasing use in the drug delivery and medical imagery fields.

The Review recommended the TGA improve labelling and packaging requirements to educate and assist both customers and health practitioners in making informed decisions about the quality of therapeutic goods. As at the date of publication, the Commonwealth Government had not yet agreed to adopt this or other recommendations made by the Review.

As a direct result of the Review, the TGA began its own consideration in early August into how goods are labelled and packaged (TGA review). The purpose of the TGA review is to examine how medicines are labeled and packaged; thereby assisting consumers and healthcare practitioners to make informed decisions about the quality use of therapeutic goods. In particular, the TGA review seeks to address three specific concerns from the Parliamentary Review:

  • the inaccessibility of mandatory information on the particular medicine
  • the inconsistency of the positioning and font size for important information
  • the lack of information about non-active ingredients.

The TGA review is expected to be released in October, though it is subject to the Commonwealth Government accepting the recommendations put forth in the original Review. Ewen Hollingsworth

TGA to consider further advertising transparency measures

The TGA policy to publish its investigations into alleged breaches of its advertising code is designed to provide advertisers guidance on how the TGA interprets advertising requirements. So far two complaints for breaching the advertising code have been published; a complaint into Invisible Zinc's claim other sunscreens were harmful and Hedrin Lotion's claim that it did not contain pesticides. However, following a parliamentary review the TGA is considering revamping these transparency measures to deter sponsors from breaching advertising requirements set out in the Therapeutic Goods Advertising Code.

The advertising of therapeutic goods to consumers is regulated by, among other things, the Therapeutic Goods Advertising Code (Advertising Code). Compliance with the Advertising Code is monitored by the TGA Complaints Resolution Panel (Panel), whose purpose it is to investigate complaints regarding advertisement breaches of the Code. If the Panel determines the complaint is justified they may request that the sponsor do certain things such as withdraw the advertisement or publish a corrective statement.

If sponsors fail to adhere to the Panel's requests the complaint may be referred to the TGA. From there the TGA may initiate its own investigation and take certain action, including publishing the complaint. Prior to the parliamentary review to improve the transparency of the TGA (see TGA Review of Labelling and Packaging article) the TGA was reluctant to publish complaints.

Following the parliamentary Review, this position has subsequently changed and have already published the complaints concerning Invisible Zinc and Hedrin Lotion . The fact that the TGA has published these two complaints indicates the TGA has become increasingly willing to 'name and shame' sponsors in order prevent breaches of the Advertising Code.

As a result of the parliamentary review, the TGA has decided to review its current advertising transparency measures. The TGA's current advertising measures are designed to protect public health by promoting the safe use of therapeutic goods and ensuring that they are honestly promoted as to their benefits, uses and effects.

Little detail has been given regarding the proposed review or changes by the TGA and when they may come into effect. Despite the vagaries of how the TGA may amend their advertising transparency measures, sponsors should be hesitant not to comply with any request from the Panel. Failure to comply may see further action taken by the TGA, including publication of the investigation.

© DLA Piper

This publication is intended as a general overview and discussion of the subjects dealt with. It is not intended to be, and should not used as, a substitute for taking legal advice in any specific situation. DLA Piper Australia will accept no responsibility for any actions taken or not taken on the basis of this publication.

DLA Piper Australia is part of DLA Piper, a global law firm, operating through various separate and distinct legal entities. For further information, please refer to

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Mondaq Advice Centre (MACs)
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.