The TGA collects a variety of personal information in the course of performing its functions.
Personal information is defined in the Privacy Act 1988 (Cth) (Privacy Act). Your personal information is protected by law under the Privacy Act, which contains Australian Privacy Principles. For more information, see the Office of the Australian Information Commissioner website.
The TGA is part of the Australian Government Department of Health.
- How you may access your personal information and seek correction of it.
- How you can complain about a breach of the Australian Privacy Principles and how the Department will deal with that complaint.
In particular, the TGA collects personal information in relation to its key functions of approving therapeutic goods for supply in Australia and licensing Australian manufacturers of therapeutic goods. The TGA uses personal information for these functions, including the following:
Personal information in applications relating to placing goods in the ARTG or entries in the ARTG
- The TGA collects personal information in applications to place therapeutic goods in the Australian Register of Therapeutic Goods, and in associated and ancillary applications in relation to Registration of therapeutic goods (for example to vary entries for goods already in the Register, for a proposed name for a chemical substance, for a conformity assessment certificate for medical devices).
- The personal information is used to maintain a record of these applications, to consider the applications, and to contact applicants about their application(s).
- Personal information provided in applications may also be used to contact sponsors of goods in the Register where there is a need to do so - for example, in the event of a safety, quality or efficacy issue concerning the goods, or to administer fees and payments relating to the goods.
- Personal information relating to sponsors of therapeutic goods may be disclosed where authorised or required by an Australian law, Court or Tribunal order; or with the consent of the person the information is about.
- Manufacturing licences.
Personal information in applications relating to manufacturing licences
- The TGA collects personal information in applications for Australian manufacturing licences, and associated applications such as to vary existing manufacturing licences.
- The personal information is used to maintain a record of manufacturing licence applications, to consider applications, and to contact applicants about their application.
- Personal information provided in applications may also be used to contact sponsors or manufacturers of goods in the Register where there is a need to do so - for example, in the event of a safety, quality or efficacy issue concerning the manufacture of certain goods, or to administer fees and payments relating to the licence.
- Personal information relating to holders of licences to manufacture therapeutic goods may be disclosed where authorised or required by an Australian law, Court or Tribunal order; or with the consent of the person the information is about.
Personal information in advertising complaints
Where you provide personal information about yourself, the TGA will use this information to contact you if necessary to ask you about your complaint. Complaints, and the personal information contained within this complaint, may be referred to Australian and/or overseas bodies (referred to above under 'Industry self-regulation') including
- Government departments and bodies in Australia and overseas who have roles in regulating health, food, therapeutic goods or consumer law
- The office administering the National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
- Law enforcement agencies
to administer the complaint.
Other information about how the TGA uses personal information for its other functions is available on the parts of the TGA website that refer to those functions, or on specific forms that collect the information.
- the user's server address
- the user's top level domain name
- the date and time of access to the site
- pages accessed and documents downloaded
- the previous site visited
- type of browser used
- how they have accessed the site (for example from a search engine, a link, an advertisement) and what they did on the site.
This information is analysed to show broken links in our website, bottlenecks, and other site problems. We use this information to maintain our site for your efficient use.
Google Analytics Demographic and Interest Reporting is also enabled. This may make de-identified information such as your age, gender and affinity categories (eg educational and training interests) available as well as in-market segments and other categories based on acquisition, behaviour, and conversions metrics. These analytics do not allow us to identify an individual user.
The information generated about your use of this website (including your IP address) will be transmitted to and stored by Google on servers located outside Australia. Google is based in the United States of America (USA), and details for contacting Google are available via their Contact us page.
No attempt will be made to identify users or their browsing activities unless legally compelled to do so, such as in the event of an investigation, where a law enforcement agency may exercise a warrant to inspect the Internet Service Provider's log files.
Email subscription service (ActiveCampaign)
Note: The TGA is switching to ActiveCampaign in the first quarter of 2017. Before this switch all current email list subscribers will be notified and will have the opportunity to opt out before the transition date. If you are a subscriber and you wish to opt out of the transition you may do so at any time by unsubscribing from the mailing list before the transition date.
We use ActiveCampaign to provide our email subscription services. ActiveCampaign is based in the United States of America (USA) and the information collected about your use of the website (including your IP address) will be transmitted to and stored by ActiveCampaign on servers located outside Australia.
ActiveCampaign provides online tools that can be used to create, send, and manage emails. ActiveCampaign may collect personal information, such as distribution lists which contain email addresses, and other information relating to those email addresses.
The TGA will only use this information to:
- create, send and manage emails relating to the work of the TGA
- measure email campaign performance
- improve the features for specific segments of customers
- evaluate your use of our website
- compile reports on website activity for website operators, and
- provide other services relating to website activity and internet usage.
ActiveCampaign may transfer this information to third parties where required to do so by law, or where such third parties process the information on its behalf. ActiveCampaign collects information about you when you visit the website or use the services they provide. This information includes your browser type and version, your operating system and device type, and other similar information.
We are required to inform you that by subscribing to our mailing lists, you:
- Acknowledge that this service utilises ActiveCampaign's platform, which is located in the USA and relevant legislation of the USA will apply.
- Acknowledge that Australian Privacy Principle 8.1 contained in Schedule 1 of the Privacy Act will not apply.
- Acknowledge that ActiveCampaign is not subject to the Privacy Act 1988 (Cth) and in the event of any privacy breaches by Active Campaign you would not be able to seek redress against Active Campaign under the Privacy Act 1988 (Cth) but would need to seek redress under the laws of the USA.
Opt out or unsubscribe
If you have questions about ActiveCampaign you may also contact ActiveCampaign directly.
Links to other websites
This website contains links to other sites. The Australian Government is not responsible for the privacy practices of any third parties nor are they responsible for the material contained in a website that is linked to this site.
Queries, concerns and further information
If you have any queries, concerns or require further information relating to privacy and the Therapeutic Goods Administration, please email the TGA at: firstname.lastname@example.org.
If you have concerns about emailing this site, please use our postal address and write to:
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606