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:
- 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.
- 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.
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 Department of Health uses 'cookies' for maintaining contact with a user through a website session. A cookie is a small file supplied by the Department, and stored by the web browser software on your computer when you access our site. Cookies allow us to recognise you as an individual web user, as you browse our website. Two cookie types may be used by this website:
- Session cookies
These exist only for the duration of a web browser session with a particular website/host. All cookies will be immediately lost when you end your internet session or shut down your computer. Our copy of your information will be automatically deleted twenty minutes after you last used the system. This information is only used to help you use our website systems more efficiently, not to track your movements through the internet, or to record private information about you.
- Persistent cookies
These exist for a defined period of time (usually beyond the termination of the current session) before expiring.
No personally identifiable information is stored within cookies used by this website. No attempt will be made to identify anonymous 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.
Any system on this website that records information about you, will specifically ask your permission first.
When you visit this site, the Department of Health makes a record of your visit and logs the following information for statistical or systems administration purposes:
- 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
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.
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.
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.
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