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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.
Personal information in or in relation to applications for conformity assessment body determinations
- The TGA collects personal information in applications for conformity assessment body determinations, and supporting information relating to such applications.
- The personal information is used to maintain a record of conformity assessment body determination applications, to verify and consider such applications (including in relation to the "fit and proper person" criteria relating to such applications in subregulation 4A.6(3) of the Therapeutic Goods (Medical Devices) Regulations 2002) and to contact applicants about their application.
- Where a conformity assessment body determination is made, personal information provided in an application may be used to contact manufacturers and sponsors of kinds of medical devices that have been assessed by the Australian conformity assessment body if there is a need to do so – for example, in the event of a safety or performance issue concerning such devices.
- Personal information relating to applications for conformity assessment body determinations, and Australian conformity assessment bodies, may be disclosed under Commonwealth privacy laws in certain circumstances including where authorised or required by an Australian law, Court or Tribunal order, or with the consent of the relevant individual.
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.
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: email@example.com.
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