Treatment of information provided to the TGA

7 May 2014

How your information is treated

Information that you provide to the TGA, such as personal, business or commercially confidential information, is treated as official information. The TGA, as part of the Commonwealth, is required to take measures to protect this information under the Australian Government Protective Security Policy Framework (PSPF).

Under the PSPF, the TGA is required to classify the information using the Australian Government Classification System. Classifications including COMMERCIAL -IN-CONFIDENCE, RESTRICTED and HIGHLY PROTECTED are no longer used by the Commonwealth. Instead, five (5) Disseminating Limiting Markers (DLMs) are used and indicate access to official information is to be limited. These five DLMs are:

  • For Official Use Only - for use only on unclassified information when its compromise may cause limited damage to, amongst other things, commercial entities or members of the public
  • SENSITIVE - for use where secrecy provisions of legislation apply, and/or disclosure may be limited or prohibited under legislation
  • SENSITIVE: Legal - information that may be subject to legal professional privilege
  • SENSITIVE: Cabinet
  • SENSITIVE: Personal - for use only for 'sensitive information' as defined in section 6 of the Privacy Act 1988 (ie particular types of personal information including health information about a person).

Please note that it is likely that any sensitive business or commercial information that was previously classified as 'COMMERCIAL-IN-CONFIDENCE' will now be classified as 'For Official Use Only'.

Refer to the Attorney-General's Department document; Information security management guidelines - Protectively marking and handling sensitive security classified information for more information on the PSPF requirements.

Once your information has been identified as requiring a protective marking, the protection and special handling requirements for the specific marking are applied by the TGA to the material. This is to protect your information from unauthorised use or accidental modification, loss or release.

Authorised release of official information

Circumstances where release of official information is permitted

The TGA, as part of the Department of Health, may release official information (including information provided by a third party) in certain circumstances.

These circumstances include the following:

  • to the extent required by law or by a lawful requirement of any government or governmental body, authority or agency including any administrative or statutory review, audit or inquiry (whether within or external to the TGA)
  • if required in connection with legal proceedings (such as a request for information in response to a subpoena)
  • for purposes of public accountability, including disclosure on request to other Government Agencies, and a request for information by parliament or a parliamentary committee or a Commonwealth Minister
  • to allow the TGA to fulfil its statutory functions including as permitted under the provisions as set out in section 61 of the Therapeutic Goods Act 1989 which includes release of information, release of which is necessary to ensure the safe use of particular therapeutic goods
  • in response to the exercise of the authorised function, power, right or entitlement of the Auditor-General, the Ombudsman or the Privacy Commissioner.

Commercially confidential information

'Commercially confidential information' refers to information provided to the TGA by the owner of the information which is 'not in the public domain or publicly available, and where disclosure may undermine the economic interest or competitive position of the owner of the information'. Such information received by the TGA from the owner of the information is likely to be classified as 'For Official Use Only' as will potentially sensitive commercial information received from a third party or generated by the TGA.

Whether you as the owner of information provided to the TGA regard particular information as commercially confidential information is relevant but not determinative of its status. Certain types of information (for instance, trade secrets, financial information about a company's business that is not in the public domain, the fact and content of applications to the TGA what are under evaluation etc) will normally be designated as commercially confidential information.

Other than in the circumstances described above in relation to the release of official information, the TGA does not release to the public information that is commercially confidential information except in particular circumstances where the TGA can justify the release in the public interest and it is lawful to do so. More information can be found at TGA approach to disclosure of commercially confidential information (CCI) on TGA website

Other sensitive information

The TGA is bound by the Privacy Act 1988 in relation to the collection, use and disclosure of personal information. Any such information cannot be released by the TGA under the Freedom of Information Act 1982 unless the person to whom it relates has been consulted and has had the opportunity to make submissions as to why it should not be released.

Other than in the circumstances described above in relation to the release of official information, the TGA does not release to the public the identity of individuals or companies that provide information to the TGA in the form of complaints, adverse events, information about problems with therapeutic goods or about suspected breaches of the Act or questionable practices, or other information that is relevant to any other aspect of the TGA's regulatory functions.