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Australian Public Assessment Report (AusPAR) guidance document
Version 1.5, March 2015
2. Legislative framework
Under 61 of the Therapeutic Goods Act 1989 (the Act) the TGA can publish information about therapeutic goods. The following provisions are relevant:
- subsection 61(5A) which provides that the Secretary of the Department of Health can release to the public 'therapeutic goods information'1 relating to any decision or action taken under the Act or the regulations made under the Act;
- subsection 61(5C) which provides that the Secretary can release to the public 'therapeutic goods information' of a kind specified under subsection 61(5D);
- subsection 61(5D) which provides that the Minister for Health can, by legislative instrument, specify kinds of therapeutic goods information for the purpose of subsection 61(5C).
The Therapeutic Goods Information Specification 2015 (the 2015 Specification) is a legislative instrument made by a delegate of the Minister under subsection 61(5D) and replaces the Therapeutic Goods Information Specification 2009. The 2015 Specification sets out various kinds of therapeutic goods information that can be released to the public by the Secretary under subsection 61(5C) and refers to the kind of information included in an AusPAR. A copy of the instrument is at Appendix 1.
- 'Therapeutic goods information' means information in relation to therapeutic goods that is held by the Department of Health and relates to the performance of the Department's functions (see subsection 61(1) of the Act).