Specifications

If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.

2024

• Therapeutic Goods (Information Specification—Medicine Shortages and Availability Data) Instrument 2024
  Specifies kinds of therapeutic goods information that the Secretary may release to specified persons, bodies or authorities, and the purposes for which the Secretary may do so; and kinds of therapeutic goods information that may be released to the public by the Secretary, under subsections 61(5AA) and 61(5C) of the Therapeutic Goods Act 1989.

2023

• Therapeutic Goods (Prescription Medicines - Sharing of AusPARs) (Information) Specification 2023
  Specifies kinds of therapeutic goods information that may be released to the public by the Secretary under subsection 61(5C) of the Therapeutic Goods Act 1989
• Therapeutic Goods (Adverse Event Management System - Sponsors) (Information) Specification 2023
  Specifies certain therapeutic goods information relating to adverse events involving medicines or biologicals that the Secretary may release to the sponsor (and persons authorised to act on behalf of the sponsor) of the relevant goods under subsection 61(5AA) of the Act.

2022

• Therapeutic Goods (Database of Adverse Event Notifications) (Information) Specification 2022
  Specifies certain therapeutic goods information relating to adverse events involving medicines or biologicals that the Secretary may release to the public under subsection 61(5C) of the Act.
• Therapeutic Goods (Minamata Convention) (Information) Specification 2022
  Specifies kinds of therapeutic goods information relating to the importation and exportation of therapeutic goods that are mercury to the Department of Home Affairs, the Department of Agriculture, Water and the Environment and the Office of Chemical Safety in the Department of Health, in connection with Australia's international obligations under the Minamata Convention on Mercury.
• Therapeutic Goods (Analysis of Adverse Events Following Immunisation) (Information) Specification 2022
  Specifies certain therapeutic goods information relating to adverse events following immunisation that may be released to specified bodies and persons for the purpose of facilitating appropriate and effective analysis of data relating to safety signals associated with vaccines.
• Therapeutic Goods (Advisory Committee Meetings) (Information) Specification 2022
  Specifies kinds of therapeutic goods information that the Secretary may release to the public, in relation to matters or items considered by certain advisory committees.

2021

• Therapeutic Goods (Restricted Medicines) Specification 2021
  Specifies medicines or classes of medicine for the purposes of the definition of 'restricted medicine' in subsection 3(1) of the Therapeutic Goods Act 1989.
• Therapeutic Goods (Medicinal Cannabis Products) (Information) Specification 2021
  Specifies the publication of aggregated and de-identified statistical information; being, the numbers of applications or notifications (collectively, "submissions") made in relation to medicinal cannabis products under the Authorised Prescriber, Special Access Scheme Category A and Special Access Scheme Category B pathways in Australia. The aggregated and deidentified statistical information made available through the instrument includes: time periods; the relevant state or territory in which the medicinal cannabis products are prescribed; the indications for which the products have been prescribed; the active ingredients relating to those products; and the status of the submissions (such as approved, withdrawn, refused, pending or received).
• Therapeutic Goods (Adverse Events Following Immunisation) (Information) Specification 2021
  Specifies certain therapeutic goods information relating to adverse events following immunisation that may be released to specified bodies and persons for the purpose of ensuring meaningful and effective participation in meetings on vaccine safety to support the safety, quality and safe use of vaccines in Australia.

2020

• Therapeutic Goods (Prescription Medicines - Transparency Measures) Specification 2020
  Specifies kinds of therapeutic goods information relating to applications for the registration of prescription medicines in the Australian Register of Therapeutic Goods, that the Secretary may release to the public under section 61 of the Therapeutic Goods Act 1989
• Therapeutic Goods (Medical Devices - Excluded Purposes) Specification 2020
  Specifies excluded purposes for Class 2, 3 and 4 in vitro diagnostic (IVD) medical devices for self-testing.
• Therapeutic Goods (Clinical Trial Inspections) Specification (No. 2) 2020
  Specifies certain therapeutic goods information relating to clinical trials that may be released to approving authorities and responsible ethics committees for a specified purpose under section 61 of the Therapeutic Goods Act 1989
• Therapeutic Goods (Medicines and Biologicals - Ingredients and Components Information) Specification 2020
  Specifies therapeutic goods information relating to ingredients in medicines and components of biologicals that the Secretary may release to the public under section 61 of the Therapeutic Goods Act 1989

2019

• Therapeutic Goods (Listed Medicines - Compliance Reviews) Specification 2019
  Specifies therapeutic goods information, relating to compliance reviews for listed medicines, that the Secretary may release to the public under section 61 of the Therapeutic Goods Act 1989
• Therapeutic Goods (Australian Breast Device Registry) Specification 2019
  Specifies certain therapeutic goods information that may be released to the Australian Breast Device Registry for specified purposes under section 61 of the Therapeutic Goods Act 1989
• Therapeutic Goods (Breast Implants Information) Specification 2019
  Specifies the publication of certain therapeutic goods information relating to breast implants, mammary implants or tissue expanders
• Therapeutic Goods (Advertising Complaints and Investigations Information) Specification 2019
  Specifies the kinds of therapeutic goods information, relating to advertising complaints and investigations, that the Secretary may release to the public under section 61 of the Therapeutic Goods Act 1989

2018

• Therapeutic Goods (Information relating to Shortages and Discontinuations of Supply of Medicines) Specification 2018
  Specifies the kinds of therapeutic goods information that may be released to the public by the Secretary under subsection 61(5C) of the Act, in relation to shortages and discontinuations of the supply of medicines

2017

• Therapeutic Goods Information (Approvals relating to Medicine Shortages) Specification 2017
  Specifies the kinds of therapeutic goods information that may be released to the public by the Secretary. It will facilitate the publication of information relating to approvals granted by the Secretary to address shortages or unavailability of registered medicines.
• Therapeutic Goods Information (Sharing of Committee Information) Specification 2017
  Reflects changes that have been made recently to the Committees established under the Therapeutic Goods Regulations 1990 (the Regulations) to ensure appropriate sharing of Committee information may continue, and to make certain other minor amendments to keep the Specification up- to- date.
• Therapeutic Goods Information (Medical Devices) Specification 2017
  Specifies kinds of therapeutic goods information, relating to medical devises including their chemical and physical properties and possible residues, that may be released by the Secretary under subsection 61(5AA) of the Therapeutic Goods Act 1989
• Therapeutic Goods Information (Sharing information about in-house in vitro diagnostic medical devices) Specification 2017
  Permits the Secretary of the Department of Health to release certain therapeutic goods information that relates to in-house in vitro diagnostic (IVD) medical devices, to NATA, the National Association of Testing Authorities, of Australia
• Therapeutic Goods Information Specification 2017
  Specifies kinds of therapeutic goods information that may be released to the public by the Secretary under subsection 61(5C) of the Therapeutic Goods Act 1989
• Therapeutic Goods Information (Laboratory Testing) Specification 2017
  Specifies kinds of therapeutic goods information, relating to laboratory testing, that may be released to the public by the Secretary under subsection 61(5C) of the Therapeutic Goods Act 1989

2016

• Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016
  Specifies the kinds of therapeutic goods information that may be released to the public by the Secretary under subsection 61(5C) of the Act

2015

• Therapeutic Goods Information (Sharing of Information about Prescription Medicines) Specification 2015 
  Permits the Secretary to release certain kinds of therapeutic goods information to NPS MedicineWise for publication in Australian Prescriber as soon as reasonably possible after its registration in the Australian Register of Therapeutic Goods

2013

• Therapeutic Goods Information (Adverse Event Notifications - Medical Devices) Specification 2013
  Specifies the kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) of the Act
• Therapeutic Goods Information (Early Warning System) Specification 2013
  Specifies particular kinds of information that the Secretary may release to the public under subsection 61(5C) of the Act
• Therapeutic Goods Information (Stakeholder Consultation on Database of Adverse Event Notifications - Medical Devices) Specification 2013
  Specifies the kinds of therapeutic goods information, the bodies and kinds of persons to whom the information can be released and the purposes for which it can released by the Secretary under subsection 61(5AA) of the Therapeutic Goods Act 1989
• Therapeutic Goods Information (System for Australian Recall Actions) Specification 2013
  Specifies under subsection 61(5D) of the Therapeutic Goods Act 1989 (the Act) the kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) of the Act. The Specification has the effect of permitting the Secretary to release to the public therapeutic goods information in relation to recall actions being information kept by the TGA in its System for Australian Recall Actions database as set out in Schedule 1 to the Specification
• Therapeutic Goods Information (Stakeholder Consultation on the System for Australian Recall Actions) Specification 2013
  Permits the Secretary to release therapeutic goods information of a kind mentioned in the specification to the persons and bodies mentioned in the Specification, for the purposes set out in the specification

2012

• Therapeutic Goods Information (Joint Adverse Event Notifications System) Specification 2012
  Specifies a number of kinds of therapeutic goods information relating to adverse events in Australia and New Zealand involving medicines, which the Secretary of the Department of Health and Ageing may release to the public under subsection 61(5C) of the Therapeutic Goods Act 1989