Australian Government

Federal Register of Legislation

Therapeutic Goods Act 1989

In force

Administered by

Department of Health, Disability and Ageing

Superseded version

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View as made version

C2012C00355

27 December 2011 - 21 September 2012

Table of contents

Chapter 1—Preliminary
- 1 Short title [see Note 1]
- 2 Commencement [see Note 1]
- 3 Interpretation
- 3AA Homoeopathic preparations and homoeopathic standards
- 3AB Anthroposophic preparations and anthroposophic standards
- 3A Declaration—member of European Community
- 3B Declaration—country covered by non-EC/EFTA MRA
- 3C Exempting monographs in pharmacopoeias
- 4 Objects of Act
- 5 Act to bind Crown
- 5A Application of the Criminal Code—extended geographical jurisdiction
- 6 Operation of Act
- 6AAA Commonwealth consent to conferral of functions etc. on its officers and authorities by corresponding State laws
- 6AAB When duty imposed
- 6AAC Imposing duty under State law
- 6AAD Conferral of jurisdiction on federal courts
- 6AAE Consequences of State law conferring duty, function or power on Commonwealth officer or Commonwealth authority
- 6B Review of certain decisions under State laws
- 6C Fees payable to Commonwealth under State laws
- 7 Declaration that goods are/are not therapeutic goods
- 7A Authorised persons
- 7B Kits
- 7C Secretary may arrange for use of computer programs to make decisions
- 7D Form for product information for medicine
- 8 Power to obtain information with respect to therapeutic goods
- 9 Arrangements with States etc.
Chapter 2—Australian Register of Therapeutic Goods
- 9A Australian Register of Therapeutic Goods
- 9B When registrations or listings of medical devices are taken to be cancelled
- 9C Inspection of entries in Register
- 9D Variation of entries in Register
- 9E Publication of list of goods on Register
Chapter 3—Medicines and other therapeutic goods that are not medical devices
Part 3-1—Standards
- 10 Determination of standards
- 10A Application of standards to medical devices
- 13 Special provisions relating to Ministerial standards and default standards
- 13A Special provisions relating to homoeopathic standards and anthroposophic standards
- 14 Criminal offences for importing, supplying or exporting goods that do not comply with standards
- 14A Civil penalties for importing, supplying or exporting goods that do not comply with standards
- 14B Application of Customs Act 1901
- 15 Criminal offences relating to breaching a condition of a consent
- 15AA Civil penalty relating to breaching a condition of a consent
- 15AB Conditions relating to exceptional release of biologicals
Part 3-2—Registration and listing of therapeutic goods
- Division 1—Preliminary
- Division 2—Registration and listing
- Division 2A—Public notification and recovery of therapeutic goods
- Division 3—General
Part 3-2A—Biologicals
- Division 1—Preliminary
- Division 2—Main criminal offences and civil penalties
- Division 3—Exemptions
- Division 4—Including biologicals in the Register
- Division 5—Conditions
- Division 6—Suspension from the Register
- Division 7—Cancellation from the Register
- Division 8—Public notification and recovery of biologicals
- Division 9—Obtaining information or documents
Part 3-3—Manufacturing of therapeutic goods
- 33A Application of this Part to medical devices
- 33B Application of this Part to biologicals
- 34 Exempt goods and exempt persons
- 35 Criminal offences relating to manufacturing therapeutic goods
- 35A Civil penalties relating to manufacturing therapeutic goods
- 35B Criminal offences relating to breaching a condition of a licence
- 35C Civil penalty relating to breaching a condition of a licence
- 36 Manufacturing principles
- 37 Application for licence
- 38 Grant of licence
- 38A Guidelines for multi-site licences
- 38B Splitting multi-site licences
- 39 Term of licence
- 40 Conditions of licences
- 40A Variation of manufacturing site authorisations—Secretary’s own initiative
- 40B Variation of licences—application by licence holder
- 41 Revocation and suspension of licences
- 41AA Spent convictions scheme
- 41AAA Transfer of licences
- 41A Publication of list of manufacturers etc.
Chapter 4—Medical devices
Part 4-1—Introduction
- Division 1—Overview of this Chapter
- Division 2—Interpretation
- Division 3—Application provisions
Part 4-2—Essential principles and medical device standards
- 41C What this Part is about
- Division 1—Essential principles
  - 41CA Essential principles
- Division 2—Medical device standards
Part 4-3—Conformity assessment procedures
- 41D What this Part is about
- Division 1—Conformity assessment procedures
  - 41DA Conformity assessment procedures
  - 41DB Medical device classifications
- Division 2—Conformity assessment standards
Part 4-4—Conformity assessment certificates
- 41E What this Part is about
- Division 1—Issuing conformity assessment certificates
- Division 2—Conditions
- Division 3—Suspension of conformity assessment certificates
- Division 4—Revocation of conformity assessment certificates
Part 4-5—Including medical devices in the Register
- 41F What this Part is about
- Division 1—Including medical devices in the Register
- Division 2—Conditions
Part 4-6—Suspension and cancellation from the Register
- Division 1—Suspension from the Register
- Division 2—Cancellation of entries from the Register
Part 4-6A—Exempting medical devices to deal with emergencies
- 41GR What this Part is about
- 41GS Minister may make exemptions
- 41GT Conditions of exemptions
- 41GU Variation or revocation of exemption
- 41GV Informing persons of exemption etc.
- 41GW Notification and tabling
- 41GY Disposal of unused medical devices
Part 4-7—Other exemptions from including medical devices in the Register
- 41H What this Part is about
- 41HA Devices exempted from inclusion in the Register
- 41HB Exemptions for special and experimental uses
- 41HC Exemptions for medical practitioners
- 41HD Approvals if substitutes for medical devices are unavailable or in short supply
Part 4-8—Obtaining information
- 41J What this Part is about
- Division 1—Information relating to compliance with requirements and other matters
- Division 2—Information relating to medical devices covered by exemptions
Part 4-9—Public notification and recovery of medical devices
- 41K What this Part is about
- 41KA Public notification and recovery of medical devices
- 41KB Publication of requirements
- 41KC Criminal offences for failing to comply with requirements relating to a kind of medical device
- 41KCA Civil penalty for failing to comply with requirements relating to a kind of medical device
- 41KD Powers of suspension and cancellation unaffected
Part 4-10—Assessment fees
- 41L What this Part is about
- 41LA Assessment fees
- 41LB When assessment fee due for payment
- 41LC Payment of assessment fee by instalments
- 41LD Recovery of assessment fee
- 41LE Reduction of conformity assessment fee where decision not made within prescribed period
Part 4-11—Offences and civil penalty provisions relating to medical devices
- 41M What this Part is about
- Division 1—Non-compliance with essential principles
- Division 2—Failure to apply conformity assessment procedures
- Division 3—Medical devices not included in the Register and related matters
- Division 3A—Offences and civil penalties related to exemptions under Part 4-6A
- Division 4—Other offences and civil penalty provisions
Chapter 5—Advertising, counterfeit therapeutic goods and product tampering
Part 5-1—Advertising and generic information
- Division 1—Preliminary
- Division 2—Therapeutic goods advertisements for which an approval is required
  - 42BA Application of Division
  - 42C Offences relating to publication of advertisements
- Division 3—General provisions about advertising therapeutic goods
- Division 3A—Therapeutic goods advertisements for which an approval is not required
- Division 4—Generic information about ingredients or components of therapeutic goods
Part 5-2—Counterfeit therapeutic goods
- 42E Offence of dealing with counterfeit therapeutic goods
- 42EA Civil penalty relating to dealing with counterfeit therapeutic goods
- 42EB Relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods
- 42F Customs treatment of counterfeit therapeutic goods
Part 5-3—Product tampering
- 42T Notifying of actual or potential tampering
- 42U Meaning of actual or potential tampering etc.
- 42V Recovery of therapeutic goods because of actual or potential tampering
- 42VA Civil penalty relating to the recovery of therapeutic goods because of actual or potential tampering
- 42VB Relief from liability for contraventions relating to the recovery of therapeutic goods because of actual or potential tampering
- 42W Supply etc. of therapeutic goods that are subject to recovery requirements
- 42X Saving of other laws
Chapter 5A—Enforcement
Part 5A-1—Civil penalties
- Division 1—Obtaining an order for a civil penalty
- Division 2—Civil penalty proceedings and criminal proceedings
Part 5A-2—Infringement notices
- 42YJ Infringement notices in respect of offences
- 42YK Infringement notices in respect of civil penalty provisions
Part 5A-3—Enforceable undertakings
- 42YL Enforcement of undertakings
Chapter 6—Administration
Part 6-1—Payment of charges
- 43 By whom charges payable
- 44 Time for payment of charges
- 44A Exemptions from liability to pay charges
- 44B Recovery of unpaid charges
- 45 Therapeutic Goods Administration Account
Part 6-2—Entry, searches and warrants
- 45A Definitions
- 46 Searches to monitor compliance with Act
- 46A Searches of certain premises to monitor compliance with Act
- 46B Searches and seizures on public health grounds
- 47 Searches and seizures related to offences and civil penalty provisions
- 48 General powers of authorised persons in relation to premises
- 48A Details of warrant to be given to occupier etc.
- 48B Announcement before entry
- 48C Use of electronic equipment at premises
- 48D Compensation for damage to electronic equipment
- 48E Copies of seized things to be provided
- 48F Occupier entitled to be present during search
- 48G Receipts for things seized under warrant
- 48H Retention of seized things
- 48J Magistrate may permit a thing to be retained
- 49 Monitoring warrants
- 50 Offence and civil penalty provision related warrants
- 51 Offence and civil penalty provision related warrants by telephone
- 51A Searches at request of manufacturer
- 51B Offences relating to warrants
- 52 Identity cards
Part 6-3—Scheduling of substances
- 52AA Overview
- 52A Definitions
- 52B Advisory Committee on Medicines Scheduling
- 52C Advisory Committee on Chemicals Scheduling
- 52CA Joint meetings
- 52D Poisons Standard
- 52E Secretary to take certain matters into account in exercising powers
- 52EAA Application for amendment of the Poisons Standard
- 52EA Poisons Standard—validation etc.
- 52EB Compensation for acquisition of property
- 52EC Review of scheduling regime
Chapter 7—Miscellaneous
- 53 Retention of material on withdrawal of application
- 53A Alternative verdicts for various offences
- 54 Offences and forfeiture
- 54AA Offences for contravening conditions or requirements imposed under the regulations
- 54AB Criminal offence for damaging etc. documents
- 54AC Civil penalty for damaging etc. documents
- 54A Time for bringing prosecutions
- 54B Application of this Act to an executive officer of a body corporate
- 54C Establishing whether an executive officer took reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision
- 55 Conduct by directors, servants and agents
- 56 Judicial notice
- 56A Certificates to provide evidence of certain matters
- 57 Delegation
- 58 Export certifications
- 59 Fees
- 60 Review of decisions
- 60A New information on review—discretion to remit
- 61 Release of information
- 61A Immunity from civil actions
- 62 Consequential amendments
- 63 Regulations
Chapter 8—Repeal and transitional provisions
- 64 Interpretation
- 65 Repeal
- 66 Transitional arrangements for goods required to be registered or listed
- 67 Transitional provision for therapeutic goods for export only
- 68 Transitional arrangements for Part 3-3
- 69 Continuation of standards and requirements
Schedule—Consequential Amendments
- Notes to the Therapeutic Goods Act 1989