Therapeutic Goods Regulations 1990

In force

Administered by

Department of Health, Disability and Ageing

This item is authorised by the following title:

Therapeutic Goods Act 1989

Superseded version

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View as made version

F2016C00775 C71

01 July 2016 - 15 August 2016

This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003

Table of contents

Part 1—Preliminary
- 1 Name of Regulations
- 2 Interpretation
- 2A Authorised officers
- 3 Corresponding State law
- 3AA Unacceptable presentation of therapeutic goods—prescribed class of medicine
- 3A Unacceptable presentations
Part 2—Advertisements
- Division 1—Application of Part
  - 4 Application of Part 2
  - 4A Interpretation
- Division 2—Advertisements for which approval is needed
- 5B Interpretation
- 5BA Means that are not broadcast media
- 5C Application of Division
- 5F Applications for approval of advertisements
- 5G Approval of advertisements
- 5H Notice of approval or refusal to approve an advertisement
- 5J Distinguishing numbers for approved advertisements
- 5K Variation of conditions of approval
- 5L Withdrawal of approval
- 5M Review by Minister of decisions of the Secretary
- 5N Notice of Minister’s decisions
- 5P Review by Tribunal of decisions of the Minister
- 5Q Delegations
- Division 3—General provisions about advertising therapeutic goods
- 6 Restricted representations
- 6AA Prescribed committees
- 6A Approval of use of restricted representation—public interest criteria
- 6B Prohibited and required representations
- 7 Exempt goods and exempt devices
- Division 4—Generic information about ingredients or components of therapeutic goods
- 8 Compliance with the Code
- 8A Publication of generic information
- Division 5—General
- 9 Orders about advertisements or generic information
Part 2A—Patient information
- 9A Information about certain therapeutic goods to be supplied
- 9B Information about therapeutic goods manufactured using human embryos
Part 2C—Australian Register of Therapeutic Goods
- Division 2C.1—Registered and listed therapeutic goods
- Division 2C.2—Medical devices included in the Register under Chapter 4
  - 10E Goods to be included in part of the Register for medical devices (Act s 9A)
  - 10F Change of person in relation to whom a medical device is included in the Register under Chapter 4 of the Act
- Division 2C.3—Biologicals included in the Register
Part 3—Registration, inclusion, listing and exemption of therapeutic goods
- 11 Characteristics that separate and distinguish certain medicines from other therapeutic goods
- 11A Characteristics that separate and distinguish certain biologicals from other biologicals
- 12 Exempt goods
- 12A Unapproved medicines and biological—exemption in life threatening cases
- 12AAB Disposal of unused emergency goods and unused emergency biologicals
- 12AA Applications for special and experimental uses
- 12AB Goods imported etc for experimental uses
- 12AC Powers of authorised officers in relation to goods imported etc for experimental uses
- 12AD Use of goods for experimental purposes—specified conditions
- 12B Exemptions for special and experimental uses—medicines
- 12C Exemptions for special and experimental uses—biologicals
- 15 Application of registration or listing number to goods
- 15A Conditions of registration and listing of medicines
- 16 Listing of Therapeutic Goods
- 16AA Information or documents that Secretary may require
- 16AB Specified periods
Part 3A—Applications for evaluation
- Division 1—Goods mentioned in Part 1 of Schedule 10
- Division 2—Applications for evaluation of substances
  - 16GA Evaluation other than evaluation under subsection 9D(1), (2) or (3) or 24(1) of the Act
- Division 3—Class 2, Class 3 and Class 4 biologicals
Part 3B—Orphan drugs
- 16H Orphan drug
- 16I Application for orphan drug designation
- 16J Orphan drug designation
Part 4—Licensing of manufacturers
- 17 Exempt goods for the purposes of subsection 34(1) of the Act
- 18 Exempt Persons
- 19 Requirements for licence holders
- 20 Conditions of licences
- 21 Persons having control of production etc to be named
- 22 Transfer of licences
Part 5—Examination, testing and analysis of goods
- 23 Interpretation
- 24 Authorised officer—powers and duties
- 25 Official analysts
- 26 Taking of samples for testing
- 26A Receiving samples for testing
- 27 Examination and testing of sample
- 28 Relevant tests
- 29 Certificate of official analyst
- 30 Review of findings of official analyst
- 31 Payment for samples
- 32 Offences relating to analysis etc
- 33 Identity cards
Part 5A—Exceptional release
- 33A Prescribed circumstances under which biologicals may be imported, exported or supplied
- 33B Conditions for supply of biologicals
- 33C Report on release of nonconforming biological
Part 6—Committees
- Division 1—Therapeutic Goods Committee
  - 34 Establishment
  - 34A Functions
  - 34B Membership
- Division 1A—Advisory Committee on Prescription Medicines
  - 35 Establishment
  - 35A Functions
  - 35B Membership
- Division 1B—Advisory Committee on Non prescription Medicines
  - 36 Establishment
  - 36A Functions
  - 36B Membership
- Division 1C—Advisory Committee on the Safety of Medicines
  - 37 Establishment
  - 37A Functions
  - 37B Membership
- Division 1D—Advisory Committee on Medical Devices
  - 38 Establishment
  - 38A Functions
  - 38B Membership
- Division 1DA—Advisory Committee on the Safety of Medical Devices
  - 38C Establishment
  - 38D Functions
  - 38E Membership
- Division 1E—Advisory Committee on Complementary Medicines
  - 39 Establishment
  - 39A Functions
  - 39B Membership
- Division 1EA—Advisory Committee on Biologicals
  - 39C Establishment
  - 39D Functions
  - 39E Membership
- Division 1EB—Advisory Committee on Safety of Vaccines
  - 39F Establishment
  - 39G Functions
  - 39H Membership
- Division 1F—General
  - 40 Application of this Division
  - 41 Appointment of members
  - 41A Appointment of the chair
  - 41B Resignation or vacancy
  - 41C Termination of appointment
  - 41D Leave of absence
  - 41E Acting members
  - 41F Committee procedures
  - 41G Meetings
  - 41H Presiding member
  - 41I Quorum
  - 41J Voting
  - 42 Miscellaneous
- Division 2—Therapeutic Goods Advertising Code Council
  - 42A Therapeutic Goods Advertising Code Council
  - 42B Functions of the Council
  - 42C Membership of the Council
  - 42D Term of office of Council members
  - 42E Chairperson of the Council
  - 42F Resignation
  - 42G Cessation of membership
  - 42H Alternate members
  - 42J Observers to Council
  - 42K Quorum
  - 42L Meetings
  - 42M Effect of vacancy
  - 42N Disclosure of interest
  - 42P Procedure generally
  - 42Q Annual report
- Division 3—Complaints Resolution Panel
  - Subdivision 1—General
  - Subdivision 2—Procedure—Complaints about advertisements and generic information
  - 42ZCAA Definitions for Subdivision 2
  - 42ZCAB Complaints about advertisements or generic information
  - 42ZCAC Procedure on receipt of a complaint
  - 42ZCAD Dealing with complaint
  - 42ZCAE Powers of Panel
  - 42ZCAF Withdrawal of complaint
  - 42ZCAG Dealing with subject matter despite withdrawal of complaint
  - 42ZCAGA Panel may refer complaint to another authority
  - 42ZCAH Dealing with matters not specified in complaint
  - 42ZCAI Action that Panel may take
  - 42ZCAJ Dealing with complaint if court proceedings begun
  - 42ZCAK Procedure generally
  - 42ZCAL Register of complaints
- Division 3A—Advisory Committee on Medicines Scheduling
- Subdivision 3A.1—Preliminary
  - 42ZCA Definitions for Division 3A
- Subdivision 3A.2—Constitution of Committee
  - 42ZCB Membership of Committee
  - 42ZCC Committee members
  - 42ZCD Appointed members
  - 42ZCE Nominated members
  - 42ZCF Appointment of the Chair and acting Chair
  - 42ZCG Resignation or vacancy
  - 42ZCH Termination of appointment
  - 42ZCI Leave of absence
  - 42ZCJ Acting members
- Subdivision 3A.3—Committee meetings
  - 42ZCK Committee meetings
  - 42ZCL Meeting procedure
  - 42ZCM Presiding member
  - 42ZCN Quorum
  - 42ZCO Voting
  - 42ZCP Miscellaneous
- Division 3B—Advisory Committee on Chemicals Scheduling
- Subdivision 3B.1—Preliminary
  - 42ZCQ Definitions for Division 3B
- Subdivision 3B.2—Constitution of Committee
  - 42ZCR Membership of Committee
  - 42ZCS Committee members
  - 42ZCT Appointed members
  - 42ZCU Nominated members
  - 42ZCV Appointment of the Chair and acting Chair
  - 42ZCW Resignation or vacancy
  - 42ZCX Termination of appointment
  - 42ZCY Leave of absence
  - 42ZCZ Acting members
- Subdivision 3B.3—Committee meetings
  - 42ZCZA Committee meetings
  - 42ZCZB Meeting procedure – general
  - 42ZCZC Presiding member
  - 42ZCZD Quorum
  - 42ZCZE Voting
  - 42ZCZF Miscellaneous
- Division 3C—Joint meetings
- 42ZCZG Joint meetings
- 42ZCZH Procedure for joint meetings
- Division 3D—Procedure for amending the current Poisons Standard
- Subdivision 3D.1—Preliminary
  - 42ZCZI Definitions for Division 3D
- Subdivision 3D.2—Procedure if proposed amendment referred to expert advisory committee
  - 42ZCZJ Application
  - 42ZCZK Proposed amendment to be referred to expert advisory committee
  - 42ZCZL Consideration of public submissions
  - 42ZCZM Committee to advise Secretary
  - 42ZCZN Interim decision of Secretary
  - 42ZCZO Secretary may make final decision if no interim decision required
  - 42ZCZP Call for further submissions
  - 42ZCZQ Reconsideration of interim decision
  - 42ZCZR Final decision if there is an interim decision
  - 42ZCZS Publication of final decision
- Subdivision 3D.3—Procedure if proposed amendments not referred to expert advisory committee
  - 42ZCZT Application
  - 42ZCZU Final decision without interim decision
  - 42ZCZV Interim decision required if Secretary decides not to amend as requested
  - 42ZCZW Final decision if there is interim decision
  - 42ZCZX Publication of final decision
Part 7—Charges for registration, listing and inclusion, licences, exemptions, costs and fees
- Division 1—Charges for registration, listing and inclusion of therapeutic goods, exemptions and licences
- Division 2—Fees and costs
Part 7A—Infringement notices
- 45B Purpose and effect of Part
Part 8—Miscellaneous
- 46A Delegation under the Act
- 46 Release of information
- 47 Delegation—powers and functions under these Regulations
- 47A Delegation—powers under paragraphs 19(1)(a), 32CK(1)(d) and 41HB(1)(d) of the Act
- 47B Provision of information concerning medicines, biologicals and medical devices
- 48 Review of decisions
Part 9—Transitional
- Division 1—Transitional provisions relating to the Therapeutic Goods Amendment Regulations 2010 (No. 1)
  - 48A Definitions
  - 48B Application of 2010 Amendment Regulations
- Division 2—Transitional provisions relating to the Therapeutic Goods Amendment Regulation 2012 (No. 3)
  - 49 Transitional
- Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015
  - 50 Application
- Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
  - 51 Application
Schedule 1—Part 2 does not apply to members of an Australian branch of one of these bodies
Schedule 2—Prohibited and required representations
- Part 1—Prohibited representations
- Part 2—Required representations
- Part 3—Vitamins referred to in Item 3 of Part 1 of this Schedule
Schedule 3—Therapeutic goods required to be included in the part of the Register for registered goods
- Part 1—Therapeutic devices attracting a higher fee, and medicines
- Part 2—Therapeutic devices attracting a lower fee
- Part 3—Therapeutic goods attracting no fee under Division 1 or 2 of Part 3 2 of the Act
Schedule 4—Therapeutic goods required to be included in the part of the Register for listed goods
Schedule 5—Therapeutic goods exempt from the operation of Parts 3 2 and 3 2A of the Act
Schedule 5A—Therapeutic goods exempt from operation of Parts 3 2 and 3 2A of Act subject to conditions
Schedule 5B—Disposal of unused emergency goods and unused emergency biologicals
- 1 Early end of exemption—notice of goods held
- 1A Early cessation of exemption—notice of biologicals held
- 2 Expiration of period of exemption—notice of goods held
- 2A Expiration of period of exemption—notice of biologicals held
- 3 Storage and disposal of unused emergency goods and unused emergency biologicals
- 4 Direction for disposal of unused emergency goods and unused emergency biologicals
- 5 Relocation of unused emergency goods and unused emergency biologicals
- 6 Disposal of unused emergency goods and unused emergency biologicals—destruction
- 7 Disposal of unused emergency goods and unused emergency biologicals—export
- 8 Disposal of unused emergency goods and unused emergency biologicals—supply
- 9 Owner to be paid for goods or biologicals supplied
- 10 Records about unused emergency goods and unused emergency biologicals
- 11 Failure to comply with this Schedule
Schedule 6—Therapeutic devices prescribed for the purposes of paragraph 26(1)(g) of the Act
Schedule 7—Therapeutic goods exempt from the operation of Part 3 3 of the Act unless supplied as pharmaceutical benefits
Schedule 8—Persons exempt from the operation of Part 3 3 of the Act
Schedule 9—Fees—therapeutic goods other than biologicals
- Part 1—Interpretation
  - 1 Definitions
  - 2 Part 2 fees do not apply in relation to applications and evaluations covered by Part 3
- Part 2—Table of fees other than for applications and evaluations covered by Part 3
  - 3 Table of fees
- Part 3—Table of particular application and evaluation fees in relation to certain OTC medicines
  - 4 Table of application and evaluation fees
Schedule 9A—Fees—biologicals
- Part 1—Interpretation of table
  - 1 Definitions
- Part 2—Table of fees
Schedule 10—Therapeutic goods for evaluation
- Part 1—Evaluation of prescription and other medicines by the Prescription Medicines Authorisation Branch
- Part 2—Evaluation of complementary medicines by the Complementary and OTC Medicines Branch
- Part 3—Evaluation of non prescription and other medicines by the Complementary and OTC Medicines Branch
Schedule 12—Patient information documents
- 1. Identification
- 2. What the product is used for and how it works
- 3. Advice before using the medicinal product
- 4. How to use the medicinal product properly
- 5. Further information
- 6. Unwanted effects
- 7. In case of overdose
- 8. Storage conditions
- 9. Where to go for further information
- 10. Sponsor
- 11. Date of information
Schedule 13—Patient information documents
- 1. Identification
- 2. What the product is used for and how it works
- 3. Advice before using the medicinal product
- 4. How to use the medicinal product properly
- 5. Further information
- 6. Unwanted effects
- 7. In case of overdose
- 8. Storage conditions
- 9. Where to go for further information
- 10. Sponsor
- 11. Date of information
Schedule 14—Designated active ingredients
Schedule 15—Infringement notices
- 1 Definitions
- 2 Issue of infringement notice
- 3 Contents of infringement notice
- 4 Service of infringement notices
- 5 Extension of time to pay penalty
- 6 Payment of penalty by instalments
- 7 Withdrawal of infringement notice
- 8 Notice of withdrawal of infringement notice
- 9 Effect of payment of infringement notice penalty
- 10 Refund of penalty
- 11 Matter not to be taken into account in determining sentence
- 12 Infringement notice not compulsory
Schedule 16—Classes of biologicals
- Endnotes

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Therapeutic Goods Regulations 1990

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Therapeutic Goods Regulations 1990 Citation change

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Therapeutic Goods Regulations 1990