Commonwealth Consolidated Regulations
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THERAPEUTIC GOODS REGULATIONS 1990
- made under the Therapeutic Goods Act 1989
TABLE OF PROVISIONS
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
3B. Definitions relating to goods comprising etc. human cells and tissues
3C. Classes of biologicals
PART 2--ADVERTISEMENTS
Division 1--Application of Part
4. Application of Part 2
4A. Interpretation
Division 3--General provisions about advertising therapeutic goods
6AA. Prescribed committees
6B. Prohibited and required representations
7. Prescribed goods for advertising offence and civil penalty
7A. Publisher exception for civil penalty provisions
Division 4--Generic information about ingredients or components of therapeutic goods
8. Compliance with the Code
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
10. Goods to be included in parts of the Register (Act s 9A)
10AAA. Variation of entries in Register--registered complementary medicines and registered OTC medicines
10AAB. Variation of entries in Register--prescription medicines other than biological medicines
10AAC. Variation of entries in Register--biological medicines
10AAD. Variation of entries in Register--biologicals
10AA. Prescribed requests for variations of entries in Register
10AB. Change of person in whose name goods are listed or registered
10AC. Change of name of person
10B. Transfers within the Register
10C. Re - assignment of registration or listing numbers
10D. Notice of reassignment of registration or listing numbers
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
10FA. Change of name of person
Division 2C.3--Biologicals included in the Register
10G. Goods to be included in the part of the Register for biologicals
10H. Change of person for whom a biological is included in the Register under Part 3 - 2A of the Act
10HA. Change of name of person
10I. Re - assignment of biological numbers
10J. Notice of reassignment of biological numbers
PART 2CA--PROHIBITION--ON IMPORT, EXPORT OR MANUFACTURE OF CERTAIN THERAPEUTIC GOODS--INTERNATIONAL AGREEMENTS
Division 1--Prescribed international agreements
10JA. Prescribed international agreements
Division 2--Prohibition on importation of mercury
10JB. Importation of a therapeutic good that is mercury from a non - party to the Minamata Convention is prohibited unless approved by the Secretary before importation
Division 3--Prohibition on export of mercury
10JC. Export of a therapeutic good that is mercury is prohibited unless approved by the Secretary before exportation
Division 4--Applications to import or export mercury
10JD. Applications to import or export mercury
10JE. When approval may be granted--importation
10JF. When approval may be granted--export
Division 5--Mercury-added products
10JG. Import, export and manufacture of therapeutic goods that are mercury - added products
10JH. Manufacture of therapeutic goods containing mercury - added products
PART 2D--PROVISIONAL--DETERMINATIONS FOR MEDICINE
10K. Applications for provisional determinations
10L. Provisional determinations
PART 2E--SCIENTIFIC--ADVICE ABOUT ASPECTS OF QUALITY, SAFETY OR EFFICACY OF MEDICINE
10M. Scientific advice about aspects of quality, safety or efficacy of medicine
PART 2F--VAPING--GOODS
10N. Commercial quantity of vaping goods
10P. Unit of vaping goods
10Q. Permitted quantity
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 certain uses--medicines
12BA. Authorities for certain uses--therapeutic vaping substances that are not medicines
12C. Exemptions for health practitioners--biologicals
15. Application of registration or listing number to goods
15AA. Clinical trial registries
15A. Conditions of registration and listing of medicines
16AA. Information or documents that Secretary may require
16AB. Specified periods
PART 3A--APPLICATIONS--FOR EVALUATION
Division 1--Preliminary
16A. Interpretation-- working day
Division 1A--Goods mentioned in Part 1 of Schedule 10
16C. Applications for registration--notification of effectiveness and period for completing evaluations--general
16D. Applications for variations--notification of effectiveness and period for deciding applications--general
16DA. Conditions for periods for regulations 16C and 16D
16E. Applications for variations--effect of failure to decide applications within specified period
16F. Applications for variations--shorter period for deciding applications
16G. Applications for registration--shorter period for completing evaluations
Division 2--Applications for evaluation of substances
16GA. Evaluation other than evaluation under subsection 9D(1), (2) or (3) or section 25 of the Act
Division 3--Class 2, Class 3 and Class 4 biologicals
16GC. Notification of preliminary assessment of applications and periods within which certain evaluations must be made
16GD. Notification of effective request and period within which certain applications must be decided
16GE. Failure to decide an application within specified time
16GF. Evaluation, other than evaluation under subsection 9D(3A) or (3AA) or section 32DE of the Act
Division 4--Complementary medicines and certain other listed medicines
16GG. Variation of certain entries in the Register--notification of effective requests and period within which decisions must be made
16GH. Registration and listing of certain medicines--notification of preliminary assessment of applications and period within which evaluations must be completed
16GI. Registration and listing of certain medicines--notification of preliminary assessment of applications and period within which decisions on recommendations must be made
16GIA. Period for paying evaluation fee for application under subsection 26BD(1) of the Act
16GJ. Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications
PART 3B--DESIGNATED--ORPHAN DRUGS
16H. Application to designate medicine as orphan drug
16J. Designation of medicine as orphan drug
16K. Period during which designation is in force
16L. Extension of designation
16M. Revocation of designation
PART 3C--THERAPEUTIC--GOODS (PRIORITY APPLICANT) DETERMINATIONS
16P. Application of Part
16Q. Application for therapeutic goods (priority applicant) determination
16R. Making of therapeutic goods (priority applicant) determination
16S. Period during which therapeutic goods (priority applicant) determination is in force
16T. Revocation of therapeutic goods (priority applicant) determination
PART 3D--BIOLOGICALS--(PRIORITY APPLICANT) DETERMINATIONS
16U. Application of Part
16V. Application for biologicals (priority applicant) determination
16W. Making of biologicals (priority applicant) determination
16X. Period during which biologicals (priority applicant) determination is in force
16Y. Revocation of biologicals (priority applicant) determination
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. Appointment of analysts and official analysts and powers of official analysts
26. Taking of samples for testing
26A. Receiving samples for testing
27. Examination and testing of sample
28. Tests for determining conformity with a standard or compliance with essential principles
29. Certificate of responsible analyst
30. Review of results of examination and analysis
31. Payment for samples
32. Offences relating to analysis etc
33. Production of identity card
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 1A--Advisory Committee on Medicines
35. Establishment
35A. Functions
35B. Membership
Division 1D--Advisory Committee on Medical Devices
38. Establishment
38A. Functions
38B. 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 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 3A--Advisory Committee on edicines 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
Subdivision 1--Preliminary
43AAA. Meaning of turnover and when turnover is of low value
Subdivision 1A--Time for payment of certain annual charges
43AAB. Time for payment of certain annual charges
Subdivision 2--Exemption from liability to pay certain annual charges--therapeutic goods other than IVD devices
43AAAA. Application
43AABA. Purpose of this Subdivision
43AABB. Exemption from liability to pay certain annual charges--2014 - 15 financial year--goods entered on Register on or after 1 May 2015 and on or before 30 June 2015
43AAC. Exemption from liability to pay certain annual charges--2015 - 16 financial year
43AAD. Exemption from liability to pay certain annual charges--financial years commencing on or after 1 July 2016
43AAE. Exemption from liability to pay certain annual charges--late notice that turnover was of low value
43AAF. Person may notify Secretary that turnover of goods for financial year will not be of low value
43AAG. Secretary may notify person that annual charge is payable if turnover is not of low value
Subdivision 2A--Exemption from liability to pay annual charge--IVD devices
43AAGA. Purpose of this Subdivision
43AAGB. Exemption from liability to pay annual charge--2017 - 18 financial year
43AAGC. Exemption from liability to pay annual charge--financial years commencing on or after 1 July 2018
43AAGD. Exemption from liability to pay annual charge--late notice that turnover was of low value
43AAGE. Person may notify Secretary that turnover of IVD device for financial year will not be of low value
43AAGF. Secretary may notify person that annual charge is payable if turnover is not of low value
Subdivision 2B--Waiver of certain annual charges
43AAGG. Purpose of Subdivision
43AAH. Waiver of certain annual charges
Subdivision 3--Charges for licensing
43AAJ. Licensing charge--reduction in certain circumstances
Division 2--Fees and costs
43. Fees
43A. When is no application fee payable?
43AA. Fee for evaluation--refund in certain circumstances
43AB. Circumstances in which inspection fee covered by annual charge
43AC. Refund of fees where no evaluation undertaken--registered OTC medicines
43ACA. Refund of fees where no evaluation undertaken--certain registered and listed medicines
43AD. Fee for therapeutic goods (priority applicant) determination application--refund in certain circumstances
43AE. Fee for application for provisional determination relating to medicine--refund in certain circumstances
43AF. Fee for request for variation of certain registered and listed medicines--refund in certain circumstances
44. Testing of samples--recovery of costs
45. Waiver or reduction of fees
45AA. Payment of fees in instalments
PART 8--MISCELLANEOUS
46AA. Identity cards for authorised officers
46A. Delegation under the Act
46B. Protected persons
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
47C. Enforceable directions
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
Division 5--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017
52. Definitions
53. Transitional--continuing application of evaluation fees for variations of permissible ingredients determinations
54. Transitional--existing orphan drug designations
55. Transitional--pending orphan drug designation applications
56. Transitional--fee waivers in relation to certain designations
Division 6--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017
57. Definitions
58. Application--statements in relation to unapproved medicines and biologicals
59. Transitional--approval of form for statements
Division 7--Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018
60. Application provisions
61. Operation of Schedule 2--complementary medicines
62. Saving provision
Division 8--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018
63. Application of amendments
Division 9--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018
64. Definitions
65. Transitional provisions--exemptions from Parts 3 - 2 and 3 - 2A of the Act
66. Transitional provisions--exemptions from Part 3 - 3 of the Act
Division 10--Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018
67. Application
Division 11--Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019
68. Application and transitional provisions
Division 12--Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019
Subdivision A--Definitions
69. Definitions
Subdivision B--Faecal microbiota transplant products
70. Faecal microbiota transplant products--Division 4 of Part 3 - 2A of the Act
71. Faecal microbiota transplant products--Part 3 - 3 of the Act
Subdivision C--Consumer medicine information documents
72. Consumer medicine information documents
Subdivision D--Handling and testing of samples
73. Handling and testing of samples
Subdivision E--Fee waivers and refunds for certain requests relating to prescription opioids
74. Fee waivers and refunds for certain requests relating to prescription opioids
Subdivision F--Clinical trials
75. Clinical trials
Division 13--Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020
76. Approving supply of therapeutic goods under authorised prescriber scheme
77. Preliminary assessment of applications for variation of permissible ingredients determination
Division 15--Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021
79. Application of amendments made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021
Division 16--Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021
81. Access to medicines in emergency situations
82. Consumer medicine information documents
83. Approving supply of therapeutic goods under authorised prescriber scheme
Division 17--Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021
84. Amendments made by Division 1 of Part 2 of Schedule 1
85. Amendments made by Division 2 of Part 2 of Schedule 1
Division 18--Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022
86. Extemporaneously - compounded medicinal cannabis products
Division 19--Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022
87. Reconsideration of decisions
Division 20--Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022
88. Exempt goods
89. Fee for requests to vary entries in Register
Division 21--Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023
90. Clinical trials
Division 22--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023
91. Clinical trials
92. Removal of exemptions for sunscreen preparations
Division 23--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023
93. Definitions
94. Approving supply of therapeutic goods under authorised prescriber scheme
95. Goods to be included in parts of the Register
96. Exempt goods
97. Transitional vaping manufacturers--exemption from Part 3 - 3 of the Act
Division 24--Application provision relating to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024
98. Exempt goods
Division 25--Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024
99. Definitions
100. Fee waivers in relation to the Medicines Repurposing Program
101. Examination, testing and analysis of goods
102. Identity cards
103. Sunscreen preparations
Division 26--Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024
104. Definitions
105. Authorities for therapeutic vaping substances that are not medicines
106. Therapeutic vaping packs
107. Exempt goods
108. Transitional vaping goods--exemption from Part 3 - 2 of the Act
SCHEDULE 1 Part 2 does not apply to members of an Australian branch of one of these bodies
SCHEDULE 2 Prohibited and required representations
SCHEDULE 3 Therapeutic goods required to be included in the part of the Register for goods known as registered goods or as provisionally registered goods
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
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
SCHEDULE 9A Fees--biologicals
SCHEDULE 10 Therapeutic goods for evaluation
SCHEDULE 12 Consumer medicine information documents
SCHEDULE 13 Consumer medicine information documents
SCHEDULE 14 Designated active ingredients
SCHEDULE 16 Classes of biologicals
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