Therapeutic Goods Regulations 1990
Citation changes
Therapeutic Goods Regulations 1990
01 Jan 2024
Therapeutic Goods Regulations 1990
31 Mar 2000 - 28 Nov 1990
Therapeutic Goods Regulations 1990
01 Jan 1999 - 31 Dec 1998
Therapeutic Goods Regulations
29 Nov 1990 - 30 Mar 2000

In force

Administered by

Department of Health and Aged Care

This item is authorised by the following title:

Therapeutic Goods Act 1989

Superseded version

View latest version

F2012C00121

01 March 2012 - 29 June 2012

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

Table of contents

1 Name of Regulations [see Note 1]
2 Interpretation
2A Authorised officers
3 Corresponding State law
3AA Unacceptable presentation of therapeutic goods — prescribed class of medicine
3A Unacceptable presentations
4 Application of Part 2
4A Interpretation
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
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
8 Compliance with the Code
8A Publication of generic information
9 Orders about advertisements or generic information
9A Information about certain therapeutic goods to be supplied
9B Information about therapeutic goods manufactured using human embryos
10 Goods to be included in parts of the Register (Act s 9A)
10A Change of person in whose name goods are listed or registered
10B Transfers within the Register
10C Re assignment of registration or listing numbers
10D Notice of reassignment of registration or listing numbers
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
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
10I Re-assignment of biological numbers
10J Notice of reassignment of biological numbers
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 of therapeutic goods
16 Listing of Therapeutic Goods
16AA Documents and other information that may be required (Act subs 31 (2))
16AB Specified periods
16A Interpretation — working day
16B Notification of acceptance or rejection of application
16C Periods within which certain evaluations must be made
16D Periods within which certain applications must be decided
16E Failure to decide an application within specified time
16F Applications under subsection 9D (3) of the Act — periods within which certain decisions must be made
16G Shorter evaluation period in certain cases
16GA Evaluation other than evaluation under subsection 9D (1), (2) or (3) or 24 (1) of the Act
16GB Notification of acceptance or rejection of application
16GC Periods within which certain evaluations must be made
16GD Periods 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 32DD of the Act
16H Orphan drug
16I Application for orphan drug designation
16J Orphan drug designation
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
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
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
34 Establishment
34A Functions
34B Membership
35 Establishment
35A Functions
35B Membership
36 Establishment
36A Functions
36B Membership
37 Establishment
37A Functions
37B Membership
38 Establishment
38A Functions
38B Membership
38C Establishment
38D Functions
38E Membership
39 Establishment
39A Functions
39B Membership
39C Establishment
39D Functions
39E Membership
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
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
42R Complaints Resolution Panel
42S Function of the Panel
42T Membership of the Panel
42U Term of office of Panel members
42V Cessation of office
42W Alternate members
42X Observers to Panel
42Y Quorum
42Z Meetings
42ZA Effect of vacancy
42ZB Disclosure of interest
42ZC Reports to Council
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 Panel not to deal with complaint if court proceedings begun
42ZCAK Procedure generally
42ZCAL Register of complaints
42ZCA Definitions for Division 3A
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
42ZCK Committee meetings
42ZCL Meeting procedure
42ZCM Presiding member
42ZCN Quorum
42ZCO Voting
42ZCP Miscellaneous
42ZCQ Definitions for Division 3B
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
42ZCZA Committee meetings
42ZCZB Meeting procedure – general
42ZCZC Presiding member
42ZCZD Quorum
42ZCZE Voting
42ZCZF Miscellaneous
42ZCZG Joint meetings
42ZCZH Procedure for joint meetings
42ZCZI Definitions for Division 3D
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
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
43AAA Time for payment of charge
43AAB Definitions
43AAC Application requirements
43AAD Decision by the Secretary — exemption application
43AAE Actual turnover — new entries in the Register
43AAF Decision based on actual turnover
43AAG Requests by Secretary for additional information
43AAH Decision by the Secretary — new information
43AAI Appeal to AAT
43AAJ Licensing charge — reduction in certain circumstances
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
44 Testing of samples — recovery of costs
45 Waiver or reduction of fees
45AA Payment of fees in instalments
45A Limit on application fees — low value turnover
45B Purpose and effect of Part
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
- 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
- Part 1 Listable goods
- Part 2 Vitamins and their salts to which paragraph (b) of item 3 of Part 1 of this Schedule applies
- Part 3 Minerals and their salts to which paragraph (c) of Item 3 of Part 1 of this Schedule applies
- Part 4 Herbal substances to which paragraph (d) of item 3 of Part 1 of this Schedule applies
- Division 1 Plant material from which herbal substances in listable goods must not be derived
- Division 2 Plant material from which herbal substances may be derived for listable goods that are consistent with certain qualifications
- Part 5 Substances specified for item 3 of Part 1
- Division 1 Substances, not mentioned in Division 2 or 3, that may be ingredients of preparations
- Division 2 Substances subject to dosage limit
- Division 3 Substances requiring a label with an advisory statement
- Schedule 5 Therapeutic goods exempt from the operation of Parts 3-2 and 3-2A of the Act
- Schedule 5A Therapeutic goods exempt from the operation of Parts 3-2 and 3-2A of the Act subject to conditions
- Schedule 5B Disposal of unused emergency goods and unused emergency biologicals
- 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 of table
- Part 2 Table of fees
- Schedule 9A Fees — biologicals
- Part 1 Interpretation of table
- Part 2 Table of fees
- Schedule 10 Therapeutic goods for evaluation
- Part 1 Evaluation by Office of Medicines Authorisation of prescription and other medicines
- Part 2 Evaluation by the Office of Complementary Medicines
- Part 3 Evaluation by Office of Medicines Authorisation of non-prescription and other medicines
- Schedule 12 Patient information documents
- Schedule 13 Patient information documents
- Schedule 14 Designated active ingredients
- Schedule 15 Infringement notices
- Schedule 16 Classes of biologicals
- Notes to the REF Citation \*charformat Therapeutic Goods Regulations 1990

Therapeutic Goods Regulations 1990Citation changesTherapeutic Goods Regulations 199001 Jan 2024Therapeutic Goods Regulations 199031 Mar 2000 - 28 Nov 1990Therapeutic Goods Regulations 199001 Jan 1999 - 31 Dec 1998Therapeutic Goods Regulations29 Nov 1990 - 30 Mar 2000

Legislation text

Therapeutic Goods Regulations 1990
Citation changes
Therapeutic Goods Regulations 1990
01 Jan 2024
Therapeutic Goods Regulations 1990
31 Mar 2000 - 28 Nov 1990
Therapeutic Goods Regulations 1990
01 Jan 1999 - 31 Dec 1998
Therapeutic Goods Regulations
29 Nov 1990 - 30 Mar 2000