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THERAPEUTIC GOODS REGULATIONS 1990 - List of Regulations

Regulation

Compilation Information

THERAPEUTIC GOODS REGULATIONS 1990
Part 1 Preliminary

1. Name of Regulations [ see Note 1]
2. Interpretation
2A. Authorised officers
3. Corresponding State law
3A. Unacceptable presentations
THERAPEUTIC GOODS REGULATIONS 1990
Part 2 Advertisements


THERAPEUTIC GOODS REGULATIONS 1990
Division 1 Application of Part


4. Application of Part 2
4A. Interpretation
THERAPEUTIC GOODS REGULATIONS 1990
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
THERAPEUTIC GOODS REGULATIONS 1990
Division 3 General provisions about advertising therapeutic goods


6. Restricted representations
6A. Approval of use of restricted representation — public interest criteria [ see Note 2]
6B. Prohibited and required representations
7. Exempt goods and exempt devices
THERAPEUTIC GOODS REGULATIONS 1990
Division 4 Generic information about ingredients or components of
therapeutic goods


8. Compliance with the Code
8A. Publication of generic information
THERAPEUTIC GOODS REGULATIONS 1990
Division 5 General


9. Orders about advertisements or generic information
THERAPEUTIC GOODS REGULATIONS 1990
Part 2A Patient information

9A. Information about certain therapeutic goods to be supplied
9B. Information about therapeutic goods manufactured using human embryos
THERAPEUTIC GOODS REGULATIONS 1990
Part 2C Australian Register of Therapeutic Goods


THERAPEUTIC GOODS REGULATIONS 1990
Division 2C.1 Registered and listed therapeutic goods


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
THERAPEUTIC GOODS REGULATIONS 1990
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
THERAPEUTIC GOODS REGULATIONS 1990
Part 3 Registration, listing and exemption of therapeutic
goods

11. Characteristics that separate and distinguish certain medicines from other therapeutic goods
12. Exempt goods
12A. Unapproved medicines — exemption in life-threatening cases
12AAA.Emergency goods — early cessation of exemption
12AAB.Disposal of unused emergency goods
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
12C. Application of Part 3-2 to medical devices (Act s 15A)
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))
THERAPEUTIC GOODS REGULATIONS 1990
Part 3A Applications for evaluation


THERAPEUTIC GOODS REGULATIONS 1990
Division 1 Goods mentioned in Part 1 of Schedule 10


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
THERAPEUTIC GOODS REGULATIONS 1990
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
THERAPEUTIC GOODS REGULATIONS 1990
Part 3B Orphan drugs

16H. Orphan drug
16I. Application for orphan drug designation
16J. Orphan drug designation
THERAPEUTIC GOODS REGULATIONS 1990
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
THERAPEUTIC GOODS REGULATIONS 1990
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
THERAPEUTIC GOODS REGULATIONS 1990
Part 6 Committees


THERAPEUTIC GOODS REGULATIONS 1990
Division 1 Therapeutic Goods Committee, Medical Devices Evaluation
Committee and Australian Drug Evaluation Committee


34. Therapeutic Goods Committee
35. Medical Devices Evaluation Committee
36. Australian Drug Evaluation Committee
37. Minister or Secretary may seek further advice
38. Tenure of office of members
39. Disclosure of interest
40. Acting members
41. Meetings of Committees
42. Effect of vacancy on Committees
THERAPEUTIC GOODS REGULATIONS 1990
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
THERAPEUTIC GOODS REGULATIONS 1990
Division 3 Complaints Resolution Panel


THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 1 General


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
THERAPEUTIC GOODS REGULATIONS 1990
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
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
THERAPEUTIC GOODS REGULATIONS 1990
Division 3A National Drugs and Poisons Schedule Committee


THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 1 Preliminary


42ZCA.Definitions for Division 3A
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 2 Functions of Committee


42ZCB.Committee may establish subcommittees
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 3 Constitution of Committee


42ZCC.Membership of Committee
42ZCD.Committee members
42ZCE.Jurisdictional members
42ZCF.Appointment to be in writing
42ZCG.Appointment of Chair
42ZCH.Term of appointment
42ZCI.Resignation
42ZCJ.Disclosure of interests
42ZCK.Termination of Committee membership
42ZCL.Leave of absence
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 4 Committee procedures


42ZCM.Committee procedures
42ZCN.Committee procedures generally
42ZCO.Meetings
42ZCP.Presiding member
42ZCQ.Quorum
42ZCR.Voting
42ZCS.Records and reports
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 5 Scheduling procedures


42ZCT.Definitions for Subdivision 5
42ZCU.Public notice of scheduling meetings
42ZCV.Consideration of public submissions
42ZCW.Other matters to be considered by Committee
42ZCX.Record of reasons for scheduling decisions
42ZCY.Public notice of amendment
42ZCZ.Further public submissions
42ZCZA.Public consultation by subcommittee
42ZCZB.Urgent scheduling
THERAPEUTIC GOODS REGULATIONS 1990
Division 4 Complementary Medicines Evaluation Committee


THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 1 Interpretation


42ZD. Definition
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 2 Functions of Committee


42ZE. Committee's evaluating function
42ZF. Committee may give advice to Minister or Secretary
42ZG. Committee may establish sub-committees
42ZH. Minister or Secretary may seek further advice
42ZI. Committee may seek advice and assistance
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 3 Constitution of Committee


42ZJ. Establishment and membership of Committee
42ZK. Appointment of Committee members
42ZL. Expertise and experience of members
42ZM. Appointment of Chair
42ZN. Minister may nominate expert advisers
42ZO. Term of appointment
42ZP. Resignation
42ZQ. Disclosure of interests
42ZR. Termination of appointment
42ZS. Leave of absence
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 4 Committee procedures


42ZT. Committee procedures
42ZU. Committee procedures generally
42ZV. Meetings
42ZW. Presiding member
42ZX. Quorum
42ZY. Voting
42ZZ. Records and reports
THERAPEUTIC GOODS REGULATIONS 1990
Division 5 Medicines Evaluation Committee


THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 1 Interpretation


42ZZA.Definitions
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 2 Establishment of Committee


42ZZB.Establishment and constitution of Committee
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 3 Functions of Committee


42ZZC.Committee's evaluating function
42ZZD.Committee may give advice to Minister or Secretary
42ZZE.Committee may establish sub-committees
42ZZF.Minister or Secretary may seek further advice
42ZZG.Committee may seek advice and assistance
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 4 Constitution of Committee


42ZZH.Establishment and membership of Committee
42ZZI.Appointment of Committee members
42ZZJ.Expertise and experience of members
42ZZK.Appointment of Chair
42ZZL.Minister may nominate expert advisers
42ZZM.Term of appointment
42ZZN.Resignation
42ZZO.Disclosure of interests
42ZZP.Termination of appointment
42ZZQ.Leave of absence
THERAPEUTIC GOODS REGULATIONS 1990
Subdivision 5 Committee procedures


42ZZR.Committee procedures
42ZZS.Committee procedures generally
42ZZT.Meetings
42ZZU.Presiding member
42ZZV.Quorum
42ZZW.Voting
42ZZX.Records and reports
THERAPEUTIC GOODS REGULATIONS 1990
Part 7 Fees, costs and charges

43. Fees
43A. When is no application fee payable?
43AA. Fee for evaluation — reduction 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. Charges reduced if annual turnover is not more than $65 000
THERAPEUTIC GOODS REGULATIONS 1990
Part 8 Miscellaneous

46A. Delegation under the Act
46. Release of information
47. Delegation — powers and functions under these Regulations
47A. Delegation — powers under paragraph 19 (1) (a) of the Act
47B. Provision of information concerning medicines and medical devices
48. Review of decisions
THERAPEUTIC GOODS REGULATIONS 1990
Schedule 1 Part 2 does not apply to members of an Australian branch of one of these bodies

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 2 Prohibited and required representations

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 3 Therapeutic goods required to be included in the part of the Register for registered goods

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 4 Therapeutic goods required to be included in the part of the Register for listed goods

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 5 Therapeutic goods exempt from the operation of Part 3-2 of the Act

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 5A Therapeutic goods exempt from the operation of Part 3-2 of the Act subject to conditions

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 5B Disposal of unused emergency goods

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 6 Therapeutic devices prescribed for the purposes of paragraph 26 (1) (g) of the Act

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 7 Therapeutic goods exempt from the operation of Part 3-3 of the Act unless supplied as pharmaceutical benefits

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 8 Persons exempt from the operation of Part 3-3 of the Act

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 9 Fees

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 10 Therapeutic goods for evaluation

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 11 Criteria prescribed under paragraph 26 (1) (k) of the Act

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 12 Patient information documents

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 13 Patient information documents

THERAPEUTIC GOODS REGULATIONS 1990
Schedule 14 Designated active ingredients

THERAPEUTIC GOODS REGULATIONS 1990
Notes to the Therapeutic Goods Regulations 1990

Note 2

Table A

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