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[Browse Databases] [Alphabetical Index] ['Th' Index] [Download Act] [Search Act] THERAPEUTIC GOODS ACT 1989 !!! The following amendments (No. 2, 2006 and No. 5, 2006 and No. 39, 2006 and No. 50, 2006 and No. 96, 2006) have not been incorporated. - List of Sections
Section
Compilation Information Long Title THERAPEUTIC GOODS ACT 1989 1.
Short title [ see Note 1]
2.
Commencement [ see Note 1]
3.
Interpretation
3A.
Declaration—member of European Community
3B.
Declaration—country covered by non-EC/EFTA MRA
4.
Objects of Act
5.
Act to bind Crown
5A.
Application of the Criminal Code
6.
Operation of Act
6AA.
Importation of restricted goods
6AB.
Exempt goods
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
8.
Power to obtain information with respect to therapeutic goods
9.
Arrangements with States etc.
THERAPEUTIC GOODS ACT 1989 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
THERAPEUTIC GOODS ACT 1989 THERAPEUTIC GOODS ACT 1989 10.
Determination of standards
10A.
Application of standards to medical devices
11.
Date of effect of standards
12.
Standards to be disallowable
13.
Special provisions relating to standards
14.
Compliance with standards
15.
Consent may be subject to conditions etc.
THERAPEUTIC GOODS ACT 1989 THERAPEUTIC GOODS ACT 1989 15A.
Application of this Part to medical devices
16.
Therapeutic goods and gazetted groups
18.
Exempt goods
18A.
Exemption because of emergency
19.
Exemptions for special and experimental uses
19A.
Exemptions where unavailability etc. of therapeutic goods
20.
Offences relating to importation, exportation, manufacture and supply of therapeutic goods
21.
Offence relating to wholesale supply
22.
General offences relating to this Part
22A.
False statements in applications for registration
THERAPEUTIC GOODS ACT 1989 23AA.
Ministerial approval of evaluation, registration or listing of restricted goods
23.
Applications generally
24.
Applications for registration
24A.
When evaluation fee due for payment
24B.
Payment of evaluation fee by instalments
24C.
Recovery of evaluation fee
24D.
Reduction of evaluation fee where evaluation not completed within prescribed period
24E.
Deemed refusal of application
25.
Evaluation and registration of therapeutic goods
25A.
When the Secretary must not use protected information
25B.
Registration of therapeutic device to which EC/EFTA attestation of conformity applies
26.
Listing of therapeutic goods
26AA.
Listing of therapeutic device to which EC/EFTA attestation of conformity applies
26A.
Listing of certain medicines
26B.
Certificates required in relation to patents
26C.
Certificates required in relation to patent infringement proceedings
26D.
Requirements for interlocutory injunction
27.
Registration or listing number
28.
Conditions of registration or listing
29.
Duration of registration or listing
29A.
Notification of adverse effects etc. of goods
29B.
Notification of adverse effects etc. where application withdrawn or lapses
30.
Cancellation of registration or listing
30C.
Consultation with Gene Technology Regulator
30D.
Secretary may seek advice about classes of GM products
30E.
Secretary to take advice into account
THERAPEUTIC GOODS ACT 1989 30EA.
Public notification and recovery of therapeutic goods
30EB.
Publication of requirements
30EC.
Non-compliance with requirements
30ED.
Power of cancellation unaffected
THERAPEUTIC GOODS ACT 1989 30F.
Goods exempt under section 18A not conforming to standards etc.
30G.
Disposal of unused goods exempt under section 18A
30H.
Record for goods exempt under section 18A
31.
Secretary may require information
31A.
Secretary may require information etc. about goods exempt under section 18
31AA.
Secretary may require information etc. about goods exempt under section 18A
31B.
Secretary may require information relating to approvals and authorities under section 19
31C.
Requirements in relation to information or documents sought under section 31A, 31AA or 31B
31D.
False or misleading information
31E.
False or misleading documents
31F.
Self-incrimination
THERAPEUTIC GOODS ACT 1989 33A.
Application of this Part to medical devices
34.
Exempt goods and exempt persons
35.
Offences relating to manufacturing and licences
36.
Manufacturing principles
37.
Application for licence
38.
Grant of licence
39.
Term of licence
40.
Conditions of licences
41.
Revocation and suspension of licences
41A.
Publication of list of manufacturers etc.
THERAPEUTIC GOODS ACT 1989 THERAPEUTIC GOODS ACT 1989 THERAPEUTIC GOODS ACT 1989 41B.
General
41BA.
Requirements for medical devices (Parts 4-2 and 4-3)
41BB.
Administrative processes (Parts 4-4 to 4-10)
41BC.
Enforcement (Part 4-11)
THERAPEUTIC GOODS ACT 1989 41BD.
What is a medical device
41BE.
Kinds of medical devices
41BF.
System or procedure packs
41BG.
Manufacturers of medical devices
41BH.
Meaning of compliance with essential principles
41BI.
Meaning of non-application of conformity assessment procedures
THERAPEUTIC GOODS ACT 1989 41BJ.
Application of this Chapter to medical devices covered by Part 3-2
41BK.
Application of the Criminal Code
THERAPEUTIC GOODS ACT 1989 41C.
What this Part is about
THERAPEUTIC GOODS ACT 1989 41CA.
Essential principles
THERAPEUTIC GOODS ACT 1989 41CB.
Medical device standards
41CC.
Content of medical device standards
41CD.
Inconsistencies between medical device standards
THERAPEUTIC GOODS ACT 1989 41D.
What this Part is about
THERAPEUTIC GOODS ACT 1989 41DA.
Conformity assessment procedures
41DB.
Medical device classifications
THERAPEUTIC GOODS ACT 1989 41DC.
Conformity assessment standards
41DD.
Content of conformity assessment standards
41DE.
Inconsistencies between conformity assessment standards
THERAPEUTIC GOODS ACT 1989 41E.
What this Part is about
THERAPEUTIC GOODS ACT 1989 41EA.
When conformity assessment certificates are required
41EB.
Applications
41EC.
Considering applications
41ED.
Time for making decisions on applications
41EE.
Procedure following making a decision whether to issue certificate
41EF.
Duration of certificate
41EG.
Lapsing of applications
41EH.
Treating applications as having been refused
41EI.
False statements
THERAPEUTIC GOODS ACT 1989 41EJ.
Automatic conditions on conformity assessment certificates
41EK.
Conditions imposed when conformity assessment certificates are issued
41EL.
Conditions imposed after issuing a conformity assessment certificate
THERAPEUTIC GOODS ACT 1989 41EM.
Suspension of conformity assessment certificates
41EN.
Notice of proposed suspension
41EO.
Duration of suspension
41EP.
Revocation of suspension
41EQ.
Powers of revocation of conformity assessment certificates unaffected
THERAPEUTIC GOODS ACT 1989 41ER.
Automatic revocation of conformity assessment certificates
41ES.
Immediate revocation of conformity assessment certificates
41ET.
Revocation of conformity assessment certificates after notice of proposed revocation
41EU.
Limiting revocation of conformity assessment certificates to some medical devices of a particular kind
41EV.
Publication of revocation etc. of conformity assessment certificates
41EW.
Date of effect of revocation etc. of conformity assessment certificates
THERAPEUTIC GOODS ACT 1989 41F.
What this Part is about
THERAPEUTIC GOODS ACT 1989 41FA.
What this Division is about
41FB.
How this Division works
THERAPEUTIC GOODS ACT 1989 41FC.
Applications
41FD.
Matters to be certified
41FE.
False statements
THERAPEUTIC GOODS ACT 1989 41FF.
Obligation to include kinds of medical devices in the Register
41FG.
Notification of unsuccessful applications
THERAPEUTIC GOODS ACT 1989 41FH.
Selecting applications for auditing
41FI.
Auditing of applications
41FJ.
Procedure following audits
41FK.
Lapsing of applications
THERAPEUTIC GOODS ACT 1989 41FL.
Device number
41FM.
Duration of inclusion in the Register
THERAPEUTIC GOODS ACT 1989 41FN.
Conditions applying automatically
41FO.
Conditions imposed when kinds of medical devices are included in the Register
41FP.
Conditions imposed after kinds of medical devices are included in the Register
THERAPEUTIC GOODS ACT 1989 THERAPEUTIC GOODS ACT 1989 THERAPEUTIC GOODS ACT 1989 41G.
What this Part is about
41GA.
Suspension of kinds of medical devices from the Register
41GB.
Notice of proposed suspension must be given in certain cases
41GC.
Duration of suspension
41GD.
Revocation of suspension
41GE.
Treating applications for revocation as having been refused
THERAPEUTIC GOODS ACT 1989 41GF.
Suspension of kinds of medical devices from the Register
41GG.
Duration of suspension
41GH.
Revocation of suspension
THERAPEUTIC GOODS ACT 1989 41GI.
Effect of suspension
41GJ.
Powers of cancellation from Register unaffected
THERAPEUTIC GOODS ACT 1989 41GK.
Automatic cancellation of entries of kinds of medical devices from the Register
41GL.
Immediate cancellation of entries of kinds of medical devices from the Register
41GM.
Cancellation of entries of kinds of medical devices from the Register after section 41JA notice
41GN.
Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation
41GO.
Limiting cancellation of entries from Register to some medical devices of a particular kind
41GP.
Publication of cancellation of entry from Register
41GQ.
Date of effect of cancellation of entries from Register
THERAPEUTIC GOODS ACT 1989 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
THERAPEUTIC GOODS ACT 1989 41J.
What this Part is about
THERAPEUTIC GOODS ACT 1989 41JA.
Secretary may require information
41JB.
Complying with the Secretary's requirements
41JC.
Self-incrimination
THERAPEUTIC GOODS ACT 1989 41JD.
Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register
41JE.
Secretary may require information relating to approvals under section 41HB
41JF.
Secretary may require information relating to authorities under section 41HC
41JG.
Requirements in relation to information or documents sought under this Division
41JH.
False or misleading information
41JI.
False or misleading documents
41JJ.
Self-incrimination
THERAPEUTIC GOODS ACT 1989 41K.
What this Part is about
41KA.
Public notification and recovery of medical devices
41KB.
Publication of requirements
41KC.
Non-compliance with requirements
41KD.
Powers of suspension and cancellation unaffected
THERAPEUTIC GOODS ACT 1989 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
THERAPEUTIC GOODS ACT 1989 41M.
What this Part is about
THERAPEUTIC GOODS ACT 1989 41MA.
Non-compliance with essential principles
41MB.
Exceptions
41MC.
Consent may be subject to conditions etc.
41MD.
Treating medical devices as prohibited imports or exports
THERAPEUTIC GOODS ACT 1989 41ME.
Failure to apply conformity assessment procedures—manufacturers
41MF.
Failure to apply conformity assessment procedures—sponsors
41MG.
Exceptions
41MH.
False statements in declarations
THERAPEUTIC GOODS ACT 1989 41MI.
Importation, exportation, supply or manufacture of medical devices not included in the Register
41MJ.
Treating medical devices as prohibited imports or exports
41MK.
Wholesale supply of medical devices not included in the Register
41ML.
Misrepresentations etc. about medical devices
41MM.
Claims about arranging supplies of medical devices not included in the Register
41MN.
Breaches of conditions
THERAPEUTIC GOODS ACT 1989 41MO.
Misuse of medical devices exempted for special or experimental uses
41MP.
Notification of adverse events etc.
41MQ.
Notification of adverse events etc. where application withdrawn or lapses
THERAPEUTIC GOODS ACT 1989 THERAPEUTIC GOODS ACT 1989 THERAPEUTIC GOODS ACT 1989 42AA.
This Part not to apply to advertisements directed at health professionals etc.
42AB.
This Part not to apply to advertisements for goods not for human use
42AC.
This Part not to apply to advertisements for exported goods
42B.
Definitions
THERAPEUTIC GOODS ACT 1989 42BA.
Application of Division
42C.
Offences relating to publication of advertisements
THERAPEUTIC GOODS ACT 1989 42DA.
Application of Division
42DB.
Definitions
42DC.
Certain representations not to be published or broadcast
42DD.
Restricted representations
42DE.
Applications for approval of use of restricted representation
42DF.
Approval of use of restricted representation
42DG.
Notice of approval or refusal
42DH.
Variation of conditions of approval
42DI.
Withdrawal of approval
42DJ.
Prohibited and required representations
42DK.
Use of restricted or prohibited representations
42DL.
Advertising offences
42DM.
Compliance with Code
THERAPEUTIC GOODS ACT 1989 42DN.
Application of Division
42DO.
Compliance with the Code
42DP.
Offences—publication of generic information
THERAPEUTIC GOODS ACT 1989 42E.
Offence of dealing with counterfeit therapeutic goods
42F.
Customs treatment of counterfeit therapeutic goods
THERAPEUTIC GOODS ACT 1989 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
42W.
Supply etc. of therapeutic goods that are subject to recovery requirements
42X.
Saving of other laws
THERAPEUTIC GOODS ACT 1989 THERAPEUTIC GOODS ACT 1989 43.
By whom charges payable
44.
Time for payment of charges
45.
Therapeutic Goods Administration Account
THERAPEUTIC GOODS ACT 1989 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
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 related warrants
51.
Offence related warrants by telephone
51A.
Searches at request of manufacturer
51B.
Offences relating to warrants
52.
Identity cards
THERAPEUTIC GOODS ACT 1989 52A.
Definitions
52B.
Establishment and constitution of Committee
52C.
Functions of Committee
52D.
Poisons Standard
52E.
Matters to be taken into account in exercising powers
THERAPEUTIC GOODS ACT 1989 52F.
Definitions
52G.
Establishment and constitution of Committee
THERAPEUTIC GOODS ACT 1989 53.
Retention of material on withdrawal of application
54.
Indictable offences and forfeiture
54AA.
Offences for contravening conditions or requirements imposed under the regulations
54AB.
Damage etc. to documents
54A.
Time for bringing prosecutions
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
62.
Consequential amendments
63.
Regulations
THERAPEUTIC GOODS ACT 1989 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
THERAPEUTIC GOODS ACT 1989 THERAPEUTIC GOODS ACT 1989 Note 2 Table A [Browse Databases] [Alphabetical Index] ['Th' Index] [Download Act] [Search Act] [Back to top]