THERAPEUTIC GOODS ACT 1989 - SECT 41A Publication of list of manufacturers etc.
THERAPEUTIC GOODS ACT 1989 - SECT 41A
Publication of list of manufacturers etc.The Secretary may, from time to time and in such manner as the Secretary determines, publish a list of the persons who are licensed under this Part, the classes of goods to which the licences relate, the steps of manufacture that the licences authorise and the addresses of the manufacturing sites to which the licences relate.
The regulations may prohibit imports into Australia, exports from Australia, the manufacture in Australia and supplies in Australia of therapeutic goods, or therapeutic goods containing a particular ingredient or component, to give effect to international agreements to which Australia is a party.
There is an offence and a civil penalty for contravening such a prohibition.
This Part regulates biologicals. It does this by providing a process for including biologicals in the Register and providing for enforcement through criminal offences and civil penalties.
This Part provides for the following administrative processes:
(a) exempting biologicals from the requirement to be included in the Register;
(b) making the inclusion of biologicals in the Register subject to conditions;
(c) suspending or cancelling entries of biologicals from the Register;
(d) requiring public notification of problems with biologicals, and recall of biologicals;
(e) obtaining information or documents about biologicals.
(a) exemptions of biologicals under the regulations; and
(b) exemptions of biologicals to deal with emergencies; and
(c) exemptions of biologicals for special and experimental uses; and
(d) exemptions of biologicals where substitutes are unavailable.
A Class 1 biological can be included in the Register if a proper application is made and the applicant certifies various matters (see Subdivision B).
An export only biological can be included in the Register if a proper application is made, the applicant certifies various matters and, if steps in the manufacture of the biological have been carried out outside Australia, the Secretary has certified (where appropriate) that the manufacturing and quality control procedures used in those steps are acceptable (see Subdivision BA).
A biological, other than a Class 1 biological or an export only biological, can be included in the Register if a proper application is made and the Secretary is satisfied the biological is suitable for inclusion following an evaluation of the biological (see Subdivision C).
The Secretary may by written notice seek information or documents relating to:
• applications for inclusion of biologicals in the Register; or
• biologicals included in the Register; or
• the supply of, and other matters relating to, biologicals covered by exemptions under Division 3.
There are criminal offences for failing to comply with a notice and for giving false or misleading information or documents and civil penalties for giving false or misleading information or documents.
No. 21, 1990
Compilation No. 84
Compilation date: 21 September 2023
Includes amendments up to: Act No. 10, 2023
Registered: 22 September 2023
This compilation is in 2 volumes
Endnotes
Each volume has its own contents
About this compilation
This compilation
This is a compilation of the Therapeutic Goods Act 1989 that shows the text of the law as amended and in force on 21 September 2023 (the compilation date ).
The notes at the end of this compilation (the endnotes ) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.
Self - repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Division 1--Overview of this Chapter
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)
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
41BIA Meaning of non - application of overseas requirements comparable to conformity assessment procedures
Division 3--Application provisions
41BJA Application of this Chapter to a biological
41BK Application of the Criminal Code
Part 4 - 2--Essential principles and medical device standards
Division 1--Essential principles
Division 2--Medical device standards
41CB Medical device standards
41CC Content of medical device standards
41CD Inconsistencies between medical device standards
Division 3--Database of unique device identifiers of medical devices
41CE Database of unique device identifiers of medical devices
Part 4 - 3--Conformity assessment procedures
Division 1--Conformity assessment procedures
41DA Conformity assessment procedures
41DB Medical device classifications
Division 2--Conformity assessment standards
41DC Conformity assessment standards
41DD Content of conformity assessment standards
41DE Inconsistencies between conformity assessment standards
Part 4 - 4--Conformity assessment certificates
Division 1--Issuing conformity assessment certificates
41EA When conformity assessment certificates are required
41ECA Conformity assessment (priority applicant) determinations
41ED Time for making decisions on applications
41EE Procedure following making a decision whether to issue certificate
41EH Treating applications as having been refused
41EI Criminal offences for making a false statement
41EIA Civil penalty for making a false statement
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
Division 3--Suspension of conformity assessment certificates
41EM Suspension of conformity assessment certificates
41EN Notice of proposed suspension
41EQ Powers of revocation of conformity assessment certificates unaffected
Division 4--Revocation of conformity assessment certificates
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
Part 4 - 4A--Australian conformity assessment bodies
41EWA Conformity assessment body determinations
41EWB Content of Australian conformity assessment body certificates
41EWC Duration of Australian conformity assessment body certificates
Part 4 - 5--Including medical devices in the Register
Division 1--Including medical devices in the Register
41FA What this Division is about
41FDA Basis of certification of conformity assessment procedures
41FDB Preliminary assessment of applications
41FE Criminal offences for making a false statement
41FEA Civil penalty for making a false statement
Subdivision B--Including kinds of medical devices in the Register
41FF Obligation to include kinds of medical devices in the Register
41FG Notification of unsuccessful applications
Subdivision C--Auditing of applications
41FH Selecting applications for auditing
41FIA Certificates issued by Australian conformity assessment bodies
41FJ Procedure following audits
41FKA Medical devices (priority applicant) determinations
41FM Duration of inclusion in the Register
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
Part 4 - 6--Suspension and cancellation from the Register
Division 1--Suspension from the Register
Subdivision A--General power of suspension
41GA Suspension of kinds of medical devices from the Register
41GB Notice of proposed suspension must be given in certain cases
41GE Treating applications for revocation as having been refused
Subdivision B--Suspension as a result of suspension of conformity assessment document
41GF Suspension where conformity assessment certificate suspended
41GFA Suspension where other certificates or documents are suspended
Subdivision C--Effect of suspension
41GJ Powers of cancellation from Register unaffected
Division 2--Cancellation of entries from the Register
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
41GLA Revocation of cancellation of entries upon request
41GLB Revocation of cancellation of entries--payment of annual charge
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
Part 4 - 6A--Exempting medical devices to deal with emergencies
41GS Minister may make exemptions
41GU Variation or revocation of exemption
41GV Informing persons of exemption etc.
41GY Disposal of unused medical devices
Part 4 - 7--Other exemptions from including medical devices in the Register
41HA Devices exempted from inclusion in the Register
41HB Approvals for special and experimental uses
41HC Authorities for health practitioners
41HD Approvals if substitutes for medical devices are unavailable or in short supply
Part 4 - 8--Obtaining information
Division 1--Information relating to compliance with requirements and other matters
41JA Secretary may require information or documents
41JB Complying with the Secretary's requirements
41JBA Civil penalty for giving false or misleading information in purported compliance with a notice
Division 2--Information relating to medical devices covered by exemptions
41JCA Secretary may require information etc. about medical devices exempt under Part 4 - 6A
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 health practitioner authorisations
41JFA Secretary may require information relating to approvals under section 41HD
41JG Criminal offences for failing to give information or documents sought under this Division
41JH False or misleading information
41JI False or misleading documents
Part 4 - 9--Public notification, and recall, of medical devices
41KA Public notification, and recall, of medical devices
41KB Publication of requirements
41KC Criminal offences for failing to comply with requirements relating to a kind of medical device
41KCA Civil penalty for failing to comply with requirements relating to a kind of medical device
41KD Powers of suspension and cancellation unaffected
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
Part 4 - 11--Offences and civil penalty provisions relating to medical devices
Division 1--Non - compliance with essential principles
41MA Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles
41MAA Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles
41MC Criminal offences relating to breaching a condition of a consent
41MCA Civil penalty relating to breaching a condition of a consent
41MD Treating medical devices as prohibited imports or exports
Division 2--Failure to apply conformity assessment procedures
41ME Criminal offences for failing to apply conformity assessment procedures--manufacturers
41MEA Civil penalties for failing to apply conformity assessment procedures--manufacturers
41MF Criminal offences for failing to apply conformity assessment procedures--sponsors
41MH Criminal offence for making false statements in declarations
41MHA Civil penalty for making false statements in declarations
Division 3--Medical devices not included in the Register and related matters
41MI Criminal offences for importing, exporting, supplying or manufacturing a medical device not included in the Register
41MIA Notice required to adduce evidence in support of exception under subsection 41MI(7)
41MIB Civil penalty for importing, exporting, supplying or manufacturing a medical device 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 False advertising about medical devices
41MLA Civil penalty for making misrepresentations about medical devices
41MLB Civil penalty for false advertising about medical devices
41MN Criminal offences relating to breaches of conditions
41MNA Civil penalties for breaching conditions
Division 3A--Offences and civil penalties related to exemptions under Part 4 - 6A
41MNB Criminal offences for breaching a condition of an exemption
41MNC Civil penalty for breaching a condition of an exemption
41MND Civil penalty for making misrepresentations about medical devices
Division 4--Other offences and civil penalty provisions
41MO Criminal offences for misusing medical devices exempted for special or experimental uses
41MP Criminal offence for failing to notify adverse events etc.
41MPA Civil penalty for failing to notify adverse events etc.
41MPB Relief from liability for contraventions for failing to notify adverse events etc.
41MQ Notification of adverse events etc. where application withdrawn or lapses
41MR Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses
Chapter 5--Advertising, counterfeit therapeutic goods and product tampering
Part 5 - 1--Advertising and generic information
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
42BAA Therapeutic Goods Advertising Code
Division 3--General provisions about advertising therapeutic goods
42DA Simplified outline of this Division
42DB Definitions
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
42DJ Prohibited and required representations
42DK Permitted use of restricted or prohibited representations
Division 3A--Advertising offences and civil penalties
42DKB Certain representations not to be advertised
42DL Advertising offences--general
42DLA Advertising offences--contravening section 42DKB notice
42DLB Civil penalty relating to advertisements--general
42DLC Civil penalty relating to advertisements--contravening section 42DKB notice
42DM Offences--non - compliance with the Therapeutic Goods Advertising Code
42DMA Civil penalty--non - compliance with the Therapeutic Goods Advertising Code
Division 4--Generic information about ingredients or components of therapeutic goods
42DP Offences--dissemination of generic information
42DQ Civil penalty for dissemination of generic information
Division 5--Secretary may require information or documents
42DR Secretary may require information or documents
42DS Criminal offences for failing to comply with a notice etc.
42DT Civil penalty for giving false or misleading information or document in compliance with a notice
Division 6--Directions about advertisements or generic information
42DV Directions about advertisements or generic information
42DW Offences--contravening direction under section 42DV
42DX Civil penalty for contravening direction under section 42DV
Division 7--Public warning notices
42DY Secretary may issue a public warning notice
Part 5 - 2--Counterfeit therapeutic goods
42E Offence of dealing with counterfeit therapeutic goods
42EA Civil penalty relating to dealing with counterfeit therapeutic goods
42EB Relief from liability for certain contraventions relating to dealing with counterfeit therapeutic goods
42F Customs treatment of counterfeit therapeutic goods
Part 5 - 3--Product tampering
42T Notifying of actual or potential tampering
42U Meaning of actual or potential tampering etc.
42V Recall of therapeutic goods because of actual or potential tampering
42VA Civil penalty relating to the recall of therapeutic goods because of actual or potential tampering
42VB Relief from liability for contraventions relating to the recall of therapeutic goods because of actual or potential tampering
42W Supply etc. of therapeutic goods that are subject to recall requirements
Division 1--Obtaining an order for a civil penalty
42Y Federal Court may order person to pay pecuniary penalty for contravening civil penalty provision
42YA What is a civil penalty provision ?
42YC Persons involved in contravening civil penalty provision
42YCA Continuing contraventions of civil penalty provisions
42YD Recovery of a pecuniary penalty
42YE Gathering information for application for pecuniary penalty
Division 2--Civil penalty proceedings and criminal proceedings
42YF Civil proceedings after criminal proceedings
42YG Criminal proceedings during civil proceedings
42YH Criminal proceedings after civil proceedings
42YI Evidence given in proceedings for civil penalty not admissible in criminal proceedings
Part 5A - 2--Infringement notices
42YJ Simplified outline of this Part
42YK When an infringement notice may be given
42YKA Matters to be included in an infringement notice
42YKB Extension of time to pay amount--application by person
42YKBA Extension of time to pay amount--extension by Secretary on own initiative
42YKC Withdrawal of an infringement notice
42YKD Effect of payment of amount
Part 5A - 3--Enforceable undertakings
42YL Enforcement of undertakings
42YM Simplified outline of this Part
42YP Discharging or varying injunctions
42YQ Certain limits on granting injunctions not to apply
42YR Other powers of court unaffected
Part 6 - 1--Payment of charges
44 Time for payment of charges
44A Exemptions from liability to pay charges
44B Recovery of unpaid charges
45 Therapeutic Goods Administration Account
Part 6 - 1A--Information gathering powers
45AA Simplified outline of this Part
Division 2--Obtaining information or documents
45AB Secretary may require information or documents
45AC Offences for failing to comply with notice
45AD Offences and civil penalty for giving false or misleading information or documents
Division 3--Inspecting, copying and retaining documents
45AF Secretary may inspect and copy documents
45AG Secretary may retain documents
Part 6 - 2--Entry, searches and warrants
45A Definitions
46 Searches to monitor compliance with Act or regulations
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 and civil penalty provisions
48 General powers of authorised persons in relation to premises
48A Details of warrant to be given to occupier etc.
48AA Completing execution of warrant under section 50 after temporary cessation
48BA Use of electronic equipment at premises for monitoring compliance with Act or regulations
48C Use of electronic equipment at premises relating to offences and civil penalty provisions
48D Compensation for damage to electronic equipment
48E Copies of seized things to be provided
48F Occupier entitled to be present during search
48FA Responsibility to provide facilities and assistance
48G Receipts for things seized under warrant
48H Retention of seized things
48J Magistrate may permit a thing to be retained
50 Offence and civil penalty provision related warrants
51 Offence and civil penalty provision related warrants by telephone
51A Inspections for purposes of Mutual Recognition Convention
51B Offences relating to warrants
Part 6 - 3--Scheduling of substances
52A Definitions
52B Advisory Committee on Medicines Scheduling
52C Advisory Committee on Chemicals Scheduling
52D Poisons Standard
52E Secretary to take certain matters into account in exercising powers
52EAA Application for amendment of the Poisons Standard
52F Incorporation of current Poisons Standard
52G Exemptions, approvals and authorities to be consistent with prohibitions under Chapter 2A
53 Retention of material on withdrawal of application
53A Alternative verdicts for various offences
54AA Offences for contravening conditions or requirements imposed under the regulations
54AB Criminal offence for damaging etc. documents
54AC Civil penalty for damaging etc. documents
54A Time for bringing prosecutions
54B Personal liability of an executive officer of a body corporate--general
54BA Personal liability of an executive officer of a body corporate--offences covered
54C Establishing whether an executive officer took reasonable steps to prevent the commission of an offence or the contravention of a civil penalty provision
55 Conduct by directors, employees and agents
56A Certificates to provide evidence of certain matters
60A New information on review--discretion to remit
61A Immunity from civil actions
62 Protection from criminal responsibility
Chapter 8--Repeal and transitional provisions
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
Endnote 3--Legislation history
Endnote 4--Amendment history