Conditional commencement of Therapeutic Goods Amendment Act 1996
1 July 1995
1 Mar 2006
1 Mar 2010
Therapeutic Goods Amendment (2009 Measures No. 3) Act
Therapeutic Goods Amendment (2018 Measures No. 1) Act
1 July 2020 (s 2(1)
Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 commencement and application details.
1 Mar 2021
10 July
10 Dec
10 Sept
Corporate officers may be personally liable for certain offences.
11 Section 11
11 June
Legislation history for Therapeutic Goods Act 1989
11 June 1996 (s 2)
Compilation date is defined as the date of publication
11 Nov
11 Feb
Corporate officers have an obligation to comply with certain regulations.
12 Sept
Conditional commencement of amendments to the Therapeutic Goods Amendment (2013 Measures No. 1) Act
12 Dec
Defines temporal intervals for commencement of amendments
Classifies amendments as part of a schedule
Conditional commencement of the Therapeutic Goods Amendment (2020 Measures No. 1) Act
References Schedule 2 (item 7) and Schedule 7
13 Apr
14 Sept
Conditional commencement of National Health and Medical Research Council Amendment Act 50, 2006
Amendment of Schedule 7 by Acts and Instruments (Framework Reform) (Consequential Provisions) Act 126, 2015
14 Apr 2015 (s 2)
Community Services and Health Legislation Amendment Act (No. 2) 141, 1990
15 Feb 1991 (s 2)
15 Dec
Conditional commencement of Sch 7 (item 7)
16 Aug
17 Jan 1990
17 Apr
Conditional commencement of Therapeutic Goods Legislation Amendment Act 1999
17 Apr 1998 (s 2)
17 Sept
17 Sept 2001 (s 2)
17 June
18 June 2009 (s 2(1)
Conditional commencement of certain schedules
19 June
19 Feb
20 Mar
20 Mar 2008 (s 2)
Mandatory amendment of Australian Border Force Amendment (Protected Information) Act 2017
20 May
List of items included in certain schedules
20 June 2017 (s 2(1)
21 Dec
Schedule definitions and commencement dates
21 Sept
Schedule 1: 21 March 2025 (s2(1) item 2)
21 Mar
Conditional commencement of the Therapeutic Goods Amendment Act 2001
22 June 2001 (s 2)
22 Mar
22 Sept 2001
Conditional commencement of Therapeutic Goods Amendment Act (No. 2)
22 Feb
22 Sept
Personal Liability for Corporate Fault Reform Act 2012
22 Sept 2012
23 Nov
Therapeutic Goods Amendment (2016 Measures No. 1) Act
24 Dec
24 Dec 1991 (s 2)
24 Oct
24 June 2014
Customs, Excise and Bounty Legislation Amendment Act 1995
25 Nov
25 July
25 Feb
25 June
Conditional commencement of the Therapeutic Goods Amendment Act 1991
26 June
26 July 2011 (s 2)
Conditional commencement of certain provisions
27 May
US Free Trade Agreement Implementation Act
27 Aug
27 June
Therapeutic Goods Amendment (2011 Measures No. 1) Act
27 Dec 2011
Conditional commencement of certain sections
Defines temporal intervals for commencement
28 Dec
28 Feb
List of schedules and items for the Statute Law Revision Act (No. 1) 2014
28 Feb 2014
Audit (Transitional and Miscellaneous) Amendment Act 1997
29 Mar
Schedule 1 and items 2–7 of Schedule 2 commence on 30 September 2009; Schedule 3 items 8–10 commence on 29 March 2010.
29 Sept
Defines commencement dates for schedules
Classifies commencement dates as undertakings
Conditional commencement of Narcotic Drugs Legislation Amendment Act 2016
29 Feb
Therapeutic Goods Amendment Act (No. 1) 2006
3 July 2002
Conditional commencement of Therapeutic Goods Amendment Act 2007
3 May 2006
Commencement dates for certain provisions of the Therapeutic Goods Amendment Act (No. 1)
3 Mar 2006
3 Mar 2006 (s 2)
Conditional commencement of the Therapeutic Goods Amendment (Poisons Standard) Act 2008
3 Oct 2007 (s 2)
Requires temporal relation between commencement and amendment
Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008
3 July 2008
3 Oct 2008
Conditional commencement of Health and Community Services Legislation Amendment Act (No. 2)
30 June
30 May
30 May 2000 (s 2)
Amendment of Schedule 14 by Public Governance and Resources Legislation Amendment Act (No. 1) 2015
30 Oct
Requires relation between identifiable temporal intervals for conditional commencement
Classifies the legal effect as Undertaking
No explicit duty, ban conduct, grant permission, or create a right
Requires ordered or recurring trace for conditional commencement
31 Mar
Therapeutic Goods Amendment Act (No. 2) - March 2000
31 Mar 2000 (s 2)
31 May
Reference to Statute Law Revision Act 2011
Granting permission for therapeutic goods and other legislation amendment
4 Apr 2002
4 Apr 2002 (s 2)
Amendment history for Therapeutic Goods Act 1989
4 Sept
Ensures safety and satisfactory performance of medical devices
41B General
Guarantees safety and satisfactory performance
Requirements for medical devices must conform to safety and performance standards.
41BA Requirements for medical devices (Parts 4-2 and 4-3)
Must provide requirements for medical devices.
List of administrative processes under this Chapter
41BB Administrative processes (Parts 4-4 to 4-10)
41BC Enforcement (Part 4-11)
Defines what constitutes a medical device.
41BD What is a medical device
41BE Kinds of medical devices
Medical devices of the same kind must have the same sponsor, manufacturer, device nomenclature system code, medical device classification, and other characteristics as prescribed by regulations.
41BE(1) Kinds of medical devices
Characteristics prescribed by regulations apply during the same period
either generally or in relation to medical devices of the kind in question
Characteristics prescribed by regulations apply if certain conditions are met
(e) are the same in relation to such other characteristics as the regulations prescribe, either generally or in relation to medical devices of the kind in question.
Characteristics prescribed by regulations apply until the end of the period
If a medical device is not of the same kind as any other medical device, this Chapter applies in relation to the device.
41BE(2) Kinds of medical devices
Delivering the device is temporally related to delivering a reasonable number of samples of the kind of device.
Temporal relation between delivering and delivering
References in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device.
Delivering the device is equivalent to delivering a reasonable number of samples of the kind of device.
This Chapter applies in relation to the device.
If a medical device is not of the same kind as any other medical device.
Device nomenclature codes for medical devices may be determined by the Minister.
41BE(3) Kinds of medical devices
Permission to determine device nomenclature codes
Goods are a system or procedure pack if they are interconnected or combined for use in a medical or surgical procedure.
41BF System or procedure packs
41BG Manufacturers of medical devices
Manufacturer is responsible for design, production, packaging and labelling of the device.
41BG(1) Manufacturers of medical devices
The manufacturer's responsibility for design, production, packaging and labelling begins before the device is supplied.
Manufacturer's responsibility starts before device supply
Design, production, packaging and labelling occur before the device is supplied under the person’s name.
The manufacturer's responsibility for design, production, packaging and labelling implies that the device must be supplied under their name.
Manufacturer's responsibility implies supply of device
If the manufacturer is responsible for design, production, packaging and labelling, then the device must be supplied under their name.
The manufacturer's responsibility for design, production, packaging and labelling is a cognitive action that implies the supply of the device.
Manufacturer's responsibility is a cognitive action
The manufacturer's responsibility for design, production, packaging and labelling involves making decisions and taking actions.
The manufacturer is responsible for those operations.
Design, production, packaging and labelling are operations performed by the manufacturer.
The manufacturer's responsibility for design, production, packaging and labelling implies that the device must be supplied under their name or another person acting on their behalf.
Manufacturer's responsibility spreads to supply of device
The manufacturer's responsibility for design, production, packaging and labelling is not limited to the person themselves but also extends to other persons acting on their behalf.
Manufacturer must provide information about the device's purpose.
41BG(2) Manufacturers of medical devices
Device's purpose is described by the manufacturer.
Exemptions for individuals assembling or adapting medical devices
41BG(3) Manufacturers of medical devices
Exempts individuals from being considered manufacturers of medical devices if they are part of a prescribed class.
41BG(4) Manufacturers of medical devices
Exempts individuals from being considered manufacturers of medical devices during the applicable period.
This section applies in relation to vaping goods that are a medical device.
Applies artificial intelligence to determine exemptions from being considered manufacturers of medical devices.
Exempts individuals from being considered manufacturers of medical devices.
Defines a class of persons prescribed by regulations for the purposes of this subsection.
The person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations.
Disseminates knowledge about exemptions from being considered manufacturers of medical devices.
41BH Meaning of compliance with essential principles
A medical device complies with the essential principles if it does not contravene any of them.
41BH(1) Meaning of compliance with essential principles
The device does not contravene any of the essential principles.
Compliance with medical device standards is sufficient for compliance with essential principles.
41BH(2) Meaning of compliance with essential principles
Medical device compliance with standards implies compliance with essential principles
41BI Meaning of non-application of conformity assessment
Defines overseas regulator A conformity assessment procedure is not applied if there has been a contravention of the procedures. A requirement that is comparable to a conformity assessment procedure is not applied if there has been a contravention of the requirement.
41BI(1) Meaning of non-application of conformity assessment
...there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture.
Temporal relation between contravention and assessment procedure
(a) there has been a contravention of the conformity assessment procedures; and (b) the contravention relates, wholly or partly, to that device or its manufacture.
...there is a CogAI from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture.
Conditional relation between contravention and assessment procedure
...if there has been a contravention of the conformity assessment procedures.
(1) A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied...
...there is a diffusion from the contravention to the assessment procedure if there has been a contravention of the conformity assessment procedures during which the contravention relates, wholly or partly, to that device or its manufacture.
The Secretary may determine a body for the purposes of subsection (1). Exemptions from conformity assessment requirements
41BI(2) Meaning of non-application of conformity assessment
Exemptions from conformity assessment requirements
A conformity assessment standard only applies to specified parts of procedures. The Secretary may determine a body by reference to a designation, recognition, approval or authorization.
41BI(3) Meaning of non-application of conformity assessment
A conformity assessment standard only applies to specified parts of procedures.
Chapter 2 of the Criminal Code applies to all offences against this Chapter.
41BK Application of the Criminal Code
Compliance with medical device standards is not required but can be used to establish compliance with essential principles.
41C What this Part is about
The database must be established and maintained.
The regulations may make provision for and in relation to the Secretary causing a database of unique device identifiers of medical devices to be established and maintained.
Dealing in medical devices is regulated by the act.
The therapeutic goods act regulates dealing in medical devices.
Compliance can be used to establish compliance.
Must comply with medical device standards.
Dealing in non-compliant medical devices is prohibited.
Dealing in medical devices that do not comply with the essential principles may be an offence or contravenes a civil penalty provision.
41CA Essential principles
Requirements for medical devices may be set out by regulations.
41CA(1) Essential principles
These requirements are to be known as the essential principles.
41CA(2) Essential principles
Requirements for unique device identifiers and medical devices in the database
41CA(3) Essential principles
(a) unique device identifiers of medical devices;
Requires information about medical devices
(b) information relating to those unique device identifiers, those medical devices or the import, export, manufacture or supply of those medical devices.
Subsection (3) has effect subject to subsection 41CE(2).
41CA(4) Essential principles
41CA(5) Essential principles
41CB Medical device standards
The Minister may make an order determining medical device standards.
41CB(1) Medical device standards
Note: Section 12 of the Legislation Act 2003 deals with when a legislative instrument commences.
Variation or revocation of orders by Minister
41CB(2) Medical device standards
Granting permission to vary or revoke orders
Allows for incorporation of existing instruments or writings into an order or variation thereof.
41CB(3) Medical device standards
41CC Content of medical device standards
Specifies how medical device standards can be established.
41CC(1) Content of medical device standards
...or (e) a standard published by a standards organisation; or...
(f) such other matters as the Minister thinks fit.
Establishes implications for medical device standards.
(1) Without limiting the scope of section 41CB, an order establishing a medical device standard...
Recognizes patterns in medical device standards.
Establishes a standard for medical devices.
Spreads information about medical device standards.
List of organisations that can declare standards
41CC(2) Content of medical device standards
41CD Inconsistencies between medical device standards
A medical device standard that is inconsistent with another standard has no effect.
41CD(1) Inconsistencies between medical device standards
is, to the extent of the inconsistency, of no effect in relation to the devices referred to in paragraph (b).
(a) applies to a kind of medical device; and (b) is inconsistent with another medical device standard that applies only to some of the devices of that kind;
Classifies inconsistent standards as having no effect.
Prohibits the application of inconsistent standards.
A medical device standard for a combination of component parts takes precedence over standards for individual parts.
41CD(2) Inconsistencies between medical device standards
Combination of component parts as a subclass of individual parts
41CE Database of unique device identifiers of medical devices
Establishment of a database for unique device identifiers of medical devices
41CE(1) Database of unique device identifiers of medical devices
Personal information must not be included in the database unless certain conditions are met.
41CE(2) Database of unique device identifiers of medical devices
Personal Information Collection → Device Registered
Temporal relationship between device registration and personal information collection
Device registered → Personal Information Collection
Personal Information Collection → Device Registration
Artificial intelligence application for device registration and personal information collection
Device Registration → Personal Information Collection
Obligation to Exclude Personal Information → State
Obligation to exclude personal information from the database
State → Obligation to Exclude Personal Information
Class hierarchy for devices and representatives
Schema-based validation for device registration and personal information collection
Regulations may provide for removal of information from database.
41CE(3) Database of unique device identifiers of medical devices
41CE(4) Database of unique device identifiers of medical devices
Database of unique device identifiers of medical devices may be made available to specified persons, authorities or bodies.
41CE(5) Database of unique device identifiers of medical devices
Personal information must not be made publicly available.
41CE(6) Database of unique device identifiers of medical devices
Prohibits public disclosure of personal information.
Database of unique device identifiers of medical devices is not a legislative instrument.
41CE(7) Database of unique device identifiers of medical devices
41CE(8) Database of unique device identifiers of medical devices
Compliance with applicable conformity assessment standards is not required, but it is one way to establish that one or more parts of the conformity assessment procedures have been applied.
41D What this Part is about
41DA Conformity assessment procedures
Manufacturers of medical devices must comply with regulations.
41DA(1) Conformity assessment procedures
41DA(2) Conformity assessment procedures
Requires temporal intervals for conformity assessment procedures
Conformity assessment procedures may be limited or apply differently to different classifications.
41DA(3) Conformity assessment procedures
Permission to limit procedure application
Procedure may be limited or apply differently
Regulations may relate to conformity assessment procedures for medical devices.
41DA(4) Conformity assessment procedures
Classifications and matters related to medical device classifications
41DB Medical device classifications
41DC Conformity assessment standards
Minister may make an order determining conformity assessment standards.
41DC(1) Conformity assessment standards
Minister has the power to make an order.
A conformity assessment standard may be limited to particular kinds of medical devices.
41DC(2) Conformity assessment standards
Minister may vary or revoke orders made under subsection (1)
41DC(3) Conformity assessment standards
Allows for provision in relation to a matter by applying, adopting or incorporating an existing instrument or writing.
41DC(4) Conformity assessment standards
Specifies how an order establishing a conformity assessment standard for a kind of medical device may be specified.
41DD Content of conformity assessment standards
Inconsistencies between conformity assessment standards are of no effect.
41DE Inconsistencies between conformity assessment standards
Prohibits inconsistency between conformity assessment standards.
Secretary can issue conformity assessment certificate for medical devices
41E What this Part is about
Regulations may prescribe requirements for manufacturers and medical devices.
41EA When conformity assessment certificates are required
41EB Applications
Application for conformity assessment certificate must be made in a specific manner.
41EB(1) Applications
Application must be made in accordance with a form approved by the Secretary.
Application is not effective if fee or false information is provided.
41EB(2) Applications
Prescribed fee not paid or false information in application.
Application may be given in accordance with specified software requirements.
41EB(3) Applications
Inspect premises and equipment for medical devices
41EB(4) Applications
...at any reasonable time specified in the notice...
...require the applicant to allow an authorised person...
41EC Considering applications
Secretary must decide whether to issue conformity assessment certificate.
41EC(1) Considering applications
Consider conformity assessment procedures when issuing a certificate.
41EC(2) Considering applications
Consider applicant's eligibility when issuing certificate
41EC(3) Considering applications
(3) In deciding whether to issue the certificate, the Secretary must also...
Decision on application must be made within a prescribed period.
41ED Time for making decisions on applications
Must provide decision within prescribed period.
41EE Procedure following making a decision whether to issue
Reasons for decision if not issuing certificate.
Secretary must notify applicant of decision within 20 working days.
41EE(1) Procedure following making a decision whether to issue
Manufacturer must specify covered medical devices on conformity assessment certificate.
41EE(2) Procedure following making a decision whether to issue
Obligation to specify covered medical devices.
41EE(3) Procedure following making a decision whether to issue
41EF Duration of certificate
Certificate commences on specified day and must be in force for no longer than 5 years.
41EF(1) Duration of certificate
41EF(2) Duration of certificate
41EF(3) Duration of certificate
41EF(4) Duration of certificate
(4) An extension must be no longer than 12 months.
41EF(5) Duration of certificate
Secretary must give notice of extension to manufacturer and applicant.
41EF(6) Duration of certificate
Failure to comply with certain requirements results in lapse of application.
41EG Lapsing of applications
Classification of applications based on compliance
Applications are classified as compliant or non-compliant.
41EH Treating applications as having been refused
Applicant may treat application as refused if no decision is made within a period.
41EH(1) Treating applications as having been refused
Applicant has an obligation to treat application as refused if no decision is made within a period.
(a) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application; and (b) at the end of the period, the applicant has not been notified of a decision whether to issue the certificate.
The notice may be given at any time before the applicant is notified of the decision.
41EH(2) Treating applications as having been refused
Before applicant is notified of decision
Act has no effect as if notice was given
41EH(3) Treating applications as having been refused
41EI Criminal offences for making a false statement
Making false statements in an application for a conformity assessment certificate is prohibited.
41EI(1) Criminal offences for making a false statement
Prohibits making false statements in an application for a conformity assessment certificate.
Classifies the statement as false or misleading in a material particular.
41EI(4) Criminal offences for making a false statement
Temporal relation between the making of false statements and the committing of an offence
(c) The person knows that the statement is false or misleading in a material particular.
Implication of making false statements on committing an offence
(a) The person makes a statement (whether orally, in a document or in any other way); and
Recognition of entities involved in the making of false statements
The person knows that the statement is false or misleading in a material particular.
Propagation of the prohibition to related statements
(b) The statement is in or in connection with an application for a conformity assessment certificate; and
41EI(5) Criminal offences for making a false statement
(5) A person commits an offence if: (a) the person makes a statement (whether orally, in a document or in any other way); and (b) the statement is in or in connection with an application for a conformity assessment certificate; and (c) the statement is false or misleading in a material particular.
Making a false statement in an application for conformity assessment certificate is prohibited.
41EI(6) Criminal offences for making a false statement
Prohibits making a false statement in an application for conformity assessment certificate.
41EJ Automatic conditions on conformity assessment certificates
Manufacturer must allow inspection and examination of premises and medical devices.
41EJ(1) Automatic conditions on conformity assessment certificates
Manufacturer must cooperate in review of conformity assessment certificate
41EJ(2) Automatic conditions on conformity assessment certificates
Notify Secretary of substantial changes to quality management systems, product range, or medical device design.
41EJ(3) Automatic conditions on conformity assessment certificates
Applicant must pay fee for review of conformity assessment certificate
41EJ(4) Automatic conditions on conformity assessment certificates
...when the fee becomes due and payable.
Fee payment occurs during review process
(4) A conformity assessment certificate is subject to the condition that...
Prescribe different levels of fees for manufacturers and medical devices.
41EJ(5) Automatic conditions on conformity assessment certificates
Conformity assessment certificates are subject to conditions prescribed by regulations.
41EJ(5A) Automatic conditions on conformity assessment certificates
Conditions imposed on conformity assessment certificates
41EK Conditions imposed when conformity assessment certificates
41EL Conditions imposed after issuing a conformity assessment
Secretary may impose new conditions on a conformity assessment certificate.
41EL(1) Conditions imposed after issuing a conformity assessment
Conditions imposed after issuing a conformity assessment take effect on the specified day.
41EL(2) Conditions imposed after issuing a conformity assessment
The condition occurs during the specified time period.
Conditions occur during the specified time period
The imposition, variation or removal of a condition under this section takes effect on the day on which the notice is given to the person; or
The condition takes effect on the specified day.
The earlier day must not be earlier than the day the notice is given to the person.
41EL(3) Conditions imposed after issuing a conformity assessment
41EM Suspension of conformity assessment certificates
Secretary may suspend conformity assessment certificate
41EM(1) Suspension of conformity assessment certificates
Suspension of conformity assessment certificates may be limited to some medical devices.
41EM(2) Suspension of conformity assessment certificates
Specify period of suspension not exceeding 6 months.
41EM(3) Suspension of conformity assessment certificates
41EN Notice of proposed suspension
Secretary must inform person of proposed suspension and give reasonable opportunity to make submissions.
41EN(1) Notice of proposed suspension
Secretary must consider submissions before making a decision.
41EN(2) Notice of proposed suspension
Exemption from section 41EN(3) if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury.
41EN(3) Notice of proposed suspension
Section 41EN(3) does not apply if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury.
Prohibits section 41EN(3) application if notice under section 41EM states suspension is necessary to prevent imminent risk of death, serious illness or serious injury.
41EO Duration of suspension
Suspension takes effect on specified day after notice is given.
41EO(1) Duration of suspension
(1) The suspension takes effect: (a) if the notice under section 41EM states that the suspension is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or (b) in any other case—on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.
Suspension takes effect on a specified day after notice is given.
Suspension takes effect if notice states suspension is necessary.
41EO(2) Duration of suspension
Extension of period for addressing grounds for revoking medical device certificate
41EO(3) Duration of suspension
41EP Revocation of suspension
Must revoke suspension if grounds no longer apply and no other grounds for suspension exist.
41EP(1) Revocation of suspension
Revocation obligation applies between specified temporal intervals
Temporal interval of revocation obligation
(1) The Secretary must revoke the suspension if the Secretary is satisfied that: (a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate.
The Secretary must revoke the suspension.
(a) the ground on which the conformity assessment certificate was suspended no longer applies; and (b) there are no other grounds for suspending the certificate.
41EP(2) Revocation of suspension
41EQ Powers of revocation of conformity assessment certificates
Does not affect Secretary's powers to revoke conformity assessment certificates
41EQ(1) Powers of revocation of conformity assessment certificates
Suspension ceases to have effect if revocation relates to conformity assessment certificate
41EQ(2) Powers of revocation of conformity assessment certificates
Suspension ceases to have effect during revocation period
(2) To the extent that a suspension under this Division relates to a conformity assessment certificate to which such a revocation relates
Revocation of conformity assessment certificates upon expiration of suspension period
41ER Automatic revocation of conformity assessment certificates
41ES Immediate revocation of conformity assessment certificates
Manufacturer must request revocation of certificate.
41ES(1) Immediate revocation of conformity assessment certificates
Manufacturer's request is an obligation.
Secretary may withdraw revocation upon request and payment of fee.
41ES(2) Immediate revocation of conformity assessment certificates
Describes the Secretary's discretion to withdraw revocation.
Revocation of conformity assessment certificates is taken never to have occurred if withdrawn.
41ES(3) Immediate revocation of conformity assessment certificates
41ET Revocation of conformity assessment certificates after notice
Revocation of conformity assessment certificates after notice
41ET(1) Revocation of conformity assessment certificates after notice
Temporal interval for revocation after notice
within a further 10 working days from the day specified in that notice;
Revocation for non-compliance with conditions
(b) the manufacturer in relation to whom the certificate is issued refuses or fails to comply with a condition to which the certificate is subject;
Revocation for breach of conformity assessment document conditions
(viii) breached a condition of a conformity assessment document;
A reference to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence.
41ET(1A) Revocation of conformity assessment certificates after notice
The text implies a temporal relationship between convictions and outstanding orders.
An order has been made relating to the offence under section 19B of the Crimes Act 1914.
The text implies a cognitive process of referencing persons with outstanding orders.
A court that has found a person to have committed an offence can take action without proceeding to record a conviction.
The text implies a duty on authorities to refer to persons with outstanding orders.
Section 19B of the Crimes Act 1914 empowers courts to take action without proceeding to record a conviction.
The text defines a class hierarchy for persons with outstanding orders.
A person convicted of an offence is included in this class.
The text implies a diffusion of information between convictions and outstanding orders.
The text implies a recurring trace between convictions and outstanding orders.
Paragraph (1)(e) does not limit paragraph (1)(f).
41ET(1B) Revocation of conformity assessment certificates after notice
Paragraph (1)(e) implies paragraph (1)(f)
Secretary must inform and give opportunity to make submissions before revoking conformity assessment certificate.
41ET(2) Revocation of conformity assessment certificates after notice
Secretary has obligation to inform and give opportunity to make submissions before revoking conformity assessment certificate.
41EU Limiting revocation of conformity assessment certificates to
Limiting revocation of conformity assessment certificates to certain medical devices
41EU(1) Limiting revocation of conformity assessment certificates to
...the Secretary must limit...only to those medical devices
Temporal interval between revocation and limitation
Secretary must vary certificate to remove medical devices from scope
41EU(2) Limiting revocation of conformity assessment certificates to
Notice setting out particulars of the revocation or variation.
Publish notice of revocation or variation of conformity assessment certificate.
41EV Publication of revocation etc. of conformity assessment
Date of effect for revocation or variation of conformity assessment certificate
41EW Date of effect of revocation etc. of conformity assessment
Medical devices must comply with certain principles and requirements to be included in the Register.
41F What this Part is about
Must comply with principles and requirements
Applications for medical devices must pass preliminary assessment.
41FA What this Division is about
Application must pass preliminary assessment.
Kind of medical device is included in the Register if application passes preliminary assessment.
41FC Making an application
A person may make an application to the Secretary for a kind of medical device to be included in the Register.
41FC(1) Making an application
Application for a kind of medical device
Application must not contain false or misleading information.
41FC(2) Making an application
Prohibition of false or misleading information
Applicant must certify that devices are medical devices.
41FD Matters to be certified
41FE Criminal offences for making a false statement
Making false statements in connection with medical devices is prohibited.
41FE(1) Criminal offences for making a false statement
Making false statements in connection with medical device applications or certifications is prohibited.
41FE(4) Criminal offences for making a false statement
The statement is in or in connection with...
Requires temporal overlap between statements and their context.
(c) the statement is in or in connection with: (i) an application for including a kind of medical device in the Register under this Chapter; or (ii) a certification or purported certification under section 41FD.
Prohibits making false statements in specified contexts.
(a) the person makes a statement (whether orally, in a document or in any other way); and (b) the person knows that the statement is false or misleading in a material particular;
Imposes an obligation to avoid making false statements in specified contexts.
The person knows that the statement is false or misleading in a material particular;
Classifies statements as true or false based on knowledge.
(b) the person knows that the statement is false or misleading in a material particular;
Requires recurring traces of statements and their context.
Making false statements in certain contexts is an offence.
41FE(5) Criminal offences for making a false statement
Prohibits making false statements in certain contexts.
Classifies the provision as a prohibition.
An offence against subsection (5) is an offence of strict liability.
41FE(6) Criminal offences for making a false statement
41FF Obligation to include kinds of medical devices in the Register
Secretary must include kind of medical device in Register if application has passed preliminary assessment and not selected for audit.
41FF(1) Obligation to include kinds of medical devices in the Register
...the Secretary must include the kind of device in the Register in relation to the person.
Temporal interval for inclusion in Register
Inference from preliminary assessment and audit selection
(a) an application for a kind of medical device...
Artificial intelligence application for medical device inclusion
Obligation to include kind of medical device in Register
...the kind of device in the Register in relation to the person.
Classifies medical devices as part of the Register
Influence on audit selection and inclusion in Register
(b) the application has not been selected for audit under section 41FH;
The Secretary must not include a device in the Register if it is to be used exclusively for purposes specified under section 41BEA.
41FF(1A) Obligation to include kinds of medical devices in the Register
Excludes devices from the Register if they are to be used exclusively for specified purposes during a certain time period.
The kind of device is to be used exclusively...
Prohibits including a device in the Register if it is to be used exclusively for specified purposes.
Includes devices that are not to be included in the Register if used exclusively for specified purposes.
The Secretary must provide a certificate of inclusion to the applicant.
41FF(2) Obligation to include kinds of medical devices in the Register
The Secretary must provide a certificate.
The Register has part of the device included.
Specify commencement day for inclusion of medical devices in the Register
41FF(3) Obligation to include kinds of medical devices in the Register
Specify the day on which the inclusion of the kind of device in the Register commences.
41FG Notification of unsuccessful applications
Notification of unsuccessful applications for medical device inclusion in the Register
41FG(1) Notification of unsuccessful applications
Secretary must notify applicant in writing within 20 working days after application is received and fee is paid.
41FG(2) Notification of unsuccessful applications
41FH Selecting applications for auditing
Secretary must select applications for auditing.
41FH(1) Selecting applications for auditing
Selects applications of a kind prescribed by regulations.
This section applies to applications that have passed preliminary assessment.
41FH(1A) Selecting applications for auditing
Section applies to specified applications.
(1A) This section applies to applications that have passed preliminary assessment.
Secretary must give applicant a written notice upon selection for auditing.
41FH(2) Selecting applications for auditing
Secretary must give applicant a written notice.
41FI Auditing of applications
The Secretary may consider certain aspects of an application during auditing. Secretary may have regard to certificate in auditing application
41FI(1) Auditing of applications
The certificate was issued within a specified timeframe.
Certificate must be given to Secretary within a specified timeframe
(d) the certificate has been given to the Secretary;
The Secretary may have regard to the certificate in auditing the application.
Permits Secretary to consider certificate
(a) a section 41FC application is made for a kind of medical device...
The Secretary must consider the certificate in auditing the application.
Secretary must consider certificate in auditing application
The Secretary is satisfied that the certificate has been issued consistently with the determination.
Certificate must be consistent with conformity assessment body determination
(e) if the conformity assessment body determination that relates to the body is limited as mentioned in paragraph 41EWA(4)(b)—the Secretary is satisfied that the certificate has been issued...
The certificate is a requirement for the audit.
Certificate is a requirement for audit of section 41FC application
The certificate is part of a recurring audit process.
Certificate must be audited as part of recurring audit process
(b) the application has been selected for audit;
The applicant must deliver a reasonable number of samples within 14 days after receiving the notice.
41FI(1A) Auditing of applications
The application has a part that requires delivery of samples
The Secretary must decide to include a device in the Register. The Secretary may have regard for matters beyond the scope of this section.
41FI(2) Auditing of applications
Secretary must decide not to include device in Register if not satisfied.
41FI(3) Auditing of applications
Notify applicant of decision within 20 working days and state reasons for non-inclusion in Register if applicable.
41FJ Procedure following audits
41FK Lapsing of applications
Regulations may empower Secretary to make medical devices priority applicant determinations.
41FK(1) Lapsing of applications
A medical devices (priority applicant) determination is a specified person's priority applicant in relation to any section 41FC application.
41FK(2) Lapsing of applications
specified information or documents within a specified period
Regulations may make provision for and in relation to applications for medical devices.
41FK(3) Lapsing of applications
Must provide specified information or documents
Regulations may revoke medical devices priority applicant determination
41FK(4) Lapsing of applications
Subsections (3) and (4) do not limit subsection (1).
41FK(5) Lapsing of applications
Secretary must assign unique device number to included medical devices.
41FL Device number
Classification of medical devices in the Register.
41FM Duration of inclusion in the Register
41FM(1) Duration of inclusion in the Register
Device must be included in Register until cancellation or suspension.
41FM(2) Duration of inclusion in the Register
41FN Conditions applying automatically
Allow authorised person to inspect premises and devices
41FN(1) Conditions applying automatically
Grant permission to inspect premises and devices
Deliver a reasonable number of samples if requested by the Secretary.
41FN(2) Conditions applying automatically
The kind of device is included in the Register
sufficient information to substantiate compliance with essential principles and conformity assessment procedures
Conditions for inclusion of medical devices in the Register
41FN(3) Conditions applying automatically
Temporal interval for obtaining information from the manufacturer
(ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;
Obligation to provide sufficient information
Obligation to provide sufficient information for conformity assessment procedures
(i) has available sufficient information to substantiate that the conformity assessment procedures have been applied to the kind of medical device or that requirements, comparable to those procedures, have been applied to the kind of medical device to the satisfaction of an overseas regulator; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;
Description of conditions for inclusion in the Register
(i) has available sufficient information to substantiate compliance with the essential principles; or (ii) has procedures in place, including a written agreement with the manufacturer of the kind of device, to ensure that such information can be obtained from the manufacturer within 20 working days;
41FO Conditions imposed when kinds of medical devices are
Secretary may impose conditions on medical device inclusion in Register
41FO(1) Conditions imposed when kinds of medical devices are
41FO(2) Conditions imposed when kinds of medical devices are
Temporal interval for tracking and location of devices
41FP Conditions imposed after kinds of medical devices are
Secretary may impose new conditions on medical devices
41FP(1) Conditions imposed after kinds of medical devices are
Conditions for imposition, variation or removal of conditions under this section
41FP(2) Conditions imposed after kinds of medical devices are
41FP(3) Conditions imposed after kinds of medical devices are
The earlier day must not be earlier than the given day.
Inclusions in the Register may be suspended or cancelled under certain circumstances.
41G What this Part is about
Defines temporal intervals for suspension and cancellation
Suspension and cancellation occur under certain circumstances.
Classification of inclusions is possible
Inclusions in the Register may be suspended or cancelled.
Suspension of medical devices from the Register
41GA Suspension of kinds of medical devices from the Register
(1) The Secretary may, by written notice...
Classifies medical devices into the Register
41GB Notice of proposed suspension must be given in certain cases
41GB(1) Notice of proposed suspension must be given in certain cases
Obligation to inform and provide reasons
Classifies as obligation under section 41GB(1)
Secretary must consider submissions before making a decision on proposed suspension.
41GB(2) Notice of proposed suspension must be given in certain cases
...until the Secretary has had regard...
41GC Duration of suspension
Suspension takes effect on specified day after notice is given to person.
41GC(1) Duration of suspension
Suspension occurs during specified period
41GC(2) Duration of suspension
Extend period of suspension for medical device removal
41GC(3) Duration of suspension
Obligation to extend period of suspension
41GC(4) Duration of suspension
41GD Revocation of suspension
Revocation of suspension under specified conditions.
41GD(1) Revocation of suspension
(1) The Secretary must revoke the suspension...
(a) the ground on which the kind of medical device concerned was suspended from the Register no longer applies;
41GD(2) Revocation of suspension
41GE Treating applications for revocation as having been refused
Applicant can treat application as refused if Secretary fails to decide within prescribed time.
41GE(1) Treating applications for revocation as having been refused
Notice may be given at any time before decision on application.
41GE(2) Treating applications for revocation as having been refused
If a notice has been given, the Act has no effect as if the Secretary had decided not to revoke the suspension.
41GE(3) Treating applications for revocation as having been refused
The Minister's decision had been made on the day on which notice was given to the Secretary.
The text describes a temporal interval where the notice being given overlaps with the day on which the Minister's decision was made.
The Act has no effect as if the Secretary had decided not to revoke the suspension.
If a notice has been given, then the Act has no effect as if the Secretary had decided not to revoke the suspension.
If a notice has been given, then the Minister's decision is confirmed by the Secretary.
The text describes a repeating pattern where the notice being given repeats indefinitely.
41GF Suspension where conformity assessment certificate
Suspension of medical device from Register upon suspension of Australian conformity assessment body certificate or overseas regulator conformity assessment document. Secretary may suspend medical device from Register if conformity assessment certificate is suspended.
41GF(1) Suspension where conformity assessment certificate
(1) The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if: (a) an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or (b) an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.
Suspension occurs during suspension of relevant certificates.
Classification of medical devices based on suspension of relevant certificates.
Prohibition of medical device from Register upon suspension of relevant certificates.
Suspension occurs if relevant certificates are suspended.
Suspension continues until relevant certificates are reinstated.
Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4. Secretary must take action before suspending a device from the Register
41GF(2) Suspension where conformity assessment certificate
Suspension under this section is limited to the same extent as suspension under Division 3 of Part 4-4.
If suspension under Division 3 of Part 4-4 is limited to some medical devices, then suspension under this section is also limited.
Suspension under Division 3 of Part 4-4 is limited to some medical devices.
Notice setting out particulars of the suspension.
Secretary must publish notice of suspension particulars.
41GF(3) Suspension where conformity assessment certificate
41GG Duration of suspension
41GG(1) Duration of suspension
41GG(2) Duration of suspension
41GH Revocation of suspension
Secretary must revoke suspension under certain conditions.
41GH(1) Revocation of suspension
Secretary has power to revoke suspension
Revocation is defined as cessation of effect
The Secretary may revoke a suspension under section 41GFA if certain conditions are met.
41GH(1A) Revocation of suspension
The Secretary may revoke a suspension under section 41GFA.
The kind of medical device is included in the Register.
Notice of revocation, publication in Gazette or website
Secretary must provide written notice and publish revocation notice within specified timeframe.
41GH(2) Revocation of suspension
Obligation to provide notice and publish revocation
Classification of revocation as a subclass of suspension
Medical devices of a particular kind are not included in the Register while suspension has effect.
41GI Effect of suspension
Prohibits dealing in medical devices not included in the Register.
Does not affect Secretary's powers to cancel medical device entries from Register
41GJ Powers of cancellation from Register unaffected
41GK Automatic cancellation of entries of kinds of medical devices
Secretary must cancel entry of medical device from Register under certain conditions.
41GK(1) Automatic cancellation of entries of kinds of medical devices
Automatic cancellation of entries of kinds of medical devices if they contravene absolute prohibitions or conditions.
41GK(2) Automatic cancellation of entries of kinds of medical devices
The device manufacture/supplies would contravene one or more of those prohibitions.
Temporal overlap between prohibitions and device manufacture/supplies.
If there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3).
Imports, exports, manufacture, and supplies would contravene one or more of those prohibitions.
Absolute prohibition on imports, exports, manufacture, and supplies.
There are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3).
Imports, exports, manufacture, and supplies would contravene one or more of those conditions.
Conditioned prohibition on imports, exports, manufacture, and supplies.
There are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions.
The device is classified as prohibited or subject to conditions.
Classification of medical devices based on prohibitions and conditions.
The Secretary must cancel the entry of the kind of device from the Register if...
Spread of prohibited devices through imports, exports, manufacture, and supplies.
If there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3).
The device would be subject to recurring prohibition.
There are one or more prohibitions in force for the purposes of subsection 9K(1) or (3).
Cancellation of medical device entries from the Register
41GL Immediate cancellation of entries of kinds of medical devices
Prohibition on continued inclusion of medical devices in the Register
The Secretary may cancel the entry of a kind of device from the Register if...
Classification of medical devices into therapeutic goods and medical devices
devices of that kind are no longer therapeutic goods; or
Cancellation of entries from medical device register upon non-compliance with notice.
41GM Cancellation of entries of kinds of medical devices from the
Prohibits cancellation of entries without compliance.
Classifies medical devices based on non-compliance with notice.
Person fails to comply with notice under section 41JA.
Cancellation upon repeated non-compliance.
Recurring trace of non-compliance leads to cancellation.
Notice given for ascertainment purposes.
The Secretary may cancel an entry of a kind of medical device from the Register under certain conditions.
41GN Cancellation of entries of kinds of medical devices from the
The cancellation must occur within a certain timeframe after notice is given.
The cancellation implies that the person has failed to comply with a condition or direction.
The Secretary can cancel an entry of a kind of medical device from the Register.
The person in relation to whom the kind of medical device is included in the Register must comply with certain conditions.
The cancellation is related to changes in the safety or performance of the device.
The cancellation must occur before the device's conformity assessment document expires.
41GO Limiting cancellation of entries from Register to some
Secretary must limit cancellation of entries from Register to some medical devices.
41GO(1) Limiting cancellation of entries from Register to some
Classify medical devices into categories.
Must vary entry in Register upon cancellation of medical device
41GO(2) Limiting cancellation of entries from Register to some
...the Secretary: (a) must vary the entry in the Register accordingly;
Varying entry in Register occurs within cancellation of medical device
(2) If the cancellation of the entry of a kind of medical device from the Register is limited to some medical devices of that kind...
...the Secretary: (b) must not delete the entry from the Register because of the cancellation.
Must not delete entry from Register upon cancellation of medical device
Varying entry in Register is a subclass of obligation to update
Not deleting entry from Register is a subclass of obligation to preserve
Notice setting out particulars of cancellation.
Publish notice of cancellation from Register after cancelling medical device entry.
41GP Publication of cancellation of entry from Register
Publication of cancellation from Register is a subclass of obligation.
Cancellation of medical device entries has a specified effective date.
41GQ Date of effect of cancellation of entries from Register
Exemption of medical devices from certain provisions
41GR What this Part is about
The Minister may exempt certain medical devices from various provisions of this Chapter so that the devices may be stockpiled to deal with possible future emergencies or made available urgently to deal with actual emergencies.
Granting permission to exempt medical devices
The Minister may exempt certain medical devices
(a) section 41JCA (providing information to the Secretary); and (b) section 41KA (public notification and recall of medical devices);
Obligation to provide information about exemptions under Part 41GR
Some of the other provisions of this Act about medical devices exempt under this Part are:
Recurring trace of exemptions under Part 41GR
41GS Minister may make exemptions
Minister may exempt specified kinds of medical devices from certain regulations.
41GS(1) Minister may make exemptions
Minister may grant exemptions under certain conditions.
41GS(1A) Minister may make exemptions
Minister may make exemptions in the national interest to stockpile medical devices quickly and provide them urgently in case of an emergency.
41GS(2) Minister may make exemptions
Minister has the obligation to make exemptions in the national interest.
Exemption from certain requirements under national emergency declaration
41GS(2A) Minister may make exemptions
Minister has discretion to make exemptions
Exemptions come into force on specified day or later
41GS(3) Minister may make exemptions
Exemptions remain in force for the specified period unless revoked earlier.
41GS(4) Minister may make exemptions
Exemption ceases to have effect when device is included in the Register.
41GS(5) Minister may make exemptions
ceases to have effect in relation to a particular kind of medical device
exemption ceases when device is included in the Register
Conditions for exemptions under section 41GS
41GT Conditions of exemptions
An exemption under section 41GS is subject to conditions
The conditions specified in the exemption about any of the following:
41GU Variation or revocation of exemption
41GU(1) Variation or revocation of exemption
41GU(2) Variation or revocation of exemption
Variation or revocation of exemption conditions
41GU(3) Variation or revocation of exemption
Variation or revocation of exemption takes effect under specified conditions.
41GU(4) Variation or revocation of exemption
Effect of variation or revocation occurs within 28 days after it is made
Temporal interval between variation or revocation and its effect
Variation or revocation is made on a specific day
Exemption has subclasses Variation and Revocation recognized by CogAI
CogAI recognizes variation or revocation as a subclass of exemption
Variation/Revocation is recognized as a subclass of Exemption by CogAI
Variation or revocation takes effect under specified conditions
Obligation to specify conditions for variation or revocation
Information about imminent risk diffuses to relevant parties
Diffusion of information about variation or revocation
Minister states imminent risk in variation or revocation
Effect of variation or revocation occurs after specified day
Temporal interval until effect of variation or revocation
Variation or revocation takes effect on a later day specified in the variation or revocation
Must provide Chapter 4 Medical devices to persons covered by paragraph 41GT(c)
41GV Informing persons of exemption etc.
The Minister must provide Chapter 4 Medical devices within a reasonable timeframe
41GW Notification and tabling
Notice setting out particulars of exemption, variation or revocation
Publish notice in Gazette within 5 working days after exemption, variation or revocation is made.
41GW(1) Notification and tabling
Minister must table document within 5 sitting days of exemption, variation or revocation made.
41GW(2) Notification and tabling
41GY Disposal of unused medical devices
Medical device must be disposed of if exemption ceases to have effect
41GY(1) Disposal of unused medical devices
(b) the medical device has not been used before the exemption so ceases to have effect.
(1) This section applies to a medical device...
(a) an exemption under section 41GS in relation to that kind of medical device ceases to have effect...
The Secretary may arrange for disposal of medical devices.
41GY(2) Disposal of unused medical devices
41GY(3) Disposal of unused medical devices
Prohibits benefit conferred on person other than owner of medical device
41GY(4) Disposal of unused medical devices
must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device.
(4) A method set out in the regulations under subsection (3)
Exemptions from prohibitions on dealing in medical devices
41H What this Part is about
41HA Devices exempted from inclusion in the Register
41HB Approvals for special and experimental uses
Grant of written approval for specified medical device use
41HB(1) Approvals for special and experimental uses
Approval for special and experimental uses must be granted only to health practitioners.
41HB(1A) Approvals for special and experimental uses
Approval of special and experimental uses has a specific temporal interval.
Defines temporal interval for approval of special and experimental uses.
(1A) An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.
Approval for special and experimental uses requires health practitioner eligibility.
Classifies approval for special and experimental uses as requiring health practitioner eligibility.
Approval must be granted only to health practitioners.
Prohibits granting approval to non-health practitioners.
Approval eligibility for special and experimental uses is diffused through the system.
Diffuses information about approval eligibility for special and experimental uses.
41HB(2) Approvals for special and experimental uses
Conditions for approval of medical devices for experimental use in humans.
41HB(3) Approvals for special and experimental uses
The conditions may relate to one or more of the following:
(a) the preconditions on another person’s use of devices of those kinds for those purposes;
(b) the principles to be followed in another person’s use of devices of those kinds for those purposes;
41HC Authorities for health practitioners
Secretary may authorise medical practitioner to supply medical devices.
41HC(1) Authorities for health practitioners
Class of recipients specified in the authorisation.
Application for authority must be in approved form
41HC(1A) Authorities for health practitioners
Authority may be given subject to conditions.
41HC(2) Authorities for health practitioners
Secretary may impose conditions on health practitioners
41HC(3) Authorities for health practitioners
Authority for health practitioners may only be given under certain conditions.
41HC(4) Authorities for health practitioners
Authority is conditional on meeting specific requirements.
Authority applies to classes of medical practitioners.
Authority to prescribe circumstances for medical device supply
41HC(5) Authorities for health practitioners
The Minister may make rules authorising health practitioners to supply medical devices.
41HC(6) Authorities for health practitioners
Rules specify class of health practitioners
Health practitioner included in a specified Medical device Chapter 4
Comply with regulations' requirements, restrictions, and limitations.
41HC(6A) Authorities for health practitioners
Requirements, restrictions, and limitations are within regulations.
(b) such restrictions (if any) as are prescribed by the regulations;
(6A) In making rules under subsection (6), the Minister...
Notify supply within 28 days after supplying medical device.
41HC(6B) Authorities for health practitioners
Notification must be made within 28 days.
Information as prescribed by regulations
Notification requirements for health practitioners
41HC(6C) Authorities for health practitioners
Approval of form may require or permit information to be given in accordance with specified software requirements.
41HC(6D) Authorities for health practitioners
Offence for subject to requirement under subsection (6B)
41HC(6E) Authorities for health practitioners
41HD Approvals if substitutes for medical devices are unavailable
Secretary may grant approval for importation and supply of medical device under certain conditions.
41HD(1) Approvals if substitutes for medical devices are unavailable
...the medical device is specified in a determination under subsection (6);
Medical device may become unavailable or be in short supply.
(ii) may, in the reasonably foreseeable future, become unavailable or be in short supply;
(1) The Secretary may, by notice in writing...
Secretary must satisfy certain conditions before granting approval.
(c) the kinds of medical devices included in the Register that...
...the Secretary may, by notice in writing...
Approval is necessary in the interests of public health.
(f) the approval is necessary in the interests of public health.
Medical device must be registered or approved for general marketing in at least one foreign country.
(i) the medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection (5);
...the kinds of medical devices included in the Register...
Medical devices included in the Register are classified as substitutes.
(i) are unavailable or are in short supply;
Secretary may grant approval for importation of medical device under certain conditions.
41HD(1A) Approvals if substitutes for medical devices are unavailable
Secretary has discretion to grant approval
The Secretary may seek information or documents relating to certain matters.
41J What this Part is about
The Secretary may require information or documents from a person related to medical devices.
41JA Secretary may require information or documents
The Secretary must require information or documents.
The provision is part of the Therapeutic Goods Act 1989.
41JB Complying with the Secretary’s requirements
Provide information or documents to the Secretary within a specified time and form.
41JB(1) Complying with the Secretary’s requirements
Offence for failing to comply with a notice
Comply with specified software requirements for data processing device or electronic transmission.
41JB(2) Complying with the Secretary’s requirements
Complying with requirements is a form of compliance
Failure to comply with notice leads to penalty and potential suspension/cancellation of certificates.
41JB(3) Complying with the Secretary’s requirements
Prohibits failure to comply with notice.
Suspension or revocation of conformity assessment certificate.
Includes conditions for suspension/cancellation of certificates.
Suspension or cancellation of entry in Register.
Includes conditions for suspension/cancellation of medical device entries.
Must provide a reasonable excuse to avoid liability.
41JB(3A) Complying with the Secretary’s requirements
41JC Self-incrimination
No excuse for providing information under section 41JB
41JC(1) Self-incrimination
Protection from self-incrimination in certain cases
41JC(2) Self-incrimination
Prohibits admissibility of information in certain cases
(2) However, in the case of an individual:
Secretary may give sponsor permission to exclude from Division 3 of Part 4-11
41JD Secretary may require information etc. about devices
Permission to exclude from Division 3 of Part 4-11
41JE Secretary may require information relating to approvals
The Secretary may require a person granted an approval to provide specified information or documents.
41JE(1) Secretary may require information relating to approvals
The Secretary may require the person to provide information.
Secretary may require information from a person using specified medical devices.
41JE(2) Secretary may require information relating to approvals
Secretary must specify a reasonable period for compliance with notice.
41JE(3) Secretary may require information relating to approvals
41JF Secretary may require information relating to health
Secretary may require specified information or documents from a person granted an approval. The Secretary may require information from a person granted an authority under subsection 41HC(1)
41JF(1) Secretary may require information relating to health
The Secretary may require a person to provide specified information or documents.
41JF(1A) Secretary may require information relating to health
The provision is part of a class hierarchy for medical device regulations.
Secretary must require information within a specified period. Secretary must specify a reasonable period for compliance with notice.
41JF(2) Secretary may require information relating to health
Secretary may require information to be given in a specified way. Secretary may require information relating to health
41JF(3) Secretary may require information relating to health
Classification of data processing devices and electronic transmissions
41JG Criminal offences for failing to give information or documents
Failure to comply with notice results in penalty.
41JG(1) Criminal offences for failing to give information or documents
Penalty applies when person fails to comply.
Describes temporal interval for penalty application.
(b) the person fails to comply with the notice.
(a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;
Imposes obligation to comply with notice.
Failure to comply with notice results in criminal offence.
41JG(2) Criminal offences for failing to give information or documents
...and (b) the person fails to comply with the notice.
Temporal overlap between notice and failure to comply.
(2) A person commits an offence if: (a) the person is given a notice under section 41JCA, 41JD, 41JE, 41JF or 41JFA;
Artificial agent enforces obligation to comply with notice.
Diffusion of obligation from notice to failure to comply.
Temporal relationship between notice and failure to comply.
Offence of strict liability for failing to give information or documents
41JG(3) Criminal offences for failing to give information or documents
Imposes a duty on the state to prosecute
41JH False or misleading information
Giving false or misleading information in compliance with a notice is an offence.
41JH(1) False or misleading information
The person gives information to the Secretary.
Giving false or misleading information is prohibited.
(a) the person gives information to the Secretary; and (b) the person knows that the information: (i) is false or misleading; or (ii) omits any matter or thing without which the information is misleading;
The person must provide accurate information.
(c) the information is given in compliance or purported compliance with the notice.
Committing an offence for providing false or misleading information in compliance with a notice.
41JH(2) False or misleading information
Prohibits providing false or misleading information.
The person commits an offence if they provide false or misleading information in compliance with the notice.
Prohibits providing false or misleading information in compliance with a notice.
The information is given in compliance or purported compliance with the notice.
The person commits an offence if they provide false or misleading information to the Secretary.
Prohibits providing false or misleading information to the Secretary.
The person commits an offence if they provide false or misleading information without which it is misleading.
Prohibits providing false or misleading information without which it is misleading.
The information omits any matter or thing without which the information is misleading.
The person commits an offence if they provide false or misleading information in any form.
Prohibits providing false or misleading information in any form.
The information is false or misleading; or omits any matter or thing without which the information is misleading.
An offence against subsection (2) is an obligation.
41JH(3) False or misleading information
(3) An offence against subsection (2) is an offence of strict liability.
Exemption from subsection (1) or (2) if information is not false or misleading in a material particular.
41JH(4) False or misleading information
Defendant bears evidential burden for information not omitting material particulars.
41JH(5) False or misleading information
Producing false or misleading documents is an offence.
41JI False or misleading documents
Prohibits producing false or misleading documents.
41JJ Self-incrimination
Must provide information or document under notice without claiming self-incrimination
41JJ(1) Self-incrimination
Contains information relating to medical devices covered by exemptions
41JJ(2) Self-incrimination
Prohibits admissibility of self-incrimination evidence in certain cases
Chief executive officer of a healthcare facility must report adverse events involving reportable medical devices.
41JK Simplified outline of this Part
Facilitate monitoring and enforcing compliance with Chapter requirements.
41JL Purposes of this Part
Facilitate monitoring and enforcing compliance.
41JM Requirement to report adverse events involving reportable
Healthcare facility must report adverse events to the Secretary.
41JM(1) Requirement to report adverse events involving reportable
Healthcare facility must report adverse events involving reportable medical devices.
41JM(2) Requirement to report adverse events involving reportable
41JM(3) Requirement to report adverse events involving reportable
Healthcare facility must report adverse events involving reportable medical devices. Healthcare facility must report adverse events involving reportable medical devices and persons.
41JM(4) Requirement to report adverse events involving reportable
Report must include information about reportable medical device and person.
41JM(5) Requirement to report adverse events involving reportable
The Secretary can require action to recall medical devices, or to inform the public about medical devices that do not comply with requirements or cannot lawfully be supplied.
41K What this Part is about
The Secretary may impose requirements on a person if certain circumstances occur.
41KA Public notification, and recall, of medical devices
Imposition of requirements is permitted.
Requirements apply to medical devices of a certain kind.
Notice setting out particulars of the requirement
Secretary must publish notice after imposing requirement.
41KB Publication of requirements
41KC Criminal offences for failing to comply with requirements
Offence for failing to comply with requirements
41KC(1) Criminal offences for failing to comply with requirements
...will result in, or is likely to result in, harm or injury to any person.
States that act resulted in harm or injury to any person
(c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.
...breaches a requirement imposed on the person under section 41KA;
Prohibits failure to comply with requirements
Imposes obligation to comply with requirements
(b) the act or omission breaches a requirement imposed on the person under section 41KA;
...may convict the person of an offence against subsection (4) instead:
Prohibits conviction of offence against subsection (4)
Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead:
Failure to comply with requirements is a criminal offence.
41KC(4) Criminal offences for failing to comply with requirements
Imposition of requirement under section 41KA does not affect suspension powers.
41KD Powers of suspension and cancellation unaffected
Powers of suspension and cancellation unaffected.
Temporal relationship between requirement imposition and suspension power.
Imposition of a requirement under section 41KA does not affect the Secretary’s powers to:
Does not affect the Secretary's powers to suspend entry.
Exclusion of suspension power from requirement imposition.
Imposition of a requirement under section 41KA.
Imposition of a requirement under section 41KA does not affect the Secretary’s powers to suspend entry.
Inclusion of suspension power within Secretary's powers.
Subclass relationship between suspension power and requirement imposition.
Conjunction of suspension power and requirement imposition.
No exclusion or limitation of other laws
41KE Saving of other laws
Fees must be paid for consideration of applications and auditing.
41L What this Part is about
41LA Assessment fees
Payable assessment fee for application of conformity assessment certificate
41LA(1) Assessment fees
Prescribe different levels of conformity assessment fees
41LA(2) Assessment fees
Pay assessment fee for auditing medical device application
41LA(3) Assessment fees
Prescribes different levels of application audit assessment fees
41LA(4) Assessment fees
Assessment fee due on specified day and manner
41LB When assessment fee due for payment
41LC Payment of assessment fee by instalments
Payment of assessment fee by instalments is obligatory.
41LC(1) Payment of assessment fee by instalments
Payment of assessment fee by instalments is not allowed if any part of an instalment is unpaid immediately after it became due.
41LC(2) Payment of assessment fee by instalments
was unpaid immediately after the time when it became due for payment.
Temporal overlap between payment and evaluation fees
(a) that or any other assessment fee payable by the person; or (b) any evaluation fee under section 24 payable by the person;
if any part of an instalment is unpaid immediately after it became due.
Recognition of prohibition in AI systems
(2) Regulations may provide that a person is not allowed to pay an assessment fee by instalments
Diffusion of prohibition to related fees
Payment of assessment fee by instalments is not limited by subsection (2).
41LC(3) Payment of assessment fee by instalments
Payment of assessment fee is obligatory.
Subsection (2) does not limit subsection (1).
Payment of assessment fee by instalments is obligatory if it is due.
Payment of assessment fee is obligatory if it is due.
Payment of assessment fee by instalments is obligatory if it is due and paid.
Payment of assessment fee is obligatory if it is due and paid.
Payment of assessment fee by instalments implies obligation to pay.
Payment of assessment fee implies obligation to pay.
41LD Recovery of assessment fee
41LE Reduction of conformity assessment fee where decision not
Reduction of conformity assessment fee under certain conditions.
41LE(1) Reduction of conformity assessment fee where decision not
Temporal interval for reduction of conformity assessment fee.
(a) the application is for the issuing of a conformity assessment certificate under Part 4-4; and (b) consideration of the application will involve an examination of the design of medical devices; and (c) a period is prescribed under paragraph 63(2)(dc) for making a decision on the application.
Classification of reduction of conformity assessment fee using CogAI.
Obligation to reduce conformity assessment fee.
(1) Nothing in section 41LA, 41LB or 41LC requires the applicant to pay more than 3/4 of the conformity assessment fee before the making of the decision if:...
Diffusion of reduction of conformity assessment fee.
Recurring trace of reduction of conformity assessment fee.
Conformity assessment fee reduction upon non-decision within period
41LE(2) Reduction of conformity assessment fee where decision not
Obligation to pay reduced fee upon non-decision
Payment of part of conformity assessment fee becomes due upon decision making.
41LE(3) Reduction of conformity assessment fee where decision not
Describes a temporal relationship between payment and decision making.
(3) If: (a) the decision is made within that period; and (b) part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;
Describes a relationship between payment and decision making.
Decision is taken when applicant notified of Secretary's decision on application.
41LE(4) Reduction of conformity assessment fee where decision not
Applicant notified of Secretary's decision on application.
Ensure conformity with essential principles and administrative processes.
41M What this Part is about
There is an obligation to comply with the essential principles.
The essential principles must be complied with.
41MA Criminal offences for importing, supplying or exporting a
Importing a non-compliant medical device is prohibited.
41MA(1) Criminal offences for importing, supplying or exporting a
Prohibits the importation of non-compliant medical devices.
Committing an offence for importing a medical device into Australia
41MA(4) Criminal offences for importing, supplying or exporting a
A person commits an offence if they import a medical device into Australia.
Obligation to comply with import regulations
Importing a medical device into Australia without permission is prohibited.
41MB Exceptions
Exceptions for medical devices that comply with standards and fail to comply only in respect of specific principles.
41MB(1) Exceptions
The exemption is valid only if the medical device meets the specified standard.
Defines the temporal interval for which the exemption applies.
(a) the medical device complies with one or more medical device standards that apply to it;
The exemption is a permission for the medical device to comply with specific standards.
Classifies the type of duty or obligation.
The exemption is a permission for the medical device to fail to comply with specific principles.
(b) the medical device fails to comply with the essential principles only in respect of a part or parts of the essential principles.
The exemption is valid only if the non-compliance occurs within the specified interval.
Specifies the temporal relationship between the exemption and the non-compliance.
Evidence of matters in section 13.3(3) of Criminal Code.
Defendant bears evidential burden in prosecution for offence.
41MB(2) Exceptions
Defendant must prove matters in section.
41MC Criminal offences relating to breaching a condition of a
Secretary's consent may be given unconditionally or subject to conditions for certain medical devices.
41MC(1) Criminal offences relating to breaching a condition of a
Breach of consent results in harm or injury to a person.
41MC(2) Criminal offences relating to breaching a condition of a
(2) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent; and (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.
Importation or exportation of medical devices is prohibited if notified to Customs Act 1901.
41MD Treating medical devices as prohibited imports or exports
Prohibition of importation or exportation.
41ME Criminal offences for failing to apply conformity assessment
Manufacturing, supplying or using a non-exempt medical device without conformity assessment
41ME(1) Criminal offences for failing to apply conformity assessment
Establishes a temporal relationship between the manufacture/supply/use of medical devices and conformity assessment
(c) the conformity assessment procedures have not been applied to the device; and (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;
Applies artificial intelligence to reason about the obligations and consequences of conformity assessment
(d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;
Prohibits the manufacture, supply or use of non-exempt medical devices without conformity assessment
(ca) the device is not of a kind covered by an exemption in force under section 41GS; and (d) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person;
Diffuses the obligation to comply with conformity assessment across all parties involved
Establishes a recurring trace of the use of medical devices and conformity assessment
Failure to apply conformity assessment procedures for medical devices is prohibited.
41ME(4) Criminal offences for failing to apply conformity assessment
...the device is not of a kind covered by an exemption in force under section 41GS.
Temporal relation between conformity assessment procedures and medical devices.
Knowledge representation of medical devices and conformity assessment procedures.
Prohibition of failing to apply conformity assessment procedures.
Recurring trace of conformity assessment procedures for medical devices.
Schema validation of medical devices and conformity assessment procedures.
Manufacturing or supplying a medical device without conformity assessment
41ME(4A) Criminal offences for failing to apply conformity assessment
Defines the temporal interval during which the action of manufacturing or supplying a medical device without conformity assessment is prohibited
Recognizes the need for conformity assessment in medical device manufacturing and supply
Prohibits manufacturing or supplying a medical device without conformity assessment
Diffuses the prohibition to all relevant parties and entities
Defines the recurring trace of actions that must be prevented or prohibited
Offences relating to exporting a medical device are prohibited.
41ME(4B) Criminal offences for failing to apply conformity assessment
(4B) An offence against subsection (4A) is an offence of strict liability.
Manufacturing, exporting, or using a medical device without conformity assessment is prohibited.
41ME(5) Criminal offences for failing to apply conformity assessment
Offences relating to supplying a medical device
41MF Criminal offences for failing to apply conformity assessment
Exceptions for certain conformity assessment standards
41MG Exceptions
Making false statements in declarations is a criminal offence.
41MH Criminal offence for making false statements in declarations
Prohibits making false statements in declarations.
41MI Criminal offences for importing, exporting, supplying or
Importing, exporting, supplying or manufacturing a medical device without proper authorization is prohibited.
41MI(1) Criminal offences for importing, exporting, supplying or
Importing, exporting, supplying or manufacturing a medical device without proper approval is prohibited.
41MI(4) Criminal offences for importing, exporting, supplying or
Temporal interval for approval requirements
(4) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;
Implication of non-compliance with approval requirements
Recurring trace for approval requirements
Importing, exporting, supplying or manufacturing a medical device without permission is prohibited.
41MI(5) Criminal offences for importing, exporting, supplying or
Prohibits the action of importing, exporting, supplying or manufacturing a medical device.
(5) A person commits an offence if: (a) the person: (i) imports a medical device into Australia; or (ii) exports a medical device from Australia; or (iii) supplies a medical device in Australia; or (iv) manufactures a medical device in Australia;
Medical devices are prohibited imports or exports.
41MJ Treating medical devices as prohibited imports or exports
Prohibits medical devices as imports or exports.
Supplying medical devices not included in the Register is an offence.
41MK Wholesale supply of medical devices not included in the
Prohibits supplying medical devices not included in the Register.
41ML False advertising about medical devices
False advertising about medical devices is prohibited.
41ML(1) False advertising about medical devices
Prohibits false advertising about medical devices.
(a) the person, by any means, advertises a medical device as being for a purpose;
The use of the medical device for the advertised purpose must not result in harm or injury.
Prohibits harm or injury resulting from false advertising.
(d) either: (i) the use of the medical device for the advertised purpose has resulted in, will result in, or is likely to result in, harm or injury to any person;
The device must be classified as being for a purpose accepted in relation to its inclusion in the Register.
Classifies medical devices in the Register.
(b) the device is of a kind included in the Register;
Classifies the device as being for a purpose accepted in relation to its inclusion in the Register.
(c) the purpose is not a purpose accepted in relation to that inclusion;
False advertising about medical devices is prohibited if it results in harm or injury.
Implies that false advertising is prohibited if it results in harm or injury.
41ML(2) False advertising about medical devices
(Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.)
(2) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion.
Classifies medical devices as those included in the Register.
41ML(3) False advertising about medical devices
(The advertising must occur after registration.)
Requires temporal overlap between advertising and medical device registration.
(3) A person commits an offence if: (a) the person, by any means, advertises a medical device as being for a purpose; and (b) the device is of a kind included in the Register; and (c) the purpose is not a purpose accepted in relation to that inclusion.
Requires rebuttal of false advertising claims.
(The device is of a kind included in the Register.)
Classifies medical devices into categories based on their purposes.
(The information must be diffused widely.)
Requires diffusion of information about medical device registration.
Requires recurring traces of false advertising and medical device registration.
41MN Criminal offences relating to breaches of conditions
A person commits an offence if they include a kind of medical device in the Register and breach a condition related to it.
41MN(1) Criminal offences relating to breaches of conditions
Resulted in harm or injury to any person.
Includes a kind of medical device in the Register.
Breach a condition related to the inclusion of the kind of device.
Committing an offence if a medical device is included in the Register and an act or omission breaches a condition of its inclusion.
41MN(4) Criminal offences relating to breaches of conditions
The act or omission breaches a condition of the inclusion of the kind of device in the Register.
Act or omission occurs during the period of device inclusion.
(b) the person does an act or omits to do an act;
The condition of inclusion is related to the person.
Device inclusion is classified as a condition.
(a) a kind of medical device is included in the Register in relation to the person;
Obligation to comply with conditions related to medical devices.
Device inclusion in the Register is a descriptive class.
Device inclusion is related to the person if certain conditions are met.
Condition of inclusion is breached until the period ends.
(c) the act or omission breaches a condition of the inclusion of the kind of device in the Register;
A person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act that breaches a condition of the inclusion.
41MN(4A) Criminal offences relating to breaches of conditions
The act or omission must occur during the time the medical device is included in the Register.
The person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act.
The state has an obligation to ensure the medical device is included in the Register.
The person commits an offence if a kind of medical device is included in the Register.
The state has permission to include a kind of medical device in the Register.
A person commits an offence if a kind of medical device is included in the Register.
The person has a right to be included in the Register if a kind of medical device is included.
A person commits an offence if a kind of medical device is included in the Register and does an act or omits to do an act.
Medical devices are sub classes of devices that can be included in the Register.
The condition of the inclusion of the medical device in the Register must be breached until the person commits an offence.
41MO Criminal offences for misusing medical devices exempted for
Supplying a medical device without proper authority is prohibited.
41MO(1) Criminal offences for misusing medical devices exempted for
...the supply is not in accordance with the authority; or the supply is not in accordance with the conditions to which the authority is subject; or the supply is not in accordance with regulations made for the purpose of subsection 41HC(5).
Prohibits supplying a medical device without proper authority.
(a) the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and (b) the person supplies a medical device of that kind: ...
Prohibits using a medical device without proper authority.
(c) either: (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person.
Prohibits supplying a medical device without proper conditions.
(b) the person supplies a medical device of that kind: ... (ii) otherwise than in accordance with any conditions to which the authority is subject; or (iii) otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5).
...the person supplies a medical device of that kind: ...
Classifies medical devices into categories based on their specifications.
(subsection 41HC(1) relating to a specified kind of medical device)
Classifies harm or injury into categories based on their severity.
(the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person.)
Classifies conditions into categories based on their specifications.
(any conditions to which the authority is subject)
Supplying a medical device without authority is prohibited.
41MO(4) Criminal offences for misusing medical devices exempted for
Prohibition of supplying a medical device without authority.
(4AB) An offence against subsection (4AA) is an offence of strict liability.
Classification of supplying a medical device without authority as prohibited.
Supplying a medical device without authority implies prohibition.
Misusing medical devices is prohibited for specified health practitioners.
41MO(4A) Criminal offences for misusing medical devices exempted for
...the supply is not in accordance with those rules;
Temporal relation between supply and rule
(c) the person supplies a medical device of a kind specified in...
Implication of rule violation on offence
...specified in subsection 41HC(6) rules;
(b) the person is included in a class of health practitioners...
41MP Criminal offence for failing to notify adverse events etc.
Information of a kind mentioned in subsection (2)
Failing to notify adverse events is a criminal offence. Notify adverse events etc. within specified period.
41MP(1) Criminal offence for failing to notify adverse events etc.
Prohibits failing to notify adverse events.
41MP(2) Criminal offence for failing to notify adverse events etc.
(a) information relating to any malfunction or deterioration in the characteristics or performance of the kind of device;
41MQ Notification of adverse events etc. where application
Notify applicant of information about withdrawn application.
41MQ(1) Notification of adverse events etc. where application
Notification is a subclass of obligation.
Notice under subsection (1) must be given within 10 working days after an application is withdrawn or lapses.
41MQ(2) Notification of adverse events etc. where application
may only be given within 10 working days after an application is withdrawn or lapses.
Failure to comply with notice within 20 working days is an offence.
41MQ(3) Notification of adverse events etc. where application
Giving false information in response to a notice is an offence.
41MQ(4) Notification of adverse events etc. where application
The person commits an offence if the information is false or misleading in a material particular.
The person gives information in purported compliance with a notice.
41MR Civil penalties for failing to notify adverse effects etc. where
Failure to comply with notice requirements within 20 working days
41MR(1) Civil penalties for failing to notify adverse effects etc. where
Obligation to comply with notice requirements
False or misleading information in a notice
41MR(2) Civil penalties for failing to notify adverse effects etc. where
Importation of vaping goods and manufacture, supply or possession are prohibited in Australia.
41N Simplified outline of this Chapter
Prohibition of vaping goods importation and manufacture, supply or possession.
Classification of vaping goods as prohibited.
No limitation on generality of offence provisions or civil penalty provisions between Chapters.
41NA Relationship with other Chapters of this Act
41P Meaning of vaping goods and related terms
41P(1) Meaning of vaping goods and related terms
Goods must be presented in a certain way to be considered vaping goods.
41P(2) Meaning of vaping goods and related terms
Goods must meet specific presentation requirements to be considered vaping goods.
Presentation requirements for vaping goods
(a) the presentation of goods includes matters in relation to...
Goods cannot be presented in a way that is misleading or confusing.
Misleading or confusing presentation is prohibited
(i) is capable of being misleading or confusing as to the content or proper use or identification of the goods;
The Minister has the authority to determine whether goods are vaping goods or not.
Minister's discretion for determining vaping goods
Minister may determine that goods are or are not vaping goods etc.
Goods cannot be presented as having ingredients or characteristics they do not actually have.
Prohibition on presenting false information
(ii) suggests that the goods have ingredients, components or characteristics that they do not have.
The Minister has the right to determine whether goods are vaping goods or not.
(b) goods are taken to be presented as being a particular kind of goods even if...
Goods are taken to be presented as being a particular kind of goods
Authority to determine vaping goods classification
41P(3) Meaning of vaping goods and related terms
41Q Offences and civil penalty provision—importing vaping goods
Importing vaping goods into Australia is an offence.
41Q(1) Offences and civil penalty provision—importing vaping goods
Prohibits importing vaping goods into Australia.
Importing vaping goods into Australia is an offence of strict liability.
41Q(2) Offences and civil penalty provision—importing vaping goods
Importing vaping goods into Australia is prohibited.
41Q(3) Offences and civil penalty provision—importing vaping goods
Importing vaping goods without compliance with subsection (3) is prohibited.
41Q(4) Offences and civil penalty provision—importing vaping goods
Importation of vaping goods must comply with subsection (3).
Temporal overlap between subsection (3) and importation.
Subsection (3) sets conditions for importation.
Compliance with subsection (3) must be analyzed.
Analyzing compliance with subsection (3).
Importing vaping goods without compliance is prohibited.
Prohibition of importing vaping goods without compliance.
Subsection (3) sets conditions for importing vaping goods.
Compliance with subsection (3) must be recurring.
Recurring trace of compliance with subsection (3).
Compliance with subsection (3) must be validated.
Validation of compliance with subsection (3).
41Q(5) Offences and civil penalty provision—importing vaping goods
41QA Offences and civil penalty provision—manufacturing vaping
Manufacturing vaping goods in Australia is prohibited.
41QA(1) Offences and civil penalty provision—manufacturing vaping
Manufacturing vaping goods is prohibited.
41QA(2) Offences and civil penalty provision—manufacturing vaping
41QA(3) Offences and civil penalty provision—manufacturing vaping
Manufacturing vaping goods without compliance with subsection (3) is prohibited.
41QA(4) Offences and civil penalty provision—manufacturing vaping
Manufacture overlaps with subsection (3) conditions.
Temporal overlap between manufacture and subsection (3) conditions.
Manufacture occurs before or concurrently with subsection (3) conditions.
Manufacturing vaping goods must be analyzed for compliance.
Analyzing manufacturing vaping goods for compliance with subsection (3).
Manufacturing vaping goods requires analysis for compliance.
Manufacturing without compliance is prohibited.
Prohibition of manufacturing vaping goods without compliance.
Subsection (3) sets conditions for manufacture.
Non-compliance in manufacturing vaping goods spreads to other units.
Diffusion of non-compliance in manufacturing vaping goods.
Non-compliance in manufacture spreads to other units of vaping goods.
Manufacturing vaping goods without compliance has a recurring trace.
Recurring trace of manufacturing vaping goods without compliance.
Manufacturing vaping goods without compliance is a recurring action.
41QB Offences and civil penalty provision—supplying vaping goods
Supplying vaping goods in Australia is an offence.
41QB(1) Offences and civil penalty provision—supplying vaping goods
Prohibits supplying vaping goods in Australia.
Supplying vaping goods is an offence of strict liability.
41QB(2) Offences and civil penalty provision—supplying vaping goods
Supplying vaping goods in Australia is prohibited.
41QB(3) Offences and civil penalty provision—supplying vaping goods
Supplying vaping goods without compliance with subsection (3) is prohibited.
41QB(4) Offences and civil penalty provision—supplying vaping goods
Temporal overlap between supply and prohibition.
Supplying vaping goods is prohibited after subsection (3) applies.
Prohibition of supplying vaping goods without compliance.
Subsection (3) sets conditions for supply.
41QB(5) Offences and civil penalty provision—supplying vaping goods
Supply of vaping goods without proper exemption is prohibited.
41QB(6) Offences and civil penalty provision—supplying vaping goods
41QC Offences and civil penalty provision—possessing at least
Possessing vaping goods in Australia without permission
41QC(1) Offences and civil penalty provision—possessing at least
Establishes a temporal interval for imprisonment for possession of vaping goods in Australia
Penalty: Imprisonment for 2 years or 1,000 penalty units, or both.
Prohibits possession of vaping goods in Australia
(a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity of that kind of vaping goods.
Imprisonment for 2 years or 1,000 penalty units for possession of vaping goods in Australia
Classifies possession of vaping goods in Australia as an offence
Classifies imprisonment for 2 years or 1,000 penalty units as a penalty for possession of vaping goods in Australia
Establishes a recurring trace for possession of vaping goods in Australia
Absolute liability applies for possessing at least
41QC(2) Offences and civil penalty provision—possessing at least
Possessing a quantity of vaping goods without exceeding the commercial quantity is an offence.
41QC(3) Offences and civil penalty provision—possessing at least
A person commits an offence of strict liability if...
(a) the person possesses a quantity of a kind of vaping goods in Australia;
(3) A person commits an offence of strict liability if:
Possessing less than a commercial quantity of vaping goods is an offence.
41QD Offences and civil penalty provision—possessing less than
Overlaps with the definition of a commercial quantity.
Offences (1) A person commits an offence if...
Recognizes the legal concept of possessing less than a commercial quantity of vaping goods as an offence.
Prohibits possessing less than a commercial quantity of vaping goods.
The person is a retailer in relation to retail premises in Australia.
Diffuses the definition of a commercial quantity to include retail premises in Australia.
Recurring trace for the definition of a commercial quantity.
Burden of proof for exceptions to civil penalty provisions
41QE Exceptions etc. to civil penalty provisions—burden of proof
Obligation on the person to bear evidential burden
The Minister may determine that specified vaping goods may be supplied or possessed in Australia under certain circumstances.
41R Minister may determine that specified vaping goods may be
Minister may determine indications for vaping goods use
41RA Minister may determine other indications for which vaping
41RB Application to Secretary for consent to manufacture, supply
Consent required for manufacture, supply or possession of vaping goods.
41RB(1) Application to Secretary for consent to manufacture, supply
to manufacture, supply or possess vaping goods.
The key applies to a person who may apply to the Secretary for consent during the relevant period
then they may manufacture, supply or possess vaping goods.
If a person applies to the Secretary for consent
A person may apply to the Secretary for consent
Application must be in accordance with a form approved by the Secretary and accompanied by fee (if any)
41RB(2) Application to Secretary for consent to manufacture, supply
Application must be in accordance with a form approved by the Secretary
Secretary may require applicant to provide further information within a reasonable time.
41RB(3) Application to Secretary for consent to manufacture, supply
Secretary may require applicant to provide further information.
Information in accordance with specified software requirements
Application for consent may be required or permitted
41RB(4) Application to Secretary for consent to manufacture, supply
41RC Secretary may give consent
Secretary may give consent for manufacture, supply or possession of vaping goods.
41RC(1) Secretary may give consent
Secretary may give consent for vaping goods
41RC(2) Secretary may give consent
Secretary must comply with decision-making principles
41RC(2A) Secretary may give consent
Decision-making principle is a prerequisite for decision making
(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B).
Decision making is a subclass of general action
Decision making is contingent on compliance with principle
41RC(2B) Secretary may give consent
The decision-making principles apply to decisions made within the interval of the Minister's power.
Decision-making principles apply to decisions made within this interval
(2B) The Minister may, by legislative instrument...
The decision-making principles imply that the Secretary must take certain actions.
Decision-making principles imply certain actions
The decision-making principles are a type of AI algorithm that the Secretary must use.
Decision-making principles are a type of AI algorithm
The Secretary must comply with the decision-making principles.
The decision-making principles spread to other agents who must comply with the Secretary's decisions.
Decision-making principles spread to other agents
Secretary may give consent under certain circumstances.
41RC(2C) Secretary may give consent
Secretary must publish decision particulars on website after giving consent
41RC(3) Secretary may give consent
41RD Offences and civil penalty provision—breaching condition of
Offence for breaching condition of consent
41RD(1) Offences and civil penalty provision—breaching condition of
Defines temporal interval for penalty application
...breaches a condition of a consent imposed under subsection 41RC(2); and
Imposes obligation to comply with consent conditions
(a) the person does an act or omits to do an act; and
Prohibits certain actions resulting in harm or injury
Imposes obligation to prevent harm or injury
(b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2); and
Breach of condition results in an offence and a penalty.
41RD(2) Offences and civil penalty provision—breaching condition of
Offence of strict liability for breaching condition of consent
41RD(3) Offences and civil penalty provision—breaching condition of
Prohibits strict liability for breaching condition of consent
(3) A person commits an offence of strict liability if...
Imposes obligation to comply with condition of consent
Traces breach of condition to strict liability
Breaching a condition of consent imposed under subsection 41RC(2) is prohibited.
41RD(4) Offences and civil penalty provision—breaching condition of
Prohibition of breaching a condition of consent.
42AA This Part not to apply to advertisements directed at health
Exemptions from advertising restrictions
42AA(1) This Part not to apply to advertisements directed at health
Registered or licensed to practice in a specific health profession
Minister may specify class of persons for purposes of paragraph (1)(d)
42AA(1A) This Part not to apply to advertisements directed at health
Specify a class of persons for purposes of paragraph (1)(d)
This Part does not apply to advertisements directed exclusively to members of an Australian branch of one of the bodies prescribed for the purposes of this subsection.
42AA(2) This Part not to apply to advertisements directed at health
Person must have qualifications and training for membership of relevant body.
42AA(3) This Part not to apply to advertisements directed at health
Person is a member of the relevant body.
Exemption from Part for certain patient advice
42AA(4) This Part not to apply to advertisements directed at health
This Part does not apply to advertisements in respect of goods that are not for use in humans.
42AB This Part not to apply to advertisements for goods not for
42AC This Part not to apply to advertisements for exported goods
This Part applies to advertisements for goods other than therapeutic goods intended exclusively for export.
42AC(1) This Part not to apply to advertisements for exported goods
The advertisement does not comply with this Part.
The advertisement's applicability to this Part overlaps with the time period during which the exported goods are intended to be used.
The advertisement is for therapeutic goods intended exclusively for export.
The advertisement's applicability to this Part is recognized by the AI system.
If the advertisement is not solely for therapeutic goods intended exclusively for export, then it must comply with this Part.
Exported goods are subject to this Part.
The advertisement's applicability to this Part diffuses through the time period during which the exported goods are intended to be used.
The advertisement's applicability to this Part repeats every time the exported goods are intended to be used.
Sections 42DKB, 42DLA and 42DLC apply to advertisements of that kind.
42AC(2) This Part not to apply to advertisements for exported goods
Exemption from Part for advertisements about vaping goods
42AD This Part not to apply to advertisements or generic
Prohibits application of Part to advertisements about vaping goods
42B Definitions
The Minister may make a code relating to advertisements about therapeutic goods.
42B(1) Definitions
Allows modification of existing instruments or writings in legislative instruments.
42B(2) Definitions
Representations in advertisements about therapeutic goods may be restricted, required or prohibited.
42DA Simplified outline of this Division
Prohibits representations in advertisements about therapeutic goods.
Definition of applicant and approval holder.
42DB Definitions
Restricted representations in therapeutic goods advertising
42DD Restricted representations
42DE Applications for approval of use of restricted representation
Application for approval of use of restricted representation must be made to the Secretary.
42DE(1) Applications for approval of use of restricted representation
Application for approval of use of restricted representation may be required or permitted
42DE(2) Applications for approval of use of restricted representation
Classification of applications based on software requirements
42DF Approval of use of restricted representation
Secretary must approve use of restricted representation if it is accurate and balanced.
42DF(1) Approval of use of restricted representation
Time period for approval of use of restricted representation.
Secretary must approve use of restricted representation.
(1) If an application for approval of the use of a restricted representation is made, the Secretary must approve the use of the restricted representation if the Secretary is satisfied that:
Secretary must be satisfied that the representation is accurate and balanced.
(a) the representation is accurate and balanced;
Secretary must be satisfied that the representation is not misleading or likely to be misleading.
(b) the representation is not misleading or likely to be misleading.
Must approve restricted representation use
42DF(2) Approval of use of restricted representation
Approval may be subject to conditions imposed by the Secretary.
42DF(3) Approval of use of restricted representation
Secretary must consider certain factors when deciding to approve or refuse the use of a restricted representation.
42DF(4) Approval of use of restricted representation
Secretary has an obligation to consider certain factors.
42DG Notice of approval or refusal
Secretary must give written notice to applicant of approval or refusal.
42DG(1) Notice of approval or refusal
Failure to provide written notice within 60 days results in approval of use.
42DG(2) Notice of approval or refusal
Conditions for approval must be set out in the notice.
42DG(3) Notice of approval or refusal
Must provide reasons for refusal and inform applicant of right to review decision.
42DG(4) Notice of approval or refusal
42DH Variation of conditions of approval
42DH(1) Variation of conditions of approval
Secretary must provide reasons and inform approval holder of right to review decision.
42DH(2) Variation of conditions of approval
42DI Withdrawal of approval
Withdrawal of approval for restricted representation
42DI(1) Withdrawal of approval
42DI(2) Withdrawal of approval
42DJ Prohibited and required representations
Prohibited representations about therapeutic goods
42DJ(1) Prohibited and required representations
...are prohibited representations about therapeutic goods...
(1) For the purposes of this Part, representations...
Representations about therapeutic goods are required.
42DJ(2) Prohibited and required representations
42DK Permitted use of restricted or prohibited representations
Permits use of restricted representations in advertisements
42DK(1) Permitted use of restricted or prohibited representations
Permits use of specified prohibited representations under certain conditions.
42DK(2) Permitted use of restricted or prohibited representations
...the representations are necessary for the appropriate use of the goods.
Defines a temporal interval for the permitted use of prohibited representations.
Represents knowledge about permitted use of restricted or prohibited representations.
Allows the Secretary to permit use of prohibited representations.
Diffuses the permitted use of restricted or prohibited representations.
Defines a recurring trace for the permitted use of prohibited representations.
Permits use of prohibited representations in advertisements under certain conditions.
42DK(3) Permitted use of restricted or prohibited representations
Allows the use of prohibited representations in advertisements.
Permitted use of restricted or prohibited representations
42DK(4) Permitted use of restricted or prohibited representations
Permission under this section is not a legislative instrument.
42DK(5) Permitted use of restricted or prohibited representations
Publishing permission on Department's website after giving a permission under this section.
42DK(6) Permitted use of restricted or prohibited representations
Advertising therapeutic goods without permission is prohibited.
42DL Advertising offences—general
...and (b) subsection (5), (6), (7), (8), (9), (10), (11) or (12) applies to the advertisement;
Defines a temporal interval for the offence.
(1) A person commits an offence if: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;
Classifies the advertising as a cognitive task.
(a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods;
Prohibits advertising therapeutic goods.
Defines a recurring trace for the offence.
42DM Offences—non-compliance with the Therapeutic Goods
Advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code is prohibited.
42DM(1) Offences—non-compliance with the Therapeutic Goods
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Prohibition of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code.
(1) A person commits an offence if: (a) the person: (i) advertises, by any means, therapeutic goods; or (ii) causes the advertising, by any means, of therapeutic goods; and
(c) either: (i) the use of the goods in reliance on the advertisement has resulted in, will result in, or is likely to result in, harm or injury to any person; or
(c) either: (ii) the use of the goods in reliance on the advertisement, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person.
Classification of advertising as therapeutic goods without compliance with the Therapeutic Goods Advertising Code.
(b) the advertisement does not comply with the Therapeutic Goods Advertising Code; and
Implication of advertising therapeutic goods without compliance with the Therapeutic Goods Advertising Code on imprisonment.
Non-compliance with Therapeutic Goods Advertising Code is an offence.
42DM(2) Offences—non-compliance with the Therapeutic Goods
Prohibits non-compliance with the Therapeutic Goods Advertising Code.
Defines a class of persons who are subject to this prohibition.
Non-compliance with therapeutic goods advertising
42DM(3) Offences—non-compliance with the Therapeutic Goods
...if the person advertises, by any means, therapeutic goods;
Defines a temporal interval for non-compliance
Defines a recurring trace for non-compliance
Division applies to generic information about goods used in therapeutic goods manufacture or representation.
42DN Application of Division
Division applies to generic information about goods.
Generic information must comply with the Therapeutic Goods Advertising Code.
42DO Compliance with the Code
42DP Offences—dissemination of generic information
Dissemination of generic information about therapeutic goods to the public or a section of the public is prohibited.
42DP(1) Offences—dissemination of generic information
Classification of generic information as prohibited
Dissemination of generic information about therapeutic goods is prohibited.
42DP(2) Offences—dissemination of generic information
Prohibits the dissemination of generic information.
(2) A person commits an offence if: (a) the person disseminates, by any means, generic information about therapeutic goods to the public or a section of the public; and (b) the dissemination of that generic information does not comply with the provisions of the Therapeutic Goods Advertising Code that are prescribed by regulations for the purposes of section 42DO.
An offence against subsection (2) is an offence of strict liability.
42DP(3) Offences—dissemination of generic information
If there is a strict liability offence, then punishment must follow.
States that punishment follows from the existence of a strict liability offence.
42DQ Civil penalty for dissemination of generic information
42DR Secretary may require information or documents
Secretary may require information or documents from a person responsible for advertising therapeutic goods.
42DR(1) Secretary may require information or documents
Secretary may require information or documents from a person responsible for disseminating generic information.
42DR(2) Secretary may require information or documents
Secretary may require information or documents.
Must provide information or documents within a specified period and in the form specified by the notice.
42DR(3) Secretary may require information or documents
The person must provide the information or documents within that period.
The period within which the person must provide the information or documents is not less than 14 days after the day the notice is given.
The Secretary may require information or documents in a specified way.
42DR(4) Secretary may require information or documents
42DR(5) Secretary may require information or documents
Requires information or documents from the recipient
Legislative instruments are excluded from the notice
(5) A notice under subsection (1) or (2)
42DS Criminal offences for failing to comply with a notice etc.
Failure to comply with a notice results in an offence.
42DS(1) Criminal offences for failing to comply with a notice etc.
42DS(2) Criminal offences for failing to comply with a notice etc.
Offence of strict liability for failing to comply with a notice
42DS(3) Criminal offences for failing to comply with a notice etc.
42DS(4) Criminal offences for failing to comply with a notice etc.
Prohibits failing to comply with a notice.
42DS(5) Criminal offences for failing to comply with a notice etc.
Giving false or misleading information in compliance with a notice is prohibited.
42DT Civil penalty for giving false or misleading information or
The person contravenes this section if...
Prohibition of giving false or misleading information.
The person is given a notice under section 42DR.
42DU Self-incrimination
No excuse for refusing to provide information or produce a document under section 42DR.
42DU(1) Self-incrimination
Must provide information or produce a document.
42DU(2) Self-incrimination
...the information or producing the document; ... are not admissible in evidence against the individual:
Prohibits admissibility of self-incrimination in certain cases
(2) However, in the case of an individual...
...in criminal proceedings, except proceedings for an offence against subsection 42DS(4) or (5); ...
Establishes a right to protection from self-incrimination in certain cases
Imposes an obligation on the state to protect self-incrimination in certain cases
...in civil proceedings, except proceedings under section 42Y for a contravention of section 42DT.
Permits admissibility in certain cases under specific circumstances
Imposes an obligation on the state to protect self-incrimination in certain cases under specific circumstances
42DV Directions about advertisements or generic information
Directs a person to cease advertising or take corrective action.
42DV(1) Directions about advertisements or generic information
Directs a person responsible for disseminating generic information to take corrective action.
42DV(2) Directions about advertisements or generic information
...the Secretary may, in writing, direct a person...
Analyzes the impact of generic information on public health.
(2) If, in relation to the dissemination of generic information...
Directs a person to withdraw or correct generic information.
Affects the dissemination of generic information.
Defines the scope of prohibited generic information.
Validates the accuracy of generic information.
42DW Offences—contravening direction under section 42DV
Offence for contravening direction under section 42DV
42DW(1) Offences—contravening direction under section 42DV
...the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result...
Temporal relation between contravention and harm
(d) either: (i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury...
...the use of the goods has resulted in, will result in, or is likely to result in, harm or injury...
(c) the act or omission contravenes the direction or a condition...
...the act or omission contravenes the direction...
Recurring trace of contravention and harm
42DW(2) Offences—contravening direction under section 42DV
...the act or omission contravenes the direction or a condition of the direction.
Establishes temporal relation between direction under section 42DV and acts/omissions
Prohibits contravening direction under section 42DV
Imposes obligation to comply with direction under section 42DV
Prohibits acts/omissions that contravene direction under section 42DV
Establishes recurring trace between direction under section 42DV and acts/omissions
42DW(3) Offences—contravening direction under section 42DV
...the person does an act or omits to do an act.
(a) the Secretary has given a direction to the person under subsection 42DV(1) or (2); and...
Prohibits omission of act under direction under section 42DV
(b) the person does an act or omits to do an act; and...
Imposes obligation to comply with conditions of direction under section 42DV
(c) the act or omission contravenes the direction or a condition of the direction.
Prohibits failure to comply with conditions of direction under section 42DV
An offence against subsection (3) is an offence of strict liability.
42DW(4) Offences—contravening direction under section 42DV
Contravening direction under section 42DV is prohibited.
42DX Civil penalty for contravening direction under section 42DV
42DY Secretary may issue a public warning notice
Secretary may issue a public warning notice about therapeutic goods under certain conditions.
42DY(1) Secretary may issue a public warning notice
Secretary may issue a public warning notice.
Secretary may issue a public warning notice if person fails to comply with substantiation notice.
42DY(2) Secretary may issue a public warning notice
the warning notice is issued during the period of non-compliance
Warning notice issued during period of non-compliance.
(c) the Secretary is satisfied that it is in the public interest to issue a notice under this subsection;
the warning notice implies that the person has failed to comply
Warning notice implies that person has failed to comply.
(2) If: (a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;
the Secretary may issue to the public a written notice containing a warning that the person has failed to comply with the substantiation notice, and specifying the matter to which the substantiation notice related.
Prohibits person from failing to comply with substantiation notice.
(a) the Secretary gives a person a notice (the substantiation notice) under subsection 42DR(1) or (2); and (b) the person fails to comply with the substantiation notice;
the warning notice spreads to the public
the warning notice remains in effect until the person complies
Warning notice remains in effect until person complies.
Secretary must issue a public warning notice
42DY(3) Secretary may issue a public warning notice
42DY(4) Secretary may issue a public warning notice
42E Offence of dealing with counterfeit therapeutic goods
Dealing with counterfeit therapeutic goods is an offence.
42E(1) Offence of dealing with counterfeit therapeutic goods
Prohibits dealing with counterfeit therapeutic goods.
42E(2) Offence of dealing with counterfeit therapeutic goods
This provision overlaps with other provisions related to therapeutic goods.
Overlaps with other provisions related to therapeutic goods.
(2) Goods are counterfeit if any of the following contain a false representation...
This provision recognizes counterfeit therapeutic goods based on representations.
Recognizes counterfeit therapeutic goods based on representations.
This provision diffuses to other provisions related to therapeutic goods.
Diffuses to other provisions related to therapeutic goods.
Dealing with counterfeit therapeutic goods is a recurring trace.
Recurring trace for dealing with counterfeit therapeutic goods.
Offence of dealing with counterfeit therapeutic goods
42E(3) Offence of dealing with counterfeit therapeutic goods
Defines term for therapeutic goods in section
42E(5) Offence of dealing with counterfeit therapeutic goods
Dealing with counterfeit therapeutic goods is prohibited.
42EA Civil penalty relating to dealing with counterfeit therapeutic
Excuse from liability for certain contraventions relating to counterfeit therapeutic goods
42EB Relief from liability for certain contraventions relating to
The person ought fairly be excused for the contravention
Excuse from liability overlaps with other excuses
Obligation to excuse liability for certain contraventions
42F Customs treatment of counterfeit therapeutic goods
Customs treatment of counterfeit therapeutic goods
42F(1) Customs treatment of counterfeit therapeutic goods
Customs treatment applies until commencement
Customs treatment applies during the period from notification to commencement
Secretary notifies Comptroller-General of Customs in writing
Notification implies application of the Customs Act 1901
Comptroller-General of Customs acknowledges receipt of notification
Comptroller-General of Customs recognizes the notification as a directive from Secretary
Act has effect as if goods were forfeited to the Crown
Imposes duty on Secretary to notify Comptroller-General of Customs
Secretary wishes the Customs Act 1901 to apply
Comptroller-General of Customs receives notification
Notification diffuses to Comptroller-General of Customs
42F(2) Customs treatment of counterfeit therapeutic goods
Overlaps with section 229 of the Customs Act 1901
Prohibits export of counterfeit therapeutic goods
Diffuses prohibition to export of counterfeit therapeutic goods
Recurring trace with section 229 of the Customs Act 1901
42T Notifying of actual or potential tampering
Notify Secretary of actual or potential tampering within 24 hours.
42T(1) Notifying of actual or potential tampering
The person has a duty to notify the Secretary.
Failure to notify of actual or potential tampering with therapeutic goods within 24 hours.
42T(2) Notifying of actual or potential tampering
Notification is required within 24 hours
Negligence standard for notification of tampering
42T(3) Notifying of actual or potential tampering
...of the standard of care that a reasonable person would exercise in the circumstances;
Temporal relation between notification and standard of care
(a) the person’s acts or omissions involve such a great falling short...
Knowledge representation of negligence standard
the person is only taken to be negligent...
(3) For the purposes of subparagraph (2)(c)(ii)
...that the acts or omissions merit criminal punishment.
Risk assessment for tampering notification
Recurring trace of notification and risk assessment
No possession or control required for notification
42T(4) Notifying of actual or potential tampering
Tampering with therapeutic goods is prohibited.
42U Meaning of actual or potential tampering etc.
Tampering occurs during the manufacturing or distribution of therapeutic goods.
Therapeutic goods are manufactured or distributed at specific times.
The entity or action responsible for tampering is specified.
Tampering with therapeutic goods is done by a specific entity or action.
Therapeutic goods have a specific purpose and are subject to regulation.
Prohibits tampering with therapeutic goods.
Tampering is prohibited for these goods.
Classifies therapeutic goods as subject to tampering prohibition.
Therapeutic goods have a specific meaning in this context.
The risk of harm is diffused through tampering.
Tampering with therapeutic goods diffuses the risk of harm to others.
Therapeutic goods can cause harm if tampered with.
Tampering occurs until this safety condition is met.
Tampering is prohibited until the therapeutic goods reach a safe state.
Therapeutic goods must be in a safe state before they can be used.
42V Recall of therapeutic goods because of actual or potential
Secretary may impose requirements on a person supplying therapeutic goods
42V(1) Recall of therapeutic goods because of actual or potential
specified steps, in the specified manner and within a reasonable period
Recall of therapeutic goods because of actual or potential tampering
42V(2) Recall of therapeutic goods because of actual or potential
Classification of therapeutic goods based on tampering risk
Therapeutic goods that have been administered to a person cannot be recalled.
42V(3) Recall of therapeutic goods because of actual or potential
The recall requirement overlaps with the administration of therapeutic goods.
(3) Requirements referred to in paragraph (2)(a) do not apply...
Prohibits recall of therapeutic goods administered to a person.
Secretary must publish notice setting out requirements after imposing them.
42V(4) Recall of therapeutic goods because of actual or potential
Secretary may impose requirements under this section
42V(5) Recall of therapeutic goods because of actual or potential
Failure to comply with a requirement under subsection (1) in relation to a supply of therapeutic goods is an offence.
42V(6) Recall of therapeutic goods because of actual or potential
Prohibition of non-compliance with a requirement.
The person fails to comply with a requirement under subsection (1).
Failure to comply with a requirement in relation to a supply of therapeutic goods is an offence.
42V(6C) Recall of therapeutic goods because of actual or potential
42V(6D) Recall of therapeutic goods because of actual or potential
Obligation to comply with a requirement.
Offence of strict liability for recall of therapeutic goods
42V(6E) Recall of therapeutic goods because of actual or potential
Failure to comply with a requirement under subsection 42V(1) in relation to a supply of therapeutic goods is prohibited.
42VA Civil penalty relating to the recall of therapeutic goods
42VB Relief from liability for contraventions relating to the recall of
Relief from liability for contraventions relating to the recall of
42VB(1) Relief from liability for contraventions relating to the recall of
Relief from liability is granted during a specific temporal interval.
Temporal interval during which relief from liability applies
The relief from liability applies if the proceedings are brought within a certain timeframe.
The person's actions are justified by their honesty and circumstances.
Justification for exemption from liability
The person's honesty and circumstances of the case justify relief from liability.
The Court recognizes the person's exemption from liability.
The Court recognizes the person's honesty and circumstances as justification for relief from liability.
The person has acted honestly and ought fairly to be excused for the contravention.
The exemption from liability propagates to the person.
Relief from liability is granted to the person if they have acted honestly.
Right to apply for relief from liability
42VB(2) Relief from liability for contraventions relating to the recall of
Granting relief from liability for contraventions relating to the recall of therapeutic goods.
42VB(3) Relief from liability for contraventions relating to the recall of
42VB(4) Relief from liability for contraventions relating to the recall of
42W Supply etc. of therapeutic goods that are subject to recall
Supply of therapeutic goods subject to recall is prohibited.
42W(1) Supply etc. of therapeutic goods that are subject to recall
...requirements have been imposed under section 42V, on that person or another person, to recall therapeutic goods;
Defines temporal interval for recall requirements.
(i) the person knows that the therapeutic goods are of a kind, or are included in a batch, in respect of which requirements have been imposed...
...the person supplies therapeutic goods in Australia;
Prohibits supply of therapeutic goods subject to recall.
Prohibits supply of therapeutic goods without consent.
(c) the Secretary has not consented in writing to the supply.
Prohibits reckless supply of therapeutic goods subject to recall.
(ii) the therapeutic goods are of such a kind, or are included in such a batch, and the person is reckless as to that fact;
Exporting therapeutic goods from Australia is prohibited.
42W(2) Supply etc. of therapeutic goods that are subject to recall
Prohibits exportation of therapeutic goods.
42X Saving of other laws
42Y Federal Court may order person to pay pecuniary penalty for
Order to pay pecuniary penalty for contravening a civil penalty provision.
42Y(1) Federal Court may order person to pay pecuniary penalty for
Secretary may apply for an order within this time frame
Within 6 years of the wrongdoer's contravention
Secretary has authority to act on behalf of the Commonwealth
Secretary may apply on behalf of the Commonwealth
Pay the Commonwealth a pecuniary penalty
Wrongdoer is subject to the court's order
May order wrongdoer to pay pecuniary penalty
Order to pay pecuniary penalty for contravention of civil penalty provision
42Y(2) Federal Court may order person to pay pecuniary penalty for
Legal obligation to pay pecuniary penalty
Court must consider certain factors when determining pecuniary penalty.
42Y(3) Federal Court may order person to pay pecuniary penalty for
(3) In determining the pecuniary penalty, the Court...
42YA What is a civil penalty provision?
42YC Persons involved in contravening civil penalty provision
Continuation of obligation despite expired period or passed time. Aiding, abetting, or inducing a contravention of a civil penalty provision is prohibited.
42YC(1) Persons involved in contravening civil penalty provision
Requires a relation between identifiable temporal intervals.
Conditional commencement is Undertaking, not Prohibition.
Continuation of obligation despite expired period or passed time.
(1) If an act or thing is required under a civil penalty provision to be done:
Do not invent a bearer, holder, condition, cross-reference, premise, or conclusion.
Separate contravention for each day of non-compliance Continuing contraventions of civil penalty provisions are obligations on the person involved.
42YC(2) Persons involved in contravening civil penalty provision
each day during which the contravention occurs (including the day the order under subsection 42Y(2) is made or any later day)
Describes temporal overlap of contraventions
(2) A person who contravenes a civil penalty provision...
Describes recognition of contraventions by AI system
commits a separate contravention of that provision in respect of each day during which the contravention occurs
The person involved must comply with the civil penalty provision.
Describes diffusion of contraventions over time
Describes recurring nature of contraventions
The Commonwealth may enforce a pecuniary penalty order as if it were a judgment of the Court.
42YD Recovery of a pecuniary penalty
The Commonwealth may enforce the order as if it were a judgment of the Court.
The penalty is payable to the Commonwealth.
42YE Gathering information for application for pecuniary penalty
Duty to gather information for pecuniary penalty application
42YE(1) Gathering information for application for pecuniary penalty
Secretary may require person to give assistance in connection with application for civil penalty order.
42YE(2) Gathering information for application for pecuniary penalty
Federal Court cannot impose pecuniary penalty order on a person convicted of an offence substantially similar to the contravention.
42YF Civil proceedings after criminal proceedings
must be considered when imposing pecuniary penalty order
Temporal intervals of conviction and contravention must overlap
Conviction of an offence constituting substantially similar conduct to the contravention
must be taken into account when imposing pecuniary penalty order
Knowledge-based system must consider conviction and contravention
Federal Court must not make a pecuniary penalty order against a person convicted of an offence substantially similar to the contravention
against a person convicted of an offence substantially similar to the contravention
Federal Court must not make a pecuniary penalty order
Diffusive effect of conviction on contravention must be considered
Conviction of an offence substantially similar to the contravention
Recurring traces of conviction and contravention must be considered
42YG Criminal proceedings during civil proceedings
Stay of pecuniary penalty order proceedings during criminal proceedings for same offence.
42YG(1) Criminal proceedings during civil proceedings
Defines a temporal overlap between criminal proceedings and pecuniary penalty order proceedings.
(a) criminal proceedings are started or have already been started against the person for an offence; and (b) the offence is constituted by conduct that is substantially the same as the conduct alleged to constitute the contravention.
Recognizes the prohibition of pecuniary penalty order proceedings during criminal proceedings for same offence.
Prevents pecuniary penalty order proceedings during criminal proceedings for same offence.
Diffuses the prohibition of pecuniary penalty order proceedings during criminal proceedings for same offence.
Defines a recurring relationship between criminal proceedings and pecuniary penalty order proceedings.
Proceedings for order may be resumed if not convicted.
42YG(2) Criminal proceedings during civil proceedings
...the proceedings for the order are dismissed.
(2) The proceedings for the order may be resumed...
Criminal proceedings cannot start against conduct substantially similar to a civil penalty provision if a pecuniary penalty order has been made.
42YH Criminal proceedings after civil proceedings
Prohibits criminal proceedings against similar conduct.
Evidence of information given or production of documents by an individual is not admissible in criminal proceedings against the individual.
42YI Evidence given in proceedings for civil penalty not admissible
Secretary can issue infringement notice for contravention of Act or regulations.
42YJ Simplified outline of this Part
Secretary can issue infringement notice.
42YK When an infringement notice may be given
Secretary may give infringement notice for alleged contravention.
42YK(1) When an infringement notice may be given
Infringement notice must be given within 12 months after contravention.
42YK(2) When an infringement notice may be given
Obligation to give infringement notice within 12 months.
(2) The infringement notice must be given...
A single infringement notice must relate only to a single contravention of a single provision.
42YK(3) When an infringement notice may be given
Single infringement notice must relate to a single contravention.
Secretary may give a person an infringement notice relating to multiple contraventions of a single provision if certain conditions are met.
42YK(4) When an infringement notice may be given
Secretary may give an infringement notice
42YL Enforcement of undertakings
Secretary may accept written undertaking from person in connection with a matter.
42YL(1) Enforcement of undertakings
(1) The Secretary may accept a written undertaking...
The person may withdraw or vary the undertaking with consent from the Secretary.
42YL(2) Enforcement of undertakings
Secretary must publish details of undertaking on the internet.
42YL(3) Enforcement of undertakings
Secretary may apply for order if undertaking is breached
42YL(4) Enforcement of undertakings
Court may make orders to enforce breach of undertaking.
42YL(5) Enforcement of undertakings
Secretary can seek injunctions from Federal Court or Family Court to restrain contravention of Act or regulations.
42YM Simplified outline of this Part
42YN Grant of injunctions
Grant of injunctions for conduct in contravention of the Act or regulations.
42YN(1) Grant of injunctions
Prohibits conduct in contravention of the Act or regulations.
Grant of injunctions for refusal or failure to comply with the Act
42YN(2) Grant of injunctions
the Federal Court or Federal Circuit and Family Court of Australia may grant an injunction requiring the person to do that thing.
42YO Interim injunctions
42YO(1) Interim injunctions
Cannot require the Secretary to give an undertaking as a condition of granting an interim injunction.
42YO(2) Interim injunctions
May discharge or vary an injunction granted by that court under this Part.
42YP Discharging or varying injunctions
Permits discharge or variation of an injunction
Court may grant injunction without considering intent or previous conduct.
42YQ Certain limits on granting injunctions not to apply
Court permits exercise of power to grant injunction.
42YR Other powers of court unaffected
Secretary may give directions to a person requiring specified actions in relation to goods.
42YS Simplified outline of this Part
42YT Secretary may give directions if this Act or an instrument is
Secretary may give directions if this Act or an instrument is not complying with the Act in relation to particular goods.
42YT(1) Secretary may give directions if this Act or an instrument is
if the Secretary believes on reasonable grounds that...
it is in the interests of public health or safety to give the person directions under this section.
This section applies if the Secretary believes...
is not complying with this Act or an instrument
(a) a person is not complying with this Act or an instrument made under this Act in relation to particular goods;
is in the interests of public health or safety
Secretary may give directions to a person regarding the relabeling, repackaging, or disposal of goods.
42YT(2) Secretary may give directions if this Act or an instrument is
43 By whom charges payable
Annual registration charge payable by person in relation to whom therapeutic goods are registered, listed or included.
43(1) By whom charges payable
Specifies the temporal interval during which the annual registration charge must be paid.
Imposes a duty on the person to pay the annual registration charge.
Annual licensing charge payable by licence holder
43(2) By whom charges payable
Obligation to pay annual licensing charge
Annual conformity assessment body determination charge payable by Australian corporation
43(3) By whom charges payable
Annual registration charge becomes payable on a specific date.
44 Time for payment of charges
44A Exemptions from liability to pay charges
Exemptions from liability to pay charges
44A(1) Exemptions from liability to pay charges
if the person’s turnover of the therapeutic goods concerned for the financial year specified in the regulations is of low value;
Exempts a person from liability to pay annual registration charge
(1) The regulations may make provision for and in relation to:
Requires payment of charge for current year if application is refused
(b) the making of an application for an exemption and requiring payment of that charge for the current year if the application is refused;
Cancels exemption and requires payment of charge for current year
(c) cancelling an exemption and requiring payment of that charge for the current year.
Exempts a person from liability to pay annual listing charge or annual charge for inclusion in the Register
(a) exempting a person from liability to pay annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year (the current year) if the person’s turnover of the therapeutic goods concerned for the financial year specified in the regulations is of low value;
Fee for exemption applications must not amount to taxation.
44A(2) Exemptions from liability to pay charges
Person must provide statement upon exemption application or grant
44A(3) Exemptions from liability to pay charges
Regulations may obtain additional information or documents from applicants for exemptions.
44A(4) Exemptions from liability to pay charges
Regulations may obtain additional information or documents.
Review of exemptions by Administrative Review Tribunal
44A(5) Exemptions from liability to pay charges
Recovery of unpaid charges after 28 days
44B Recovery of unpaid charges
45 Therapeutic Goods Administration Account
Continued existence of Therapeutic Goods Administration Account
45(1) Therapeutic Goods Administration Account
The Account is a special account for the purposes of the Public Governance, Performance and Accountability Act 2013.
45(2) Therapeutic Goods Administration Account
Amounts must be credited to the Account from various sources.
45(3) Therapeutic Goods Administration Account
There must be credited to the Account...
Payment obligations for therapeutic goods administration account
45(4) Therapeutic Goods Administration Account
Defines evidential material and occupier for this Part.
45A Definitions
Includes definitions for occupier and person assisting.
The Secretary can gather information or documents relevant to a contravention or possible contravention of this Act.
45AA Simplified outline of this Part
45AB Secretary may require information or documents
Secretary may require information or documents from a person.
45AB(1) Secretary may require information or documents
Requires the person to give information or produce documents.
Notice with a reasonable compliance period
Secretary must require person to comply within a specified period.
45AB(2) Secretary may require information or documents
Secretary must provide notice with specified information
45AB(3) Secretary may require information or documents
Secretary must require information or documents in specified format.
45AB(4) Secretary may require information or documents
Information must be provided in specified format.
45AC Offences for failing to comply with notice
Failure to comply with notice results in an offence.
45AC(1) Offences for failing to comply with notice
Section 45AC(1) overlaps with Chapter 6.
Compilation date: 05/09/2025 Penalty: 500 penalty units. Strict liability offence
If the person fails to comply, they commit an offence.
Failing to comply with notice implies committing an offence.
(1) A person commits an offence if: (a) the person is given a notice under section 45AB; and (b) the person fails to comply with the notice.
If the person fails, they are subject to a strict liability offence.
Failing to comply with notice implies being subject to a strict liability offence.
The person commits an offence if they fail to comply with the notice.
Prohibits failing to comply with notice.
If the person fails, they are subject to penalty units.
Failing to comply with notice implies being subject to penalty units.
Failure to comply with notice results in an offence of strict liability.
45AC(2) Offences for failing to comply with notice
Failure to comply results in an offence of strict liability.
No obligation if person has a reasonable excuse.
45AC(3) Offences for failing to comply with notice
45AD Offences and civil penalty for giving false or misleading
Giving false or misleading information in response to a notice is an offence.
45AD(1) Offences and civil penalty for giving false or misleading
The person commits an offence if the information or document is false or misleading in a material particular.
The person is given a notice under section 45AB.
The provision prohibits imprisonment for 12 months or 1,000 penalty units.
Prohibition of imprisonment for 12 months or 1,000 penalty units.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
The provision prohibits liability for an executive officer of a body corporate.
Prohibition of liability for an executive officer of a body corporate.
Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
The provision is classified as a strict liability offence.
Prohibition of strict liability offence.
Giving false or misleading information is an offence.
45AD(2) Offences and civil penalty for giving false or misleading
Prohibits giving false or misleading information.
45AE Self-incrimination
45AE(1) Self-incrimination
Protection from self-incrimination in criminal proceedings
45AE(2) Self-incrimination
... criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989
Defines the temporal scope of admissible evidence
(2) However: ...; (d) subsection 45AC(1) or (2); or (e) subsection 45AD(1) or (2); or (f) section 137.1 or 137.2 of the Criminal Code
... not admissible in evidence against the individual in criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989
Prevents admissibility of self-incriminating information
... proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989
Allows for exceptions to the prohibition on self-incrimination
(f) section 137.1 or 137.2 of the Criminal Code in relation to giving the information or producing the document.
... against the individual in criminal proceedings other than proceedings for an offence against Administration Chapter 6 Information gathering powers Part 6-1A Obtaining information or documents Division 2 Section 45AE Therapeutic Goods Act 1989
Establishes the duty to protect against self-incrimination
Defines the repetition of admissible evidence
(a) the information given or document produced; and (b) the giving of the information or the production of the document;
No claim of privilege against self-exposure to penalty for giving information or producing document under section 45AB.
45AE(3) Self-incrimination
Prohibits claiming privilege against self-exposure to penalty.
The Secretary may inspect and copy documents produced under section 45AB.
45AF Secretary may inspect and copy documents
The Secretary may inspect and copy documents.
45AG Secretary may retain documents
The Secretary may retain documents for as long as necessary.
45AG(1) Secretary may retain documents
The Secretary must provide a certified copy of the document as soon as practicable.
45AG(2) Secretary may retain documents
The Secretary must provide a certified copy.
The certified copy must be received in all courts and tribunals as evidence.
45AG(3) Secretary may retain documents
The state has an obligation to provide the certified copy.
Must provide access to document for inspection and copying.
45AG(4) Secretary may retain documents
46 Searches to monitor compliance with Act or regulations
Authorized person may enter premises and exercise powers to monitor compliance.
46(1) Searches to monitor compliance with Act or regulations
...for the purpose of finding out whether this Act or the regulations have been complied with:
Temporal relation: Authorized person monitors compliance during specific time period
(1) Subject to subsections (2) and (3), an authorised person may...
...an authorised person may, for the purpose of finding out whether this Act or the regulations have been complied with:
...and exercise the powers set out in subsection 48(1) and section 48BA.
(a) enter any premises; and (b) exercise the powers set out in subsection 48(1) and section 48BA.
Spread of information: Authorized person monitors compliance through specific means
Temporal relation: Authorized person monitors compliance until specific time period ends
Authorized person cannot enter premises without consent or warrant.
46(2) Searches to monitor compliance with Act or regulations
Entry requires warrant issued under section 49.
The entry is made under a warrant issued under section 49.
Authorized person must not enter premises.
The authorised person must not enter the premises.
Authorized person cannot exercise powers under subsection (1) if occupier requests identity card inspection.
46(3) Searches to monitor compliance with Act or regulations
Exercise of powers under subsection (1) is prohibited
Prohibition of exercising powers under subsection (1)
Authorized person has required identity card inspection
Occupier's request for identity card inspection is a permission
Occupier requests identity card inspection
46A Searches of certain premises to monitor compliance with Act
Authorized person may enter premises to monitor compliance with Act.
46A(1) Searches of certain premises to monitor compliance with Act
No unauthorized entry into residential premises without consent or commercial use.
46A(2) Searches of certain premises to monitor compliance with Act
(2) An authorised person must not enter premises that are a residence unless: (a) the occupier of the premises has consented to the entry; or (b) the premises are used for commercial purposes in relation to therapeutic goods or vaping goods, in addition to residential purposes.
Prohibition of unauthorized entry into residential premises.
(2) An authorised person must not, under subsection (1), enter premises that are a residence unless: (a) the occupier of the premises has consented to the entry; or (b) the premises are used for commercial purposes in relation to therapeutic goods or vaping goods, in addition to residential purposes.
Authorized person cannot exercise powers under subsection (1) if occupier requires identity card inspection.
46A(3) Searches of certain premises to monitor compliance with Act
An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises
(a) the occupier of the premises has required the authorised person to produce his or her identity card for inspection by the occupier;
Prohibition of failing to comply with occupier's requirement
(b) the authorised person fails to comply with the requirement.
(3) An authorised person is not entitled to exercise any powers under subsection (1) in relation to premises if:
Occupier's requirement implies authorized person cannot exercise powers under subsection (1)
Searches of certain premises to monitor compliance with Act
46A(4) Searches of certain premises to monitor compliance with Act
This section applies to: (a) premises of a person:
(iaa) who is required to comply with a condition of an exemption...
46B Searches and seizures on public health grounds
Prohibition on entering premises without reasonable grounds and in the interests of public health.
46B(1) Searches and seizures on public health grounds
The authorised person may enter the premises within a reasonable time frame to search for the item.
Temporal interval for exercising powers under this section.
The authorised person may enter premises and seize items if there is a risk to public health.
Inference from the text that the authorised person may enter premises and seize items under certain circumstances.
(a) there may be on any premises a particular thing in respect of which this Act or the regulations have not been complied (b) it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness or serious injury;
The authorised person may not enter the premises.
(a) there may be on any premises a particular thing in respect of which this Act or the regulations have not been complied
The authorised person has an obligation to exercise their powers if there is a risk to public health.
Obligation to exercise powers under this section in certain circumstances.
(b) it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness or serious injury;
The authorised person may seize the item repeatedly within a reasonable time frame.
Recurring trace of searches and seizures on public health grounds.
(d) if the authorised person finds the thing on the premises—seize it;
Authorized person cannot exercise powers under subsection (1) in relation to premises if occupier requires identity card inspection.
46B(2) Searches and seizures on public health grounds
47 Searches and seizures related to offences and civil penalty
Authorized person may enter premises and seize evidential material if reasonable grounds exist.
47(1) Searches and seizures related to offences and civil penalty
Overlaps with time intervals for entering premises.
(1) Subject to subsections (2) and (3), if an authorised person has reasonable grounds for suspecting that there may be evidential material in respect of an offence against this Act, in respect of a contravention of a civil penalty provision or in respect of both on any premises
Authorized person implies they have authority to enter premises.
Implies that authorized person has authority to enter premises.
(a) enter the premises; and (b) exercise the powers set out in subsection (4), subsection 48(1) and section 48C;
May not enter premises without reasonable grounds.
Prohibits entering premises without reasonable grounds.
Diffuses information about reasonable grounds to others.
Recurring trace for authorized person's actions.
Authorized person must not enter premises without consent or warrant.
47(2) Searches and seizures related to offences and civil penalty
48 General powers of authorised persons in relation to premises
Authorised persons have powers to search, inspect, and require information from premises.
48(1) General powers of authorised persons in relation to premises
Must be taken onto premises during entry
Can take equipment onto premises during entry
Authorised person has authority to enter premises.
Can require occupier to answer questions
Authorised person has power to enter premises.
Occupier is required to provide information.
Must comply with a requirement under paragraph (1)(e)
48(3) General powers of authorised persons in relation to premises
A person must comply with a requirement under paragraph (1)(e)
(3) A person must not refuse or fail to comply...
A person must not refuse or fail to comply with a requirement under paragraph (1)(e)
Refusal or failure to comply is prohibited
A person has an obligation to comply with a requirement under paragraph (1)(e)
Defendant bears evidential burden in relation to reasonable excuse.
48(3A) General powers of authorised persons in relation to premises
Defendant must provide evidence for reasonable excuse.
Excuse for refusing or failing to answer a question or produce a document that may incriminate the person.
48(4) General powers of authorised persons in relation to premises
Excuse applies to a specific temporal relationship between events.
Excuse is based on reasoning about the person's situation.
Excuse for refusing or failing to answer a question or produce a document.
Person has knowledge that answering the question or producing the document may incriminate them.
Excuse applies to a specific temporal interval.
48A Details of warrant to be given to occupier etc.
Must provide a copy of the warrant to the occupier or apparent representative.
48A(1) Details of warrant to be given to occupier etc.
Authorised person must identify themselves to the occupier.
48A(2) Details of warrant to be given to occupier etc.
The authorised person must identify themselves.
No signature of issuing officer is required on warrant copy.
48A(3) Details of warrant to be given to occupier etc.
48AA Completing execution of warrant under section 50 after
Authorized persons must cease execution and leave premises.
48AA(1) Completing execution of warrant under section 50 after
Authorized persons and assistants may complete warrant execution under certain conditions.
48AA(2) Completing execution of warrant under section 50 after
Temporal overlap between absence and emergency situation
Recognition of occupier's written consent
the occupier of the premises consents in writing.
(2) One or more of the authorised persons...
Diffusion of authorized persons' absence to emergency situation
(iii) for a longer period if the occupier of the premises consents in writing.
Recurring trace of authorized persons' absence
(ii) if there is an emergency situation, for not more than 12 hours or such longer period as allowed by an issuing officer under subsection (5);
Authorized person may apply for extension of warrant execution period under emergency situation.
48AA(3) Completing execution of warrant under section 50 after
the authorized person or person assisting the authorized person will not be able to return to the premises within that period.
Extension request overlaps with warrant execution period
CogAI recognizes extension request as warrant execution process part
The authorized person or person assisting the authorized person believes on reasonable grounds that...
for an extension of the warrant execution period
Extension request diffuses into warrant execution process
Extension request until warrant execution period ends
48B Announcement before entry
Announcement before entry into premises under warrant.
48B(1) Announcement before entry
Authorized person not required to comply with subsection (1) if believes immediate entry is necessary for safety or warrant execution.
48B(2) Announcement before entry
Belief on reasonable grounds necessary for exemption
Authorized person believes immediate entry is necessary
48BA Use of electronic equipment at premises for monitoring
Authorized person may operate electronic equipment to monitor premises.
48BA(1) Use of electronic equipment at premises for monitoring
Authorized person may operate electronic equipment to gather information.
48BA(2) Use of electronic equipment at premises for monitoring
Authorized person may operate electronic equipment under certain conditions.
48BA(3) Use of electronic equipment at premises for monitoring
Authorized person must believe conditions are met
Authorized person has obligation to secure electronic equipment.
48BA(4) Use of electronic equipment at premises for monitoring
he or she may do whatever is necessary...
(4) If the authorised person believes...
48C Use of electronic equipment at premises relating to offences and
Authorized person may operate electronic equipment to access evidential material.
48C(1) Use of electronic equipment at premises relating to offences and
Authorized person may seize equipment or operate electronic equipment to access evidential material.
48C(2) Use of electronic equipment at premises relating to offences and
Seize equipment or operate electronic equipment.
Authorized person has permission to seize equipment or operate electronic equipment.
Authorized person is authorized to access evidential material.
48C(2A) Use of electronic equipment at premises relating to offences and
Temporal overlap between authorized operation and potential damage
(2A) An authorised person may operate electronic equipment as mentioned in subsection (1) or (2)
Integration of authorized operation with other conditions
Permission to operate electronic equipment
Spread of authorized operation to other conditions
Temporal relationship between authorized operation and potential damage
Seizure of equipment under certain conditions
48C(3) Use of electronic equipment at premises relating to offences and
Prohibits seizure without specified conditions
(3) An authorised person may seize equipment...
Authorized person may take necessary actions to secure electronic equipment.
48C(4) Use of electronic equipment at premises relating to offences and
Temporal relation: authorized action during premises visit.
Authorised person must give notice to occupier of premises before securing equipment.
48C(5) Use of electronic equipment at premises relating to offences and
The authorised person must give notice...
48D Compensation for damage to electronic equipment
Compensation for damage to electronic equipment if caused by insufficient care.
48D(1) Compensation for damage to electronic equipment
...compensation for the damage is payable.
Compensation is payable out of money appropriated by the Parliament for the purpose.
48D(2) Compensation for damage to electronic equipment
Imposes a duty on the State to provide compensation.
Occupier must provide warning or guidance about equipment operation.
48D(3) Compensation for damage to electronic equipment
48E Copies of seized things to be provided
Must provide a copy of seized documents or information to the occupier upon request.
48E(1) Copies of seized things to be provided
Must provide a copy of seized documents or information.
Possession of seized things may constitute an offence against a law or civil penalty provision.
48E(2) Copies of seized things to be provided
48F Occupier entitled to be present during search
Occupier entitled to be present during search
48F(1) Occupier entitled to be present during search
Right to observe search ceases if person impedes search.
48F(2) Occupier entitled to be present during search
Right to observe ceases during overlap with impediment
Search and impediment are temporal intervals
48F(3) Occupier entitled to be present during search
Occupier must provide facilities and assistance for warrant execution.
48FA Responsibility to provide facilities and assistance
48G Receipts for things seized under warrant
Authorised person must provide a receipt for seized thing.
48G(1) Receipts for things seized under warrant
Things seized or moved may be covered in one receipt.
48G(2) Receipts for things seized under warrant
48H Retention of seized things
Must return seized thing if reason for seizure no longer exists or period ends
48H(1) Retention of seized things
Seizure period is an interval that must be considered when determining return of seized thing
Authorised person must return seized thing if condition is met
Reason for seizure no longer exists or period ends
Return of seized thing depends on reason for seizure no longer existing or period ending
Seizure period is a trace that must be considered when determining return of seized thing
Return seized things after 120 days unless proceedings are ongoing or authorized by law.
48H(2) Retention of seized things
Thing must be returned within 120 days unless proceedings are ongoing or authorized by law.
End of 120 days specified in subsection (1)
Thing is subject to retention requirements
Knowledge representation of seized things
Thing must be returned unless proceedings are ongoing or authorized by law.
Authorized person must take reasonable steps to return thing
Authorized person may retain thing because of order under section 48J
Recurring requirement to return seized things
Proceedings in respect of which thing may afford evidence were instituted before end of 120 days
The thing may be returned under subsection (2) either unconditionally or on such terms and conditions as the Secretary sees fit.
48H(3) Retention of seized things
48J Issuing officer may permit a thing to be retained
Issuing officer may permit a thing to be retained for a further period under certain conditions.
48J(1) Issuing officer may permit a thing to be retained
Thing may be retained for a further period
Issuing officer may permit a thing to be retained
Issuing officer may permit an authorised person to retain a thing for a specified period.
48J(2) Issuing officer may permit a thing to be retained
Authorised person may retain the thing for a specified period.
Permission granted by the issuing officer.
Issuing officer may permit an authorised person to retain a thing.
48J(3) Issuing officer may permit a thing to be retained
49 Monitoring warrants
Authorized person may apply for a warrant under this section.
49(1) Monitoring warrants
Issuing officer must issue warrant if satisfied by oath that access is necessary.
49(2) Monitoring warrants
Information on oath is sufficient for issuing officer to make decision.
Further information (if any) as the issuing officer requires concerning the grounds on which the issue of the warrant is being sought.
Issuing officer must provide additional information before issuing warrant.
49(3) Monitoring warrants
The issuing officer must provide additional information.
Warrant must authorise entry and exercise powers under specified conditions.
49(4) Monitoring warrants
...on which the warrant ceases to have effect;
Warrant's effect is limited to a specified time period.
(4) The warrant must: (c) specify the day (not more than 6 months after the issue of the warrant) on which the warrant ceases to have effect...
...with such assistance and by such force as is necessary and reasonable...;
Warrant implies specified conditions for entry.
(4) The warrant must: (a) authorise one or more authorised persons...
...and exercise the powers set out in subsection 48(1)...
Prohibits warrant from authorising entry without specified conditions.
Warrant authorises entry and exercise of powers under specified conditions.
Warrant's authority is limited to a specified time period.
Compilation information and notes on amendments, applications, saving, transitional provisions, editorial changes, presentational changes, modifications, and self-repealing provisions.
5 September 2025
5 Dec 1999 (gaz 1999,
5 Sept 2006
5 Sept 2006 (s 2)
5 Mar 2018
Classifies the text as a compilation of the Therapeutic Goods Act 1989.
The text describes itself as a compilation.
The compilation date is September 5, 2025, and it includes sections 1-41A and 41B-69.
Identifies the compilation date and contents.
The text mentions the compilation date and contents.
Uncommenced amendments are not shown in the text of the compiled law.
Notes on amendments and uncommenced amendments.
The text mentions uncommenced amendments.
Application, saving, and transitional provisions.
The text mentions applications, saving, and transitional provisions.
Presentational changes are applied to give a more consistent look and feel.
Editorial changes and presentational changes.
The compiled law operates as modified but the modification does not amend the text of the law.
Modifications and self-repealing provisions.
50 Offence and civil penalty provision related warrants
Authorized person may apply for warrant under this section.
50(1) Offence and civil penalty provision related warrants
Issuing officer may issue warrant if satisfied of reasonable grounds for suspecting evidential material within 72 hours.
50(2) Offence and civil penalty provision related warrants
Issuing officer has reasonable grounds for suspecting evidential material
Issuing officer must provide further information before issuing warrant.
50(3) Offence and civil penalty provision related warrants
Issuing officer must provide further information.
Warrant requirements for entry and seizure of evidential material
50(4) Offence and civil penalty provision related warrants
Prohibits warrant issuance without specified conditions
Authorized person may apply for warrant by telephone in urgent cases.
51 Offence and civil penalty provision related warrants by telephone
Request for inspection under Mutual Recognition Convention
51A Inspections for purposes of Mutual Recognition Convention
51B Offences relating to warrants
Making false statements in a warrant application is prohibited.
51B(1) Offences relating to warrants
Prohibits false statements about warrants
51B(2) Offences relating to warrants
51C Issuing officers—personal capacity
Issuing officers must act in a personal capacity when exercising powers under this Part.
51C(1) Issuing officers—personal capacity
Obligation to act in a personal capacity
Issuing officers must act in a personal capacity.
No court or judicial authority can override the issuing officer's personal capacity
No court or judicial authority can override this obligation
The issuing officer must act in a personal capacity when exercising powers under this Part
(1) A power conferred on an issuing officer by this Part is conferred on the issuing officer: (a) in a personal capacity; and
(b) not as a court, or as a member or an officer of a court.
Issuing officer must accept power conferred.
51C(2) Issuing officers—personal capacity
The issuing officer MUST accept the power conferred.
The issuing officer need not accept the power conferred.
Issuing officers have protection and immunity in their personal capacity.
51C(3) Issuing officers—personal capacity
Same protection and immunity as court or officer
52 Identity cards
The Secretary must ensure that each authorised person is issued with an identity card.
52(1) Identity cards
Return identity card after ceasing to be authorised person.
52(3) Identity cards
Temporal interval for returning identity card
Consequence of ceasing to be authorised person
An offence under subsection (3) is prohibited.
52(4) Identity cards
Prohibits an offence under subsection (3)
(4) An offence under subsection (3) is an offence of strict liability.
52A Definitions
Defines terms for the current Poisons Standard and substance scheduling.
52A(1) Definitions
scheduling in relation to a substance means determining the schedule or schedules...
substance means an ingredient, compound, material or preparation...
the first Poisons Standard is the latest edition at the commencement of this Part of the document known as the Standard for...
Defines the first Poisons Standard as the latest edition at commencement.
first Poisons Standard means the latest edition at the commencement of this Part of the document known as the Standard for...
the substance is an ingredient, compound, material or preparation that may cause death, illness or injury.
Defines substance as an ingredient, compound, material or preparation that may cause death, illness or injury.
substance means: (a) an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury to persons or animals;
the current Poisons Standard is the document last prepared under paragraph 52D(2)(b).
Defines the current Poisons Standard as the document last prepared under paragraph 52D(2)(b).
(1) In this Part, unless the contrary intention appears: current Poisons Standard means: (a) if no document has been prepared under paragraph 52D(2)(b)—the first Poisons Standard; or (b) otherwise—the document last prepared under that paragraph...
scheduling in relation to a substance means determining the schedule or schedules to the current Poisons Standard.
Defines scheduling as determining the schedule or schedules to the current Poisons Standard.
scheduling, in relation to a substance, means determining the schedule or schedules to the current Poisons Standard in which the name or a description of the substance is to be included.
the substance is an ingredient, compound, material or preparation specified under subsection (2).
Defines substance as an ingredient, compound, material or preparation specified under subsection (2).
substance means: (b) an ingredient, compound, material or preparation specified under subsection (2);
Secretary may specify ingredients for purposes of definition
52A(2) Definitions
Restrictions on supply of scheduled substances for public health and safety
52AA Overview
Imposes an obligation on the state to restrict supply
52B Advisory Committee on Medicines Scheduling
Establishment of Advisory Committee on Medicines Scheduling
52B(1) Advisory Committee on Medicines Scheduling
Committee constitution and meeting requirements
52B(2) Advisory Committee on Medicines Scheduling
Each State and the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling.
52B(3) Advisory Committee on Medicines Scheduling
The nomination and appointment of a member of the Advisory Committee on Medicines Scheduling occur between these entities.
There is an interval between the nomination and the appointment of a member of the Advisory Committee on Medicines Scheduling.
(3) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled...
A State or the Commonwealth can nominate a member of the Advisory Committee on Medicines Scheduling.
Entitlement to nominate a member of the Advisory Committee on Medicines Scheduling.
The Commonwealth, each State, the Australian Capital Territory and the Northern Territory are each entitled...
The information about the nomination of a member of the Advisory Committee on Medicines Scheduling is diffused to the relevant parties.
Makes recommendations to the Secretary on therapeutic goods classification and scheduling.
52B(4) Advisory Committee on Medicines Scheduling
52C Advisory Committee on Chemicals Scheduling
Establishment of Advisory Committee on Chemicals Scheduling
52C(1) Advisory Committee on Chemicals Scheduling
Establishes the Advisory Committee on Chemicals Scheduling
52C(2) Advisory Committee on Chemicals Scheduling
Each State and the Commonwealth can nominate a member to the Advisory Committee on Chemicals Scheduling.
52C(3) Advisory Committee on Chemicals Scheduling
The Committee must make recommendations to the Secretary on certain matters.
52C(4) Advisory Committee on Chemicals Scheduling
The Committee must make recommendations.
Exempts therapeutic goods from certain provisions.
52C(5) Advisory Committee on Chemicals Scheduling
Therapeutic goods include certain substances.
do not apply in relation to substances...
Exempts substances from certain provisions.
52CA Joint meetings
52D Poisons Standard
Commences with a prepared Poisons Standard
52D(1) Poisons Standard
the first Poisons Standard is taken to have been prepared and made available at the commencement of this Part
Describes a temporal relationship between events
the first Poisons Standard is taken to have been prepared and made available by the then National Drugs and Poisons Schedule Committee
Describes a fact about the standard's preparation using AI
the first Poisons Standard is taken to have been prepared and made available
Establishes the commencement of a standard
Describes a fact about the standard's preparation using N3 logic
Describes a fact about the standard's preparation using SHACL
Secretary may amend or prepare a new Poisons Standard.
52D(2) Poisons Standard
52D(3) Poisons Standard
(3) The Secretary may exercise a power...
Instrument made under paragraph (2)(a) or (b) is a legislative instrument.
52D(4A) Poisons Standard
Allows for incorporation of existing provisions from other instruments or writings.
52D(4B) Poisons Standard
Definition of 'Administration' in relation to the current Poisons Standard
52D(5) Poisons Standard
52E Secretary to take certain matters into account in exercising
Secretary must consider certain matters when exercising power. Allow person to apply for amendment of current Poisons Standard.
52E(1) Secretary to take certain matters into account in exercising
Grant permission to apply for amendment.
Application form, amendment sought, office of Department, application fee
Application requirements Secretary must comply with guidelines from the Australian Health Ministers’ Advisory Council and the National Coordinating Committee on Therapeutic Goods.
52E(2) Secretary to take certain matters into account in exercising
The guidelines were notified to the Secretary for at least one year before this section came into effect
Guidelines are notified to the Secretary for at least one year before this section comes into effect
The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is notified to the Secretary
The guidelines are a type of knowledge that can be used to make decisions
Guidelines are a type of knowledge that can be used to make decisions
The Secretary has a power under subsection 52D(2)
The Secretary must comply with the guidelines
The subcommittee of the Council known as the National Coordinating Committee on Therapeutic Goods is a type of guideline that can be shared and applied by others
Guidelines are a type of guideline that can be shared and applied by others
The Australian Health Ministers’ Advisory Council has guidelines
All powers under subsection 52D(2) must comply with the guidelines
Guidelines are applicable to all powers under subsection 52D(2)
Must consider recommendations or advice from Advisory Committees Secretary must require person to provide further information within a reasonable time.
52E(3) Secretary to take certain matters into account in exercising
Application may be required or permitted for specified software requirements Secretary may seek advice from committees or persons when exercising power.
52E(4) Secretary to take certain matters into account in exercising
(4) In exercising a power under subsection 52D(2), the Secretary may seek advice from either or both of the following:
Incorporating committees and persons into decision-making.
Application for specified software requirements
Diffusing information to committees and persons.
Secretary must consider additional information when exercising power
52E(5) Secretary to take certain matters into account in exercising
(5) Subsections (2) to (4) do not limit the information the Secretary may consider in exercising a power under subsection 52D(2).
52F Incorporation of current Poisons Standard
Legislative instrument may incorporate current Poisons Standard.
52F(1) Incorporation of current Poisons Standard
Incorporation of matter from current Poisons Standard.
An instrument under this Act may incorporate the current Poisons Standard with modifications.
52F(2) Incorporation of current Poisons Standard
Incorporation of current Poisons Standard
52G Exemptions, approvals and authorities to be consistent with
Absolute prohibitions apply to therapeutic goods or vaping goods.
52G(1) Exemptions, approvals and authorities to be consistent with
thing referred to in subsection (3) of this section
Exemptions and approvals must be consistent with prohibitions
52G(2) Exemptions, approvals and authorities to be consistent with
List of exemptions, approvals and authorities to be consistent with
52G(3) Exemptions, approvals and authorities to be consistent with
List of exemptions, approvals and authorities
Department may retain application and material upon withdrawal.
53 Retention of material on withdrawal of application
Prohibits Department from releasing application and material.
Classifies retained application and material as confidential.
If a jury acquits a person of an offence against a provision listed in column 2 of an item in the following table, but is satisfied beyond reasonable doubt of facts that prove that the person is guilty of the offence listed in column 3 of that item, the jury may convict the person of the offence listed in column 3 of that item.
53A Alternative verdicts for various offences
...the jury may instead convict the person of an offence against...
The provision specifies a temporal overlap between two events.
If a prosecution is for an offence against...
...the jury may convict the person of the offence listed in column 3 of that item:
The provision implies a causal relationship between two events.
If a jury acquits a person of an offence against a provision listed in column 2...
The provision imposes an obligation on the State to convict a person of an offence if certain conditions are met.
The provision diffuses information from one event to another.
The provision specifies a recurring pattern.
54 Offences and forfeiture
Forfeiture of goods in relation to therapeutic or vaping products
54(3) Offences and forfeiture
The goods overlap with therapeutic or vaping products
Goods must overlap with therapeutic or vaping products
(3) If a court orders that the goods be forfeited in relation to any therapeutic goods or vaping goods
The goods must be forfeited to the Commonwealth
(3) If a court orders that the goods be forfeited
Notice of forfeiture must be published in Gazette or website.
54(4) Offences and forfeiture
Prohibits publication of notice without Secretary's action.
Goods forfeited under an order must be disposed of in a manner specified by the Secretary.
54(5) Offences and forfeiture
Prohibits disposal of goods in a manner other than specified by the Secretary.
Prosecution can be commenced within 3 years after commission of the offence.
54A Time for bringing prosecutions
Ability to commence prosecution within specified timeframe.
54AA Offences for contravening conditions or requirements
Breach of licence or permission conditions results in an offence.
54AA(1) Offences for contravening conditions or requirements
the conduct occurs during the period of the licence or permission.
Describes temporal overlap between licence/permission and conduct
(1) If: (a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct;
the person commits an offence punishable on conviction by a fine of no more than the number of penalty units specified in whichever of subsection (2) or (3) applies.
(a) a person holds a licence or a permission to import or export therapeutic goods; and (b) the person engages in conduct; and (c) the conduct breaches a condition or a requirement to which the licence or permission is subject under the regulations;
Prohibits breach of conditions or requirements
(c) the conduct breaches a condition or a requirement to which the licence or permission is subject under the regulations;
the conduct ends before the period of the licence or permission.
Describes temporal relationship between licence/permission and conduct
Engaging in conduct means doing an act or omitting to perform an act.
54AA(1A) Offences for contravening conditions or requirements
Increased penalty for contravention of certain conditions or requirements
54AA(2) Offences for contravening conditions or requirements
Penalty for contravention of conditions or requirements
54AA(3) Offences for contravening conditions or requirements
54AB Criminal offence for damaging etc. documents
Damaging or destroying documents for purposes of this Act is a criminal offence.
54AB(1) Criminal offence for damaging etc. documents
Documents must be created, retained or issued within the same temporal interval as this Act.
(b) the document is created, retained or issued for the purposes...
For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
This Act must be classified as a legal provision.
Penalty: 7 years imprisonment or 2,000 penalty units, or both.
Prohibits damaging or destroying documents.
This Act must diffuse to all documents created, retained or issued within its temporal interval.
Documents must be part of a recurring trace that includes this Act.
Strict liability applies for damaging documents
54AB(2) Criminal offence for damaging etc. documents
Damaging, destroying, altering, concealing or falsifying documents for purposes of the Act.
54AC Civil penalty for damaging etc. documents
Document is created, retained or issued for the purposes of this Act.
Documents must be created, retained or issued within a specific time frame.
Prohibits damaging, destroying, altering, concealing or falsifying documents.
Documents must be regularly updated or reviewed.
54B Personal liability of an executive officer of a body corporate—
Executive officer commits an offence if they knew and failed to prevent the commission of an offence against the Act.
54B(1) Personal liability of an executive officer of a body corporate—
Executive officer has a duty to prevent commission of offence.
Executive officer is part of a class with a specific description.
An executive officer of a body corporate.
Executive officer must know the offence will be committed.
Offence occurred within a specific time interval.
Maximum penalty for an offence against subsection (1)
54B(2) Personal liability of an executive officer of a body corporate—
Executive officer must take reasonable steps to prevent contravention of civil penalty provision.
54B(3) Personal liability of an executive officer of a body corporate—
The executive officer must take reasonable steps to prevent the contravention.
Executive officer has an obligation to prevent contravention.
The executive officer knew the contravention would occur.
The executive officer was in a position to influence the conduct of the body corporate.
The executive officer failed to take all reasonable steps to prevent the contravention.
Maximum civil penalty for contravention of subsection (3)
54B(4) Personal liability of an executive officer of a body corporate—
Defines executive officer of a body corporate
54B(5) Personal liability of an executive officer of a body corporate—
Personal liability of an executive officer of a body corporate—
54BA Personal liability of an executive officer of a body corporate—
Personal liability covered by this section
54C Establishing whether an executive officer took reasonable steps
Executive officer must take reasonable steps to prevent commission of offence.
54C(1) Establishing whether an executive officer took reasonable steps
The officer's awareness of the body's commission of an offence overlaps with their obligation to prevent the commission of the offence.
The officer's awareness of the body's commission of an offence is relevant to determining their obligations.
The officer became aware that the body was committing an offence against this Act or the regulations.
The officer must take all reasonable steps to prevent the commission of the offence.
Executive officer has an obligation to take reasonable steps.
The executive officer is responsible for preventing the commission of the offence.
The officer must take action when they become aware that the body is committing an offence.
The officer has an obligation to take action when they become aware that the body is committing an offence.
When the officer became aware that the body was committing an offence against this Act or the regulations, they had an obligation to take action.
The officer must ensure that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements.
The officer has an obligation to ensure that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements.
The officer is responsible for ensuring that employees, agents, and contractors have a reasonable knowledge and understanding of the requirements.
Does not limit the generality of section 54B by implication.
54C(2) Establishing whether an executive officer took reasonable steps
Executive officer must take reasonable steps
54C(3) Establishing whether an executive officer took reasonable steps
55 Conduct by directors, employees and agents
Director, employee or agent's actual or apparent authority and state of mind
Establishing state of mind of a body corporate in relation to conduct
55(1) Conduct by directors, employees and agents
Body corporate must take reasonable precautions to avoid conduct by directors, employees and agents.
55(2) Conduct by directors, employees and agents
Establishing state of mind for employees or agents
55(3) Conduct by directors, employees and agents
Employer liable for conduct of employee/agent within scope of authority
55(4) Conduct by directors, employees and agents
Employee/agent within scope of authority
No imprisonment for certain offences if convicted by a non-corporate person
55(5) Conduct by directors, employees and agents
If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are not liable to be punished by imprisonment for that offence.
No imprisonment implies obligation to refrain from punishment
(5) Where: ... the person is not liable to be punished by imprisonment for that offence.
If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are permitted to receive other forms of punishment
Imprisonment permits other forms of punishment
If a person would not have been convicted of the offence if subsections (3) and (4) had not been enacted, then they are justified in refraining from punishment
Obligation to refrain from punishment justifies no imprisonment
No imprisonment implies obligation to refrain from punishment and permits other forms of punishment
Directors, employees and agents must have certain knowledge or reasons for their intentions.
55(6) Conduct by directors, employees and agents
The person has that knowledge or reason during the action.
Directors, employees and agents must have certain knowledge or reasons during their actions.
The person must justify that intention with those reasons.
Directors, employees and agents must justify their intentions with certain reasons.
Directors, employees and agents must have certain knowledge.
Directors, employees and agents must have certain reasons for their intentions.
The person has a certain intention or purpose.
The person has that knowledge or reason.
Directors, employees and agents must have certain knowledge or reasons.
The person must inform others of that knowledge or reason.
Directors, employees and agents must inform others of their knowledge or reasons.
The person has certain knowledge or reasons.
Directors, employees and agents of a body corporate are subject to this section.
55(7) Conduct by directors, employees and agents
The reference to a director includes a reference to a constituent member of a body corporate.
A director of a body corporate is included in this section.
The constituent member is classified as a body corporate.
Classification of the constituent member
A constituent member is a type of body corporate.
Directors, employees and agents must engage in conduct.
55(8) Conduct by directors, employees and agents
Courts must take judicial notice of certain pharmacopeias.
56 Judicial notice
Courts are required to take judicial notice.
Certificates to provide evidence of certain matters
The Secretary or authorized person must certify certain matters in writing.
56A Certificates to provide evidence of certain matters
57 Delegation
57(1) Delegation
Delegation of power to certain individuals or positions within the Department.
57(10) Delegation
(10) The power of the Minister under subsection 18A(1) or 41P(3) may be delegated only to...
The power of the Minister under subsection 18A(1) or 41P(3) may be delegated only to...
(10AA) The power of the Minister under subsection 30EK(1) may be delegated only to...
Delegation of power to the Minister under subsection 32CB(1)
57(10A) Delegation
Delegation of power to specific individuals or positions.
57(11) Delegation
Delegate must comply with directions of the person who delegated.
57(12) Delegation
Delegate powers and functions to an officer of a Department, unit or authority with related functions.
57(1A) Delegation
Permission to delegate powers and functions.
Delegation of powers to registered medical or dental practitioners or pharmacists.
57(2) Delegation
(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d)
who is registered, or eligible for registration, in a State or internal Territory
or eligible for registration, in a State or internal Territory
Delegation of powers by Secretary to registered medical or dental practitioner
57(3) Delegation
Delegate must follow directions from Secretary, officer, or person referred to in paragraph (1)(c).
57(4) Delegation
Delegate has an obligation to follow directions.
Regulations may make provision for delegates, approvals, and conditions.
57(5) Delegation
57(5A) Delegation
Delegation of powers is restricted to registered medical practitioners.
57(6) Delegation
may only be delegated during the registration period
The powers of the Secretary under subsection 32CM(1) or 41HC(1)
is authorized to delegate powers as a registered medical practitioner
Authorization for delegation by AI system
The person referred to in paragraph (1)(a) or (c)
may be delegated to a registered medical practitioner
are restricted to registered medical practitioners everywhere
Universal applicability of delegation restriction
must be validated as a registered medical practitioner
Regulations may prescribe circumstances for delegate authorities.
57(7) Delegation
Powers of Secretary can be delegated to a specific person.
57(8) Delegation
Powers of Secretary under section 41HD may be delegated to a person holding the prescribed duties.
57(9) Delegation
58 Export certifications
The Secretary may issue export certification for goods for therapeutic use in humans.
58(1) Export certifications
Permission to issue export certification
No export certifications for therapeutic use in humans.
58(2) Export certifications
Secretary may issue export certification for vaping goods not covered by subsection (1)
58(2A) Export certifications
No export certification for vaping goods under subsection (2A) may be issued.
58(2B) Export certifications
...export certification for vaping goods under subsection (2A).
Restriction on export certification timing
(2B) A State or Territory must not issue...
Representation of prohibition in knowledge base
Propagating prohibition of export certification
Fee for certification application and inspection
58(3) Export certifications
59 Fees
59(1) Fees
59(2) Fees
Refusal to grant consent or impose conditions on a grant of consent under section 14 or 14A.
60 Review of decisions
Prohibition of refusal to grant consent or impose conditions.
Classification of decisions under Part 3-2 (registration and listing of therapeutic goods).
60A New information on review—discretion to remit
Secretary or delegate has discretion to remit a decision.
60A(1) New information on review—discretion to remit
Decision must be made within a specific temporal interval.
Minister must reconsider decision or remit to delegate upon new information.
60A(2) New information on review—discretion to remit
Minister has obligation to reconsider decision.
Tribunal may remit matter to delegate for fresh decision if it thinks fit.
60A(3) New information on review—discretion to remit
Tribunal has discretion to remit matter.
Tribunal must not remit the matter under subsection (3) if all of initial new information is information that the Minister took into account.
60A(4) New information on review—discretion to remit
Tribunal's discretion to remit is limited by this overlap.
Initial new information overlaps with the Minister's decision on reconsideration.
Appellant lodges initial new information.
Tribunal's discretion to remit is limited by this repetition.
The Minister's decision on reconsideration repeats the initial new information.
Minister took initial new information into account.
Tribunal must consider initial new information that indicates unacceptable quality, safety or efficacy of therapeutic goods.
60A(5) New information on review—discretion to remit
Initial new information considered within timeframe
Tribunal must consider initial new information within a certain timeframe
Tribunal must consider initial new information
Authorised delegate must make a decision under section 25 taking into account new information.
60A(6) New information on review—discretion to remit
the authorised delegate must make a decision under section 25... within the timeframe specified by the provision.
The decision must be made within a specific timeframe.
the Minister or Tribunal has discretion to remit the matter.
The provision implies that the Minister or Tribunal has discretion to remit the matter.
the authorised delegate must make a decision under section 25...
Must provide a decision under section 25.
the provision does not prohibit making a new application for registration.
The provision is not a prohibition on making a new application for registration.
the authorised delegate must make a decision under section 25 and include the biological in the Register.
The provision requires the authorised delegate to make a decision under section 25 and include the biological in the Register.
The authorised delegate must make a decision under section 41EC, taking into account the initial new information or later new information.
60A(6A) New information on review—discretion to remit
The authorised delegate must make a decision.
Delegates' decisions are treated as decisions under Part 3-2, 3-2A or 4-4 for subsequent applications.
60A(7) New information on review—discretion to remit
Relates to temporal intervals under Part 3-2, 3-2A or 4-4
Involves knowledge representation under Part 3-2, 3-2A or 4-4
Treated as decisions under Part 3-2, 3-2A or 4-4
Involves recurring traces under Part 3-2, 3-2A or 4-4
Validates schema under Part 3-2, 3-2A or 4-4
Defines authorized delegate and conditions for new information.
60A(8) New information on review—discretion to remit
(a) was in existence at the time the decision referred to in subsection (1) was made; and
61 Release of information
Definition of therapeutic goods information and vaping goods information.
61(1) Release of information
Defines terms for the purpose of this section.
Release of information to World Health Organisation
61(2) Release of information
Release of information to authorities for therapeutic goods functions
61(3) Release of information
Release of information to certain authorities and bodies.
61(3A) Release of information
Release of information to national regulatory authorities of other countries.
61(4) Release of information
...of therapeutic goods and their compliance with the manufacturing principles;
Defines the temporal scope of the permission.
(4) The Secretary may release to a national regulatory authority...
Describes how the permission is applied.
Allows release of information to national regulatory authorities.
Describes how the permission is disseminated.
Describes the validation rules for the permission.
Release of information to authorities and international organisations
61(4A) Release of information
...contraventions, or possible contraventions, of Part 5-2 or
Temporal overlap between release and therapeutic goods information
...action taken by the Secretary under Part 5-3;
Implication of release on therapeutic goods information
...action taken by the Secretary under section 32HA (about notification and recall of biologicals);
Inference of release on action taken by the Secretary
...therapeutic goods information relating to one or more of the following:
...action taken by the Secretary under section 30EA (about notification and recall of therapeutic goods);
Propagation of release to action taken by the Secretary
61A Immunity from civil actions
No civil action against Commonwealth or protected person for loss/damage/injury caused by their actions.
61A(1) Immunity from civil actions
Imposes duty on Commonwealth and protected persons.
Immunity from civil actions in bad faith
61A(2) Immunity from civil actions
The period of exemption includes acts in bad faith
Acts in bad faith occur during the period of exemption
(2) Subsection (1) does not apply to an act or omission in bad faith.
Inferential relationship between exemption and bad faith
Subsection (1) does not apply to an act or omission in bad faith.
Exempts acts in bad faith from civil actions
Acts in bad faith are permitted without civil liability
Permits acts in bad faith without civil liability
Subsection (1) is excluded for acts in bad faith
Excludes acts in bad faith from general applicability of subsection (1)
A reference to a failure to make a decision includes a reference to anything omitted to be done.
61A(3) Immunity from civil actions
(3) A reference in subsection (1) to anything omitted to be done includes a reference to a failure to make a decision.
(x) during (y) if and only if x starts before y ends.
(x) includes (y) if and only if x is an obligation that requires y.
(x) requires (y) if and only if x is an obligation that necessitates y.
(x) includes (y) if and only if x is a description that contains y.
(x) contains (y) if and only if x is a description that encompasses y.
(x) includes (y) if and only if x is a linear logic statement that implies y.
Protected persons are defined for immunity from civil actions.
61A(4) Immunity from civil actions
protected person means any of the following:
62 Protection from criminal responsibility
Protected person not criminally responsible for obtaining or possessing goods to comply with laws.
62(1) Protection from criminal responsibility
Temporal overlap: Protected person's actions overlap with law compliance
Protected person obtains goods for compliance
Protected person not criminally responsible for offense related to conveyance of goods
62(2) Protection from criminal responsibility
The conveyance of goods overlaps with finding out compliance
Conveyance of goods overlaps with finding out compliance
(2) If a protected person, in connection with finding out whether this Act or the regulations have been complied with...
The other person is not criminally responsible for an offence against a law of the Commonwealth, or a State law...
The conveyance of goods diffuses to other persons
Conveyance of goods diffuses to other persons
(a) the possession of the goods by the other person, to the extent the possession is in connection with that conveyance of the goods
The conveyance of goods repeats in connection with finding out compliance
Conveyance of goods repeats in connection with finding out compliance
62(3) Protection from criminal responsibility
(b) a person of a kind prescribed by the regulations
Expresses temporal relationships between events
63 Regulations
Governor-General may make regulations not inconsistent with the Act.
63(1) Regulations
Regulations for therapeutic goods and vaping goods
63(2) Regulations
Classify therapeutic goods and vaping goods
Regulations may prescribe different fees under this Act.
63(3) Regulations
Licence or permission to import/export therapeutic goods may be granted.
63(3A) Regulations
Permission to import/export therapeutic goods.
Regulations may incorporate existing instruments or writings.
63(4) Regulations
Regulations may be made before commencement.
63(5) Regulations
66 Transitional arrangements for goods required to be registered or
Therapeutic goods supplying person must comply with transitional arrangements.
66(1) Transitional arrangements for goods required to be registered or
Exemptions from subsection 20(1) and (2) for certain individuals
66(2) Transitional arrangements for goods required to be registered or
Therapeutic goods registration application within 3 months after commencement.
66(3) Transitional arrangements for goods required to be registered or
Notice must be given to person in relation to whom goods are registered.
66(3A) Transitional arrangements for goods required to be registered or
No application fee for registration or listing of goods.
66(4) Transitional arrangements for goods required to be registered or
Transitional arrangements for goods required to be registered or
66(4A) Transitional arrangements for goods required to be registered or
Secretary may give written notice to person listed goods
66(4B) Transitional arrangements for goods required to be registered or
If notice is given under subsection (4B), section 26 applies as if the person in relation to whom the goods are listed were an applicant for the listing of the goods.
66(4C) Transitional arrangements for goods required to be registered or
Exemption from Section 21 for goods during transitional period
66(5) Transitional arrangements for goods required to be registered or
Exempts goods from Section 21 during transitional period
No liability attaches to Commonwealth, Secretary, or delegate for losses caused by therapeutic goods.
66(6) Transitional arrangements for goods required to be registered or
The Commonwealth, Secretary, or delegate is not responsible for losses
No liability implies lack of responsibility
Lack of liability implies no responsibility
The Commonwealth, Secretary, or delegate must provide compensation
This section implies a duty to provide compensation for losses caused by therapeutic goods
Losses are caused by therapeutic goods subject to this section
Loss or damage is covered by this section
Therapeutic goods are a subclass of goods subject to this section
This section applies to therapeutic goods
No liability attaches until this section applies
Liability attaches until loss or damage is covered by this section
Loss or damage occurs before this section applies
Therapeutic goods manufactured in Australia solely for export from Australia are exempt from Section 20 during the first 6 months after commencement.
67 Transitional provision for therapeutic goods for export only
68 Transitional arrangements for Part 3-3
Applicability of transitional arrangements for Part 3-3
68(1) Transitional arrangements for Part 3-3
...to a person in relation to premises in Australia if...
Transitional arrangement applies to a step in the manufacture of therapeutic goods
No prosecution for 4 months after commencement
68(2) Transitional arrangements for Part 3-3
(a) this section applies to a step in the manufacture...
Diffusion of obligation to not prosecute
Application for licence must be made within 4 months after commencement.
68(3) Transitional arrangements for Part 3-3
Continues standards and requirements from Therapeutic Goods Act 1966.
69 Continuation of standards and requirements
Continues existing standards and requirements.
7 July 1997
9 June 2006
Therapeutic Goods Act 1989