Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 (Cth)

Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 No. 38, 2009 An Act to amend the Therapeutic Goods Act 1989, and for related purposes Contents 1 Short title 2 Commencement 3 Schedule(s) Schedule 1—Medical devices Therapeutic Goods Act 1989 Schedule 2—Emergency exemption for therapeutic goods that are not medical devices Therapeutic Goods Act 1989 Schedule 3—Fit and proper person test Therapeutic Goods Act 1989 Schedule 4—Additional default standards Therapeutic Goods Act 1989 Schedule 5—Information disclosure provisions Therapeutic Goods Act 1989 Schedule 6—Advertising Therapeutic Goods Act 1989 Schedule 7—Other amendments Therapeutic Goods Act 1989 Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 No. 38, 2009 An Act to amend the Therapeutic Goods Act 1989, and for related purposes [Assented to 17 June 2009] The Parliament of Australia enacts: 1 Short title This Act may be cited as the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009. 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Commencement information Column 1 Column 2 Column 3 Provision(s) Commencement Date/Details 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day on which this Act receives the Royal Assent. 17 June 2009 2. Schedules 1 and 2 The day after this Act receives the Royal Assent. 18 June 2009 3. Schedule 3 A single day to be fixed by Proclamation. 1 December 2009 However, if any of the provision(s) do not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period. (see F2009L03387) 4. Schedule 4 1 July 2009. 1 July 2009 5. Schedules 5 to 7 The day after this Act receives the Royal Assent. 18 June 2009 Note: This table relates only to the provisions of this Act as originally passed by both Houses of the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent. (2) Column 3 of the table contains additional information that is not part of this Act. Information in this column may be added to or edited in any published version of this Act. 3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. Schedule 1—Medical devices Therapeutic Goods Act 1989 1 After paragraph 41BB(c) Insert: (ca) exempting medical devices from various provisions of this Chapter to deal with emergency situations; and 2 After Part 4‑6 Insert: Part 4‑6A—Exempting medical devices to deal with emergencies 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. Note 1: There are offences and civil penalty provisions related to the making of exemptions under this Part: see Division 3A of Part 4‑11. Note 2: Some of the other provisions of this Act about medical devices exempt under this Part are: (a) section 41JCA (providing information to the Secretary); and (b) section 41KA (public notification and recovery of medical devices); and (c) section 46A (search of premises). 41GS Minister may make exemptions (1) The Minister may, by writing, exempt specified kinds of medical devices from the operation of the following: (a) Division 1 of Part 4‑2 (essential principles); (b) Division 1 of Part 4‑3 (conformity assessment procedures); (c) Part 4‑4 (conformity assessment certificates); (d) Part 4‑5 (including medical devices in the Register). (2) The Minister may make an exemption under subsection (1) only if the Minister is satisfied that, in the national interest, the exemption should be made so that: (a) the devices may be stockpiled as quickly as possible in order to create a preparedness to deal with a potential threat to public health that may be caused by a possible future emergency; or (b) the devices can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred. Period of exemption (3) An exemption under subsection (1) comes into force: (a) on the day the exemption is made; or (b) on a later day specified in the exemption. (4) An exemption under subsection (1) remains in force for the period specified in the exemption, unless revoked earlier. Note: Section 41GU deals with variation and revocation of the exemption. Effect of inclusion of kind of medical device in the Register (5) An exemption under subsection (1) ceases to have effect in relation to a particular kind of medical device when that kind of medical device becomes included in the Register under Part 4‑5. Exemption not a legislative instrument (6) An exemption under subsection (1) is not a legislative instrument. Disregard section 41BE (7) For the purposes of this Act, disregard section 41BE in working out the kinds of medical devices covered by an exemption under subsection (1) of this section. 41GT Conditions of exemptions An exemption under section 41GS is subject to conditions specified in the exemption about any of the following: (a) the quantity of medical devices that are exempt; (b) the source of those medical devices; (c) the persons or class of persons who may import, manufacture, supply or export those medical devices; (d) the supply of those medical devices (including the persons or class of persons to whom medical devices may be supplied for use and the circumstances under which a stockpile of medical devices may be supplied for use); (e) the storage and security of those medical devices; (f) the keeping and disclosure of, and access to, records about those medical devices; (g) the disposal of those medical devices; (h) the manner in which any of those medical devices are to be dealt with if a condition of the exemption is breached; (i) any other matters that the Minister thinks appropriate. Whether or not medical devices are exempt under section 41GS is not affected by whether or not there is a breach of a condition under this section in relation to those medical devices. Note 1: There are offences and civil penalty provisions related to the breach of a condition of an exemption: see Division 3A of Part 4‑11. Note 2: Section 41GU deals with variation and revocation of the conditions. 41GU Variation or revocation of exemption Variation of exemption (1) The Minister may, by writing, vary an exemption made under section 41GS by removing specified kinds of medical devices from the exemption. Revocation of exemption (2) The Minister may, by writing, revoke an exemption made under section 41GS. Variation or revocation of conditions (3) The Minister may, by writing: (a) vary the conditions of an exemption made under section 41GS (including by imposing new conditions); or (b) revoke the conditions of an exemption made under section 41GS. When variation or revocation takes effect (4) A variation or revocation under this section takes effect: (a) if the Minister states in the variation or revocation that the variation or revocation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day the variation or revocation is made; or (b) in any other case—on a later day specified in the variation or revocation (which must not be earlier than 28 days after the day the variation or revocation is made). 41GV Informing persons of exemption etc. If the Minister makes an exemption under section 41GS, the Minister must take reasonable steps to give a copy of the following to each person covered by paragraph 41GT(c): (a) the exemption; (b) any variation or revocation of the exemption under section 41GU. 41GW Notification and tabling Notification (1) The Secretary must cause a notice setting out particulars of the following: (a) an exemption made under section 41GS because of paragraph 41GS(2)(b); (b) a variation or revocation under section 41GU, to the extent that the variation or revocation relates to an exemption made under section 41GS because of paragraph 41GS(2)(b); to be published in the Gazette within 5 working days after the day on which the exemption, variation or revocation is made. However, the exemption, variation or revocation is not invalid merely because of a failure to comply with this subsection. Tabling (2) The Minister must cause a document setting out particulars of the following: (a) an exemption made under section 41GS because of paragraph 41GS(2)(b); (b) a variation or revocation under section 41GU, to the extent that the variation or revocation relates to an exemption made under section 41GS because of paragraph 41GS(2)(b); to be tabled in each House of the Parliament within 5 sitting days of that House after the day on which the exemption, variation or revocation is made. However, the exemption, variation or revocation is not invalid merely because of a failure to comply with this subsection. 41GX Exclusion of liability of the Commonwealth etc. An exemption under section 41GS does not render the Commonwealth, the Minister or a delegate of the Minister liable to a person for loss, damage or injury of any kind suffered by the person as a result of, or arising out of, the use by that person or another person of a medical device of a kind covered by the exemption. 41GY Disposal of unused medical devices (1) This section applies to a medical device if: (a) an exemption under section 41GS in relation to that kind of medical device ceases to have effect otherwise than because that kind of medical device becomes included in the Register under Part 4‑5; and (b) the medical device has not been used before the exemption so ceases to have effect. (2) The Secretary may arrange for the disposal of the medical device in accordance with the regulations. (3) Regulations made for the purposes of subsection (2) may set out the methods by which the medical device is to be stored, supplied, destroyed, exported or otherwise disposed of. (4) A method set out in the regulations under subsection (3) must not enable or permit any benefit to be conferred on a person (including the Commonwealth) other than the owner of the medical device. 3 Part 4‑7 (heading) Repeal the heading, substitute: Part 4‑7—Other exemptions from including medical devices in the Register 4 Section 41H Omit "There are 3", substitute "In addition to Part 4‑6A, there are 3 other". 5 Section 41J After "exemptions under", insert "Part 4‑6A or". 6 Before section 41JD Insert: 41JCA Secretary may require information etc. about medical devices exempt under Part 4‑6A (1) This section applies to a person who is required to comply with a condition of an exemption of a kind of medical device under section 41GS. (2) The Secretary may, by written notice given to the person, require the person to give to the Secretary specified information or documents relating to one or more of the following: (a) the supply of devices of that kind; (b) the handling of devices of that kind; (c) the monitoring of the supply of devices of that kind; (d) the results of the supply of devices of that kind; (e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of that kind. (3) The notice must specify a reasonable period within which the person to whom the notice is given must comply. The period must be at least 10 working days starting on the day on which the notice is given. (4) The notice may require information to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. 7 Paragraph 41JG(a) After "section", insert "41JCA,". 8 Section 41JG (note) After "sections", insert "41JCA,". 9 Section 41JH After "section", insert "41JCA,". 10 Paragraph 41JI(1)(c) After "section", insert "41JCA,". 11 Subsection 41JJ(1) After "section", insert "41JCA,". 12 Subsection 41KA(1) (after paragraph (a) of the cell at table item 5, column headed "Circumstance relating to a kind of medical device") Insert: (aa) it is not covered by an exemption in force under section 41GS; and 13 Subsection 41KA(1) (after table item 5) Insert: 5A. It is supplied while it is covered by an exemption in force under section 41GS, and the Secretary is satisfied that it is not fit to be used for its intended purpose The person supplying the kind of medical device 14 Section 41M After "Divisions 3", insert ", 3A". 15 After paragraphs 41MA(1)(c) and (2)(c) Insert: (ca) the device is not of a kind covered by an exemption in force under section 41GS; and 16 After paragraph 41MA(4)(c) Insert: ; and (d) the device is not of a kind covered by an exemption in force under section 41GS. 17 After paragraphs 41MA(5)(c) and (6)(c) Insert: (ca) the device is not of a kind covered by an exemption in force under section 41GS; and 18 After paragraph 41MA(8)(c) Insert: ; and (d) the device is not of a kind covered by an exemption in force under section 41GS. 19 After paragraphs 41MA(9)(c) and (10)(c) Insert: (ca) the device is not of a kind covered by an exemption in force under section 41GS; and 20 After paragraph 41MA(12)(c) Insert: ; and (d) the device is not of a kind covered by an exemption in force under section 41GS. 21 After paragraphs 41MAA(1)(c), (2)(c) and (3)(c) Insert: ; and (d) the device is not of a kind covered by an exemption in force under section 41GS. 22 After paragraphs 41ME(1)(c) and (2)(c) Insert: (ca) the device is not of a kind covered by an exemption in force under section 41GS; and 23 After paragraph 41ME(4)(c) Insert: ; and (d) the device is not of a kind covered by an exemption in force under section 41GS. 24 After paragraphs 41ME(5)(c) and (6)(c) Insert: (ca) the device is not of a kind covered by an exemption in force under section 41GS; and 25 After paragraph 41ME(8)(c) Insert: ; and (d) the device is not of a kind covered by an exemption in force under section 41GS. 26 After paragraphs 41MEA(1)(c) and (2)(c) Insert: ; and (d) the device is not of a kind covered by an exemption in force under section 41GS. 27 After paragraph 41MF(1)(b) Insert: (ba) the device is not of a kind covered by an exemption in force under section 41GS; and 28 After paragraph 41MF(2)(b) Insert: ; and (c) the device is not of a kind covered by an exemption in force under section 41GS. 29 After paragraph 41MF(3)(b) Insert: (ba) the device is not of a kind covered by an exemption in force under section 41GS; and 30 After paragraph 41MF(4)(b) Insert: ; and (c) the device is not of a kind covered by an exemption in force under section 41GS. 31 After subparagraphs 41MI(1)(b)(i), (2)(b)(i) and (4)(b)(i) Insert: (ia) the device is of a kind covered by an exemption in force under section 41GS; 32 Paragraph 41MIB(1)(b) Omit "paragraphs", substitute "subparagraphs". 33 After subparagraph 41MIB(1)(b)(i) Insert: (ia) the device is of a kind covered by an exemption in force under section 41GS; 34 After subparagraph 41MK(b)(i) Insert: (ia) the device is of a kind covered by an exemption in force under section 41GS; 35 After Division 3 of Part 4‑11 Insert: Division 3A—Offences and civil penalties related to exemptions under Part 4‑6A 41MNB Criminal offences for breaching a condition of an exemption (1) A person commits an offence if: (a) the person does an act or omits to do an act in relation to a medical device; and (b) the device is of a kind covered by an exemption in force under section 41GS; and (c) the act or omission results in the breach of a condition of the exemption; and (d) the act or omission is likely to cause a serious risk to public health. Penalty: Imprisonment for 5 years or 2,000 penalty units, or both. (2) Strict liability applies to paragraph (1)(b). Note: For strict liability, see section 6.1 of the Criminal Code. (3) A person commits an offence if: (a) the person does an act or omits to do an act in relation to a medical device; and (b) the device is of a kind covered by an exemption in force under section 41GS; and (c) the act or omission results in the breach of a condition of the exemption. Penalty: Imprisonment for 4 years or 240 penalty units, or both. (4) Strict liability applies to paragraph (3)(b). Note: For strict liability, see section 6.1 of the Criminal Code. (5) A person commits an offence if: (a) the person does an act or omits to do an act in relation to a medical device; and (b) the device is of a kind covered by an exemption in force under section 41GS; and (c) the act or omission results in the breach of a condition of the exemption. Penalty: 60 penalty units. (6) An offence against subsection (5) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. 41MNC Civil penalty for breaching a condition of an exemption A person contravenes this section if: (a) the person does an act or omits to do an act in relation to a medical device; and (b) the device is of a kind covered by an exemption in force under section 41GS; and (c) the act or omission results in the breach of a condition of the exemption. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. 41MND Civil penalty for making misrepresentations about medical devices A person contravenes this section if: (a) the person makes a representation that medical devices are of a kind covered by an exemption in force under section 41GS; and (b) the representation is false or misleading. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. 36 After subparagraph 46A(4)(a)(ii) Insert: (iiaa) who is required to comply with a condition of an exemption of a kind of medical device under section 41GS; or 37 After paragraph 56A(1)(a) Insert: (aaa) there was no exemption in force under section 41GS in relation to a particular kind of medical device; or 38 Subsection 57(1) Omit "(10)", substitute "(11)". 39 At the end of section 57 Add: (11) The power of the Minister under subsection 41GS(1) may be delegated only to the Secretary. 40 Subsection 61(3A) After "31B,", insert "41JCA,". Schedule 2—Emergency exemption for therapeutic goods that are not medical devices Therapeutic Goods Act 1989 1 Subsection 18A(9A) Repeal the subsection, substitute: Exemption not a legislative instrument (9A) An exemption under subsection (1) is not a legislative instrument. Informing persons of exemption etc. (9B) If the Minister makes an exemption under subsection (1), the Minister must take reasonable steps to give a copy of the following to each person covered by paragraph (7)(d): (a) the exemption; (b) any revocation or variation of the exemption under this section. 2 Paragraphs 18A(10)(b) and (11)(b) Omit "subsection (8)", substitute "this section". 3 Subsection 57(10) Omit "paragraph 18A(2)(a)", substitute "subsection 18A(1)". 4 Application (1) The amendment made by item 1 applies in relation to an exemption made on or after the commencement of that item. (2) The amendment made by item 2 applies in relation to a revocation or variation made on or after the commencement of that item (whether the exemption was made before, on or after that commencement). Schedule 3—Fit and proper person test Therapeutic Goods Act 1989 1 Subsection 3(1) Insert: major interest holder of a body corporate means a person who: (a) is in a position to cast, or control the casting of, more than one‑fifth of the maximum number of votes that might be cast at a general meeting of the body corporate; or (b) holds more than one‑fifth of the issued share capital of the body corporate (excluding any part of that issued share capital that carries no right to participate beyond a specified amount in a distribution of either profits or capital). 2 Paragraphs 38(1)(g) to (i) Repeal the paragraphs, substitute: (g) at least one of the following persons: (i) the applicant; (ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant's affairs; (iii) if the applicant is a body corporate—a major interest holder of the body corporate; has, within the 10 years immediately before the application: (iv) been convicted of an offence against this Act or a corresponding State law; or (v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or (vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (viii) breached a condition of a manufacturing licence; or (ix) had a manufacturing licence suspended or revoked; or (x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or (h) any other circumstances prescribed by the regulations for the purposes of this paragraph exist. 3 Subsection 38(1A) Repeal the subsection, substitute: (1A) A reference in paragraph (1)(g) 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 under: (a) section 19B of the Crimes Act 1914; or (b) a corresponding provision of a law of a State or Territory. Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction. (1AA) Paragraph (1)(g) does not limit paragraph (1)(h). 4 Subsection 38(1B) Omit "subsection (1A)", substitute "paragraph (1)(g)". 5 Subsection 38(2) Omit "paragraphs (1)(g), (h) and (i)", substitute "paragraph (1)(g)". 6 Subsection 38(2) Omit "one or more of those paragraphs", substitute "that paragraph". 7 After paragraph 40(4)(ab) Insert: (ac) give the Secretary the information specified in a notice under subsection (6) within the period, and in the manner, specified in the notice; and 8 At the end of section 40 Add: (6) The Secretary may, by notice in writing given to the holder of a licence, require the holder to give the Secretary, within the specified period and in the specified manner, specified information to be used by the Secretary in deciding whether to revoke or suspend the licence under section 41 in the circumstances referred to in paragraph 41(1)(a). (7) The period specified in a notice given under subsection (6) must be at least 14 days after the notice is given. 9 Paragraphs 41(1)(a) to (cd) Repeal the paragraphs, substitute: (a) at least one of the following persons: (i) the holder; (ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the holder's affairs; (iii) if the holder is a body corporate—a major interest holder of the body corporate; has: (iv) been convicted of an offence against this Act or a corresponding State law; or (v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or (vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (viii) breached a condition of a manufacturing licence; or (ix) had a manufacturing licence suspended or revoked; or (x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or 10 At the end of subsection 41(1) Add: ; or (h) any other circumstances prescribed by the regulations for the purposes of this paragraph exist. 11 Subsection 41(1A) Repeal the subsection, substitute: (1A) A reference in paragraph (1)(a) 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 under: (a) section 19B of the Crimes Act 1914; or (b) a corresponding provision of a law of a State or Territory. Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction. (1B) Paragraph (1)(a) does not limit paragraph (1)(h). (1C) In paragraph (1)(a): manufacturing licence means: (a) a licence granted under this Part; or (b) a licence, granted under a law of a State or Territory relating to therapeutic goods, relating to manufacturing therapeutic goods. 12 After section 41 Insert: 41AA Spent convictions scheme Nothing in section 40 or 41 affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them). 13 Paragraphs 41EC(3)(a) to (c) Repeal the paragraphs, substitute: (a) whether at least one of the following persons: (i) the applicant; (ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the applicant's affairs; (iii) if the applicant is a body corporate—a major interest holder of the body corporate; has, within the 10 years immediately before the application: (iv) been convicted of an offence against this Act or a corresponding State law; or (v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or (vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (viii) breached a condition of a conformity assessment certificate; or (ix) had a conformity assessment certificate suspended or revoked; or (x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 year period, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or (b) whether any other circumstances prescribed by the regulations for the purposes of this paragraph exist. 14 Subsection 41EC(4) Repeal the subsection, substitute: (4) A reference in paragraph (3)(a) 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 under: (a) section 19B of the Crimes Act 1914; or (b) a corresponding provision of a law of a State or Territory. Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction. (5) Paragraph (3)(a) does not limit paragraph (3)(b). 15 Paragraph 41EG(c) Omit "relating to a kind of medical device to which the application relates". 16 After subsection 41EJ(5) Insert: Conditions in regulations (5A) A conformity assessment certificate is subject to any conditions prescribed by the regulations for the purposes of this subsection. 17 Paragraph 41ET(1)(c) Repeal the paragraph, substitute: (c) the Secretary gives to the person a notice under section 41JA that requires the person to give to the Secretary information or documents and the person fails to comply with that notice within a further 10 working days from the day specified in that notice; or 18 Paragraphs 41ET(1)(e) to (g) Repeal the paragraphs, substitute: (e) at least one of the following persons: (i) the person (the holder) in relation to whom the certificate is issued; (ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the holder's affairs; (iii) if the holder is a body corporate—a major interest holder of the body corporate; has: (iv) been convicted of an offence against this Act or a corresponding State law; or (v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of this Act or a corresponding State law; or (vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (viii) breached a condition of a conformity assessment certificate; or (ix) had a conformity assessment certificate suspended or revoked; or (x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; or (f) any other circumstances prescribed by the regulations for the purposes of this paragraph exist. 19 Subsection 41ET(1A) Repeal the subsection, substitute: (1A) A reference in paragraph (1)(e) 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 under: (a) section 19B of the Crimes Act 1914; or (b) a corresponding provision of a law of a State or Territory. Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction. (1B) Paragraph (1)(e) does not limit paragraph (1)(f). 2