Commonwealth: Therapeutic Goods Amendment Act (No. 1) 2006 (Cth)

Therapeutic Goods Amendment Act (No. 1) 2006 Act No. 39 of 2006 as amended This compilation was prepared on 3 October 2007 [This Act was amended by Act No. 140 of 2007] Amendments from Act No. 140 of 2007 [Schedule 1 (item 4) repealed table item 5 of subsection 2(1) Schedule 1 (item 5) repealed heading after item 157 of Schedule 1 Schedule 1 (item 6) repealed item 158 of Schedule 1 Schedule 1 (items 4–6) commenced on 3 October 2007] Prepared by the Office of Legislative Drafting and Publishing, Attorney‑General's Department, Canberra Contents 1 Short title 2 Commencement 3 Schedule(s) Schedule 1—Amendments Therapeutic Goods Act 1989 An Act to amend the Therapeutic Goods Act 1989, and for related purposes [Assented to 3 May 2006] The Parliament of Australia enacts: 1 Short title This Act may be cited as the Therapeutic Goods Amendment Act (No. 1) 2006. 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. 3 May 2006 2. Schedule 1, items 1 to 117 The 28th day after the day on which this Act receives the Royal Assent. 31 May 2006 3. Schedule 1, item 118 27 November 2003. 27 November 2003 4. Schedule 1, items 119 to 157 The 28th day after the day on which this Act receives the Royal Assent. 31 May 2006 Note: This table relates only to the provisions of this Act as originally passed by 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in any published version of this Act. 3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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—Amendments Therapeutic Goods Act 1989 1 Subsection 3(1) Insert: civil penalty provision has the meaning given by section 42YA. 2 Subsection 3(1) Insert: oath includes affirmation. 3 Subsection 3(1) Insert: penalty unit, in relation to a civil penalty provision, has the meaning given by section 42YB. 4 Subsection 3(8) After "maximum penalty", insert ", other than a maximum civil penalty,". 5 At the end of section 5 Add "or to be subject to civil proceedings for a contravention of a civil penalty provision". 6 Section 5A Repeal the section, substitute: 5A Application of the Criminal Code—extended geographical jurisdiction Section 15.2 of the Criminal Code (extended geographical jurisdiction—category B) applies to offences against subsections 21A(1), (2) and (4) and sections 22A, 41FE, 42E and 42T. 7 Section 14 Repeal the section, substitute: 14 Criminal offences for importing, supplying or exporting goods that do not comply with standards Offences relating to importing goods into Australia (1) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods; and (d) either: (i) the use of the goods has resulted in, or will result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in harm or injury to any person; and (e) the harm or injury has resulted, will result, or would result, because the goods do not conform with the standard. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A. (2) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods; and (d) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and (e) the harm or injury would be likely to result because the goods do not conform with the standard. Maximum penalty: 2,000 penalty units. (3) Subsection (2) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (4) A person commits an offence if: (a) the person imports therapeutic goods into Australia; and (b) the goods are imported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods. Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Exception (5) Paragraphs (1)(a), (2)(a) and (4)(a) do not apply to goods that do not conform with a standard applicable to the goods by reason only of matters relating to labelling or packaging. Note: A defendant bears an evidential burden in relation to the matters in subsection (5): see subsection 13.3(3) of the Criminal Code. Offences relating to supplying goods for use in Australia (6) A person commits an offence if: (a) the person supplies therapeutic goods for use in Australia; and (b) the goods are supplied without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods; and (d) either: (i) the use of the goods has resulted in, or will result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in harm or injury to any person; and (e) the harm or injury has resulted, will result, or would result, because the goods do not conform with the standard. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (9) instead: see section 53A. (7) A person commits an offence if: (a) the person supplies therapeutic goods for use in Australia; and (b) the goods are supplied without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods; and (d) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and (e) the harm or injury would be likely to result because the goods do not conform with the standard. Maximum penalty: 2,000 penalty units. (8) Subsection (7) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (9) A person commits an offence if: (a) the person supplies therapeutic goods for use in Australia; and (b) the goods are supplied without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods. Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Offences relating to exporting goods from Australia (10) A person commits an offence if: (a) the person exports therapeutic goods from Australia; and (b) the goods are exported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia); and (d) either: (i) the use of the goods has resulted in, or will result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in harm or injury to any person; and (e) the harm or injury has resulted, will result, or would result, because the goods do not conform with the standard. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (13) instead: see section 53A. (11) A person commits an offence if: (a) the person exports therapeutic goods from Australia; and (b) the goods are exported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia); and (d) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and (e) the harm or injury would be likely to result because the goods do not conform with the standard. Maximum penalty: 2,000 penalty units. (12) Subsection (11) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (13) A person commits an offence if: (a) the person exports therapeutic goods from Australia; and (b) the goods are exported without the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia). Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Decisions on whether to give consent (14) The Secretary must, as soon as practicable after making a decision to give a consent, cause particulars of the decision to be published in the Gazette. (15) The Secretary must, within 28 days after making a decision to refuse to give a consent, notify the applicant in writing of the decision and of the reasons for the decision. 14A Civil penalties for importing, supplying or exporting goods that do not comply with standards Civil penalty relating to importing goods into Australia (1) A person contravenes this subsection if: (a) the person imports therapeutic goods into Australia; and (b) the person does not have the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than by reason of a matter relating to labelling or packaging). Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Civil penalty relating to supplying goods for use in Australia (2) A person contravenes this subsection if: (a) the person supplies therapeutic goods for use in Australia; and (b) the person does not have the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Civil penalty relating to exporting goods from Australia (3) A person contravenes this subsection if: (a) the person exports therapeutic goods from Australia; and (b) the person does not have the consent in writing of the Secretary; and (c) the goods do not conform with a standard applicable to the goods (other than a standard relating to the labelling of the goods for supply in Australia). Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Decisions on whether to give consent (4) The Secretary must, as soon as practicable after making a decision to give a consent, cause particulars of the decision to be published in the Gazette. (5) The Secretary must, within 28 days after making a decision to refuse to give a consent, notify the applicant in writing of the decision and of the reasons for the decision. 14B Application of Customs Act 1901 Where: (a) the importation or exportation of goods is an offence under subsection 14(1), (2), (4), (10), (11) or (13) or a contravention of subsection 14A(1) or (3); and (b) the Secretary notifies the Chief Executive Officer of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation; the Customs Act 1901 has effect as if the goods included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were: (c) prohibited imports within the meaning of that Act; or (d) prohibited exports within the meaning of that Act; as the case requires. 8 Section 15 Repeal the section, substitute: 15 Criminal offences relating to breaching a condition of a consent (1) The consent of the Secretary under section 14 or 14A may be given: (a) unconditionally or subject to conditions; or (b) in respect of particular goods or classes of goods. (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, or will result in, harm or injury to any person. Maximum penalty: 2,000 penalty units. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A. (3) 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 is likely to result in harm or injury to any person. Maximum penalty: 1,000 penalty units. (4) Subsection (3) is an offence of strict liability. 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; and (b) the act or omission breaches a condition of a consent. Maximum penalty: 500 penalty units. 15AA Civil penalty relating to breaching a condition of a consent A person contravenes this section 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 imposed under section 15. Maximum civil penalty: (a) for an individual—3,000 penalty units; and (b) for a body corporate—30,000 penalty units. 9 Subsection 18A(7) (note) Omit "Note", substitute "Note 1". 10 At the end of subsection 18A(7) Add: Note 2: A person may also contravene a civil penalty provision, see section 22AA. 11 Subsection 18A(12) (paragraph (a) of the note) Omit "and 22", substitute ", 22 and 22AA". 12 Subsection 18A(12) (paragraph (b) of the note) Omit "section 30F", substitute "sections 30F and 30FA". 13 Subsection 18A(12) (paragraph (f) of the note) After "sections 35,", insert "35A,". 14 After section 19A Insert: 19B Criminal offences relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods Offences relating to importing, exporting, manufacturing or supplying goods for use in humans (1) A person commits an offence if: (a) the person: (i) imports into Australia therapeutic goods for use in humans; or (ii) exports from Australia therapeutic goods for use in humans; or (iii) manufactures in Australia therapeutic goods for use in humans; or (iv) supplies in Australia therapeutic goods for use in humans; and (b) none of the following subparagraphs applies in relation to the goods: (i) the goods are registered goods or listed goods in relation to the person; (ii) the goods are exempt goods; (iii) the goods are exempt under section 18A; (iv) the goods are the subject of an approval or authority under section 19; (v) the goods are the subject of an approval under section 19A; and (c) either: (i) the use of the goods has resulted in, or will result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in harm or injury to any person. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. 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: see section 53A. Note 2: A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A. (2) A person commits an offence if: (a) the person: (i) imports into Australia therapeutic goods for use in humans; or (ii) exports from Australia therapeutic goods for use in humans; or (iii) manufactures in Australia therapeutic goods for use in humans; or (iv) supplies in Australia therapeutic goods for use in humans; and (b) none of the following subparagraphs applies in relation to the goods: (i) the goods are registered goods or listed goods in relation to the person; (ii) the goods are exempt goods; (iii) the goods are exempt under section 18A; (iv) the goods are the subject of an approval or authority under section 19; (v) the goods are the subject of an approval under section 19A; and (c) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person. Maximum penalty: 2,000 penalty units. Note: A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A. (3) Subsection (2) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (4) A person commits an offence if: (a) the person: (i) imports into Australia therapeutic goods for use in humans; or (ii) exports from Australia therapeutic goods for use in humans; or (iii) manufactures in Australia therapeutic goods for use in humans; or (iv) supplies in Australia therapeutic goods for use in humans; and (b) none of the following subparagraphs applies in relation to the goods: (i) the goods are registered goods or listed goods in relation to the person; (ii) the goods are exempt goods; (iii) the goods are exempt under section 18A; (iv) the goods are the subject of an approval or authority under section 19; (v) the goods are the subject of an approval under section 19A. Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Defence if person was not the sponsor of the goods (5) It is a defence to a prosecution under subsection (1), (2) or (4) if the defendant proves that the defendant was not the sponsor of the goods at the time of the importation, exportation, manufacture or supply, as the case may be. Note: The defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code. Exception (6) Subsection (1) does not apply if: (a) harm or injury did not, or will not, directly result from: (i) the quality, safety or efficacy of the goods; or (ii) a matter relating to the labelling or packaging of the goods; or (iii) the improper use of the goods; or (b) harm or injury would not directly result from: (i) the quality, safety or efficacy of the goods; or (ii) a matter relating to the labelling or packaging of the goods; or (iii) the improper use of the goods. Note: A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code. Application of Customs Act 1901 (7) Where: (a) the importation or exportation of goods is an offence under subsection (1), (2) or (4); and (b) the Secretary notifies the Chief Executive Officer of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation; the Customs Act 1901 has effect as if the goods included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were: (c) prohibited imports within the meaning of that Act; or (d) prohibited exports within the meaning of that Act; as the case requires. 19C Notice required to adduce evidence in support of exception under subsection 19B(6) (1) If: (a) a defendant is committed for trial for an offence against subsection 19B(1); or (b) an offence against subsection 19B(1) is to be heard and determined by a court of summary jurisdiction; the committing magistrate or the court must: (c) inform the defendant of the requirements of this section; and (d) cause a copy of this section to be given to the defendant. (2) A defendant must not, without leave of the court, adduce evidence in support of the exception under subsection 19B(6) unless: (a) if paragraph (1)(a) applies—more than 21 days before the trial begins; or (b) if paragraph (1)(b) applies—more than 21 days before the hearing of the offence begins; he or she gives notice of particulars of the exception. (3) A defendant must not, without leave of the court, call any other person to give evidence in support of the exception unless: (a) the notice under subsection (2) includes the name and address of the person or, if the name and address is not known to the defendant at the time he or she gives the notice, any information in his or her possession that might be of material assistance in finding the person; and (b) if the name or the address is not included in the notice—the court is satisfied that the defendant before giving the notice took, and after giving the notice continued to take, all reasonable steps to ascertain the name or address; and (c) if the name or address is not included in the notice, but the defendant subsequently ascertains the name or address or receives information that might be of material assistance in finding the person—the defendant immediately gives notice of the name, address or other information, as the case may be; and (d) if the defendant is told by or on behalf of the prosecutor that the person has not been found by the name, or at the address, given by the defendant: (i) the defendant immediately gives notice of any information in the defendant's possession that might be of material assistance in finding the person; or (ii) if the defendant later receives any such information—the defendant immediately gives notice of the information. (4) A notice purporting to be given under this section on behalf of the defendant by his or her legal practitioner is, unless the contrary is proved, taken as having been given with the authority of the defendant. (5) Any evidence tendered to disprove that the exception applies may, subject to direction by the court, be given before or after evidence is given in support of the exception. (6) A notice of particulars of the exception must be given, in writing, to the Director of Public Prosecutions. A notice is taken as having been given if it is: (a) delivered to or left at the Office of the Director of Public Prosecutions; or (b) sent by certified mail addressed to the Director of Public Prosecutions at the Office of the Director of Public Prosecutions. (7) In this section: Director of Public Prosecutions means a person holding office as, or acting as, the Director of Public Prosecutions under the Director of Public Prosecutions Act 1983. 19D Civil penalties relating to registration or listing etc. of imported, exported, manufactured and supplied therapeutic goods Civil penalty relating to importing, exporting, manufacturing or supplying goods for use in humans (1) A person contravenes this subsection if: (a) the person does any of the following: (i) imports into Australia therapeutic goods for use in humans; (ii) exports from Australia therapeutic goods for use in humans; (iii) manufactures in Australia therapeutic goods for use in humans; (iv) supplies in Australia therapeutic goods for use in humans; and (b) none of the following subparagraphs applies in relation to the goods: (i) the goods are registered goods or listed goods in relation to the person; (ii) the goods are exempt goods; (iii) the goods are exempt under section 18A; (iv) the goods are the subject of an approval or authority under section 19; (v) the goods are the subject of an approval under section 19A. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Note: A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A. Exception if person was not the sponsor of the goods (2) Subsection (1) does not apply if the person proves that he or she was not the sponsor of the goods at the time of the importation, exportation, manufacture or supply, as the case may be. Civil penalty relating to the importing of registered or listed goods (3) A person contravenes this subsection if: (a) therapeutic goods are registered or listed in relation to the person (other than listed goods that are therapeutic devices); and (b) the person imports the goods into Australia; and (c) the registration number or listing number of the goods is not set out on the label of the goods in the prescribed manner before the goods are supplied in Australia. Maximum civil penalty: (a) for an individual—200 penalty units; and (b) for a body corporate—2,000 penalty units. Civil penalty relating to the supply of registered or listed goods (4) A person contravenes this subsection if: (a) therapeutic goods are registered or listed in relation to the person (other than listed goods that are therapeutic devices); and (b) the person supplies the goods in Australia; and (c) the registration number or listing number of the goods is not set out on the label of the goods in the prescribed manner. Maximum civil penalty: (a) for an individual—200 penalty units; and (b) for a body corporate—2,000 penalty units. Application of Customs Act 1901 (5) Where: (a) the importation or exportation of goods contravenes subsection (1); and (b) the Secretary notifies the Chief Executive Officer of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation; the Customs Act 1901 has effect as if the goods included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were: (c) prohibited imports within the meaning of that Act; or (d) prohibited exports within the meaning of that Act; as the case requires. 15 Subsections 20(1), (1AA), (1A), (2) and (3) Repeal the subsections. Note: The heading to section 20 is replaced by the heading "Criminal offences relating to notifying the Secretary and to importing goods exempt under section 18A". 16 After section 20 Insert: 20A Civil penalty relating to the importation, exportation, manufacture or supply of sponsored goods without proper notification (1) A person contravenes this section if: (a) the person does any of the following: (i) imports therapeutic goods into Australia; (ii) exports therapeutic goods from Australia; (iii) manufactures therapeutic goods in Australia; (iv) supplies therapeutic goods in Australia; and (b) the person is the sponsor of the goods for use in humans; and (c) the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following: (i) the manufacturer of the goods; (ii) premises used in the manufacture of the goods. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Meaning of properly notified (2) For the purposes of paragraph (1)(c): (a) a manufacturer is properly notified to the Secretary if: (i) the manufacturer was nominated, as a manufacturer of the goods, in an application for the registration or listing of the goods; or (ii) the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the goods; and (b) premises are properly notified to the Secretary if: (i) the premises were nominated, as premises used in the manufacture of the goods, in an application for the registration or listing of the goods; or (ii) the Secretary was subsequently informed in writing that the premises are used in the manufacture of the goods. 17 After section 21 Insert: 21A General criminal offences relating to this Part Offences for making a false or misleading statement (1) A person commits an offence if: (a) the person makes a statement; and (b) the statement is made in or in connection with a certification of any matter under subsection 26A(2); and (c) the statement is false or misleading in a material particular; and (d) either: (i) the use of the medicine has resulted in, or will result in, harm or injury to any person; or (ii) the use of the medicine, if the medicine were used, would result in harm or injury to any person. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A. (2) A person commits an offence if: (a) the person makes a statement; and (b) the statement is made in or in connection with a certification of any matter under subsection 26A(2); and (c) the statement is false or misleading in a material particular; and (d) the use of the medicine, if the medicine were used, would be likely to result in harm or injury to any person. Maximum penalty: 2,000 penalty units. (3) Subsection (2) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (4) A person commits an offence if: (a) the person makes a statement; and (b) the statement is made in or in connection with a certification of any matter under subsection 26A(2); and (c) the statement is false or misleading in a material particular. Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Offences relating to breaching a condition of registration or listing of therapeutic goods (5) A person commits an offence if: (a) therapeutic goods are registered or listed in relation to the person; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the registration or listing of the goods; and (d) the act or omission has resulted in, or will result in, harm or injury to any person. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A. (6) A person commits an offence if: (a) therapeutic goods are registered or listed in relation to the person; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the registration or listing of the goods; and (d) the act or omission is likely to result in harm or injury to any person. Maximum penalty: 2,000 penalty units. (7) Subsection (6) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (8) A person commits an offence if: (a) therapeutic goods are registered or listed in relation to the person; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the registration or listing of the goods. Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Offences relating to the supply of therapeutic goods in breach of authority etc. (9) A person commits an offence if: (a) the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and (b) the person supplies those goods; and (c) any of the following applies: (i) the supply is not in accordance with the authority; or (ii) the supply is not in accordance with the conditions to which the authority is subject; or (iii) the supply is not in accordance with regulations made for the purpose of subsection 19(7); and (d) either: (i) the use of the goods has resulted in, or will result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in harm or injury to any person; and (e) the harm or injury has resulted, will result, or would result, because: (i) the supply is not in accordance with the authority; or (ii) the supply is not in accordance with the conditions to which the authority is subject; or (iii) the supply is not in accordance with regulations made for the purpose of subsection 19(7). Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(7A) instead: see section 53A. (10) A person commits an offence if: (a) the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and (b) the person supplies those goods; and (c) any of the following applies: (i) the supply is not in accordance with the authority; or (ii) the supply is not in accordance with the conditions to which the authority is subject; or (iii) the supply is not in accordance with regulations made for the purpose of subsection 19(7); and (d) the use of the goods, if goods were used, would be likely to result in harm or injury to any person; and (e) the harm or injury would be likely to result because: (i) the supply is not in accordance with the authority; or (ii) the supply is not in accordance with the conditions to which the authority is subject; or (iii) the supply is not in accordance with regulations made for the purpose of subsection 19(7). Maximum penalty: 2,000 penalty units. (11) Subsection (10) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. Offences relating to using therapeutic goods without approval etc. (12) A person commits an offence if: (a) the person uses therapeutic goods; and (b) the goods are used: (i) in the treatment of another person; or (ii) solely for experimental purposes in humans; and (c) the goods are not: (i) exempt goods; or (ii) listed goods; or (iii) registered goods; or (iv) goods exempt under section 18A; or (v) goods that are the subject of an approval under section 19A; and (d) the goods are not used in accordance with: (i) an approval or authority under section 19; or (ii) a condition applicable under regulations made for the purposes of subsection 19(4A); and (e) either: (i) if the person used the goods in the treatment of another person—the use of the goods has resulted in, or will result in, harm or injury to that person; or (ii) if the person used the goods solely for experimental purposes in humans—the use of the goods has resulted in, or will result in, harm or injury to any of those persons. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(8) instead: see section 53A. (13) A person commits an offence if: (a) the person uses therapeutic goods; and (b) the goods are used: (i) in the treatment of another person; or (ii) solely for experimental purposes in humans; and (c) the goods are not: (i) exempt goods; or (ii) listed goods; or (iii) registered goods; or (iv) goods exempt under section 18A; or (v) goods that are the subject of an approval under section 19A; and (d) the goods are not used in accordance with: (i) an approval or authority under section 19; or (ii) a condition applicable under regulations made for the purposes of subsection 19(4A); and (e) either: (i) if the person used the goods in the treatment of another person—the use of the goods, if the goods were used, is likely to result in harm or injury to that person; or (ii) if the person used the goods solely for experimental purposes in humans—the use of the goods, if the goods were used, is likely to result in harm or injury to any of those persons. Maximum penalty: 2,000 penalty units. (14) Subsection (13) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. 21B General civil penalties relating to this Part Civil penalty for making a false or misleading statement (1) A person contravenes this subsection if the person, in or in connection with a certification of any matter under subsection 26A(2), makes a statement that is false or misleading in a material particular. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Civil penalty relating to breaching a condition of registration or listing of therapeutic goods (2) A person contravenes this subsection if: (a) therapeutic goods are registered or listed in relation to the person; and (b) the person does an act or omits to do an act that breaches a condition of the registration or listing of the goods. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Civil penalty for falsely representing therapeutic goods (3) A person contravenes this subsection if: (a) the person represents therapeutic goods that are not included in the Register as being so included; or (b) the person represents therapeutic goods that are not exempt goods as being exempt goods; or (c) the person represents therapeutic goods that are not goods exempt under section 18A as being goods exempt under that section; or (d) the person represents therapeutic goods that are included in one part of the Register as being included in another part of the Register; or (e) the person represents therapeutic goods that are not the subject of an approval or authority under section 19 as being the subject of such an approval or authority; or (f) the person represents therapeutic goods that are not the subject of an approval under section 19A as being the subject of such an approval. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. 18 Subsections 22(2A), (3), (3A) and (4) Repeal the subsections. 19 Subsection 22(7AB) (penalty) Omit "300 penalty units", substitute "2,000 penalty units". 20 Subsection 22(7AB) (note 1) Repeal the note, substitute: Note 1: A person may commit an offence against subsection 20(2A) or (2C), or contravene section 22AA (a civil penalty provision), by breaching a condition of an exemption of therapeutic goods under section 18A that relates to the importation of the goods. 21 Subsection 22(7A) (penalty) Repeal the penalty, substitute: Maximum penalty: 500 penalty units. 22 Subsection 22(8) (penalty) Repeal the penalty, substitute: Maximum penalty: 500 penalty units. 23 After section 22 Insert: 22AA 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 therapeutic goods; and (b) the goods are exempt under section 18A; and (c) the act or omission breaches 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. 24 Section 22A Repeal the section, substitute: 22A Criminal offences for false statements in applications for registration (1) A person commits an offence if: (a) the person makes a statement; and (b) the statement is made in or in connection with an application for registration of therapeutic goods; and (c) the statement is false or misleading in a material particular; and (d) either: (i) the use of the goods has resulted in, or will result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in harm or injury to any person. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A. (2) A person commits an offence if: (a) the person makes a statement; and (b) the statement is made in or in connection with an application for registration of therapeutic goods; and (c) the statement is false or misleading in a material particular; and (d) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person. Maximum penalty: 2,000 penalty units. (3) Subsection (2) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (4) A person commits an offence if: (a) the person makes a statement; and (b) the statement is made in or in connection with an application for registration of therapeutic goods; and (c) the statement is false or misleading in a material particular. Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 22B Civil penalty for false statements in applications for registration A person contravenes this section if the person in or in connection with an application for registration of therapeutic goods, makes a statement that is false or misleading in a material particular. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. 25 Subsection 29A(1) (penalty) Repeal the penalty, substitute: Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Note: The heading to section 29A is replaced by the heading "Criminal offence for failing to notify adverse effects etc. of goods". 26 After section 29A Insert: 29AA Civil penalty for failing to notify adverse effects etc. of goods (1) A person contravenes this section if: (a) therapeutic goods are registered or listed in relation to a person; and (b) the person becomes aware of information of a kind mentioned in subsection (2) relating to the goods; and (c) the person does not give the information to the Secretary in writing as soon as he or she becomes aware of it. Maximum civil penalty: (a) for an individual—3,000 penalty units; and (b) for a body corporate—30,000 penalty units. (2) The information with which subsection (1) is concerned is information of the following kinds: (a) information that contradicts information already given by the person under this Act; (b) information that indicates that the use of the goods in accordance with the recommendations for their use may have an unintended harmful effect; (c) information that indicates that the goods, when used in accordance with the recommendations for their use, may not be as effective as the application for registration or listing of the goods or information already given by the person under this Act suggests; (d) information that indicates that the quality, safety or efficacy of the goods is unacceptable. 27 Paragraph 29B(1)(a) After "subsection 29A(2)", insert " or 29AA(2)". 28 Subsection 29B(3) (penalty) Repeal the penalty, substitute: Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 29 Subsection 29B(4) (penalty) Repeal the penalty, substitute: Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 30 After section 29B Insert: 29C Civil penalties for failing to notify adverse effects etc. where application withdrawn or lapses Civil penalty for failing to comply with requirements of a notice (1) A person contravenes this subsection if the person does not comply with the requirements of a notice under subsection 29B(1) within 30 days after the day on which the notice is given to the person. Maximum civil penalty: (a) for an individual—3,000 penalty units; and (b) for a body corporate—30,000 penalty units. Civil penalty for giving false or misleading information in purported compliance with requirements of a notice (2) A person contravenes this subsection if the person, in purported compliance with a notice under subsection 29B(1), gives information that is false or misleading in a material particular. Maximum civil penalty: (a) for an individual—3,000 penalty units; and (b) for a body corporate—30,000 penalty units. 31 Paragraph 30(2)(ca) After "subsection 29A(1)", insert "or 29AA(1)". 32 Subsection 30EA(1) (table item 5) Omit "20(1) or 42E(1)", substitute "19B(1), (2) or (4), 19D(1), 42E(1) or 42EA(1)". 33 Section 30EC Repeal the section, substitute: 30EC Criminal offences for non‑compliance with requirements (1) 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 requirement imposed on the person under section 30EA; and (c) the act or omission has resulted in, or will result in, harm or injury to any person. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A. (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 requirement imposed on the person under section 30EA; and (c) the act or omission is likely to result in harm or injury to any person. Maximum penalty: 2,000 penalty units. (3) Subsection (2) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (4) 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 requirement imposed on the person under section 30EA. Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 30ECA Civil penalty for non‑compliance with requirements A person contravenes this section if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a requirement imposed on the person under section 30EA. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. 34 After subsection 30F(4) Insert: Written notice is not a legislative instrument (4A) A written notice given to a person by the Secretary under this section is not a legislative instrument for the purposes of the Legislative Instruments Act 2003. Offences (4B) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement; and (d) either: (i) the use of the goods has resulted in, or will result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in harm or injury to any person; and (e) the harm or injury has resulted, will result, or would result, because the person failed to comply with that requirement. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A. (4C) A person commits an offence if: (a) the Secretary gives a notice to the person under subsection (2); and (b) the notice specifies a particular requirement mentioned in subsection (3); and (c) the person fails to comply with that requirement; and (d) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and (e) the harm or injury would be likely to result because the person failed to comply with that requirement. Maximum penalty: 2,000 penalty units. (4D) Subsection (4C) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. Note: The heading to section 30F is altered by omitting "Goods" and substituting "Criminal offences for goods". 35 Subsection 30F(5) (penalty) Repeal the penalty, substitute: Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 36 After section 30F Insert: 30FA Civil penalty for goods exempt under section 18A not conforming to standards etc. A person contravenes this section if: (a) the Secretary gives a notice to the person under subsection 30F(2); and (b) the notice specifies a particular requirement mentioned in subsection 30F(3); and (c) the person does not comply with the requirement. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. 37 Subsection 31(4) (penalty) Repeal the penalty, substitute: Maximum penalty: 500 penalty units. 38 After subsection 31(5) Insert: (5A) A person commits an offence if: (a) a medicine is listed under section 26A in relation to the person; and (b) the person provides information in purported compliance with a notice under section 31 relating to the medicine; and (c) the information is false or misleading in a material particular; and (d) either: (i) the use of the medicine has resulted in, or will result in, harm or injury to any person; or (ii) the use of the medicine, if the medicine were used, would result in harm or injury to any person. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (6) instead: see section 53A. (5B) A person commits an offence if: (a) a medicine is listed under section 26A in relation to the person; and (b) the person provides information in purported compliance with a notice under section 31 relating to the medicine; and (c) the information is false or misleading in a material particular; and (d) the use of the medicine, if the medicine were used, would be likely to result in harm or injury to any person. Maximum penalty: 2,000 penalty units. (5C) Subsection (5B) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. 39 Subsection 31(6) Repeal the penalty, substitute: Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 40 After section 31 Insert: 31AAA Civil penalty for providing false or misleading information in relation to medicines listed under section 26A A person contravenes this section if: (a) a medicine is listed under section 26A in relation to the person; and (b) the person provides information in purported compliance with a notice under section 31 relating to the medicine; and (c) the information is false or misleading in a material particular. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. 41 At the end of section 31A Add: Information may need to be given in accordance with specified software requirements (4) A notice under subsection (1) or (2) 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. 42 At the end of section 31AA Add: Information may need to be given in accordance with specified software requirements (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. 43 At the end of section 31B Add: Information may need to be given in accordance with specified software requirements (5) A notice under subsection (1), (2) or (3) 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. 44 Section 31C Repeal the section, substitute: 31C Criminal offence for failing to give information or documents sought under section 31A, 31AA or 31B A person commits an offence if: (a) the person is given a notice under section 31A, 31AA or 31B; and (b) the person fails to comply with the notice. Maximum penalty: 400 penalty units. Note: The privilege against self incrimination is not a reasonable excuse for the purposes of this section. However, the information given, and the fact that a document was given under this section (and other information, documents or things obtained because of giving the information or document) generally cannot be used in a prosecution (see section 31F). 45 Paragraph 31D(1)(a) Omit "subsection 31C(1)", substitute "the notice". 46 Subsection 31D(1) (penalty) Repeal the penalty, substitute: Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 47 Paragraph 31E(1)(c) Omit "subsection 31C(1)", substitute "a notice given under section 31A, 31AA or 31B". 48 Subsection 31E(1) (penalty) Repeal the penalty, substitute: Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 49 Subsection 31F(1) Omit "section 31C", substitute "a notice given under section 31A, 31AA or 31B". 50 Subsection 31F(2) Omit all the words after paragraph (c), substitute: is not admissible in evidence in: (d) criminal proceedings against the individual, except proceedings under, or arising out of, section 31D or 31E; or (e) proceedings for a pecuniary penalty order against the individual for a contravention of a civil penalty provision. 51 Section 35 Repeal the section, substitute: 35 Criminal offences relating to manufacturing therapeutic goods (1) A person commits an offence if: (a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods (other than goods exempt under section 18A); and (b) the goods are for supply for use in humans; and (c) none of the following applies: (i) the goods are exempt goods; (ii) the person is an exempt person in relation to the manufacture of the goods; (iii) the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises; and (d) either: (i) the use of the goods has resulted in, or will result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in harm or injury to any person; and (e) the harm or injury has resulted, will result, or would result, because the person carried out the step in the manufacture of the goods. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A. (2) A person commits an offence if: (a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods (other than goods exempt under section 18A); and (b) the goods are for supply for use in humans; and (c) none of the following applies: (i) the goods are exempt goods; (ii) the person is an exempt person in relation to the manufacture of the goods; (iii) the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises; and (d) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and (e) the harm or injury would be likely to result because the person carried out the step in the manufacture of the goods. Maximum penalty: 2,000 penalty units. (3) Subsection (2) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (4) A person commits an offence if: (a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods (other than goods exempt under section 18A); and (b) the goods are for supply for use in humans; and (c) none of the following applies: (i) the goods are exempt goods; (ii) the person is an exempt person in relation to the manufacture of the goods; (iii) the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises. Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (5) A person commits an offence if: (a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods; and (b) the goods are for supply for use in humans; and (c) the goods are exempt under section 18A; and (d) the person is not the holder of a licence that: (i) is in force; and (ii) authorises the carrying out of that step in relation to the goods at those premises; and (e) either: (i) the use of the goods has resulted in, or will result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in harm or injury to any person; and (f) the harm or injury has resulted, will result, or would result, because the person carried out the step in the manufacture of the goods. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (9) instead: see section 53A. (6) Strict liability applies to paragraph (5)(c). Note: For strict liability, see section 6.1 of the Criminal Code. (7) A person commits an offence if: (a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods; and (b) the goods are for supply for use in humans; and (c) the goods are exempt under section 18A; and (d) the person is not the holder of a licence that: (i) is in force; and (ii) authorises the carrying out of that step in relation to the goods at those premises; and (e) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and (f) the harm or injury would be likely to result because the person carried out the step in the manufacture of the goods. Maximum penalty: 2,000 penalty units. (8) Subsection (7) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (9) A person commits an offence if: (a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods; and (b) the goods are for supply for use in humans; and (c) the goods are exempt under section 18A; and (d) the person is not the holder of a licence that: (i) is in force; and (ii) authorises the carrying out of that step in relation to the goods at those premises. Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (10) Strict liability applies to paragraph (9)(c). Note: For strict liability, see section 6.1 of the Criminal Code. 35A Civil penalties relating to manufacturing therapeutic goods (1) A person contravenes this subsection if: (a) the person carries out a step in the manufacture of therapeutic goods at premises in Australia; and (b) the goods are for supply for use in humans; and (c) the goods are not exempt under section 18A; and (d) none of the following applies: (i) the goods are exempt goods; (ii) the person is an exempt person in relation to the manufacture of the goods; (iii) the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. (2) A person contravenes this subsection if: (a) the person carries out a step in the manufacture of therapeutic goods at premises in Australia; and (b) the goods are for supply for use in humans; and (c) the goods are exempt under section 18A; and (d) the person is not the holder of a licence that: (i) is in force; and (ii) authorises the carrying out of that step in relation to the goods at those premises. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. 35B Criminal offences relating to breaching a condition of a licence (1) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence; and (d) the act or omission has resulted in, or will result in, harm or injury to any person. Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A. (2) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence; and (d) the act or omission is likely to result in harm or injury to any person. Maximum penalty: 2,000 penalty units. (3) Subsection (2) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. (4) A person commits an offence if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence. Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both. 35C Civil penalty relating to breaching a condition of a licence A person contravenes this section if: (a) the person holds a licence; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the licence. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. 52 After paragraph 38(1A)(b) Insert: (ba) an order requiring any of the following persons to pay a pecuniary penalty for the contravention of a civil penalty provision: (i) the applicant or person; (ii) another person who controls the applicant or person (whether directly, or indirectly through one or more interposed entities); (iii) another person whom the applicant or person controlled (whether directly, or indirectly through one or more interposed entities) at the time the civil penalty provision was contravened or at the time of the order; or 53 Paragraphs 41(1)(aa), (ab) and (ac) Repeal the paragraphs, substitute: (aa) the holder has been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision; or (ab) the holder controls another person (whether directly, or indirectly through one or more interposed entities) and that other person: (i) has been convicted of an offence against this Act or a law of a State or Territory relating to therapeutic goods; or (ii) has been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision; or (ac) the holder controlled another person (whether directly, or indirectly through one or more interposed entities) when that other person: (i) committed an offence against this Act or a law of a State or Territory relating to therapeutic goods, being an offence for which the person was convicted; or (ii) contravened a civil penalty provision, being a contravention for which the person was ordered to pay a pecuniary penalty; or (ad) the holder is controlled by another person (whether directly, or indirectly through one or more interposed entities) when that other person: (i) has been convicted of an offence against this Act or a law of a State or Territory relating to therapeutic goods; or (ii) has been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision; or 54 Subsection 41(1A) After "(b)", insert ", (ba)". 55 At the end of paragraph 41B(c) Add "and civil penalty provisions". 56 Section 41BC After "contains offences", insert "and civil penalty provisions". 57 Section 41BC (note) After "some offences", insert "and civil penalty provisions". 58 Section 41C (note) After "offence", insert "or may contravene a civil penalty provision". 59 Section 41D (note 1) After "offence", insert "or may contravene a civil penalty provision". 60 Subsection 41EB(2) (