Commonwealth: Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010 (Cth)

Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010 No. 54, 2010 An Act to amend the Therapeutic Goods Act 1989, and for related purposes Contents 1 Short title 2 Commencement 3 Schedule(s) Schedule 1—Biologicals Therapeutic Goods Act 1989 Schedule 2—Immunity from civil actions Therapeutic Goods Act 1989 Schedule 3—Recall of therapeutic goods Therapeutic Goods Act 1989 Schedule 4—Information gathering Therapeutic Goods Act 1989 Schedule 5—Unpaid annual charges Therapeutic Goods Act 1989 Schedule 6—Other amendments Therapeutic Goods Act 1989 Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010 No. 54, 2010 An Act to amend the Therapeutic Goods Act 1989, and for related purposes [Assented to 31 May 2010] The Parliament of Australia enacts: 1 Short title This Act may be cited as the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010. 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 this Act receives the Royal Assent. 31 May 2010 2. Schedule 1 A single day to be fixed by Proclamation. 31 May 2011 However, if any of the provision(s) do not commence within the period of 12 months beginning on the day this Act receives the Royal Assent, they commence on the day after the end of that period. However, if the Therapeutic Goods (Charges) Amendment Act 2010 does not receive the Royal Assent before the end of that period, the provision(s) do not commence at all. 3. Schedules 2 to 6 The day after this Act receives the Royal Assent. 1 June 2010 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in any published version of this Act. 3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.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—Biologicals Therapeutic Goods Act 1989 1 Subsection 3(1) Insert: biological has the meaning given by section 32A. 2 Subsection 3(1) Insert: biological number of a biological means: (a) the number assigned to the biological under subsection 32DB(2), 32DF(2) or 32DN(5); or (b) if, in accordance with regulations made for the purposes of paragraph 9A(4)(ca), a different number is assigned to the biological—that different number. 3 Subsection 3(1) Insert: Class 1 biological means a biological included in a class of biologicals that is: (a) a class prescribed by the regulations for the purposes of section 32AA; and (b) a class referred to in those regulations as Class 1 biologicals. 4 Subsection 3(1) (definition of included in the Register) Repeal the definition, substitute: included in the Register: (a) in relation to a biological—means included in the Register under Part 3‑2A; and (b) in relation to a medical device to which Chapter 4 applies—means included in the Register under Chapter 4. Note: Section 41BJ deals with the application of Chapter 4 to medical devices. 5 Subsection 3(1) (paragraph (a) of the definition of medicine) After "goods", insert "(other than biologicals)". 6 Subsection 3(1) (definition of therapeutic device) After "means therapeutic goods", insert "(other than biologicals)". 7 Subsection 3(1) (definition of therapeutic goods) After "and includes", insert "biologicals,". 8 After paragraph 6AAE(6)(b) Insert: (ba) in the part of the Register for biologicals included under Part 3‑2A; or 9 Paragraph 7B(1)(b) Omit "or are exempt goods in relation to Part 3‑2", substitute ", are exempt goods in relation to Part 3‑2, are included in the Register under Part 3‑2A or are exempt under subsection 32CA(2) or section 32CB". 10 After paragraph 9(1)(a) Insert: (aa) the evaluation of a biological, other than a Class 1 biological, for inclusion in the Register under Part 3‑2A; or 11 Subsection 9A(3) Omit "3 parts", substitute "4 parts". 12 After paragraph 9A(3)(b) Insert: (ba) a part for biologicals included in the Register under Part 3‑2A; and 13 Paragraph 9A(4)(b) Repeal the paragraph, substitute: (b) the ways in which goods that are included in one part of the Register may be transferred, or may be required to be transferred, to another part of the Register; and 14 After paragraph 9A(4)(c) Insert: (ca) the ways in which a biological that has been assigned a number under subsection 32DB(2), 32DF(2) or 32DN(5) may be assigned a different number (which may be any combination of numbers and either or both of letters and symbols); and 15 After subsection 9D(3) Insert: (3A) If: (a) the person in relation to whom a biological is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the biological; and (b) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the biological for the purposes for which it is to be used; the Secretary may vary the entry in accordance with the request. (3B) If: (a) a particular biological ceases to be a biological because of a determination under subsection 32A(3); and (b) the biological is included in the Register under Part 3‑2A; the Secretary must move the entry relating to the biological from the part of the Register for biologicals to whichever other part of the Register is applicable. 16 Subsection 9D(4) Omit "the part for goods to be known as registered goods or to the part for goods to be known as listed goods (whichever is applicable)", substitute "whichever other part of the Register is applicable". 17 After subsection 14(5) Insert: (5A) Subsection (1), (2) or (4) does not apply if: (a) the therapeutic goods are a biological; and (b) the person imports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred. Note: A defendant bears an evidential burden in relation to the matter in subsection (5A): see subsection 13.3(3) of the Criminal Code. Note: The heading to subsection 14(5) is replaced by the heading "Exceptions". 18 After subsection 14(9) Insert: Exception (9A) Subsection (6), (7) or (9) does not apply if: (a) the therapeutic goods are a biological; and (b) the person supplies the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred. Note: A defendant bears an evidential burden in relation to the matter in subsection (9A): see subsection 13.3(3) of the Criminal Code. 19 After subsection 14(13) Insert: Exception (13A) Subsection (10), (11) or (13) does not apply if: (a) the therapeutic goods are a biological; and (b) the person exports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred. Note: A defendant bears an evidential burden in relation to the matter in subsection (13A): see subsection 13.3(3) of the Criminal Code. 20 After subsection 14A(1) Insert: Exception (1A) Subsection (1) does not apply if: (a) the therapeutic goods are a biological; and (b) the person imports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred. 21 After subsection 14A(2) Insert: Exception (2A) Subsection (2) does not apply if: (a) the therapeutic goods are a biological; and (b) the person supplies the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred. 22 After subsection 14A(3) Insert: Exception (3A) Subsection (3) does not apply if: (a) the therapeutic goods are a biological; and (b) the person exports the biological after the circumstances prescribed by the regulations for the purposes of this paragraph have occurred. 23 At the end of Part 3‑1 Add: 15AB Conditions relating to exceptional release of biologicals (1) Regulations made for the purposes of paragraphs 14(9A)(b) and 14A(2A)(b) may also prescribe conditions that apply in relation to the supply of a biological that occurs after the circumstances prescribed for the purposes of those paragraphs have occurred. (2) The conditions prescribed by those regulations must apply only to the person supplying the biological. (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 results in the breach of any of the conditions referred to in subsection (1). Penalty for contravention of this subsection: 60 penalty units. 24 After section 15A Insert: 15B Application of this Part to a biological (1) Subject to this section, this Part does not apply to a biological on and after the commencement of this section. Biologicals currently included in the Register (2) If, immediately before the commencement of this section, therapeutic goods that are a biological were registered goods or listed goods, this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3‑2A. Note: Section 32DN deals with including the biological under Part 3‑2A. Pending applications (3) If: (a) before the commencement of this section, an application was made under this Part for the registration or listing of therapeutic goods that are a biological; and (b) immediately before that commencement, the application was not finally determined; and (c) the application had not been withdrawn before that commencement; this Part continues to apply to the biological on and after that commencement until the earliest of the following: (d) the time the biological is included in the Register under Part 3‑2A; (e) if the application is unsuccessful when it is finally determined—the time the application is finally determined; (f) the time the application is withdrawn; (g) the time the application lapses. Note: Section 32DN deals with including the biological under Part 3‑2A. (4) For the purposes of this section, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of. Transitional (5) This Part applies to a biological on and after the commencement of this section in relation to things done, or omitted to be done, in relation to the biological before the commencement of this section. (6) If this Part continues to apply to a biological during a period described in subsection (2) or (3), then this Part also applies to the biological after the end of that period in relation to things done, or omitted to be done, in relation to the biological during that period. 25 After Part 3‑2 Insert: Part 3‑2A—Biologicals Division 1—Preliminary 32 What this Part is about This Part regulates biologicals. It does this by providing a process for including biologicals in the Register and providing for enforcement through criminal offences and civil penalties. This Part provides for the following administrative processes: (a) exempting biologicals from the requirement to be included in the Register; (b) making the inclusion of biologicals in the Register subject to conditions; (c) suspending or cancelling entries of biologicals from the Register; (d) requiring public notification of problems with biologicals, and recovery of biologicals; (e) obtaining information or documents about biologicals. 32A Meaning of biological (1) Subject to subsection (3), a biological is a thing that: (a) either: (i) comprises, contains or is derived from human cells or human tissues; or (ii) is specified under subsection (2); and (b) is represented in any way to be, or is, whether because of the way in which it is presented or for any other reason, likely to be taken to be: (i) for use in the treatment or prevention of a disease, ailment, defect or injury affecting persons; or (ii) for use in making a medical diagnosis of the condition of a person; or (iii) for use in influencing, inhibiting or modifying a physiological process in persons; or (iv) for use in testing the susceptibility of persons to a disease or ailment; or (v) for use in the replacement or modification of parts of the anatomy in persons. (2) The Secretary may, by legislative instrument, specify things for the purposes of subparagraph (1)(a)(ii). Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003. (3) The Secretary may, by legislative instrument, determine that a specified thing is not a biological for the purposes of this Act. Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003. 32AA Biological classes The regulations may prescribe different classes of biologicals. Note 1: The regulations may prescribe the circumstances in which a biological included in a class of biologicals is separate and distinct from other biologicals: see section 32AB. Note 2: The Secretary may approve different application forms for different classes of biologicals: see section 32DD. 32AB When biologicals are separate and distinct from other biologicals (1) The regulations may prescribe the circumstances in which a biological included in a specified class of biologicals is separate and distinct from other biologicals. (2) The regulations may make different provision in relation to different classes of biologicals that are prescribed by the regulations for the purposes of section 32AA. Note: The Secretary may cancel the entry of a biological from the Register if the biological has changed so that it has become separate and distinct from the biological as so included: see subsection 32GC(1). Division 2—Main criminal offences and civil penalties 32B What this Division is about This Division contains criminal offences and civil penalties relating to the import, export, manufacture, supply and use of biologicals. 32BA Criminal offences for importing a biological (1) A person commits an offence if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological; (v) the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person; and (c) either: (i) the use of the biological has resulted in, or will result in, harm or injury to any person; or (ii) the use of the biological, if the biological were used, would result in harm or injury to any person. 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 into Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological; (v) the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person; and (c) the use of the biological, if the biological were used, would be likely to result in harm or injury to any person. Penalty: 2,000 penalty units. (3) An offence against 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 into Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological; (v) the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Defences (5) Subsection (1), (2) or (4) does not apply if the defendant proves that the defendant was not the sponsor of the biological at the time of the importation. Note: A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code. (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 biological; or (ii) a matter relating to the labelling or packaging of the biological; or (iii) the improper use of the biological; or (b) harm or injury would not directly result from: (i) the quality, safety or efficacy of the biological; or (ii) a matter relating to the labelling or packaging of the biological; or (iii) the improper use of the biological. Note: A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code. 32BB Criminal offences for exporting a biological (1) A person commits an offence if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological; and (c) either: (i) the use of the biological has resulted in, or will result in, harm or injury to any person; or (ii) the use of the biological, if the biological were used, would result in harm or injury to any person. 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 exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological; and (c) the use of the biological, if the biological were used, would be likely to result in harm or injury to any person. Penalty: 2,000 penalty units. (3) An offence against 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 exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Defences (5) Subsection (1), (2) or (4) does not apply if the defendant proves that the defendant was not the sponsor of the biological at the time of the exportation. Note: A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code. (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 biological; or (ii) a matter relating to the labelling or packaging of the biological; or (iii) the improper use of the biological; or (b) harm or injury would not directly result from: (i) the quality, safety or efficacy of the biological; or (ii) a matter relating to the labelling or packaging of the biological; or (iii) the improper use of the biological. Note: A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code. 32BC Criminal offences for manufacturing a biological (1) A person commits an offence if: (a) the person manufactures in Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; and (c) either: (i) the use of the biological has resulted in, or will result in, harm or injury to any person; or (ii) the use of the biological, if the biological were used, would result in harm or injury to any person. 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 manufactures in Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; and (c) the use of the biological, if the biological were used, would be likely to result in harm or injury to any person. Penalty: 2,000 penalty units. (3) An offence against 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 manufactures in Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Defences (5) Subsection (1), (2) or (4) does not apply if the defendant proves that the defendant was not the sponsor of the biological at the time of the manufacture. Note: A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code. (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 biological; or (ii) a matter relating to the labelling or packaging of the biological; or (iii) the improper use of the biological; or (b) harm or injury would not directly result from: (i) the quality, safety or efficacy of the biological; or (ii) a matter relating to the labelling or packaging of the biological; or (iii) the improper use of the biological. Note: A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code. 32BD Criminal offences for supplying a biological (1) A person commits an offence if: (a) the person supplies in Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological; (v) the biological is the subject of an authority under subsection 32CM(1) that is held by the person; (vi) the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological; and (c) either: (i) the use of the biological has resulted in, or will result in, harm or injury to any person; or (ii) the use of the biological, if the biological were used, would result in harm or injury to any person. 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 supplies in Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological; (v) the biological is the subject of an authority under subsection 32CM(1) that is held by the person; (vi) the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological; and (c) the use of the biological, if the biological were used, would be likely to result in harm or injury to any person. Penalty: 2,000 penalty units. (3) An offence against 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 supplies in Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological; (v) the biological is the subject of an authority under subsection 32CM(1) that is held by the person; (vi) the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Defences (5) Subsection (1), (2) or (4) does not apply if the defendant proves that the defendant was not the sponsor of the biological at the time of the supply. Note: A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code. (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 biological; or (ii) a matter relating to the labelling or packaging of the biological; or (iii) the improper use of the biological; or (b) harm or injury would not directly result from: (i) the quality, safety or efficacy of the biological; or (ii) a matter relating to the labelling or packaging of the biological; or (iii) the improper use of the biological. Note: A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code. 32BE Notice required to adduce evidence in support of exception to offences (1) If: (a) a defendant is committed for trial for an offence against subsection 32BA(1), 32BB(1), 32BC(1) or 32BD(1); or (b) an offence against subsection 32BA(1), 32BB(1), 32BC(1) or 32BD(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 32BA(6), 32BB(6), 32BC(6) or 32BD(6) unless the defendant gives notice of particulars of the exception: (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. (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 the defendant gives the notice, any information in the defendant's 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; and (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 the defendant's 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 under this section 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 an office of the Office of the Director of Public Prosecutions; or (b) sent by certified mail addressed to the Director of Public Prosecutions at an office of 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. 32BF Civil penalties for importing, exporting, manufacturing or supplying a biological Importing a biological for use in humans (1) A person contravenes this subsection if: (a) the person imports into Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological; (v) the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Exporting a biological for use in humans (2) A person contravenes this subsection if: (a) the person exports from Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Manufacturing a biological for use in humans (3) A person contravenes this subsection if: (a) the person manufactures in Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Supplying a biological for use in humans (4) A person contravenes this subsection if: (a) the person supplies in Australia a biological for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological; (v) the biological is the subject of an authority under subsection 32CM(1) that is held by the person; (vi) the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Exception if person was not the sponsor of the biological (5) Subsection (1), (2), (3) or (4) does not apply if the person proves that he or she was not the sponsor of the biological at the time of the importation, exportation, manufacture or supply, as the case may be. Civil penalty relating to the supply of biologicals included in the Register (6) A person contravenes this subsection if: (a) a biological is included in the Register in relation to the person; and (b) the biological is of a kind prescribed by the regulations for the purposes of this paragraph; and (c) the person supplies the biological in Australia; and (d) the biological number of the biological is not set out on the label of the biological in the prescribed manner. Maximum civil penalty: (a) for an individual—200 penalty units; and (b) for a body corporate—2,000 penalty units. 32BG Criminal offence and civil penalty relating to a failure to notify the Secretary about manufacturing Criminal offence (1) A person commits an offence if: (a) the person: (i) imports a biological into Australia for use in humans; or (ii) exports a biological from Australia for use in humans; or (iii) manufactures a biological in Australia for use in humans; or (iv) supplies a biological in Australia for use in humans; and (b) the person is the sponsor of the biological; and (c) the person is not exempt under subsection 32CA(1) in relation to the biological and the biological is not exempt under subsection 32CA(2); and (d) 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 biological; (ii) the premises used in the manufacture of the biological. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. Civil penalty (2) A person contravenes this subsection if: (a) the person: (i) imports a biological into Australia for use in humans; or (ii) exports a biological from Australia for use in humans; or (iii) manufactures a biological in Australia for use in humans; or (iv) supplies a biological in Australia for use in humans; and (b) the person is the sponsor of the biological; and (c) the person is not exempt under subsection 32CA(1) in relation to the biological and the biological is not exempt under subsection 32CA(2); and (d) 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 biological; (ii) the premises used in the manufacture of the biological. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Definition (3) For the purposes of this section: (a) a manufacturer is properly notified to the Secretary if: (i) the manufacturer was nominated, as a manufacturer of the biological, in an application for inclusion of the biological in the Register; or (ii) the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the biological; and (b) premises are properly notified to the Secretary if: (i) the premises were nominated, as premises used in the manufacture of the biological, in an application for inclusion of the biological in the Register; or (ii) the Secretary was subsequently informed in writing that the premises are used in the manufacture of the biological. 32BH Criminal offence relating to wholesale supply A person commits an offence if: (a) the person supplies a biological in Australia for use in humans; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological; (v) the biological is the subject of an authority under subsection 32CM(1) that is held by the person; (vi) the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological; and (c) the person to whom the biological is supplied is not the ultimate consumer of the biological. Penalty: 120 penalty units. 32BI Criminal offence for using a biological not included in the Register (1) A person commits an offence if: (a) the person uses a biological; and (b) the biological is used: (i) in the treatment of another person; or (ii) solely for experimental purposes in humans; and (c) none of the following subparagraphs applies: (i) the biological is included in the Register; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CO(1) or (2); (v) the person uses the biological in accordance with an approval under subsection 32CK(1); (vi) the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section 32CL; (vii) the person uses the biological in accordance with an authority under subsection 32CM(1); and (d) either: (i) if the person used the biological in the treatment of that other person—the use of the biological has resulted in, or will result in, harm or injury to that other person; or (ii) if the person used the biological solely for experimental purposes in humans—the use of the biological has resulted in, or will result in, harm or injury to any of those humans. 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 uses a biological; and (b) the biological is used: (i) in the treatment of another person; or (ii) solely for experimental purposes in humans; and (c) none of the following subparagraphs applies: (i) the biological is included in the Register; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CO(1) or (2); (v) the person uses the biological in accordance with an approval under subsection 32CK(1); (vi) the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section 32CL; (vii) the person uses the biological in accordance with an authority under subsection 32CM(1); and (d) either: (i) if the person used the biological in the treatment of another person—the use of the biological is likely to result in harm or injury to that other person; or (ii) if the person used the biological solely for experimental purposes in humans—the use of the biological is likely to result in harm or injury to any of those humans. Penalty: 2,000 penalty units. (3) An offence against 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 uses a biological; and (b) the biological is used: (i) in the treatment of another person; or (ii) solely for experimental purposes in humans; and (c) none of the following subparagraphs applies: (i) the biological is included in the Register; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CO(1) or (2); (v) the person uses the biological in accordance with an approval under subsection 32CK(1); (vi) the person uses the biological in accordance with a condition applicable under regulations made for the purposes of section 32CL; (vii) the person uses the biological in accordance with an authority under subsection 32CM(1). Penalty for contravention of this subsection: 500 penalty units. 32BJ General criminal offences relating to this Part Including incorrect biological number on containers etc. (1) A person commits an offence if: (a) the person sets out or causes to be set out, on a container or package that contains a biological or on a label of a biological, a number that purports to be the biological number of the biological; and (b) the number is not that biological number. Penalty: 60 penalty units. (2) For the purposes of subsection (1), number includes any combination of one or more of the following: (a) numbers; (b) letters; (c) symbols. Advertising biological for an indication (3) A person commits an offence if: (a) the person, by any means, advertises a biological for an indication; and (b) the biological is included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion. Penalty: 60 penalty units. Arranging supply of biological not included in Register (4) A person commits an offence if: (a) the person claims, by any means, that the person or another person can arrange the supply of a biological; and (b) none of the following subparagraphs applies: (i) the biological is included in the Register in relation to the person; (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2); (iii) the biological is exempt under section 32CB; (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological; (v) the biological is the subject of an authority under subsection 32CM(1) that is held by the person; (vi) the biological is the subject of an approval under subsection 32CO(1) or (2) that is held by the person, being an approval covering the supply in Australia of the biological. Penalty for contravention of this subsection: 60 penalty units. 32BK Civil penalty for making misrepresentations about biologicals (1) A person contravenes this section if: (a) the person makes a representation of a kind referred to in subsection (2); 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. (2) Subsection (1) applies to the following representations: (a) representations that a biological is included in the Register; (b) representations that a person is exempt under subsection 32CA(1) in relation to a biological or that a biological is exempt under subsection 32CA(2); (c) representations that a biological is exempt under section 32CB; (d) representations that a biological is the subject of an approval under subsection 32CK(1); (e) representations that a biological is the subject of an authority under subsection 32CM(1); (f) representations that a biological is the subject of an approval under subsection 32CO(1) or (2). Division 3—Exemptions Subdivision A—Preliminary 32C What this Division is about There are 4 kinds of exemptions in relation to biologicals: (a) exemptions of biologicals under the regulations; and (b) exemptions of biologicals to deal with emergencies; and (c) exemptions of biologicals for special and experimental uses; and (d) exemptions of biologicals where substitutes are unavailable. Subdivision B—Exempting biologicals under the regulations 32CA Exempt biologicals (1) The regulations may exempt specified persons from the operation of Division 4 in relation to specified biologicals. Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003. (2) The regulations may exempt specified biologicals from the operation of Division 4. Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003. (3) An exemption under this section may be subject to conditions that are prescribed in the regulations. (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 results in the breach of a condition of an exemption under this section. Penalty: 60 penalty units. (5) If the regulations revoke an exemption, the revocation takes effect on the day specified in the regulations. The day must not be earlier than 28 days after the day on which the regulations revoking the exemption take effect. Subdivision C—Exempting biologicals to deal with emergencies 32CB Minister may make exemptions (1) The Minister may, by writing, exempt specified biologicals from the operation of Division 4. Note 1: For specification by class, see subsection 46(3) of the Acts Interpretation Act 1901. Note 2: There are criminal offences and a civil penalty relating to biologicals exempt under this section not conforming to standards etc.: see section 32CJ. (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 biologicals 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 biologicals 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 32CD deals with variation and revocation of the exemption. Effect of inclusion of biological in the Register (5) An exemption under subsection (1) ceases to have effect in relation to a particular biological when that biological becomes included in the Register under Division 4. Exemption not a legislative instrument (6) An exemption under subsection (1) is not a legislative instrument. 32CC Conditions of exemptions An exemption under section 32CB is subject to conditions specified in the exemption about any of the following: (a) the quantity of biologicals that are exempt; (b) the source of those biologicals; (c) the persons or class of persons who may import, export, manufacture or supply those biologicals; (d) the supply of those biologicals (including the persons or class of persons to whom biologicals may be supplied for use and the circumstances under which a stockpile of biologicals may be supplied for use); (e) the storage and security of those biologicals; (f) the keeping and disclosure of, and access to, records about those biologicals; (g) the disposal of those biologicals; (h) the manner in which any of those biologicals is to be dealt with if a condition of the exemption is breached; (i) any other matters that the Minister thinks appropriate. Whether or not biologicals are exempt under section 32CB is not affected by whether or not there is a breach of a condition under this section in relation to those biologicals. Note 1: There are criminal offences and civil penalties related to the breach of a condition of an exemption: see sections 32CH and 32CI. Note 2: Section 32CD deals with variation and revocation of the conditions. 32CD Variation or revocation of exemption Variation of exemption (1) The Minister may, by writing, vary an exemption made under section 32CB by removing specified biologicals from the exemption. Note: For specification by class, see subsection 46(3) of the Acts Interpretation Act 1901. Revocation of exemption (2) The Minister may, by writing, revoke an exemption made under section 32CB. Variation or revocation of conditions (3) The Minister may, by writing: (a) vary the conditions of an exemption made under section 32CB (including by imposing new conditions); or (b) revoke the conditions of an exemption made under section 32CB. 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). 32CE Informing persons of exemption etc. If the Minister makes an exemption under section 32CB, the Minister must take reasonable steps to give a copy of the following to each person covered by paragraph 32CC(c): (a) the exemption; (b) any variation or revocation of the exemption under section 32CD. 32CF Notification and tabling Notification (1) The Secretary must cause a notice setting out particulars of the following: (a) an exemption made under section 32CB because of paragraph 32CB(2)(b); (b) a variation or revocation under section 32CD, to the extent that the variation or revocation relates to an exemption made under section 32CB because of paragraph 32CB(2)(b); to be published in the Gazette within 7 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 32CB because of paragraph 32CB(2)(b); (b) a variation or revocation under section 32CD, to the extent that the variation or revocation relates to an exemption made under section 32CB because of paragraph 32CB(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. 32CG Disposal of unused biologicals (1) This section applies to a biological if: (a) an exemption under section 32CB in relation to that biological ceases to have effect otherwise than because that biological becomes included in the Register under Division 4; and (b) that biological has not been used before the exemption so ceases to have effect. (2) The Secretary may arrange for the disposal of the biological in accordance with the regulations. (3) Regulations made for the purposes of subsection (2) may set out the methods by which the biological 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 biological. 32CH 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 biological; and (b) the biological is covered by an exemption in force under section 32CB; 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 biological; and (b) the biological is covered by an exemption in force under section 32CB; 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 biological; and (b) the biological is covered by an exemption in force under section 32CB; 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. 32CI 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 biological; and (b) the biological is covered by an exemption in force under section 32CB; 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. 32CJ Criminal offences and civil penalty for biologicals not conforming to standards etc. (1) This section applies if: (a) a biological is exempt under section 32CB; and (b) a person supplies a batch of the biologicals; and (c) the Secretary is satisfied that the biologicals included in that batch: (i) do not conform to a standard applicable to the biologicals; or (ii) are otherwise not fit to be used for their intended purposes. (2) The Secretary may, by written notice given to the person, require the person to take steps to recover the biologicals included in that batch (except any of those biologicals that cannot be recovered because they have been administered to, or applied in the treatment of, a person). (3) The notice may specify one or more of the following requirements: (a) the steps to be taken to recover the biologicals; (b) the manner in which the steps are to be taken; (c) a reasonable period within which the steps are to be taken. (4) The Secretary must, as soon as practicable after giving the notice, cause particulars of it to be published in the Gazette. Notice is not a legislative instrument (5) A notice given under subsection (2) is not a legislative instrument. Offences (6) 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 any of the biologicals has resulted in, or will result in, harm or injury to any person; or (ii) the use of any of the biologicals, if any of the biologicals 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. Penalty: Imprisonment for 5 years or 4,000 penalty units, or both. (7) 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 any of the biologicals, if any of the biologicals 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. Penalty: 2,000 penalty units. (8) An offence against 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 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. Penalty: 60 penalty units. (10) An offence against subsection (9) is an offence of strict liability. Note: For strict liability, see section 6.1 of the Criminal Code. Civil penalty (11) A person contravenes this subsection 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 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. Subdivision D—Exempting biologicals for special and experimental uses 32CK Approvals for importing, exporting or supplying a biological for special and experimental uses (1) The Secretary may, by notice in writing, grant an approval to a person for one or more of the following: (a) the importation into Australia of a specified biological; (b) the exportation from Australia of a specified biological; (c) the supply in Australia of a specified biological; that is: (d) for use in the treatment of another person; or (e) for use solely for experimental purposes in humans. (2) Subsection (1) does not apply if the biological is included in the Register, the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2). Application for approval (3) An application for an approval for use of the kind referred to in paragraph (1)(d) must: (a) be made to the Secretary; and (b) be accompanied by such information relating to the biological the subject of the application as is required by the Secretary. (4) An application for an approval for use of the kind referred to in paragraph (1)(e) must: (a) be made to the Secretary; and (b) be made in writing; and (c) be accompanied by such information relating to the biological the subject of the application as is required by the Secretary; and (d) be accompanied by the prescribed evaluation fee. Secretary's decision (5) If an application for an approval is made, the Secretary must: (a) after having considered the application; and (b) in the case of an application for an approval for use of the kind referred to in paragraph (1)(e)—after having evaluated the information submitted with the application; notify the applicant of the decision on the application as soon as practicable after making the decision and, in the case of a decision not to grant the approval, of the reasons for the decision. Conditions (6) The Secretary may grant an approval under subsection (1) subject to any conditions that are specified in the notice of approval. (7) Those conditions may include a condition relating to the charges that may be made for the biological to which the approval relates. This subsection does not limit subsection (6). (8) An approval under subsection (1) for use of the kind referred to in paragraph (1)(e) is subject to the conditions (if any) specified in the regulations. Those conditions (if