Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 TABLE OF PROVISIONS Section Page PART 1—PRELIMINARY 1. 2. 1 Purposes Commencement 1 2 PART 2—DRUGS, POISONS AND CONTROLLED SUBSTANCES ACT 1981—REPEAL OF LICENSING REQUIREMENTS FOR SCHEDULE 5 POISONS AND SCHEDULE 6 POISONS 3. 4. 5. Authorisation to sell or supply by retail Schedule 5 poisons or Schedule 6 poisons Licence no longer required to manufacture and sell or supply by wholesale or retail Schedule 5 poisons or Schedule 6 poisons New sections 138 and 139 inserted 138. Refund of licence fee in relation to Schedule 5 poisons and Schedule 6 poisons 139. Transitional provisions relating to licences—Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 PART 3—DRUGS, POISONS AND CONTROLLED SUBSTANCES ACT 1981—POISONS CODE AND OTHER AMENDMENTS 6. 7. 8. 9. 10. 11. 12. 13. 14. Definitions The Poisons List Amendment of Poisons Code Repeal of section 12M Authorisations New section 18A inserted 18A. Definitions Licences under Division 4 of Part II Permits for the provision of health services Offences concerning labelling, containers and advertising i 3 3 3 4 4 5 7 7 8 9 10 10 10 10 11 11 11 Section 15. 16. 17. 18. 19. 20. 21. Page Section 32 substituted 32. Record keeping in relation to sale or supply of drugs of addiction Prohibition on administration of drugs for continuous period greater than 8 weeks Repeal of regulation-making power to amend Schedule Eleven New section 135A inserted 135A. Transitional provisions—Drugs, Poisons and Controlled Substances (Amendment) Act 1994 Schedule Eleven amended Repeal of Drugs, Poisons and Controlled Substances (Amendment) Act 1994 Amendment of Corrections Act 1986 PART 4—THERAPEUTIC GOODS (VICTORIA) ACT 1994 22. 23. 24. 13 13 14 15 15 15 16 16 16 17 Definitions Part 5 substituted 17 17 PART 5—CODES OF PRACTICE 17 45. Codes of Practice 46. Status of a Code of Practice 47. Procedure for making or adopting Codes of Practice 48. Commencement of Code of Practice 49. Availability of Codes of Practice 50. Tabling in Parliament 51. Conviction of offence under Code of Practice 52. Requirement to comply with Code of Practice Repeal of redundant sections ═══════════════ 17 18 19 20 20 21 22 22 22 ENDNOTES 23 ii Victoria No. 74 of 2004 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004† [Assented to 9 November 2004] The Parliament of Victoria enacts as follows: PART 1—PRELIMINARY 1. Purposes The main purposes of this Act are— (a) to amend the Drugs, Poisons and Controlled Substances Act 1981 to provide for the scheduling of poisons, to amend certain licence, permit and warrant 1 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 2 Part 1—Preliminary provisions and to repeal certain licensing requirements in relation to Schedule 5 poisons and Schedule 6 poisons; (b) to amend the Therapeutic Goods (Victoria) Act 1994 to provide for Codes of Practice in relation to therapeutic goods. 2. Commencement This Act comes into operation on the day after the day on which it receives the Royal Assent. __________________ 2 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Part 2—Drugs, Poisons and Controlled Substances Act 1981—Repeal of Licensing Requirements for Schedule 5 Poisons and Schedule 6 Poisons PART 2—DRUGS, POISONS AND CONTROLLED SUBSTANCES ACT 1981—REPEAL OF LICENSING REQUIREMENTS FOR SCHEDULE 5 POISONS AND SCHEDULE 6 POISONS 3. Authorisation to sell or supply by retail Schedule 5 poisons or Schedule 6 poisons After section 13(4) of the Drugs, Poisons and Controlled Substances Act 1981 insert— "(4A) A person is authorised to sell or supply by wholesale, subject to and in accordance with the regulations— (a) any Schedule 5 poison; or (b) any Schedule 6 poison. (4B) A person is authorised to manufacture and sell or supply by retail, subject to and in accordance with the regulations— (a) any Schedule 5 poison; or (b) any Schedule 6 poison. (4C) A person is authorised to manufacture and sell or supply by wholesale, subject to and in accordance with the regulations— (a) any Schedule 5 poison; or (b) any Schedule 6 poison.". 4. Licence no longer required to manufacture and sell or supply by wholesale or retail Schedule 5 poisons or Schedule 6 poisons (1) For section 20(1)(b) of the Drugs, Poisons and Controlled Substances Act 1981 substitute— "(b) manufacture and sell or supply by wholesale any Schedule 2 poison, Schedule 3 poison, Schedule 4 poison or Schedule 7 poison;". 3 s. 3 See: Act No. 9719. Reprint No. 7 as at 1 July 2004 and amending Act No. 16/2004. LawToday: www.dms. dpc.vic. gov.au Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 5 Part 2—Drugs, Poisons and Controlled Substances Act 1981—Repeal of Licensing Requirements for Schedule 5 Poisons and Schedule 6 Poisons (2) In section 20(1)(c) of the Drugs, Poisons and Controlled Substances Act 1981 omit "Schedule 5 poison, Schedule 6 poison or a". (3) For section 20(1)(e) of the Drugs, Poisons and Controlled Substances Act 1981 substitute— "(e) sell or supply by wholesale any Schedule 2 poison, Schedule 3 poison, Schedule 4 poison or Schedule 7 poison;". 5. New sections 138 and 139 inserted After section 137 of the Drugs, Poisons and Controlled Substances Act 1981 insert— "138. Refund of licence fee in relation to Schedule 5 poisons and Schedule 6 poisons (1) The Secretary may refund to a licence holder an amount equal to the proportion of the fee paid for a licence in relation to the period that starts on the date of the commencement of the Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 and ends on the expiry of the licence if— (a) the licence is issued under Division 4 of Part II for— (i) the sale or supply by wholesale of a Schedule 5 poison or a Schedule 6 poison; or (ii) the manufacture and sale or supply by retail of a Schedule 5 poison or a Schedule 6 poison; or (iii) the manufacture and sale or supply by wholesale of a Schedule 5 poison or a Schedule 6 poison; and 4 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Part 2—Drugs, Poisons and Controlled Substances Act 1981—Repeal of Licensing Requirements for Schedule 5 Poisons and Schedule 6 Poisons (b) at that commencement, the licence has a period of at least 6 months to run before its expiry. (2) A refund paid to a licence holder under subsection (1) is to be paid from the Consolidated Fund which is, to the necessary extent, appropriated accordingly. 139. Transitional provisions relating to licences—Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 (1) An application for a new licence of a kind referred to in section 20(1)(b) or (e) of this Act as in force immediately before the commencement of the Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 or for the renewal of such a licence must be taken to be an application for a licence or for its renewal (as the case requires) of a kind of licence referred to in the relevant section as amended by the Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004. (2) A licence— (a) of a kind referred to in section 20(1)(b) or (e) of this Act as in force immediately before the commencement of the Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 (including a suspended licence); and 5 s. 5 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 5 Part 2—Drugs, Poisons and Controlled Substances Act 1981—Repeal of Licensing Requirements for Schedule 5 Poisons and Schedule 6 Poisons (b) in existence at the date of that commencement— must be taken to have been issued under this Act as amended by the Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 and may be renewed, amended, suspended or cancelled accordingly. (3) The amendments to section 20(1)(b) and (e) made by the Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 do not affect the continuity or suspension of a licence of a kind referred to in section 20(1)(b) or (e) of this Act as in force immediately before the commencement of that Act.". __________________ 6 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code and Other Amendments PART 3—DRUGS, POISONS AND CONTROLLED SUBSTANCES ACT 1981—POISONS CODE AND OTHER AMENDMENTS 6. Definitions (1) In section 4(1) of the Drugs, Poisons and Controlled Substances Act 1981, in the definition of "drug of dependence"— (a) in paragraph (a) omit "or added thereto by regulations made under section 12M" (where twice occurring); (b) in paragraph (b) omit "or added thereto by regulations made under section 12M"; (c) in paragraph (c) omit "or added thereto by regulations made under section 12M" (where twice occurring). (2) In section 4(1) of the Drugs, Poisons and Controlled Substances Act 1981— (a) in the definition of "Schedule 2 Poison", for "in the Poisons List" substitute "of the Commonwealth standard"; (b) in the definition of "Schedule 3 Poison", for "in the Poisons List" substitute "of the Commonwealth standard"; (c) in the definition of "Schedule 4 Poison", for "in the Poisons List" substitute "of the Commonwealth standard"; (d) in the definition of "Schedule 5 Poison", for "in the Poisons List" substitute "of the Commonwealth standard"; (e) in the definition of "Schedule 6 Poison", for "in the Poisons List" substitute "of the Commonwealth standard"; 7 s. 6 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 7 Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code and Other Amendments (f) in the definition of "Schedule 7 Poison", for "in the Poisons List" substitute "of the Commonwealth standard"; (g) in the definition of "Schedule 8 Poison", for "in the Poisons List" substitute "of the Commonwealth standard"; (h) in the definition of "Schedule 9 Poison", for "in the Poisons List" substitute "of the Commonwealth standard". 7. The Poisons List (1) In section 12A(1) of the Drugs, Poisons and Controlled Substances Act 1981— (a) for "must contain" substitute "may contain"; (b) for paragraph (a) substitute— "(a) a list of substances that are of plant, animal or mineral origin that in the public interest should be available only from a person registered under the Chinese Medicine Registration Act 2000 or authorised under another Act, being Schedule 1 poisons; and"; (c) in paragraph (b), for "those Schedules" substitute "Schedule 1 of the Poisons List or Schedules 2 to 9 of the Commonwealth standard"; (d) in paragraph (c), for "those Schedules" substitute "Schedule 1 of the Poisons List or Schedules 2 to 9 of the Commonwealth standard". (2) Section 12A(2) of the Drugs, Poisons and Controlled Substances Act 1981 is repealed. (3) Section 12A(3)(a) of the Drugs, Poisons and Controlled Substances Act 1981 is repealed. 8 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code and Other Amendments (4) For section 12A(4) of the Drugs, Poisons and Controlled Substances Act 1981 substitute— "(4) In this Act, a reference to a particular substance in Schedule 1 of the Poisons List or to a particular substance in Schedules 2 to 9 of the Commonwealth standard excludes that substance to the extent that it is included in the list of exemptions under sub-section (1)(c).". (5) The table at the end of section 12A of the Drugs, Poisons and Controlled Substances Act 1981 is repealed. 8. Amendment of Poisons Code (1) In section 12E(1)(d) of the Drugs, Poisons and Controlled Substances Act 1981, for "any of the Schedules" substitute "Schedule 1". (2) After section 12E(1B) of the Drugs, Poisons and Controlled Substances Act 1981 insert— "(1C) The Minister may, at any time, amend the Poisons Code to— (a) specify the substances to be included in the Poisons List in the list of substances that are not for general sale by retail but can only be supplied to persons specifically authorised by this Act or the Regulations, or with a permit or warrant under this Act, to obtain them; and (b) amend, revoke, substitute or insert substances in the list referred to in paragraph (a). 9 s. 8 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 9 Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code and Other Amendments (1D) The Minister may, at any time, amend the Poisons Code to— (a) specify the substances to be included in the Poisons List in the list of exemptions from Schedule 1 of the Poisons List or Schedules 2 to 9 of the Commonwealth standard; and (b) amend, revoke, substitute or insert substances in the list of exemptions referred to in paragraph (a).". 9. Repeal of section 12M Section 12M of the Drugs, Poisons and Controlled Substances Act 1981 is repealed. 10. Authorisations In section 13(2B) of the Drugs, Poisons and Controlled Substances Act 1981— (a) omit "the Table to section 12A or"; (b) omit "number"; (c) for "Poisons List" substitute "Commonwealth standard". 11. New section 18A inserted Before section 19 of the Drugs, Poisons and Controlled Substances Act 1981 insert— '18A. Definitions In this Division— "licence" means a licence issued under this Division; "permit" means a permit issued under this Division; "warrant" means a warrant issued under this Division.'. 10 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code and Other Amendments 12. Licences under Division 4 of Part II In section 19(4) of the Drugs, Poisons and Controlled Substances Act 1981, for "Act" substitute "Division". 13. Permits for the provision of health services After section 20(3) of the Drugs, Poisons and Controlled Substances Act 1981 insert— "(3A) A person who is the holder of a permit issued under sub-section (3) authorising the person to purchase or otherwise obtain poisons or controlled substances for the provision of health services is authorised to sell or supply any poison or controlled substance to which that permit relates without obtaining a further licence to do so under this section if that sale or supply— (a) is carried out by a person who is authorised under section 13(1)(a), (ba) or (c) to sell or supply that poison or controlled substance in the lawful practice of his or her profession; and (b) is for the purposes of the provision of health services.". 14. Offences concerning labelling, containers and advertising (1) For section 27A(1) of the Drugs, Poisons and Controlled Substances Act 1981 substitute— "(1) A person must not sell or supply a poison or controlled substance with a label that does not comply with the requirements of— (a) in the case of a Schedule 1 poison, the Poisons Code; or 11 s. 12 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 14 Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code and Other Amendments (b) in the case of any other poison or controlled substance, the Commonwealth standard. Penalty: 20 penalty units. (1A) A person must not sell or supply a poison or controlled substance in a container that does not comply with the requirements of— (a) in the case of a Schedule 1 poison, the Poisons Code; or (b) in the case of any other poison or controlled substance, the Commonwealth standard. Penalty: 20 penalty units.". (2) In section 27A(2) of the Drugs, Poisons and Controlled Substances Act 1981 for "poison or controlled substance" substitute "Schedule 1 poison". (3) After section 27A(2) of the Drugs, Poisons and Controlled Substances Act 1981 insert— "(2A) A person must not sell or supply a poison or controlled substance (other than a Schedule 1 poison)— (a) which the person has stored or packaged otherwise than in accordance with the Commonwealth standard; or (b) which the person knows to have been stored or packaged otherwise than in accordance with the Commonwealth standard. Penalty: 20 penalty units.". (4) In section 27A(3) of the Drugs, Poisons and Controlled Substances Act 1981 for "poison or controlled substance" substitute "Schedule 1 poison". 12 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code and Other Amendments (5) After section 27A(3) of the Drugs, Poisons and Controlled Substances Act 1981 insert— "(3A) A person must not advertise for sale or supply a poison or controlled substance (other than a Schedule 1 poison) otherwise than in accordance with the Commonwealth standard. Penalty: 20 penalty units.". (6) In section 29(2) of the Drugs, Poisons and Controlled Substances Act 1981, after "this Act," insert "the Commonwealth standard,". 15. Section 32 substituted For section 32 of the Drugs, Poisons and Controlled Substances Act 1981 substitute— "32. Record keeping in relation to sale or supply of drugs of addiction (1) A person who is licensed under this Part to manufacture, sell, supply or distribute any Schedule 8 poison or Schedule 9 poison must record or cause to be recorded, in accordance with sub-section (2)— (a) details of any Schedule 8 poison or Schedule 9 poison obtained by the person; and (b) quantities of those poisons used, sold, supplied or otherwise disposed of; and (c) such other particulars as are prescribed. Penalty: 60 penalty units. (2) For the purposes of sub-section (1), the record kept must be recorded— (a) by printing or writing in a legible form in the English language; or 13 s. 15 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 16 Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code and Other Amendments (b) in an electronic form that is readily convertible into legible print in the English language.". 16. Prohibition on administration of drugs for continuous period greater than 8 weeks After section 35(4) of the Drugs, Poisons and Controlled Substances Act 1981 insert— "(5) For the purposes of this section, a registered medical practitioner administers, supplies or prescribes a Schedule 8 poison or Schedule 9 poison to a patient for a continuous period mentioned in sub-section (2), (2A) or (3) if the registered medical practitioner— (a) actually administers, supplies or prescribes that Schedule 8 poison or Schedule 9 poison for that period; or (b) supplies a quantity or quantities of a Schedule 8 poison or Schedule 9 poison to the patient and instructs the patient to take the drug for that period; or (c) prescribes for the patient a quantity or quantities of a Schedule 8 poison or Schedule 9 poison which, if taken in accordance with the prescription, would be taken for that period. (6) For the purposes of this section, a nurse practitioner administers, supplies or prescribes a Schedule 8 poison to a patient for a continuous period mentioned in subsection (2AA), (2A) or (4) if the nurse practitioner— (a) actually administers, supplies or prescribes that Schedule 8 poison for that period; or 14 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code and Other Amendments (b) supplies a quantity or quantities of a Schedule 8 poison to the patient and instructs the patient to take the drug for that period; or (c) prescribes for the patient a quantity or quantities of a Schedule 8 poison which, if taken in accordance with the prescription, would be taken for that period.". 17. Repeal of regulation-making power to amend Schedule Eleven Section 132(zcb) of the Drugs, Poisons and Controlled Substances Act 1981 is repealed. 18. New section 135A inserted After section 135 of the Drugs, Poisons and Controlled Substances Act 1981 insert— "135A. Transitional provisions—Drugs, Poisons and Controlled Substances (Amendment) Act 1994 Despite the repeal of the Drugs, Poisons and Controlled Substances (Amendment) Act 1994 by the Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004, a warrant to which section 19(2) of the Drugs, Poisons and Controlled Substances (Amendment) Act 1994 (including a suspended warrant) applied immediately before that repeal must be taken to have been issued under this Act and may be amended, suspended or cancelled accordingly.". 15 s. 17 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 19 Part 3—Drugs, Poisons and Controlled Substances Act 1981—Poisons Code and Other Amendments 19. Schedule Eleven amended In Part 3 of Schedule Eleven to the Drugs, Poisons and Controlled Substances Act 1981, after the item relating to "AMPHETAMINE"— (a) in column 1 insert "BUPRENORPHINE"; (b) in column 3 insert "2·0g". 20. Repeal of Drugs, Poisons and Controlled Substances (Amendment) Act 1994 The Drugs, Poisons and Controlled Substances (Amendment) Act 1994 is repealed. 21. Amendment of Corrections Act 1986 For section 29A(1)(c) of the Corrections Act 1986 substitute— "(c) any Schedule 8 poison or Schedule 9 poison within the meaning of the Drugs, Poisons and Controlled Substances Act 1981.". __________________ 16 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Part 4—Therapeutic Goods (Victoria) Act 1994 PART 4—THERAPEUTIC GOODS (VICTORIA) ACT 1994 22. Definitions In section 3 of the Therapeutic Goods (Victoria) Act 1994— (a) after the definition of "British Pharmacopoeia (Veterinary)" insert— ' "Code of Practice" means a Code of Practice made or adopted under Part 5;'; (b) in the definition of "licence" omit "or Part 5". 23. Part 5 substituted For Part 5 of the Therapeutic Goods (Victoria) Act 1994 substitute— "PART 5—CODES OF PRACTICE 45. Codes of Practice (1) The Victorian Secretary may make or adopt Codes of Practice in accordance with this Part. (2) A Code of Practice must be approved by the Minister before it is made or adopted. (3) A Code of Practice may apply, adopt or incorporate any matter contained in any document, code, standard, rule, specification or method formulated, issued, prescribed or published by any authority or body whether— (a) wholly or partially or as amended by the Code of Practice; or 17 s. 22 See: Act No. 79/1994. Reprint No. 1 as at 11 May 1999 and amending Act No. 67/2001. LawToday: www.dms. dpc.vic. gov.au Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 23 Part 4—Therapeutic Goods (Victoria) Act 1994 (b) as formulated, issued, prescribed or published at the time the Code of Practice is made or adopted or at any time before then; or (c) as formulated, issued, prescribed or published from time to time. (4) If a Code of Practice has applied, adopted or incorporated any matter contained in any document, code, standard, rule, specification or method as formulated, issued, prescribed or published from time to time and that document, code, standard, rule, specification or method is at any time amended, until the Victorian Secretary causes notice to be published in the Government Gazette of that amendment, the document, code, standard, rule, specification or method is to be taken not to have been so amended. (5) A Code of Practice may— (a) confer a discretionary authority or impose a duty on a specified person or body or a specified class of persons and bodies; (b) leave any matter or thing to be from time to time determined, applied, dispensed with or regulated by the Victorian Secretary; (c) authorise an authorised person to enforce the Code of Practice. 46. Status of a Code of Practice A Code of Practice is a subordinate instrument for the purposes of the Interpretation of Legislation Act 1984 except section 32 of that Act. 18 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Part 4—Therapeutic Goods (Victoria) Act 1994 47. Procedure for making or adopting Codes of Practice (1) Before the Victorian Secretary makes or adopts a Code of Practice, the Victorian Secretary must give a notice stating— (a) the purpose and general purport of the proposed Code of Practice; (b) where a copy of the proposed Code of Practice can be obtained or inspected; (c) in the case of the proposed making of a Code of Practice, that any person may make a submission on the proposed Code of Practice to the Victorian Secretary within the period specified in the notice. (2) In the case of the proposed making of a Code of Practice, the Victorian Secretary must— (a) allow at least 28 days after the day on which a notice is given under subsection (1) for the making of submissions; and (b) if, after considering any submissions made, the Victorian Secretary determines to make the Code of Practice, give a notice stating that the Victorian Secretary intends to make the Code of Practice. (3) A notice under this section must be— (a) published in the Government Gazette; and (b) published in a daily newspaper generally circulating in Victoria; and 19 s. 23 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 23 Part 4—Therapeutic Goods (Victoria) Act 1994 (c) sent to bodies or organisations that the Victorian Secretary considers are likely to be affected by the proposed Code of Practice. 48. Commencement of Code of Practice A Code of Practice or a provision of a Code of Practice comes into operation— (a) on the day on which the Code of Practice is approved by the Minister; or (b) on such later day as is expressed in the Code of Practice as the day on which the Code of Practice or provision comes into operation. 49. Availability of Codes of Practice (1) Upon the making or adoption of a Code of Practice, the Victorian Secretary must cause to be published in the Government Gazette notice of— (a) the making or adoption of the Code of Practice; and (b) the date of commencement of the Code of Practice; and (c) the place where copies of the Code of Practice may be obtained. (2) A notice published under sub-section (1) or a notice of an amendment published under section 45(4) must include a statement that the Code of Practice, any incorporated document or any amendment to an incorporated document (as the case may be) may be inspected at the office of the Victorian Secretary specified in the notice. 20 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Part 4—Therapeutic Goods (Victoria) Act 1994 50. Tabling in Parliament (1) The Minister must cause a copy of a Code of Practice that is made or adopted under section 45 and of the notice of its making or adoption to be laid before each House of Parliament within 7 sitting days of that House after the notice is published in the Government Gazette. (2) If the Code of Practice has applied, adopted or incorporated any matter contained in any document, code, standard, rule, specification or method as formulated, issued, prescribed or published, the Minister must include that applied, adopted or incorporated matter in the material laid before each House of Parliament under sub-section (1). (3) If the Code of Practice has applied, adopted or incorporated any matter contained in any document, code, standard, rule, specification or method as formulated, issued, prescribed or published and that document, code, standard, rule, specification or method is at any time amended, the Minister must cause a copy of the amendment and of the notice of amendment under section 45(4) to be laid before each House of Parliament within 7 sitting days of that House after the notice under section 45(4) is published in the Government Gazette. 21 s. 23 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 s. 24 Part 4—Therapeutic Goods (Victoria) Act 1994 51. Conviction of offence under Code of Practice A person must not be convicted of an offence or be prejudicially affected or made subject to any liability under a Code of Practice if it is proved that at the relevant time— (a) notice of the Code of Practice had not been published in the Government Gazette; or (b) a copy of the Code of Practice and any incorporated matter was not available for inspection. 52. Requirement to comply with Code of Practice A person who carries out an activity to which a Code of Practice relates must comply with the relevant Code of Practice. Penalty: 10 penalty units.". 24. Repeal of redundant sections (1) Section 72(1)(e) of the Therapeutic Goods (Victoria) Act 1994 is repealed. (2) Section 76 of the Therapeutic Goods (Victoria) Act 1994 is repealed. ═══════════════ 22 Drugs, Poisons and Controlled Substances and Therapeutic Goods (Victoria) Acts (Amendment) Act 2004 Act No. 74/2004 Endnotes ENDNOTES † Minister's second reading speech— Legislative Assembly: 16 September 2004 Legislative Council: 13 October 2004 The long title for the Bill for this Act was "to amend the Drugs, Poisons and Controlled Substances Act 1981 in relation to the scheduling of poisons and certain licence, permit and warrant provisions, to repeal the licensing requirements in relation to Schedule 5 poisons and Schedule 6 poisons, to amend the Therapeutic Goods (Victoria) Act 1994 and to consequentially amend other Acts and for other purposes." 23