Drugs, Poisons and Controlled Substances Further Amendment Bill 2014 Introduction Print EXPLANATORY MEMORANDUM Clause Notes PART 1—PRELIMINARY Clause 1 sets out the main purpose of the Bill which is to amend the Drugs, Poisons and Controlled Substances Act 1981 (the Principal Act)— to provide for a licence to be issued under Division 4 of Part II in respect of a mobile facility in certain circumstances; and to further provide for the terms and conditions that apply to licences, permits or warrants issued under Division 4 of Part II; and to replace the definition of Commonwealth standard with the new definition of Poisons Standard; and to make other minor consequential amendments. Clause 2 provides for the provisions of the Bill to come into operation on a day or days to be proclaimed or, on 1 September 2015 if not proclaimed before that date. Clause 3 provides that in this Bill the Principal Act is the Drugs, Poisons and Controlled Substances Act 1981. 571512 1 BILL LA INTRODUCTION 18/8/2014 PART 2—LICENCES, PERMITS AND WARRANTS Clause 4 sets out the definitions of mobile facility, mobile facility licence and mobile facility location for inclusion in section 4(1) of the Principal Act. Mobile facility is defined for the purpose of a mobile facility licence, to mean a trailer or vehicle that is suitably fitted out or containing equipment and apparatus for the purpose of the manufacture of perishable pest animal bait that is a Schedule 7 poison. Mobile facility licence is defined to mean a licence issued under section 19(6) of the Principal Act. A mobile facility licence is a new type of licence inserted by clause 5(4) of the Bill. A mobile facility licence is issued for the purpose of authorising the mobile manufacture of perishable pest animal bait that is a Schedule 7 poison. Mobile facility location is defined to mean a location where the manufacture, sale or supply of a perishable pest animal bait that is a Schedule 7 poison authorised under a mobile facility licence is carried out. Clause 5 subclause (1) inserts a new subclause (3A) into section 19 of the Principal Act. Under section 19(3) of the Principal Act the Secretary may issue a licence, permit or warrant subject to such terms, conditions, limitations and restrictions as the Secretary may determine. New clause19(3A)(a) provides in addition to the powers under section 19(3) of the Principal Act for the Secretary's powers with respect to the matter that may be the subject of a condition in a licence, permit or warrant. This includes that a licence, permit or warrant be issued subject to a condition requiring the licence holder to comply with any document, code, standard, guideline, rule, method or specification formulated, issued, prepared, prescribed or published by any person or body. The insertion of new clause 19(3A)(b) provides that a licence, permit or warrant may be issued subject to a condition requiring a licence holder to hold a licence, permit or warrant issued under any Victorian law or Commonwealth law. 2 Clause 5(2) amends section 19(4) of the Principal Act by limiting the application of this provision to licences, permits or warrants other than mobile facility licences. The amendment is required because the limitation in section 19(4) of the Principal Act that provides that a licence, permit or warrant, other than a mobile facility licence, cannot be issued for premises in more than one locality, will not apply to a mobile facility licence. New section 19(7) will provide that a mobile facility licence relates to the period the mobile facility is located at a mobile facility location. This is required because a mobile facility may travel to and from a number of mobile facility locations as well as being parked at a permanent fixed address specified on the mobile facility licence, but is only authorised to manufacture, sell or supply perishable pest animal baits while located at a mobile facility location. Clause 5(3) amends section 19(5) of the Principal Act by extending the application of section 19(5) to a mobile facility. Section 19(5) of the Principal Act provides that the Secretary must not issue a licence, permit or warrant unless the Secretary is satisfied that an applicant's premises are sanitary and suitable for the manufacture, sale, supply or use of poisons. Clause 5(4) inserts new section 19(6) into the Principal Act which authorises the Secretary to issue a licence to a person in respect of a mobile facility. Clause 5(4) also inserts new section 19(7) into the Principal Act, which sets out the particular characteristics of a mobile facility licence. A mobile facility licence— relates to the mobile facility licence during the period it is located at a mobile facility location; and is personal to the licence holder and not transferable to another person; and is subject to the condition that the licence holder ensures the mobile facility is parked at a permanent fixed address as specified in the mobile facility licence during any period that the mobile facility is not travelling to or from or located at a mobile facility location; and 3 is subject to the condition that the mobile facility is registered under the Road Safety Act 1986 and identified by a number plate bearing a registration number; and may be issued in respect of one or more mobile facilities if the mobile facilities are usually parked at the same permanent address as specified in the licence. The purpose of this amendment is to reflect the features for the proposed mobile manufacturing of perishable pest animal bait and assist with the location of a mobile facility for the purpose of monitoring compliance with the Act and the conditions of the mobile facility licence. Clause 6 Subclause (1) makes a licence that authorises a person to do certain things under section 20(1) of the Principal Act subject to new section 20(2) of the Principal Act. Subclause (3) inserts new section 20(2) into the Principal Act, which sets out all or any of the activities a person is authorised to do pursuant to a mobile facility licence. New section 20(2)(a) provides that a mobile facility licence authorises a person to manufacture and sell or supply by wholesale any perishable pest animal bait that is a Schedule 7 poison (other than a Schedule 7 poison included in the Poisons Code in the list of substances that are for general sale by retail) at a mobile facility location to which the mobile facility licence relates. New section 20(2)(b) reflects the same wording as new section 20(2)(a) with respect to the manufacture, sale and supply of perishable pest animal bait except provides for these activities to occur by retail. Clause 7 amends section 22B of the Principal Act, which provides that the Secretary may require premises to be inspected under the Act before issuing, renewing or amending a licence. The purpose of this amendment is to extend the Secretary's authority to require a mobile facility to be inspected on the same basis as premises under the Act. 4 Clause 8 amends section 22C(1)(e) of the Principal Act which currently provides the basis on which the Secretary may suspend or cancel a licence, permit or warrant. The purpose of this amendment is to extend the application of this provision to the holder of a mobile facility licence for a mobile facility. Clause 9 amends section 132(p) of the Principal Act which currently provides that the Governor in Council may make regulations for or with respect to the inspection of premises, stocks books and any other documents relating to poisons or controlled substances to include the power to make regulations with respect to the inspection of mobile facilities. PART 3—POISONS STANDARD Clause 10 inserts a definition of Poisons Standard and repeals the definition of Commonwealth standard in section 4(1) of the Principal Act. The purpose of this amendment is for clarity and consistency so that the terminology in the Act is consistent with the terminology applied in the Therapeutic Goods Act 1989 of the Commonwealth. As a consequence of the insertion of the new definition of Poisons Standard, clause 10(2) substitutes the term Poisons Standard for Commonwealth standard, wherever the term occurs in section 4(1) of the Principal Act. Clause 11 substitutes the term Poisons Standard for Commonwealth standard wherever the term occurs in section 12(2) of the Principal Act as a consequence of the insertion of the new definition of Poisons Standard. Clause 12 substitutes the term Poisons Standard for Commonwealth standard wherever the term occurs in section 12A of the Principal Act as a consequence of the insertion of the new definition of Poisons Standard. Clause 13 substitutes the term Poisons Standard for Commonwealth standard wherever the term occurs in section 12B of the Principal Act as a consequence of the insertion of the new definition of Poisons Standard. 5 Clause 14 inserts a new section heading to section 12D of the Principal Act and substitutes the term Poisons Standard for Commonwealth standard wherever the term occurs in section 12D of the Principal Act. Clause 15 substitutes the term Poisons Standard for Commonwealth standard wherever the term occurs in section 12E of the Principal Act. Clause 16 substitutes the term Poisons Standard for Commonwealth standard wherever the term occurs in section 12H of the Principal Act. Clause 17 substitutes the term Poisons Standard for Commonwealth standard in section 12K of the Principal Act. Clause 18 repeals redundant section 13(2B) of the Principal Act. Clause 19 substitutes the term Poisons Standard for Commonwealth standard wherever the term occurs in section 27A of the Principal Act. Clause 20 substitutes the term Poisons Standard for Commonwealth standard where the term occurs in section 29(2) of the Principal Act. PART 4—OTHER AMENDMENTS Clause 21 substitutes the reference in section 80I(b) of the Principal Act to the Therapeutic Goods (Victoria) Act 1994 with a reference to the Therapeutic Goods (Victoria) Act 2010. The purpose of this amendment is to accurately reflect the Victorian statute book as the 2010 Act has superseded the 1994 Act. Clause 22 amends section 119 of the Principal Act so that the evidentiary provisions under section 244 of the Health Practitioner Regulation National Law apply for the purposes of legal proceedings under the Act with respect to establishing the registration status of a registered medical practitioner, registered Chinese medicine practitioner, registered Chinese herbal dispenser, dentist, pharmacist, registered podiatrist, registered optometrist, nurse practitioner, registered nurse or registered midwife. 6 Clause 23 substitutes the term Poisons Standard for Commonwealth standard where the term occurs in the regulation making powers under section 132(zca) of the Principal Act as a consequence of the insertion of the new definition of Poisons Standard. Clause 24 substitutes the term Poisons Standard for Commonwealth standard where the term occurs in section 133A(1) of the Principal Act. PART 5—REPEAL OF AMENDING ACT Clause 25 provides for the automatic repeal of this amending Act on 1 September 2016. The repeal of this Act does not affect in any way the continuing operation of the amendments made by this Act (see section 15(1) of the Interpretation of Legislation Act 1984). 7