New Zealand Legislation: Acts
Acts are laws made by Parliament
(1) The Governor-General may from time to time, by Order in Council made on the advice of the Minister tendered after consultation with such organisations or bodies as appear to the Minister to be representative of persons likely to be substantially affected by the regulations, make regulations for all or any of the following purposes:
(a) Prescribing forms, fees, registers, particulars, notifications, and records for the purposes of this Act, the method of keeping such registers and records, and the manner of making applications under this Act; and prescribing the persons or classes of persons by or to whom any such records shall be kept or notifications given:
(aa) Approving persons or organisations, or classes of persons or organisations, for the purposes of section 23C(1)(c)(iv) of this Act:
(b) Prescribing qualifications for and conditions of licences under this Act; and providing for or regulating the custody, production, suspension, or revocation of licences:
(c) Permitting the manufacture, packing, labelling, administration, sale, or supply of medicines otherwise than pursuant to a licence under this Act and otherwise than in accordance with an authority conferred by this Act, subject to such conditions or restrictions (if any) as may be prescribed by or imposed under the regulations:
(d) Prohibiting, limiting, restricting, or imposing conditions on, either generally or in relation to particular cases or classes of case, or particular descriptions or classes of medicines, or particular classes of person, the prescribing, manufacture, packing, labelling, administration, sale, or supply of medicines pursuant to any provision of this Act:
(e) Prohibiting, limiting, restricting, or imposing conditions on the import, export, manufacture, packing, labelling, storage, sale, or supply of medicines of any description or medical devices of any kind:
(f) Withdrawing medicines and medical devices from sale:
(g) Regulating the situation, construction, sanitation, and use of premises in which medicines or medical devices are manufactured, packed, labelled, stored, sold, or supplied; prescribing the accommodation (including the amount of space) to be provided for any such purpose; prescribing standards of sanitation, cleanliness, temperature, and humidity, or other factors relating to the risks of deterioration or contamination, to be observed in connection with any such purpose; and prohibiting, or providing for the prohibition of, the use of particular premises or particular classes of premises for any such purpose:
(h) Regulating the manufacture, packing, labelling, storage, safe-keeping, and destruction of medicines and medical devices:
(i) Specifying, by name or description, kinds or classes of substances or articles that shall not be medicines or medical devices for the purposes of this Act:
(j) Specifying descriptions of medicines that are prescription medicines or restricted medicines or pharmacy-only medicines:
(k) Prescribing standards of composition, including standards of strength, weight, quality, purity, or quantity for any description or class of medicine or any kind or class of medical device or for anything contained in or added to or intended to be contained in or added to any medicine or medical device; prescribing standards of accuracy of performance for any kind or class of medical device; permitting the addition of a specified thing, or specified class of thing, in a specified quantity or proportion to medicines or medical devices, or to medicines of any specified description or class, or to medical devices of any specified kind or class, for which a standard is prescribed; and prohibiting the sale or supply of any medicine or medical device, not belonging to a description or class of medicine, or kind or class of medical device, for which a standard is prescribed, to which a specified thing or specified class of thing has been added or has been added in a quantity or proportion in excess of or less than a specified quantity or proportion:
(l) Prescribing and regulating the mode of labelling of packages and containers of medicines or medical devices or substances or articles used or intended for use in the manufacture, or as ingredients or parts, of any medicine or medical device; prescribing the matter to be contained or not to be contained in any such label and the nature and appearance of any package or container enclosing a particular description or class of medicine or particular kind or class of medical device; and permitting the sale or supply of medicines or medical devices otherwise than in packages and containers labelled in accordance, and otherwise conforming with, any such regulations:
(m) Prescribing methods to be used in the colouring of medicines of any description or class; requiring that any specified description or class of medicines shall be artificially coloured by the addition thereto of such colouring substance or substances as may be prescribed, in such proportion or proportions as may be prescribed; and prohibiting the sale or supply of any such medicine not so coloured:
(n) Prohibiting the use of any package or container of a kind specified or described in the regulations for any purpose other than the storage of medicines for internal use:
(o) Providing for the ascertainment, assessment, notification, and correction of damage to or leakage from packages or containers of medicines or medical devices, and the notification of any suspected contamination of medicines or medical devices sustained, in the course of storage or transportation by any means:
(p) Requiring persons who are engaged in the manufacture, import, packing, labelling, sale, or supply of any medicines, or who utilise any medicine in the course of or in connection with their profession, trade, or calling, or any occupation whether paid or unpaid, or who otherwise undertake the supply or administration of any medicine, to furnish information with respect to such matters and in such form as may be prescribed:
(q) Regulating the issue by practitioners, veterinarians, registered midwives, and designated prescribers of prescriptions for the supply of any medicine, and requiring persons issuing or dispensing prescriptions in respect of any medicine to furnish such information relating to those prescriptions as may be prescribed:
(qa) Authorising any class of registered health professional, other than a practitioner or registered midwife, to prescribe prescription medicines of a specified class or description in accordance with such conditions, limitations, requirements, or restrictions specified in or imposed under the regulations:
(qb) Regulating the issue of standing orders, imposing conditions, limitations, requirements, or restrictions in relation to the contents of standing orders and their use, and providing for such other matters as are necessary or desirable for the administration of standing orders:
(r) Requiring any medical practitioner who attends a person whom he considers, or has reasonable grounds to suspect, is dependent (within the meaning of the regulations) on medicines of any description or class to furnish such particulars with respect to that person as may be prescribed:
(s) Prohibiting, regulating, or restricting the sale or supply of medicines to any person so dependent, and the issue of prescriptions for such sale or supply:
(t) Regulating the dispensing and compounding of medicines:
(u) Regulating the procedure of any committee established under this Act:
(v) Regulating and controlling the exercise of powers by officers:
(w) Applying any provision of this Act, subject to any exceptions and modifications that may be prescribed, that refers to things done in the course of a business carried on by a person, to things done by him or by his agent or employee in the course of any other activity specified or described in the regulations:
(x) Providing for the waiver of fees in whole or in part in particular cases or classes of cases and for the total or partial refund of fees:
(y) Prescribing offences in respect of the contravention of or non-compliance with any regulations made under this Act, and the amounts of fines that may be imposed in respect of any such offences, which fines shall be an amount not exceeding $500 and, where the offence is a continuing one, a further amount not exceeding $50 for every day or part of a day during which the offence has continued:
(z) Exempting, or providing for the exemption of, any persons or classes of persons, or excepting any description or class of medicines, or any description or classes of medical devices, from any provision of any regulation made under this Act that imposes conditions or obligations:
(za) Providing for such other matters as are contemplated by or necessary for giving full effect to the provisions of this Act and for its due administration.
(2) Any regulations made under subsection (1) of this section may—
(a) Apply to medicines or medical devices generally or to particular descriptions or classes of medicines, or particular kinds or classes of medical devices, specified or described in the regulations, and may make different provision for different descriptions or classes of medicines, or different kinds or classes of medical devices, so specified or described:
(b) Relate to any description or kind of substances or articles specified by their name or trade names, or to any class of substances or articles identified in such manner as may be appropriate:
(c) identify any substances or articles or class of substances or articles by reference to their registration under any enactments, or to their pharmacological action, or to their use for the purpose for which they are used or intended to be used:
(d) Specify the circumstances in which any description or kind of substances or articles are or are not to be medicines, prescription medicines, restricted medicines, or medical devices, or any 2 or more of those things for the purposes of this Act:
(e) Provide for depriving particular persons of any rights, privileges, or exemptions conferred on any class of person to which those persons belong by this Act or any such regulations.
(3) Any regulations made under subsection (1) of this section may prescribe a standard by reference to the name or description of a medicine, and the standard applicable thereto, appearing in a monograph contained in a specified publication within the meaning of section 108(1) of this Act, or otherwise incorporate the whole or any part of any such monograph in the regulations by reference to any such specified publication.
(4) Any reference included in any regulations pursuant to subsection (3) of this section may be expressed to be to a particular edition of a specified publication or to a specified publication without mentioning a particular edition, and to medicines generally or to any particular description or descriptions or class or classes of medicines, and to monographs generally, or to any particular monograph or monographs or class or classes of monographs, and the following provisions shall apply in relation to any such reference:
(a) If the regulations refer to a particular edition of a specified publication, the reference shall be construed as including all amendments, additions, and deletions made to that edition and published before the date on which the regulations are made:
(b) If the regulations do not refer to a particular edition of a specified publication, the reference shall be construed as applying to the edition of the specified publication in force when the regulations are made, so long as that edition remains in force, and thereafter to every subsequent edition of that publication for the time being in force, and as extending to all amendments, additions, and deletions made to any such edition and published whether before, on, or after the date on which the regulations are made.
(5) All or any of the powers conferred by paragraphs (g), (h), (k), and (l) of subsection (1) of this section may be exercised in respect of any cosmetic or dentifrice (whether or not it is a related product within the meaning of Part 7 of this Act).
(6) Notwithstanding anything contained in any regulation made under this section, any person may, at any time within 12 months after the date of the commencement of the regulation, sell any medicine or medical device of which the sale is otherwise lawful, if he proves that at that date the medicine or medical device was part of the existing stock-in-trade in New Zealand of any person carrying on business there, and that since that date no act has been done whereby the medicine or medical device fails to conform to the regulation.
(7) For the purposes of subsection (6) of this section any goods purchased before the said date for importation into New Zealand shall be deemed to be part of the purchaser's stock-in-trade in New Zealand.
Compare: 1960 No 97 ss 4, 53; 1969 No 7 s 46; 1969 No 44 s 13; 1979 No 27 s 82
Subsection (1)(aa) was inserted, as from 1 January 1995, by section 3 Medicines Amendment Act 1994 (1994 No 128). See regulation 2 Medicines Amendment Act Commencement Order 1994 (SR 1994/298).
Subsection (1)(q) was amended, as from 28 August 1990, by section 26 Nurses Amendment Act 1990 (1990 No 107) by inserting the words “and registered midwives”
.
Subsection (1)(q) was substituted, as from 15 October 1999, by section 14 Medicines Amendment Act 1999 (1999 No 117).
Subsection (1)(qa) and (qb) were inserted, as from 15 October 1999, by section 14 Medicines Amendment Act 1999 (1999 No 117).
Subsection (2)(c) was amended, as from 22 October 2003, by section 5 Medicines Amendment Act (No 3) 2003 (2003 No 84) by substituting the word “identify”
for the word “indentify”
.