105Regulations

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:

2. prescribing forms, fees, registers, particulars, notifications, and records for the purposes of this Act, the method of keeping such registers and records; and prescribing the persons or classes of persons by or to whom any such records shall be kept or notifications given:
3. prescribing, in relation to any application or class of application under this Act, any of the following:
   1. the manner in which the application must be made; and
   2. the information that must accompany or be contained in the application; and
   3. the manner in which the application must be determined by the decision-maker; and
   4. any matters that the decision-maker must take into account when determining the application:
4. approving persons or organisations, or classes of persons or organisations, for the purposes of section 23C(1)(c)(iv):
5. prescribing qualifications for and conditions of licences under this Act; and providing for or regulating the custody, production, suspension, or revocation of licences:
6. 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:
7. 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:
8. 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:
9. withdrawing medicines and medical devices from sale:
10. 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:
11. regulating the manufacture, packing, labelling, storage, safe-keeping, and destruction of medicines and medical devices:
12. specifying, by name or description, substances or articles, or kinds or classes of substances or articles, that are, or are not, medicines or medical devices for the purposes of this Act:
13. specifying descriptions of medicines that are prescription medicines or restricted medicines or pharmacy-only medicines:
14. 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:
15. 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:
16. 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:
17. 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:
18. 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:
19. 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:
20. regulating the issue by authorised prescribers, veterinarians, and delegated prescribers of prescriptions for the supply of any medicine, including the transmission and storage of prescriptions, and requiring persons issuing or dispensing prescriptions in respect of any medicine to furnish such information relating to those prescriptions as may be prescribed:
21. authorising any class of registered health professional to prescribe specified prescription medicines, or a specified class or description of prescription medicines, in accordance with any conditions, limitations, requirements, or restrictions specified in or imposed under the regulations:
22. granting and regulating delegated prescribing rights:
23. 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:
24. 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:
25. 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:
26. regulating the dispensing and compounding of medicines:
27. regulating the procedure of any committee established under this Act:
28. regulating and controlling the exercise of powers by officers:
29. 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:
30. 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:
31. 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:
32. 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:
33. 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.

34. Any regulations made under subsection (1) may—

35. 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:
36. 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:
37. 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:
38. 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:
39. 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.

40. Any regulations made under subsection (1) 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), or otherwise incorporate the whole or any part of any such monograph in the regulations by reference to any such specified publication.

41. Any reference included in any regulations pursuant to subsection (3) 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:

42. 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:
43. 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.

44. All or any of the powers conferred by paragraphs (g), (h), (k), and (l) of subsection (1) may be exercised in respect of any cosmetic or dentifrice (whether or not it is a related product within the meaning of Part 7).

45. For the purposes of subsection (1)(qa),—

46. specified prescription medicines means prescription medicines specified by the Director-General by notice; and
47. specified class or description of prescription medicines means a class or description of prescription medicines specified by the Director-General by notice.

48. Before issuing a notice under subsection (5A), the Director-General must consult with those organisations or bodies that appear to the Director-General to be representative of persons likely to be substantially affected by the notice.

49. 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.

50. For the purposes of subsection (6) 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.

51. The following are secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements):

52. regulations under this section:
53. a notice under subsection (5A).