Medicines Amendment Act 2013

Coat of Arms of New Zealand

Medicines Amendment Act 2013

Public Act2013 No 141
Date of assent4 December 2013
Commencementsee section 2

Contents

1 Title

2 Commencement

3 Principal Act amended

Part 1
Amendments to principal Act

4 Interpretation

5 Meaning of medicine, new medicine, prescription medicine, and restricted medicine

6 New section 3A inserted

7 New section 4 substituted

8 Functions, powers, and procedures of Medicines Review Committee

9 Sale of medicines by retail

10 Administering prescription medicines

11 Restrictions on sale or supply of new medicines

12 New sections 20A to 23AAB substituted

13 Interpretation

14 New sections 23D to 24AA substituted

15 Exemptions for pharmacists

16 Exemptions for veterinarians and certain registered health practitioners

17 Exemption for medicine required by medical practitioner

18 Exemption for clinical trial

19 Exemptions in respect of importation by the Crown

20 Revocation and suspension of consents

21 Control of established medicines

22 Restriction on authorised prescribers holding interest in pharmacies

23 Restrictions on possession of prescription medicines

24 New section 47A inserted

25 Powers of Minister to prohibit prescribing, etc

26 Restrictions on supply to particular persons

27 Statements regarding persons dependent on prescription medicines or restricted medicines

28 Grant of licences

29 Effect of licences

30 Offences in relation to authorised prescribers

31 New section 87 substituted

32 Right of appeal to High Court

33 Interpretation

34 Certain provisions to apply to related products as if medicines

35 Regulations

36 Regulations relating to practitioners, veterinarians, and registered midwives

37 New sections 105D to 105F inserted

38 New Schedule 3 added

39 Amendment relating to Legislation Act 2012

Part 2
Consequential amendments to other enactments, transitional provisions, and related matters

Subpart 1Amendments to Misuse of Drugs Act 1975

40 Amendments to Misuse of Drugs Act 1975

41 Interpretation

42 Exemptions from sections 6 and 7

43 Statements regarding drug dependent persons

44 Powers of Minister to prohibit prescribing, etc

45 Treatment of people dependent on controlled drugs

46 Section 33 substituted

47 Regulations

Subpart 2Amendments to, and revocation of, regulations

48 Amendment to Electricity (Safety) Regulations 2010

49 Amendment to Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001

50 Amendment to Medicines (Database of Medical Devices) Regulations 2003

51 Regulations revoked

Subpart 3Transitional provision

52 Transitional provision regarding medicines

Schedule
New Schedule 3 added


The Parliament of New Zealand enacts as follows:

1 Title
  • This Act is the Medicines Amendment Act 2013.

2 Commencement
  • (1) Sections 5(2), 8, 11 to 15, 17 to 21, 29(1), 32, 33(2), and 34 come into force on the earlier of the following:

    • (a) a date appointed by the Governor-General by Order in Council (and 1 or more Orders in Council may be made bringing different provisions into force on different dates):

    • (b) 1 July 2017.

    (2) The rest of this Act comes into force on the earlier of the following:

    • (a) a date appointed by the Governor-General by Order in Council (and 1 or more Orders in Council may be made bringing different provisions into force on different dates):

    • (b) 1 July 2014.

3 Principal Act amended

Part 1
Amendments to principal Act

4 Interpretation
  • (1) Section 2(1) is amended by repealing the definition of authorised prescriber and substituting the following definition:

    authorised prescriber means—

    • (a) a nurse practitioner; or

    • (b) an optometrist; or

    • (c) a practitioner; or

    • (d) a registered midwife; or

    • (e) a designated prescriber.

    (2) The definition of designated prescriber in section 2(1) is amended by—

    • (a) inserting , nurse practitioner, optometrist, after practitioner; and

    • (b) inserting in paragraph (a) specified prescription medicines, or any after any.

    (3) Section 2(1) is amended by repealing the definition of medical device and substituting the following definition:

    medical device has the meaning given to it by section 3A.

    (4) Paragraph (a) of the definition of standing order in section 2(1) is amended by omitting a practitioner or registered midwife and substituting a practitioner, registered midwife, nurse practitioner, or optometrist.

    (5) Paragraph (c) of the definition of standing order in section 2(1) is amended by omitting a practitioner, or midwife and substituting a practitioner, registered midwife, nurse practitioner, or optometrist.

    (6) Section 2(1) is amended by inserting the following definitions in their appropriate alphabetical order:

    delegated prescriber means a health practitioner to whom a delegated prescribing order has been issued

    delegated prescribing order means a written instruction, issued in accordance with regulations by an authorised prescriber, authorising a health practitioner to prescribe prescription medicines

    delegated prescribing rights means prescribing rights granted by regulations made under section 105(1)(qaa)

    nurse practitioner means a health practitioner—

    • (a) who is, or is deemed to be, registered with the Nursing Council as a practitioner of the profession of nursing; and

    • (b) for whom the Nursing Council has authorised a scope of practice that includes prescribing medicines

    Nursing Council means the Nursing Council of New Zealand continued by section 114(1)(a) of the Health Practitioners Competence Assurance Act 2003

    optometrist means a person—

    • (a) who is, or is deemed to be, registered with the Optometrists and Dispensing Opticians Board as a practitioner of optometry; and

    • (b) for whom the Optometrists and Dispensing Opticians Board has authorised a scope of practice that includes prescribing medicines

    Optometrists and Dispensing Opticians Board means the Optometrists and Dispensing Opticians Board continued by section 114(1)(a) of the Health Practitioners Competence Assurance Act 2003

    regulations means regulations made under this Act

    responsible authority has the meaning given to it in section 5(1) of the Health Practitioners Competence Assurance Act 2003.

5 Meaning of medicine, new medicine, prescription medicine, and restricted medicine
  • (1) Section 3 is amended by repealing subsections (1) and (2) and substituting the following subsection:

    • (1) In this Act, unless the context otherwise requires, medicine

      • (a) means any substance or article that—

        • (i) is manufactured, imported, sold, or supplied wholly or principally for administering to 1 or more human beings for a therapeutic purpose; and

        • (ii) achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological, immunological, or metabolic means; and

      • (b) includes any substance or article—

        • (i) that is manufactured, imported, sold, or supplied wholly or principally for use as a therapeutically active ingredient in the preparation of any substance or article that falls within paragraph (a); or

        • (ii) of a kind or belonging to a class that is declared by regulations to be a medicine for the purposes of this Act; but

      • (c) does not include—

        • (i) a medical device; or

        • (ii) any food within the meaning of section 2 of the Food Act 1981; or

        • (iii) any radioactive material within the meaning of section 2(1) of the Radiation Protection Act 1965; or

        • (iv) any animal food in which a medicine (within the meaning of paragraph (a) or (b)) is incorporated; or

        • (v) any animal remedy; or

        • (vi) any substance or article of a kind or belonging to a class that is declared by regulations not to be a medicine for the purposes of this Act.

    (2) Paragraph (d) of the definition of new medicine in section 3(3) is amended by omitting 24(5) and substituting 24AA(2).

    (3) Section 3(3) is amended by repealing the definition of prescription medicine and substituting the following definition:

    prescription medicine means a medicine that is declared by regulations or by a notice given under section 106 to be one that, except as may be permitted by regulations, may be—

    • (a) sold by retail only under a prescription given by an authorised prescriber, veterinarian, or delegated prescriber; and

    • (b) supplied in circumstances corresponding to retail sale only—

      • (i) under a prescription given by an authorised prescriber, veterinarian, or delegated prescriber; or

      • (ii) in accordance with a standing order; and

    • (c) administered only in accordance with—

      • (i) a prescription given by an authorised prescriber, veterinarian, or delegated prescriber; or

      • (ii) a standing order.

6 New section 3A inserted
  • The following section is inserted after section 3:

    3A Meaning of medical device
    • In this Act, unless the context otherwise requires, medical device

      • (a) means any device, instrument, apparatus, appliance, or other article that—

        • (i) is intended to be used in, on, or for human beings for a therapeutic purpose; and

        • (ii) does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and

      • (b) includes a material that—

        • (i) is intended to be used in or on human beings for a therapeutic purpose; and

        • (ii) does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means (but may be assisted in its function by such means); and

      • (c) also includes—

        • (i) anything that is intended to be used with a device, instrument, apparatus, appliance, article, or material referred to in paragraph (a) or (b) to enable the device, instrument, apparatus, appliance, article, or material to be used as its manufacturer intends; and

        • (ii) any device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations to be a medical device for the purposes of this Act; but

      • (d) does not include a device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by regulations not to be a medical device for the purposes of this Act.

7 New section 4 substituted
  • Section 4 is repealed and the following section substituted:

    4 Meaning of therapeutic purpose
    • In this Act, unless the context otherwise requires, therapeutic purpose means any of the following purposes, or a purpose in connection with any of the following purposes:

      • (a) preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury; or

      • (b) influencing, inhibiting, or modifying a physiological process; or

      • (c) testing the susceptibility of persons to a disease or ailment; or

      • (d) influencing, controlling, or preventing conception; or

      • (e) testing for pregnancy; or

      • (f) investigating, replacing, or modifying parts of the human anatomy.

8 Functions, powers, and procedures of Medicines Review Committee
  • (1) Section 13(1) is amended by repealing paragraph (a) and substituting the following paragraph:

    • (a) to inquire into any objection to the decision of the Minister—

      • (i) to refuse to give consent, or provisional consent, to the distribution of a medicine; or

      • (ii) to impose any conditions under section 22(3) or 23(5):.

    (2) Section 13(2) is amended by omitting 22(4) and substituting 22A(1) or 23AA(1).

9 Sale of medicines by retail
  • Section 18 is amended by omitting a practitioner, registered midwife, veterinarian, or designated prescriber in each place where it appears and substituting in each case an authorised prescriber, a veterinarian, or a delegated prescriber.

10 Administering prescription medicines
  • Section 19(1)(a) is amended by inserting or delegated prescriber after authorised prescriber.

11 Restrictions on sale or supply of new medicines
  • (1) Section 20(1) is amended by omitting applies and substituting and sections 20A to 23AAB apply.

    (2) Section 20(2) is amended by inserting , given in accordance with sections 20A to 23AAB, after the medicine.

12 New sections 20A to 23AAB substituted
  • Sections 21 to 23 are repealed and the following sections substituted:

    20A Criteria for consenting to distribution of new medicine
    • (1) The Minister must not give consent, or provisional consent, to the distribution of a medicine under section 20 unless he or she is satisfied that the likely therapeutic value of the medicine outweighs the risk (if any) of the use of the medicine injuriously affecting the health of any person.

      (2) The Minister may give provisional consent to the distribution of a medicine under section 20 or 23 if he or she is of the opinion that it is desirable that the medicine be sold, supplied, or used on a restricted basis for the treatment of a limited number of patients.

    21 Applications for Minister's consent
    • (1) An application for the Minister's consent to the distribution of a medicine under section 20 must be made by one of the following (the applicant):

      • (a) the manufacturer, importer, or proprietor, in New Zealand of the medicine; or

      • (b) the proposed manufacturer, importer, or proprietor, in New Zealand of the medicine; or

      • (c) any authorised agent of a person referred to in paragraph (a) or (b).

      (2) The application must—

      • (a) be made in the prescribed manner; and

      • (b) contain, or be accompanied by, the information required by regulations; and

      • (c) be accompanied by the prescribed fee.

    22 Procedure for determining applications for Minister's consent
    • (1) Every application for the Minister's consent to the distribution of a medicine under section 20 must be determined in accordance with regulations.

      (2) In determining an application, the Minister may—

      • (a) give consent to the distribution of the medicine; or

      • (b) give provisional consent to the distribution of the medicine; or

      • (c) refuse to give consent to the distribution of the medicine.

      (3) On giving consent, or provisional consent, to the distribution of a medicine, the Minister may impose any conditions that he or she thinks fit, including conditions relating to—

      • (a) the persons to whom the medicine may be sold or supplied; or

      • (b) the area in which the medicine may be distributed.

      (4) The Minister must, as soon as is reasonably practicable after determining the application,—

      • (a) notify the applicant of his or her decision; and

      • (b) if applicable, publish, by notice in the Gazette, his or her consent, or provisional consent, to the distribution of the medicine.

    22A Objection to decision
    • (1) If the Minister refuses to give consent to the distribution of a medicine, or imposes any conditions under section 22(3), the applicant may object in writing to the Minister within 28 days after being notified under section 22(4)(a).

      (2) As soon as is reasonably practicable after receipt of an objection under subsection (1), the Minister must refer the matter to the Medicines Review Committee.

    23 Procedure for applications for Minister's provisional consent
    • (1) An application for the Minister's provisional consent to the distribution of a medicine must be made by one of the following (the applicant):

      • (a) the manufacturer, importer, or proprietor, in New Zealand of the medicine; or

      • (b) the proposed manufacturer, importer, or proprietor, in New Zealand of the medicine; or

      • (c) any authorised agent of a person referred to in paragraph (a) or (b).

      (2) The application must—

      • (a) be made in the prescribed manner; and

      • (b) contain, or be accompanied by, the information required by regulations; and

      • (c) be accompanied by the prescribed fee.

      (3) The Minister must determine the application in accordance with regulations.

      (4) In determining the application, the Minister may—

      • (a) give provisional consent to the distribution of the medicine; or

      • (b) refuse to give provisional consent to the distribution of the medicine.

      (5) On giving provisional consent, the Minister may impose any conditions that he or she thinks fit, including conditions relating to—

      • (a) the persons to whom the medicine may be sold or supplied; or

      • (b) the area in which the medicine may be distributed.

      (6) The Minister must, as soon as is reasonably practicable after determining the application,—

      • (a) notify the applicant of his or her decision; and

      • (b) if applicable, publish, by notice in the Gazette, his or her provisional consent to the distribution of the medicine.

    23AA Objection to decision
    • (1) If the Minister refuses to give provisional consent to the distribution of a medicine, or imposes any conditions under section 23(5), the applicant may object in writing to the Minister within 28 days after being notified under section 23(6)(a).

      (2) As soon as is reasonably practicable after receipt of an objection under subsection (1), the Minister must refer the matter to the Medicines Review Committee.

    23AAB Duration and effect of provisional consent
    • (1) A provisional consent has effect for any period, not exceeding 2 years beginning with the date of the publication of the notice under section 22(4)(b) or 23(6)(b), that the Minister specifies in that notice.

      (2) The Minister may, by notice in the Gazette, on 1 occasion only, renew a provisional consent for a period not exceeding 2 years beginning with the date of the publication of the notice.

      (3) Section 23(5) and (6)(a), with any necessary modifications, apply to a renewal of a provisional consent under subsection (2).

      (4) If, during the currency of a provisional consent, the Minister consents to the distribution of the same medicine under section 20, the provisional consent is treated as being revoked.

13 Interpretation
  • (1) Paragraph (a)(i)(A) of the definition of protected period in section 23A is amended by omitting section 20 and substituting section 22(4)(b).

    (2) Paragraph (b)(i)(A) of the definition of protected period in section 23A is amended by omitting section 20 and substituting section 22(4)(b).

14 New sections 23D to 24AA substituted
  • Section 24 is repealed and the following sections are substituted:

    23D Restrictions on sale or supply of changed medicines
    • (1) Except as provided in sections 25, 27, 28, 29, and 30, no person may do either of the following without the written consent of the Director-General:

      • (a) sell a medicine in respect of which there has been a material change; or

      • (b) supply such a medicine by way of gift or loan or sample, or in any other way.

      (2) Every person commits an offence who—

      • (a) fails to comply with subsection (1); or

      • (b) fails to comply with section 24(1).

      (3) A person who commits an offence against subsection (2) is liable on conviction,—

      • (a) in the case of an individual,—

        • (i) to imprisonment for a term not exceeding 3 months; or

        • (ii) to a fine not exceeding $20,000:

      • (b) in the case of a body corporate, to a fine not exceeding $100,000.

      (4) In this section and section 24, material change means, in relation to a medicine, any change to—

      • (a) the purpose for which the medicine is represented to be used:

      • (b) the recommended dosage:

      • (c) the recommended manner of administration:

      • (d) the labelling of the medicine, or of any container or package in which the medicine is packed:

      • (e) any descriptive matter accompanying any medicine, or accompanying any container or package in which the medicine is packed for sale:

      • (f) the strength, quality, or purity of the medicine:

      • (g) the methods of manufacture of the medicine:

      • (h) the facilities for testing the medicine's strength, quality, purity, or safety:

      • (i) the location of the premises in which the medicine is manufactured.

    24 Applications for consent to distribution of changed medicines
    • (1) If a manufacturer or importer of a medicine makes a material change to the medicine, the applicant must—

      • (a) apply to the Director-General for consent to the distribution of the changed medicine; or

      • (b) apply to the Minister for consent to distribute the medicine under section 20, if the manufacturer or importer is of the opinion that the change to the medicine is such that the medicine is now a new medicine within the meaning of paragraph (a), (b), or (c) of the definition of new medicine in section 3(3).

      (2) An application under subsection (1)(a) must—

      • (a) be made in the prescribed manner; and

      • (b) contain, or be accompanied by, the information required by regulations; and

      • (c) be accompanied by the prescribed fee.

      (3) In this section and section 24AA, applicant means—

      • (a) the manufacturer, importer, or proprietor, in New Zealand of the medicine; or

      • (b) any authorised agent of that manufacturer, importer, or proprietor.

    24AA Procedure for determining applications for Director-General’s consent
    • (1) Every application to the Director-General for consent to the distribution of a changed medicine must be determined in accordance with regulations.

      (2) If, after considering the application, the Director-General is of the opinion that the change to the medicine is such that the medicine should be treated as a new medicine, he or she must refer it to the Minister for consideration as an application under section 21.

      (3) The Director-General may, by written notice to the applicant within 45 working days of the date that the application was received, require the applicant to supply any further information or samples that the Director-General may require for the purposes of determining the application.

      (4) In any case where the Director-General has not required the applicant to supply further information or samples, the Director-General must determine the application, or, if the case requires, refer the application to the Minister, within 45 working days of the date that the application was received.

      (5) In determining the application, the Director-General may—

      • (a) give consent to the distribution of the changed medicine; or

      • (b) refuse to give consent to the distribution of the changed medicine.

      (6) The Director-General must, as soon as is reasonably practicable after determining the application or referring the application to the Minister, notify the applicant of his or her decision.

      (7) An application that is referred to the Minister must be treated as if it had been made under section 21, and sections 22 and 22A apply accordingly.

15 Exemptions for pharmacists
  • Section 26(4) is amended by omitting 24 and substituting 23D.

16 Exemptions for veterinarians and certain registered health practitioners
17 Exemption for medicine required by medical practitioner
  • Section 29(1) is amended by omitting 24 and substituting 23D.

18 Exemption for clinical trial
  • Section 30(1) is amended by omitting 24 and substituting 23D.

19 Exemptions in respect of importation by the Crown
  • (1) Section 32A(4) is amended by omitting 24 and substituting 23D.

    (2) Section 32A(5) is amended by omitting 24 and substituting 23D.

20 Revocation and suspension of consents
  • (1) Section 35(1) is amended by omitting section 20 or section 23 and substituting section 20, 23, or 24AA.

    (2) Section 35(1)(a) is amended by omitting , or in a notice deposited under section 24.

21 Control of established medicines
  • Section 36(1) is amended by omitting subsection (5) of section 24 and substituting section 24AA(2).

22 Restriction on authorised prescribers holding interest in pharmacies
  • (1) The heading to section 42C is amended by inserting and delegated prescribers after authorised prescribers.

    (2) Section 42C(1) is amended by inserting or delegated prescriber after authorised prescriber.

    (3) Section 42C(2) is amended by inserting or delegated prescriber after authorised prescriber.

    (4) Section 42C(3) is amended by—

    • (a) inserting or delegated prescriber after the authorised prescriber; and

    • (b) inserting , or delegated prescriber, after of the authorised prescriber.

23 Restrictions on possession of prescription medicines
  • (1) Section 43(2)(c)(i) is amended by—

    • (a) inserting or a delegated prescriber after an authorised prescriber; and

    • (b) inserting or delegated prescriber after another authorised prescriber.

    (2) Section 43(6) is repealed.

24 New section 47A inserted
  • The following section is inserted after section 47:

    47A Effect of grant of delegated prescribing rights
    • If regulations made under sections 105(1)(qaa) and 105D grant delegated prescribing rights to a class of registered health professional,—

      • (a) an authorised prescriber who is not a designated prescriber may, in accordance with the regulations, issue a delegated prescribing order to a specified person belonging to that class of registered health professional; and

      • (b) the person to whom the delegated prescribing order is issued (the delegated prescriber) may prescribe specified prescription medicines, or a specified class or description of prescription medicines, in accordance with the terms of his or her delegated prescribing order.

25 Powers of Minister to prohibit prescribing, etc
  • (1) Section 48(1)(a) is amended by omitting specified practitioner, veterinarian, registered midwife, or designated prescriber and substituting specified authorised prescriber, veterinarian, or delegated prescriber.

    (2) Section 48(2) is amended by inserting the following paragraph after paragraph (e):

    • (ea) in the case of an optometrist, except on the recommendation of the Optometrists and Dispensing Opticians Board; or.

    (3) Section 48(2) is amended by repealing paragraph (f) and substituting the following paragraph:

    • (f) in the case of any other designated prescriber or delegated prescriber, except on the recommendation of the responsible authority for the health profession to which the designated prescriber or delegated prescriber belongs.

26 Restrictions on supply to particular persons
  • Section 49(2) is amended by omitting practitioner, registered midwife, or designated prescriber and substituting authorised prescriber or delegated prescriber.

27 Statements regarding persons dependent on prescription medicines or restricted medicines
  • Section 49A(3) is amended by repealing paragraphs (f) to (gb) and substituting the following paragraphs:

    • (f) authorised prescribers:

    • (g) delegated prescribers:.

28 Grant of licences
  • (1) Section 51 is amended by inserting the following subsection after subsection (1):

    • (1A) In determining, under subsection (1)(b), whether an applicant is a fit and proper person or of good repute (as the case requires), the licensing authority may take into account, among other things,—

      • (a) any conviction of the applicant for—

        • (i) an offence under this Act, or regulations made under it; or

        • (ii) an offence under the Misuse of Drugs Act 1975, or regulations made under it; or

        • (iii) a crime involving dishonesty (within the meaning of section 2(1) of the Crimes Act 1961); and

      • (b) any determination of a professional conduct committee.

    (2) Section 51 is amended by repealing subsection (4) and substituting the following subsections:

    • (4) A licence—

      • (a) must be in the prescribed form; and

      • (b) is subject to—

        • (i) any conditions that the licensing authority thinks fit; and

        • (ii) any conditions specified in regulations.

    • (4A) The licensing authority may, by written notice to the holder of a licence, revoke or amend any condition imposed under subsection (4)(b)(i) or add any new condition.

    (3) Section 51 is amended by repealing subsection (6) and substituting the following subsections:

    • (6) If in any case the licensing authority is satisfied that the holder of a licence has failed or is failing to comply with any conditions attached to the licence, the licensing authority may cancel the licence.

    • (6AA) The licensing authority may not cancel a licence under subsection (6) unless the holder has been given a reasonable opportunity to be heard, or to make written submissions, in relation to the matter.

    • (6AAB) The licensing authority may suspend a licence for a reasonable period to enable the licensing authority to consider whether to cancel the licence under subsection (6).

    (4) Section 51(6A) is amended by omitting (6) and substituting (4A) or (6).

    (5) Section 51 is amended by adding the following subsection:

    • (8) In this section, professional conduct committee means a committee appointed under section 71 of the Health Practitioners Competence Assurance Act 2003.

29 Effect of licences
  • (1) Section 52(1) is amended by omitting 24 and substituting 23D.

    (2) Section 52 is amended by repealing subsection (3) and substituting the following subsection:

    • (3) A licence is subject to—

      • (a) any conditions imposed by the licensing authority under section 51(4)(b)(i) or (4A); and

      • (b) any conditions specified in regulations.

30 Offences in relation to authorised prescribers
  • (1) The heading to section 76A is amended by adding and delegated prescribers.

    (2) Section 76A is amended by inserting or to any delegated prescriber after authorised prescriber.

31 New section 87 substituted
  • Section 87 is repealed and the following section substituted:

    87 Notification of conviction of practitioners, etc
    • If a person who is a veterinarian, practitioner, pharmacist, nurse, optometrist, designated prescriber, or delegated prescriber is convicted of an offence against this Act or regulations made under it, the court must send particulars of the conviction to—

      • (a) the Registrar of the Veterinary Council of New Zealand, if the person is a veterinarian; or

      • (b) the responsible authority for the health profession to which the person belongs, in any other case.

32 Right of appeal to High Court
  • Section 89(1)(a) is amended by omitting 20, 23, 24, and 35 and substituting 20, 22, 23, 23AAB, 24AA, and 35.

33 Interpretation
  • (1) Section 94(1) is amended by inserting the following paragraph after paragraph (a):

    • (aa) any medical device:.

    (2) Section 94(2)(b) is amended by omitting 24(5) and substituting 24AA(2).

34 Certain provisions to apply to related products as if medicines
  • (1) Section 96 is amended by repealing subsection (2) and substituting the following subsection:

    • (2) Section 23D applies to related products in the same manner and to the same extent as it applies to medicines, subject to the following modifications:

      • (a) subsection (4)(b) must be read as applying only to the recommended dosage for a therapeutic purpose:

      • (b) subsection (4)(c) must be read as applying only to the recommended manner of administration for a therapeutic purpose:

      • (c) subsection (4)(d) must be read as applying only to any labelling relating to a therapeutic purpose:

      • (d) subsection (4)(e) must be read as applying only to any descriptive matter relating to a therapeutic purpose:

      • (e) subsection (4)(f) and (g) must be read as applying only to a material change that is relevant to a therapeutic purpose.

    (2) Section 96(3) is amended by omitting Subsections (3) to (6) of section 24, and sections 37, 40 and substituting Sections 24, 24AA, 37, 40.

35 Regulations
  • (1) Section 105(1)(a) is amended by omitting , and the manner of making applications under this Act.

    (2) Section 105(1) is amended by inserting the following paragraph after paragraph (a):

    • (aaa) prescribing, in relation to any application or class of application under this Act, any of the following:

      • (i) the manner in which the application must be made; and

      • (ii) the information that must accompany or be contained in the application; and

      • (iii) the manner in which the application must be determined by the decision-maker; and

      • (iv) any matters that the decision-maker must take into account when determining the application:.

    (3) Section 105(1) is amended by repealing paragraph (i) and substituting the following paragraph:

    • (i) 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:.

    (4) Section 105(1)(q) is amended by omitting practitioners, veterinarians, registered midwives, and designated prescribers of prescriptions for the supply of any medicine and substituting authorised prescribers, veterinarians, and delegated prescribers of prescriptions for the supply of any medicine, including the transmission and storage of prescriptions.

    (5) Section 105(1) is amended by repealing paragraph (qa) and substituting the following paragraphs:

    • (qa) 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:

    • (qaa) granting and regulating delegated prescribing rights:.

    (6) Section 105 is amended by inserting the following subsections after subsection (5):

    • (5A) For the purposes of subsection (1)(qa),—

      • (a) specified prescription medicines means prescription medicines specified by the Director-General by notice in the Gazette; and

      • (b) specified class or description of prescription medicines means a class or description of prescription medicines specified by the Director-General by notice in the Gazette.

    • (5B) 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.

36 Regulations relating to practitioners, veterinarians, and registered midwives
  • (1) Section 105A is amended by omitting the heading and substituting the following heading: Regulations relating to veterinarians and authorised prescribers who are not designated prescribers.

    (2) Section 105A is amended by omitting practitioner, veterinarian, or registered midwife in each place where it appears and substituting in each case veterinarian, or authorised prescriber who is not a designated prescriber.

    (3) Section 105A(2) is amended by repealing paragraphs (a) and (b) and substituting the following paragraphs:

    • (a) in the case of a veterinarian or any class of veterinarian, the Veterinary Council of New Zealand:

    • (b) in any other case, the responsible authority for the health profession to which the person belongs.

37 New sections 105D to 105F inserted
  • The following sections are inserted after section 105C:

    105D Regulations relating to delegated prescribers
    • Without limiting the generality of section 105(1)(d) or (qaa), regulations may be made under section 105(1)(qaa)—

      • (a) granting delegated prescribing rights to any class of registered health professional:

      • (b) regulating the issue of delegated prescribing orders by authorised prescribers:

      • (c) specifying the responsibilities of authorised prescribers who issue delegated prescribing orders:

      • (d) imposing conditions, limitations, requirements, or restrictions in relation to the contents of delegated prescribing orders and their use:

      • (e) requiring any person who belongs to any class of registered health professional with delegated prescribing rights, or a specified class of those persons, before commencing to prescribe prescription medicines or prescription medicines of a specified class or description under a delegated prescribing order, to satisfy 1 or more of the following requirements:

        • (i) to obtain any specified qualification or any qualification specified from time to time by notice in the Gazette by the Minister, or by the responsible authority:

        • (ii) to undertake specified training or any training specified from time to time by notice in the Gazette by the Minister, or by the responsible authority:

        • (iii) to demonstrate, to the satisfaction of the responsible authority, that the person is sufficiently knowledgeable to safely prescribe prescription medicines or prescription medicines of a specified class or description:

      • (f) requiring any delegated prescriber or any class of delegated prescriber to undergo specified training or to undergo training specified from time to time by notice in the Gazette by the Minister, or by the responsible authority (including training of an ongoing nature):

      • (g) requiring any delegated prescriber or any class of delegated prescriber to undergo an assessment of competence to prescribe prescription medicines of a specified class or description (including an assessment at regular intervals):

      • (h) prohibiting any person who fails to comply with any requirement imposed by or under regulations referred to in paragraphs (e) to (g) from prescribing prescription medicines or prescription medicines of any specified class or description.

    105E Power of Director-General to specify prescription medicines for delegated prescribers
    • (1) The Director-General may, by notice in the Gazette, specify the prescription medicines, or the class or description of prescription medicines, that may be prescribed under delegated prescribing orders (and different prescription medicines, or different classes or descriptions of prescription medicines, may be specified for different classes of health professional).

      (2) Before issuing a notice under subsection (1), 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.

    105F Incorporation by reference
    • (1) Regulations made under section 105 may incorporate the following written material by reference:

      • (a) a standard, framework, code of practice, recommended practice, or requirement of an international or national organisation:

      • (b) a standard, framework, code of practice, recommended practice, or requirement prescribed in any country or jurisdiction, or by any group of countries:

      • (c) any other written material that deals with technical matters and that can reasonably be regarded as being too large or impractical to include in, or publish as part of, the regulations.

      (2) The provisions of Schedule 3 apply to material incorporated by reference in regulations made in reliance on this section.

38 New Schedule 3 added
  • The principal Act is amended by adding the Schedule 3 set out in the Schedule of this Act.

39 Amendment relating to Legislation Act 2012
  • Schedule 3 (as added by section 38 of the Medicines Amendment Act 2013) is amended by omitting clauses 6 and 7 and substituting the following clause:

    6 Application of Legislation Act 2012 to material incorporated by reference
    • (1) Part 2 of the Legislation Act 2012 does not apply to material incorporated by reference in regulations in reliance on section 105F or to an amendment to, or replacement of, that material.

      (2) Subpart 1 of Part 3 of the Legislation Act 2012 applies to regulations that incorporate material by reference in reliance on section 105F.

      (3) However, nothing in section 41 of the Legislation Act 2012 requires material that is incorporated by reference in regulations in reliance on section 105F to be presented to the House of Representatives.

Part 2
Consequential amendments to other enactments, transitional provisions, and related matters

Subpart 1Amendments to Misuse of Drugs Act 1975

40 Amendments to Misuse of Drugs Act 1975
41 Interpretation
  • Section 2(1) is amended by inserting the following definitions in their appropriate alphabetical order:

    nurse practitioner means a health practitioner—

    • (a) who is, or is deemed to be, registered with the Nursing Council as a practitioner of the profession of nursing; and

    • (b) for whom the Nursing Council has authorised a scope of practice that includes prescribing medicines

    Nursing Council means the Nursing Council of New Zealand continued by section 114(1)(a) of the Health Practitioners Competence Assurance Act 2003

    optometrist means a person—

    • (a) who is, or is deemed to be, registered with the Optometrists and Dispensing Opticians Board as a practitioner of optometry; and

    • (b) for whom the Optometrists and Dispensing Opticians Board has authorised a scope of practice that includes prescribing medicines

    Optometrists and Dispensing Opticians Board means the Optometrists and Dispensing Opticians Board continued by section 114(1)(a) of the Health Practitioners Competence Assurance Act 2003.

42 Exemptions from sections 6 and 7
  • (1) Section 8(1) is amended by inserting nurse practitioner, optometrist, after midwife, in each place where it appears.

    (2) Section 8(2) is amended by repealing paragraph (aa).

    (3) Section 8(2)(b)(iii) is amended by inserting nurse practitioner, optometrist, midwife, after dentist,.

    (4) Section 8(2) is amended by repealing paragraph (ba).

    (5) Section 8(2) is amended by repealing paragraph (da).

    (6) Section 8(2)(l) is amended by inserting nurse practitioner, optometrist, midwife, after medical practitioner, in each place where it appears.

    (7) Section 8(2A)(a) is amended by omitting designated prescriber or any midwife and substituting designated prescriber, nurse practitioner, optometrist, or midwife.

43 Statements regarding drug dependent persons
  • Section 20(3) is amended by inserting the following paragraphs after paragraph (fb):

    • (fc) nurse practitioners:

    • (fd) optometrists:.

44 Powers of Minister to prohibit prescribing, etc
  • (1) Section 23(1)(a) is amended by inserting nurse practitioner, optometrist, after midwife,.

    (2) Section 23(1) is amended by repealing paragraph (aa).

    (3) Section 23(2) is amended by inserting the following paragraphs after paragraph (d):

    • (da) in the case of a nurse practitioner, except on the recommendation of the Nursing Council; or

    • (db) in the case of an optometrist, except on the recommendation of the Optometrists and Dispensing Opticians Board; or.

    (4) Section 23(6) is amended by inserting nurse practitioner, optometrist, after midwife,.

    (5) Section 23(7) is repealed.

45 Treatment of people dependent on controlled drugs
  • Section 24(1A) is amended by inserting , nurse practitioner, optometrist, after midwife.

46 Section 33 substituted
  • Section 33 is repealed and the following section substituted:

    33 Notification of conviction of medical practitioners, etc
    • (1) If a person who is a veterinarian, medical practitioner, pharmacist, dentist, midwife, nurse practitioner, optometrist, or designated prescriber is convicted of any offence against this Act or regulations made under it, the court must send particulars of the conviction to—

      • (a) the Registrar of the Veterinary Council of New Zealand, if the person is a veterinarian; or

      • (b) the responsible authority for the health profession to which the person belongs, in any other case.

      (2) In this section, responsible authority has the meaning given to it in section 5(1) of the Health Practitioners Competence Assurance Act 2003.

47 Regulations
  • Section 37(1)(g) is amended by inserting nurse practitioners, optometrists, after midwives,.

Subpart 2Amendments to, and revocation of, regulations

48 Amendment to Electricity (Safety) Regulations 2010
49 Amendment to Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001
50 Amendment to Medicines (Database of Medical Devices) Regulations 2003
51 Regulations revoked

Subpart 3Transitional provision

52 Transitional provision regarding medicines
  • (1) This section applies to any substance or article that—

    • (a) was a medicine within the meaning of section 3 of the principal Act immediately before the commencement date; and

    • (b) on the commencement date became a medical device by virtue of section 3A of the principal Act (as inserted by this Act); and

    • (c) on the commencement date is part of the existing stock­in­trade in New Zealand of any person carrying on a business in New Zealand.

    (2) A substance or an article to which this section applies may be sold or supplied after the commencement date as long as—

    • (a) the substance or article continues to comply with the former law; and

    • (b) any requirements in the former law that relate to or affect the continued sale or supply of the substance or article continue to be complied with.

    (3) In this section,—

    commencement date means the date on which this section comes into force

    former law means the principal Act, regulations, and any other instruments made under it as in force immediately before the commencement date.


Schedule
New Schedule 3 added

s 38

Schedule 3
Incorporation by reference

s 105F(2)

1 Requirement to consult on proposal to incorporate material by reference
  • (1) Before regulations incorporating material by reference in reliance on section 105F are made, the Director-General must—

    • (a) make copies of the material proposed to be incorporated by reference (the proposed material) available for inspection during working hours for a reasonable period, free of charge, at the head office of the Ministry of Health and any other places that the Director-General may, at his or her discretion, determine are appropriate; and

    • (b) state where copies of the proposed material are available for purchase; and

    • (c) make copies of the proposed material available, free of charge, on an Internet site maintained by or on behalf of the Ministry of Health, unless doing so would infringe copyright; and

    • (d) give notice in the Gazette stating—

      • (i) that the proposed material is available for inspection during working hours, free of charge, and stating the places at which it can be inspected and the period during which it can be inspected; and

      • (ii) that copies of the proposed material can be purchased and stating the places at which they can be purchased; and

      • (iii) if applicable, that the proposed material is available on the Internet, free of charge, and stating the Internet site address; and

    • (e) allow a reasonable opportunity for persons to comment on the proposal to incorporate the proposed material by reference; and

    • (f) consider any comments made.

    (2) The Director-General—

    • (a) may make copies of the proposed material available in any other way that he or she considers appropriate in the circumstances; and

    • (b) must, if paragraph (a) applies, give notice in the Gazette stating that the proposed material is available in other ways and giving details of where or how it can be accessed or obtained.

    (3) The Director-General may comply with subclause (1)(c) (if applicable) by providing a hypertext link from an Internet site maintained by or on behalf of the Ministry of Health to a copy of the proposed material that is available, free of charge, on an Internet site that is maintained by or on behalf of someone else.

    (4) The references in this clause to material include, if the material is not in an official New Zealand language, as well as the material itself, an accurate translation of the material in an official New Zealand language.

    (5) A failure to comply with this clause does not invalidate regulations that incorporate material by reference in reliance on section 105F.

    (6) For the purposes of subclause (1)(c), the Director-General may not rely on section 66 of the Copyright Act 1994 as authority to make the proposed material available on an Internet site.

2 Access to material incorporated by reference
  • (1) This clause applies if regulations incorporating material by reference in reliance on section 105F are made.

    (2) The Director-General must—

    • (a) make the material (the incorporated material) available for inspection during working hours, free of charge, at the head office of the Ministry of Health and any other places that the Director-General may, at his or her discretion, determine are appropriate; and

    • (b) state where copies of the incorporated material are available for purchase; and

    • (c) make copies of the incorporated material available, free of charge, on an Internet site maintained by or on behalf of the Ministry of Health, unless doing so would infringe copyright; and

    • (d) give notice in the Gazette stating—

      • (i) that the incorporated material is incorporated in the regulations and stating the date on which the regulations were made; and

      • (ii) that the incorporated material is available for inspection during working hours, free of charge, and stating the places at which it can be inspected; and

      • (iii) that copies of the incorporated material can be purchased and stating the places at which they can be purchased; and

      • (iv) if applicable, that the incorporated material is available on the Internet, free of charge, and stating the Internet site address.

    (3) The Director-General—

    • (a) may make copies of the incorporated material available in any other way that he or she considers appropriate in the circumstances; and

    • (b) must, if paragraph (a) applies, give notice in the Gazette stating that the incorporated material is available in other ways and giving details of where or how it can be accessed or obtained.

    (4) The Director-General may comply with subclause (2)(c) (if applicable) by providing a hypertext link from an Internet site maintained by or on behalf of the Ministry of Health to a copy of the incorporated material that is available, free of charge, on an Internet site that is maintained by or on behalf of someone else.

    (5) The references in this clause to material are to—

    • (a) material incorporated by reference in the regulations; and

    • (b) if the material is not in an official New Zealand language, the material itself together with an accurate translation of the material in an official New Zealand language.

    (6) A failure to comply with this clause does not invalidate regulations that incorporate material by reference.

    (7) For the purposes of subclause (2)(c), the Director-General may not rely on section 66 of the Copyright Act 1994 as authority to make the incorporated material available on an Internet site.

3 Effect of material incorporated by reference
  • (1) This clause applies to material incorporated by reference in regulations in reliance on section 105F.

    (2) Material to which this clause applies has legal effect as part of the regulations in which it is incorporated.

4 Effect of amendments to material incorporated by reference
  • (1) This clause applies if the material incorporated by reference in reliance on section 105F is amended by the originator of the material after the regulations are made.

    (2) If this clause applies, any amendments made by the originator of the material have no legal effect as part of the regulations unless they are specifically incorporated by later regulations made under this Act.

    (3) For the purposes of this section, material is amended if the material or any part of it—

    • (a) is amended or replaced; or

    • (b) expires or is revoked; or

    • (c) otherwise ceases to have effect.

5 Proof of material incorporated by reference
  • (1) A copy of material incorporated by reference in regulations in reliance on section 105F must be—

    • (a) certified as a correct copy of the material by the Director-General; and

    • (b) retained by the Director-General.

    (2) The production in proceedings of a certified copy of the material is, in the absence of evidence to the contrary, sufficient evidence of the material incorporated by reference in the regulations.

6 Application of Acts and Regulations Publication Act 1989 to material incorporated by reference
  • The Acts and Regulations Publication Act 1989 does not apply to material that is for the time being incorporated by reference in regulations in reliance on section 105F.

7 Application of Regulations (Disallowance) Act 1989 to material incorporated by reference
  • (1) Nothing in section 4 of the Regulations (Disallowance) Act 1989 requires material that is incorporated by reference in regulations in reliance on section 105F to be laid before the House of Representatives.

    (2) The Regulations (Disallowance) Act 1989, apart from the modification to the application of section 4 of that Act made by subclause (1), applies to regulations that incorporate material by reference.

8 Application of Standards Act 1988, other enactments, and rules of law not affected
  • Nothing in this schedule affects the application of sections 22 to 25 of the Standards Act 1988, any other enactment, or any rule of law.


Legislative history

13 October 2011Introduction (Bill 345–1)
28 February 2012First reading and referral to Health Committee
3 August 2012Reported from Health Committee (Bill 345–2)
20 March 2013Second reading
19 November 2013Committee of the whole House, third reading
4 December 2013Royal assent

This Act is administered by the Ministry of Health.