Medicines Amendment Act 2013

1: Title
This Act is the Medicines Amendment Act 2013.
2: Commencement
1:
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. Section 2(1) repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
3: Principal Act amended
This Act amends the Medicines Act 1981 2017-07-01 Medicines Act 1981 ss 5(2), 8, 11–15, 17–21, 29(1), 32, 33(2) & 34. Can be brought into force earlier by OIC. 2014-07-01 Medicines Act 1981 Other than ss 5(2), 8, 11–15, 17–21, 29(1), 32, 33(2) & 34. Can be brought into force earlier by OIC.
1: Amendments to principal Act
4: Interpretation
1: Section 2(1) authorised prescriber authorised prescriber
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 section 2(1)
a: inserting , nurse practitioner, optometrist, practitioner
b: inserting in paragraph (a) specified prescription medicines, or any any
3: Section 2(1) medical device medical device section 3A
4: Paragraph (a) of the definition of standing order section 2(1) a practitioner or registered midwife a practitioner, registered midwife, nurse practitioner, or optometrist
5: Paragraph (c) of the definition of standing order section 2(1) a practitioner, or midwife a practitioner, registered midwife, nurse practitioner, or optometrist
6: Section 2(1) delegated prescriber delegated prescribing order delegated prescribing rights section 105(1)﻿(qaa) nurse 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 optometrist
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 regulations responsible authority
5: Meaning of medicine, new medicine, prescription medicine, and restricted medicine
1: Section 3
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:
3: Section 3(3) prescription medicine prescription medicine
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 Section 5(2) repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
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
4: Meaning of therapeutic purpose
In this Act, unless the context otherwise requires, therapeutic purpose
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
Section 8 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
9: Sale of medicines by retail
Section 18 a practitioner, registered midwife, veterinarian, or designated prescriber an authorised prescriber, a veterinarian, or a delegated prescriber
10: Administering prescription medicines
Section 19(1)﻿(a) or delegated prescriber authorised prescriber
11: Restrictions on sale or supply of new medicines
Section 11 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
12: New sections 20A to 23AAB substituted
Section 12 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
13: Interpretation
Section 13 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
14: New sections 23D to 24AA substituted
Section 14 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
15: Exemptions for pharmacists
Section 15 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
16: Exemptions for veterinarians and certain registered health practitioners
1: Section 27(b)
2: Section 27(c)﻿(ii)
17: Exemption for medicine required by medical practitioner
Section 17 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
18: Exemption for clinical trial
Section 18 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
19: Exemptions in respect of importation by the Crown
Section 19 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
20: Revocation and suspension of consents
Section 20 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
21: Control of established medicines
Section 21 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
22: Restriction on authorised prescribers holding interest in pharmacies
1: The heading to section 42C and delegated prescribers authorised prescribers
2: Section 42C(1) or delegated prescriber authorised prescriber
3: Section 42C(2) or delegated prescriber authorised prescriber
4: Section 42C(3)
a: inserting or delegated prescriber the authorised prescriber
b: inserting , or delegated prescriber, of the authorised prescriber
23: Restrictions on possession of prescription medicines
1: Section 43(2)﻿(c)﻿(i)
a: inserting or a delegated prescriber an authorised prescriber
b: inserting or delegated prescriber another authorised prescriber
2: Section 43(6)
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
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) specified practitioner, veterinarian, registered midwife, or designated prescriber specified authorised prescriber, veterinarian, or delegated prescriber
2: Section 48(2)
ea: in the case of an optometrist, except on the recommendation of the Optometrists and Dispensing Opticians Board; or
3: Section 48(2)
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) practitioner, registered midwife, or designated prescriber authorised prescriber or delegated prescriber
27: Statements regarding persons dependent on prescription medicines or restricted medicines
Section 49A(3)
f: authorised prescribers:
g: delegated prescribers:
28: Grant of licences
1: Section 51
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
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
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) (6) (4A) or (6)
5: Section 51
8: In this section, professional conduct committee
29: Effect of licences
1:
2: Section 52
3: A licence is subject to—
a: any conditions imposed by the licensing authority under section 51(4)﻿(b)﻿(i) or (4A)
b: any conditions specified in regulations. Section 29(1) repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
30: Offences in relation to authorised prescribers
1: The heading to section 76A and delegated prescribers
2: Section 76A or to any delegated prescriber authorised prescriber
31: New section 87 substituted
Section 87
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 32 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
33: Interpretation
1: Section 94(1)
aa: any medical device:
2: Section 33(2) repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
34: Certain provisions to apply to related products as if medicines
Section 34 repealed 3 June 2017 section 3(2) Statutes Repeal Act 2017
35: Regulations
1: Section 105(1)﻿(a) , and the manner of making applications under this Act
2: Section 105(1)
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)
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) practitioners, veterinarians, registered midwives, and designated prescribers of prescriptions for the supply of any medicine 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)
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
5A: For the purposes of subsection (1)﻿(qa),—
a: specified prescription medicines Gazette
b: specified class or description of prescription medicines 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 Regulations relating to veterinarians and authorised prescribers who are not designated prescribers
2: Section 105A practitioner, veterinarian, or registered midwife veterinarian, or authorised prescriber who is not a designated prescriber
3: Section 105A(2)
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
ii: to undertake specified training or any training specified from time to time by notice in the Gazette
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
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
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
38: New Schedule 3 added
The principal Act is amended by adding the Schedule 3 Schedule
39: Amendment relating to Legislation Act 2012
Schedule 3 (as added by section 38
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
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
2: Consequential amendments to other enactments, transitional provisions, and related matters
1: Amendments to Misuse of Drugs Act 1975
40: Amendments to Misuse of Drugs Act 1975
Sections 41 to 47 2014-07-01 Misuse of Drugs Act 1975 Can be brought into force earlier by OIC
41: Interpretation
Section 2(1) nurse 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 optometrist
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
42: Exemptions from sections 6 and 7
1: Section 8(1) nurse practitioner, optometrist, midwife,
2: Section 8(2)
3: Section 8(2)﻿(b)﻿(iii) nurse practitioner, optometrist, midwife, dentist,
4: Section 8(2)
5: Section 8(2)
6: Section 8(2)﻿(l) nurse practitioner, optometrist, midwife, medical practitioner,
7: Section 8(2A)﻿(a) designated prescriber or any midwife designated prescriber, nurse practitioner, optometrist, or midwife
43: Statements regarding drug dependent persons
Section 20(3)
fc: nurse practitioners:
fd: optometrists:
44: Powers of Minister to prohibit prescribing, etc
1: Section 23(1)﻿(a) nurse practitioner, optometrist, midwife,
2: Section 23(1)
3: Section 23(2)
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) nurse practitioner, optometrist, midwife,
5: Section 23(7)
45: Treatment of people dependent on controlled drugs
Section 24(1A) , nurse practitioner, optometrist, midwife
46: Section 33 substituted
Section 33
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
47: Regulations
Section 37(1)﻿(g) nurse practitioners, optometrists, midwives,
2: Amendments to, and revocation of, regulations
48: Amendment to Electricity (Safety) Regulations 2010
1: This section amends the Electricity (Safety) Regulations 2010
2: The definition of electrical medical device regulation 4(1) section 2(1) section 3A 2014-07-01 Electricity (Safety) Regulations 2010 Can be brought into force earlier by OIC.
49: Amendment to Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001
1: This section amends the Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001
2: Regulation 5(2)﻿(a) section 3(1)﻿(b) section 3(1)﻿(b)﻿(i) 2014-07-01 Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001 Can be brought into force earlier by OIC.
50: Amendment to Medicines (Database of Medical Devices) Regulations 2003
1: This section amends the Medicines (Database of Medical Devices) Regulations 2003
2: The definition of medical device regulation 3 section 2(1) section 3A 2014-07-01 Medicines (Database of Medical Devices) Regulations 2003 Can be brought into force earlier by OIC.
51: Regulations revoked
The following regulations are revoked:
a: Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005
b: Medicines (Designated Prescriber: Optometrists) Regulations 2005 2014-07-01 Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 Medicines (Designated Prescriber: Optometrists) Regulations 2005 Can be brought into force earlier by OIC.
3: Transitional 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
b: on the commencement date became a medical device by virtue of section 3A
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 former law