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

(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 5(1) of the Radiation Safety Act 2016; 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)

[Repealed]

(3)

In this Act, unless the context otherwise requires,—

new medicine means—

(a)

any medicine that has not been generally available in New Zealand—

(i)

before the commencement of this Act; or

(ii)

at any time during the period of 5 years immediately preceding the date on which it is proposed to become so available:

(b)

any medicine that, immediately before the commencement of Part 2, was a therapeutic drug to which section 12 of the Food and Drug Act 1969 applied, and in respect of the sale or distribution of which the Minister had not given his consent under that section:

(c)

any medicine that becomes a medicine within the meaning of this Act for the first time after the commencement of this Act:

(d)

any medicine that is referred to the Minister under section 24(5)

pharmacy-only medicine means a medicine that is declared by regulations made under this Act or by a notice given under section 106 to be one that, except as may be permitted by the regulations, may be—

(a)

sold by retail only—

(i)

in a pharmacy or hospital; or

(ii)

in any shop described in section 51(2) and in accordance with a licence issued under Part 3; or

(b)

supplied in circumstances corresponding to retail sale only—

(i)

in a pharmacy or hospital; or

(ii)

in any shop described in section 51(2) and in accordance with a licence issued under Part 3; or

(iii)

in accordance with a standing order

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

restricted medicine means a medicine that is declared by regulations made under this Act or by a notice given under section 106 to be one that, except as may be permitted by the regulations, may be—

(a)

sold by retail only by a pharmacist in a pharmacy or hospital; or

(b)

supplied in circumstances corresponding to retail sale only—

(i)

by a pharmacist in a pharmacy or hospital; or

(ii)

in accordance with a standing order.

Compare: Medicines Act 1968 s 130(1), (3), (5), (7) (UK)

Section 3(1): replaced, on 1 July 2014, by section 5(1) of the Medicines Amendment Act 2013 (2013 No 141).

Section 3(1)(c)(iii): amended, on 7 March 2017, by section 99 of the Radiation Safety Act 2016 (2016 No 6).

Section 3(2): repealed, on 1 July 2014, by section 5(1) of the Medicines Amendment Act 2013 (2013 No 141).

Section 3(3) pharmacy-only medicine: substituted, on 22 October 2003, by section 4(1) of the Medicines Amendment Act (No 3) 2003 (2003 No 84).

Section 3(3) prescription medicine: replaced, on 1 July 2014, by section 5(3) of the Medicines Amendment Act 2013 (2013 No 141).

Section 3(3) restricted medicine: substituted, on 22 October 2003, by section 4(2) of the Medicines Amendment Act (No 3) 2003 (2003 No 84).