17Intended for use for therapeutic purpose
(1)
Something is intended for use in, on, or in relation to humans for a therapeutic purpose if it is, or is in a class of things that are,—
(a)
ordinarily used for that purpose; or
(b)
intended by the manufacturer to be used for that purpose; or
(c)
represented as being for use for that purpose; or
(d)
likely (because of the way in which it is presented or for any other reason) to be used for that purpose.
(2)
However, something is not intended for that use if it is intended primarily for another purpose and its therapeutic purpose is merely incidental to that primary purpose.
Example
If flour intended for human consumption as a food is fortified with folic acid, the flour is, to some extent, intended for the therapeutic purpose of providing vitamin supplementation. However, that is merely incidental to the flour’s primary purpose of being a food. Therefore, the flour would be food and not a therapeutic product.作者: Quad 时间: 2023-2-12 17:42:51
Subpart 2—Therapeutic products
15Therapeutic purpose
The following are therapeutic purposes:
(a)
preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for a disease, ailment, defect, or injury:
(b)
influencing, inhibiting, or modifying a human physiological process:
(c)
testing the susceptibility of humans to a disease or an ailment:
(d)
influencing, controlling, or preventing human conception:
(e)
testing for human pregnancy:
(f)
investigating, replacing, modifying, or supporting part of a human’s anatomy:
(g)
investigating a human physiological process:
(h)
supporting or sustaining human life:
(i)
providing vitamin, mineral, or other human nutritional supplementation:
(j)
maintaining or promoting human health:
(k)
disinfecting medical devices:
(l)
a purpose connected with a purpose referred to in paragraphs (a) to (k).作者: 匿名 时间: 2023-2-12 17:50:53
30NHP ingredient, recognised NHP ingredient, and additive or formulation aid
(1)
Each of the following is an NHP ingredient:
(a)
a plant, plant material, an alga, a fungus, or non-human animal material:
(b)
a substance or mixture of substances that—
(i)
is obtained by expressions, extraction, distillation, purification, or a traditional preparation of anything referred to in paragraph (a); and
(ii)
is not subject to any other process involving chemical transformation other than hydrolysis or electrolysis:
(c)
a vitamin or provitamin, including salts and other compounds, of the following types:
(i)
biotin:
(ii)
choline:
(iii)
folate:
(iv)
vitamin A, B1, B2, B3, B5, B6, B12, C, D, E, or K:
(d)
a mineral or mineral compound:
(e)
an amino acid:
(f)
a microorganism, whole or extracted:
(g)
a synthetic equivalent of a substance referred to in paragraph (b) to (e):
(h)
anything else that the rules say is an NHP ingredient.
(2)
An NHP ingredient is a recognised NHP ingredient if the rules say it is.
(3)
Each of the following is an additive or formulation aid:
(a)
a preservative, antioxidant, colouring, flavouring, or sweetener:
(b)
a substance that is included in a product—
(i)
as a carrier for the product’s active ingredients; or
(ii)
to modify the pH, viscosity, or handling properties of the product during its manufacture; or
(iii)
as a vehicle for the product’s administration.作者: Quad 时间: 2023-2-12 17:52:27
31Low concentration NHP
(1)
An NHP is a low concentration NHP if—
(a)
it is an NHP under section 29(2) or (4)(a); and
(b)
the concentration of every ingredient in it (other than an additive or formulation aid) is not more than 20 parts per million (or any lower concentration set out in the rules); and
(c)
it does not contain anything of human origin; and
(d)
it does not contain anything that is, or is derived from, an animal or part of an animal set out in the rules; and
(e)
it is not intended to be administered by injection or parenteral infusion or to the eye.
(2)
A therapeutic product is also a low concentration NHP if—
(a)
it is a therapeutic product under section 16(1)(a) or (b); and
(b)
it contains 1 or more ingredients (other than an additive or formulation aid) that are not NHP ingredients; and
(c)
it meets all the criteria in subsection (1)(b) to (e).
(3)
However, a product is not a low concentration NHP under subsection (2) if the rules say it is not.作者: Quad 时间: 2023-2-12 17:55:36
是说用于治疗目的健康产品需要监管
Part 1
Preliminary provisions
3Purpose
The purpose of this Act is to protect, promote, and improve the health of all New Zealanders by providing for the—
(a)
acceptable safety, quality, and efficacy of medicines and APIs across their life cycle; and
(b)
acceptable safety, quality, and performance of medical devices across their life cycle; and
(c)
acceptable safety and quality of NHPs across their life cycle.
楼主你少代表大家，你就是你，出了国还想代表别人。