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Natural Health and Supplementary Products Bill
lapsed on 22 August 2017
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Hon Tony Ryall
Natural Health
and Supplementary
Products Bill
Government Bill
324—2
Contents
Commentary
Key
1
Title
2
Commencement
Part 1
Preliminary matters
Preliminary provisions
3
Purpose
4
Principles
5
Interpretation
6
Definition of natural health
and supplementary
product
7
Act binds the Crown
Natural Health
and Supplementary
Products Regulatory Authority
8
Natural Health
and Supplementary
Products Regulatory Authority
9
Authority may declare recognised authorities
Natural health products advisory committee
Natural Health and Supplementary Products Advisory Committee
10
Natural health products advisory committee
Natural Health and Supplementary Products Advisory Committee
Natural health
and supplementary
product
products
database
11
Natural health
and supplementary
product
products
database
Sponsor
Product notifier
11A
Product notifier
12
Sponsor
Product notifier
must be resident in New Zealand
Part 2
Regulation of natural health
and supplementary
products
Health benefit claims
12A
Health benefit claims relating to named conditions
12B
Authority may determine allowable claims
12C
Named conditions
Product notification of natural health
and supplementary
products
13
Product notification of natural health
and supplementary
products
required before distribution
Natural health and supplementary products that do not require product notification
13A
Natural health and supplementary products that do not require product notification
14
Authority may exempt natural health
and supplementary
products from product notification
Audit of product notifications
15
Authority may audit
product
notifications
16
Authority may suspend or cancel product notifications
Suspension and cancellation of product notification
16
Grounds for suspension of product notification
16A
Effect of suspension of product notification
16B
Cancellation or reinstatement of product notification
17
Sponsor
Product notifier
must notify Authority of any serious adverse
reactions
reaction
to natural health
and supplementary
product
18
When new product notification needed
19
Sponsor
Product notifier
may cancel product notification
19A
Authority may cancel product notification if no longer necessary
Prohibited methods of administration
19B
Prohibited methods of administration
Ingredients of natural health
and supplementary
products
20
Authority may declare substances to be natural health product
Permitted
ingredients
21
Prohibited ingredients
New ingredients
22
If new ingredient intended for use in natural health
and supplementary
product
23
Safety assessment of new ingredient
Dietary supplements
24A
Natural health and supplementary products that are dietary supplements
Labelling
24
Labelling
Exports
25
Export certificate
26
Natural health
and supplementary
products that are animal products
Code of practice for manufacture of natural health
and supplementary
products
27
Code of practice for manufacture of natural health
and supplementary
products
Manufacture of natural health
and supplementary
products
28
Licence to manufacture natural health
and supplementary
products
29
Application for licence to manufacture
30
Conditions of licence
31
Audits of manufacturing facilities
31A
Authorised person may enter manufacturing facility and take samples in specified circumstances
32
Authority may issue compliance notice
33
Deemed compliance with code
34
Authority may revoke or suspend licence or
export
certificate for non-compliance with code
Fees
35
Authority may prescribe fees
Sanctions and penalties
36
Deception
37
Sale of natural health
and supplementary
products that have not been notified or do not meet standards
38
Manufacturing without licence
39
Obstruction of authorised person
40
Endangerment of human health
40A
Specified offences relating to natural health and supplementary products
40B
Offence relating to natural health and supplementary products that are dietary supplements
40C
Offence to publish certain advertisements relating to natural health and supplementary products
Disputes
41
Appeals committee
42
Appeals
Other powers of Authority
43
Statement by Authority
44
Recall of natural health
and supplementary
products
45
Delegation
Authority may declare product or class of product to be natural health and supplementary product in certain circumstances
45A
Authority may declare product or class of product to be natural health and supplementary product in certain circumstances
Transitional provisions
46
Natural health products before commencement of this Act
Application of this Act to certain products sold before commencement of this Act
Regulations
47
Regulations
Review of Act
48
Ministry
of Health
must review Act
Amendments to Medicines Act 1981
49
Amendments to Medicines Act 1981
50
Interpretation
51
Meaning of medicine, new medicine, prescription medicine, and restricted medicine
52
Section 28 repealed
53
Exemptions for agents and employees
54
Duty of importer and manufacturer to have and produce specifications of medicines
Amendment to Misuse of Drugs Amendment Act 2005
55
Amendment to Misuse of Drugs Amendment Act 2005
56
Interpretation
Amendment to Trans-Tasman Mutual Recognition Act 1997
56A
Amendment to Trans-Tasman Mutual Recognition Act 1997
56B
Schedule 2 amended
Revocation
57
Dietary Supplements Regulations 1985 revoked
Schedule
1
Suitable
classes of
substances
Schedule 2
Approved pharmacopoeia
Legislative history
The Parliament of New Zealand enacts as follows: