Hon Dr Jonathan Coleman
Government Bill
324—1
Explanatory note
1 Title
2 Commencement
Part 1Preliminary matters
Preliminary provisions
3 Purpose
4 Principles
5 Interpretation
6 Definition of natural health product
7 Act binds the Crown
Natural Health Products Regulatory Authority
8 Natural Health Products Regulatory Authority
9 Authority may declare recognised authorities
Natural health products advisory committee
10 Natural health products advisory committee
Natural health product database
11 Natural health product database
Sponsor
12 Sponsor must be resident in New Zealand
Part 2Regulation of natural health products
Product notification of natural health products
13 Product notification of natural health products required before distribution
14 Authority may exempt natural health products from product notification
15 Authority may audit notifications
16 Authority may suspend or cancel product notifications
17 Sponsor must notify Authority of any serious adverse reactions to natural health product
18 When new product notification needed
19 Sponsor may cancel product notification
Ingredients of natural health products
20 Authority may declare substances to be natural health product ingredients
21 Prohibited ingredients
New ingredients
22 If new ingredient intended for use in natural health product
23 Safety assessment of new ingredient
Labelling
24 Labelling
Exports
25 Export certificate
26 Natural health products that are animal products
Code of practice for manufacture of natural health products
27 Code of practice for manufacture of natural health products
Manufacture of natural health products
28 Licence to manufacture natural health products
29 Application for licence to manufacture
30 Conditions of licence
31 Audits of manufacturing facilities
32 Authority may issue compliance notice
33 Deemed compliance with code
34 Authority may revoke or suspend licence or certificate for non-compliance with code
Fees
35 Authority may prescribe fees
Sanctions and penalties
36 Deception
37 Sale of natural health 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
Disputes
41 Appeals committee
42 Appeals
Other powers of Authority
43 Statement by Authority
44 Recall of natural health products
45 Delegation
Transitional provisions
46 Natural health products before commencement of this Act
Regulations
47 Regulations
Review of Act
48 Ministry 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
Revocation
57 Dietary Supplements Regulations 1985 revoked
ScheduleSuitable classes of substances
The Parliament of New Zealand enacts as follows: