Hon Tony Ryall
Government Bill
324—2
As reported from the Health Committee
Commentary
Key
1 Title
2 Commencement
Part 1Preliminary 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 and Supplementary Products Advisory Committee
10 Natural Health and Supplementary Products Advisory Committee
Natural health and supplementary products database
11 Natural health and supplementary products database
Sponsor
Product notifier
11A Product notifier
12 Product notifier must be resident in New Zealand
Part 2Regulation 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
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 Product notifier must notify Authority of any serious adverse reaction to natural health and supplementary product
18 When new product notification needed
19 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 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 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 1Suitable substances
Schedule 2Approved pharmacopoeia
Legislative history
The Parliament of New Zealand enacts as follows: