Natural Health and Supplementary Products Bill

Hon Tony Ryall

Natural Health and Supplementary Products Bill

Government Bill

324—2

As reported from the Health Committee

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 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 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

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 1
Suitable substances

Schedule 2
Approved pharmacopoeia

Legislative history


The Parliament of New Zealand enacts as follows: