Natural Health Products Bill

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Hon Dr Jonathan Coleman

Natural Health Products Bill

Government Bill

324—1

Contents

Explanatory note

1  Title

2  Commencement

Part 1
Preliminary 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 2
Regulation 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

Schedule
Suitable classes of substances


The Parliament of New Zealand enacts as follows: