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New Zealand Legislation: Regulations

Regulations are laws made under Acts

Reprint as at 7 August 2009

Medicines Regulations 1984

(SR 1984/143)

Note

Changes authorised by section 17C of the Acts and Regulations Publication Act 1989 have been made in this eprint.

A general outline of these changes is set out in the notes at the end of this eprint, together with other explanatory material about this eprint.

These regulations are administered in the Department of Health.

PURSUANT to section 105 of the Medicines Act 1981, and, in the case of Part 3 of the regulations, to section 62 of that Act, His Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations and bodies that appeared to the Minister to be representatives of persons likely to be substantially affected, and by and with the advice and consent of the Executive Council, hereby makes the following regulations.

Contents

1 Title and commencement

2 Interpretation

Part 1
Classification of medicines

3 Classification of medicines

Part 2
Standards

4 Standards for medicines, related products, medical devices, cosmetics, and surgical dressings

5 Pharmacist may dilute medicine in particular case

6 Colouring substances

Part 3
Advertisements

7 Advertisements not to claim official approval

8 Advertisements for medicines

9 Advertisements for related products

10 Advertisements for medical devices

11 Advertisements to medical professions

Part 4
Labelling

12 Medicines, related products, and medical devices not to be sold unless properly labelled

13 Labelling of medicines

14 Labelling of related products

15 Principal display panel

16 Exemptions from regulations 13 and 14

17 Form and manner of labelling

18 Size of letters

19 Labelling of prescription medicines, restricted medicines, and pharmacy-only medicines

20 Consumer information panel

21 Labels on containers of medicines or related products containing vitamins

22 Warning statements for certain medicines, related products, and cosmetics

23 Labels on containers of medicines sold by authorised prescribers or pharmacists

24 Labels on containers of hair dyes

25 Misleading statements

Part 5
Manufacture, packing, storage, and handling

26 Persons handling medicines, related products, and cosmetics

27 Infected persons

28 Persons in contact with infected persons

29 Places of manufacture, storage, and sale

30 Dwellinghouses prohibited for manufacture and packing

31 Powers of Medical Officer of Health in respect of premises

32 Storage of medicines, etc

33 Construction and use of containers, etc

34 Exposure to toxic substances prohibited

35 Containers for medicines, related products, and cosmetics

36 Storage to be separate

37 Safety containers

Part 6
Importation and transport

Part 7
Prescriptions

39 Conditions under which authorised prescribers and veterinary surgeons may prescribe prescription medicines

40 Prescriptions to comply with regulations

40A Urgently required prescriptions of prescription medicines may be communicated orally if later confirmed in writing

41 Form of prescription

42 Dispensing of prescription medicines

43 Director-General may waive certain requirements

44 Prescriptions for prescription medicines not required in certain cases

44A Administration of vaccines in approved immunisation programmes

44B Duty to supply information

Part 7A
Export of prescription medicines

44C No export of prescription medicines for retail sale without New Zealand prescription

Part 7B
Supply of restricted medicine and pharmacy-only medicine

44D Supply of restricted medicine and pharmacy-only medicine

Part 8
Licences

45 Application for licence to manufacture, hawk, sell, or pack medicine

45A Application for licence to operate pharmacy

46 Form and conditions of licence

47 Licence to manufacture medicines

48 Licence to hawk certain medicines

48A Licensing authority to be advised of change in particulars relating to operating pharmacy

49 Surrender of licence

Part 9
Withdrawal of medicines, etc

50 Withdrawal of medicines, etc

Part 10
Data sheets

51 Interpretation

52 Approval of Director-General required for data sheet

53 Form of data sheet

54 Particulars in data sheets

Part 11
Records

54A Sale of Medicines Registers

55 Records of sales by retail or wholesale

56 Record of hawker's sales

57 Record of supplies pursuant to prescriptions

58 Records to be kept

Part 12
Miscellaneous

59 Sale of contraceptive by vending machine

60 Certificate of analyst

61A Waiver and refund of fees

61B Fees inclusive of goods and services tax

62 Medical devices

63 Restriction on, and supervision of, compounding medicine

65 Appeals to District Court

Schedule 1
Prescription, restricted, and pharmacy-only medicines

Schedule 4
Hawker's medicines book

Schedule 5
Analyst's certificate under the Medicines Act 1981

Schedule 5A
Licence fees

Schedule 6
Regulations revoked

Explanatory note

Gazette information