Reprint as at 1 December 2011
(SR 1984/143)
David Beattie, Governor-General
At the Government House at Wellington this 5th day of June 1984
Present:
His Excellency the Governor-General in Council
Changes authorised by section 17C of the Acts and Regulations Publication Act 1989 have been made in this reprint.
A general outline of these changes is set out in the notes at the end of this reprint, together with other explanatory material about this reprint.
These regulations are administered by the Ministry 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.
Part 1
Classification of medicines
4 Standards for medicines, related products, medical devices, cosmetics, and surgical dressings
5 Pharmacist may dilute medicine in particular case
6 Colouring substances [Revoked]
7 Advertisements not to claim official approval
8 Advertisements for medicines
9 Advertisements for related products
10 Advertisements for medical devices
11 Advertisements intended for health professions
12 Medicines, related products, and medical devices not to be sold unless properly labelled
14 Labelling of related products
15 Exemptions from regulations 13 and 14
17 Form and manner of labelling
19 Labelling of prescription medicines, restricted medicines, and pharmacy-only medicines
20 Consumer information panel [Revoked]
21 Labels on containers of medicines or related products containing vitamins
22 Warning statements for medicines and related products
23 Labels on containers of medicines sold by authorised prescribers or pharmacists
24 Labels on containers of hair dyes
Part 5
Manufacture, packing, storage, and handling
26 Persons handling medicines, related products, and cosmetics
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
33 Construction and use of containers, etc
34 Exposure to toxic substances prohibited
35 Containers for medicines, related products, and cosmetics
Part 6
Importation and transport
39 Conditions under which authorised prescribers and veterinarians may prescribe prescription medicines
39A Limit on period of supply of prescription medicines
40 Prescriptions to comply with regulations
40A Urgently required prescriptions of prescription medicines may be communicated orally if later confirmed in writing
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
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
Part 9
Withdrawal of medicines, etc
50 Withdrawal of medicines, etc
52 Approval of data sheets for new medicines
53 Approval of data sheets for changed medicines
54 Particulars in data sheets [Revoked]
54A Sale of Medicines Registers
55 Records of sales by retail or wholesale
57 Record of supplies pursuant to prescriptions
58A Substances that are not medicines or related products for purposes of Act
59 General sale medicines may be sold by vending machine
61B Fees inclusive of goods and services tax
63 Restriction on, and supervision of, compounding medicine
65A Transitional provision arising from enactment of Medicines Amendment Regulations 2011
Schedule 1
Prescription, restricted, and pharmacy-only medicines
Schedule 3
Loose sheet data sheet requirements
[Revoked]
Schedule 4
Hawker's Medicines book
Schedule 5
Analyst's certificate under the Medicines Act 1981