Medicines Regulations 1984

Reprint as at 6 August 2015

Coat of Arms of New Zealand

Medicines Regulations 1984

(SR 1984/143)

David Beattie, Governor-General

Order in Council

At the Government House at Wellington this 5th day of June 1984

Present:
His Excellency the Governor-General in Council

Note

Changes authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint.

Note 4 at the end of this reprint provides a list of the amendments incorporated.

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.

Contents

1Title and commencement
2Interpretation
3Classification of medicines
4Standards for medicines, related products, medical devices, cosmetics, and surgical dressings
5Pharmacist may dilute medicine in particular case
6Colouring substances [Revoked]
7Advertisements not to claim official approval
8Advertisements for medicines
9Advertisements for related products
10Advertisements for medical devices
11Advertisements intended for health professions
12Medicines, related products, and medical devices not to be sold unless properly labelled
13Labelling of medicines
14Labelling of related products
15Exemptions from regulations 13 and 14
16Principal display panel
17Form and manner of labelling
18Size of letters
19Labelling of prescription medicines, restricted medicines, and pharmacy-only medicines
20Consumer information panel [Revoked]
21Labels on containers of medicines or related products containing vitamins
22Warning statements for medicines and related products
23Labels on containers of medicines sold by authorised prescribers or pharmacists
24Labels on containers of hair dyes
25Misleading statements
26Persons handling medicines, related products, and cosmetics
27Infected persons
28Persons in contact with infected persons
29Places of manufacture, storage, and sale
30Dwellinghouses prohibited for manufacture and packing
31Powers of Medical Officer of Health in respect of premises
32Storage of medicines, etc
33Construction and use of containers, etc
34Exposure to toxic substances prohibited
35Containers for medicines, related products, and cosmetics
36Storage to be separate
37Safety containers
38Containers
39Conditions under which authorised prescribers and veterinarians may prescribe prescription medicines
39ALimit on period of supply of prescription medicines
40Prescriptions to comply with regulations
40AUrgently required prescriptions of prescription medicines may be communicated orally if later confirmed in writing
41Form of prescription
42Dispensing of prescription medicines
43Director-General may waive certain requirements
44Prescriptions for prescription medicines not required in certain cases
44AAdministration of vaccines in approved immunisation programmes
44BDuty to supply information
44CNo export of prescription medicines for retail sale without New Zealand prescription
44DSupply of restricted medicine and pharmacy-only medicine
45Application for licence to manufacture, hawk, sell, or pack medicine
45AApplication for licence to operate pharmacy
46Form and conditions of licence
47Licence to manufacture medicines
48Licence to hawk certain medicines
48ALicensing authority to be advised of change in particulars relating to operating pharmacy
49Surrender of licence
50Withdrawal of medicines, etc
51Interpretation
52Approval of data sheets for new medicines
53Approval of data sheets for changed medicines
54Particulars in data sheets [Revoked]
54ASale of Medicines Registers
55Records of sales by retail or wholesale
56Record of hawker’s sales
57Record of supplies pursuant to prescriptions
58Records to be kept
58ASubstances that are not medicines or related products for purposes of Act
58BFluoridating agents and fluoridated water not medicines or related products
59General sale medicines may be sold by vending machine
60Certificate of analyst
61Fees
61AWaiver and refund of fees
61BFees inclusive of goods and services tax
62Medical devices
63Restriction on, and supervision of, compounding medicine
64Offences
65Appeals to District Court
65ATransitional provision arising from enactment of Medicines Amendment Regulations 2011
66Revocations
[Revoked]
Gazette Information
Reprint notes