Pursuant to section 106(1) of the Medicines Act
1981, I, Anthony Hill, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of
Health, acting under delegated authority, hereby declare
the following:
1. The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
2. The medicines listed in Schedule 2 to this notice are classified as restricted medicines.
3. The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.
Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.
Unless specific reference is made otherwise, every reference applies also to medicines that are:
(a) preparations and admixtures containing any proportion of any substance listed in the notice.
(b) salts and esters of any substance listed in the notice.
(c) preparations or extracts of biological materials listed in the notice.
(d) salts or oxides of elements listed in the notice.
Unless specific reference is made otherwise, every reference to a medicine applies:
(i) if the medicine is in an injection or eye preparation, to any concentration of that medicine; and
(ii) if the medicine is not in an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.
Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using
the free acid, base, alcohol or element unless specifically stated otherwise.
Schedule 1
Prescription Medicines
Albumin; except human albumin
Alglucosidase
Anidulafungin
Chloramphenicol; except for ophthalmic use when sold in practice by a registered optometrist
Desvenlafaxine
Fluorides; for internal use in medicines containing more than 0.5 milligrams per dose unit except in medicines containing 15 milligrams or less per litre or per kilogram; except in parenteral nutrition replacement preparations; for external use in medicines containing more than 5500 milligrams per litre or per kilogram except when used in practice by a registered dental therapist
Golimumab
Lacosamide
Liraglutide
Nitric oxide
Omeprazole; except when specified elsewhere in this Schedule
Prasugrel
Romiplostim
Rotigotine
Temsirolimus
Schedule 2
Restricted Medicines
*Fluorides; for external use in liquid form in medicines containing 5500 milligrams or less and more than 1000 milligrams per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as restricted medicines; for external
use in non-liquid form in medicines containing 5500 milligrams or less and more than 1000 milligrams per litre or per kilogram, except in medicines containing 1500 milligrams or less and more than 1000 milligrams per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as general sale medicines; except when used in practice by a registered dental therapist
Glyceryl trinitrate; for rectal use
*Omeprazole; in tablets or capsules containing 10 milligrams or less and when sold in packs approved by the
Minister or the Director-General for distribution as restricted medicines
Schedule 3
Pharmacy-only Medicines
Aloes for internal use; except when obtained solely from the mucilaginous gel of the leaf
*Fluorides; for internal use in medicines containing 0.5 milligrams or less per dose unit; except in parenteral nutrition replacement preparations; for external use in liquid form in medicines containing 1000 milligrams or less per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as pharmacy-only medicines, except in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride which have been approved by the Minister or the Director-General for distribution as general sale medicines; except when used in practice by a registered dental therapist; except in medicines containing 15 milligrams or less per litre or per kilogram
Ketotifen; for ophthalmic use in medicines containing 0.025% or less except when sold in practice by a registered optometrist
Medicines for General Sale
Please note that the following medicines are no longer classified as prescription medicines, restricted medicines or pharmacy-only medicines. As such, they are now available for general sale.
Albumin; human
Aloes for internal use; when obtained solely from the mucilaginous gel of the leaf
Antithrombin
Blood clotting factors
Blood corpuscles
Blood, whole
Factor VIII inhibitor bypassing fraction
Fibrinogen
*Fluorides; for external use in liquid form in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride which have been approved by the Minister or the Director-General for distribution as general sale medicines; for external use in non-liquid form in medicines containing 1500 milligrams or less per litre or per kilogram and, when containing more than 1000 milligrams per litre or per kilogram, sold in packs approved by the Minister or the Director-General for distribution as general sale medicines; in medicines containing 15 milligrams or less per litre or per kilogram; in parenteral nutrition replacement preparations
Plasma
Plasma protein fraction
Plasmin
Plasminogen activator
Platelets
Thrombin
*Regulation 20 of the Medicines Regulations 1984 requires that all medicines sold without a practitioner’s prescription must include a consumer information panel on the label. Further, all material changes to a medicine (including changes to labelling), must be notified to the Director-General of Health in accordance with section 24 of the Medicines Act 1981.
Dated this 16th day of March 2009.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health.