Pursuant to section 106 (1) of the Medicines Act 1981,
I, G. R. Boyd, Chief Advisor, Safety and Regulation, 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 an injection or eye preparation, to any concentration of that medicine; and
(ii) if the medicine is not 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
Atazanavir
Aprepitant
Carbetocin
Fluorides; for internal use except in parenteral nutrition replacement preparations or in medicines containing
2.2 milligrams or less per dose form of sodium fluoride; for external use in medicines other than pastes, gels or powders for cleaning the teeth containing more than 2.5% except when used in practice by a registered dental therapist; except in medicines containing 15 milligrams or less per litre or per kilogram
Haemophilus influenzae vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds
Human protein C
Laronidase-rch
Lumiracoxib
Melagatran
Pneumococcal vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds
Polyacrilamide; in injections or implantations for tissue augmentation or cosmetic use
Polylactic acid; in injections or implantations for tissue augmentation or cosmetic use
Ximelagatran
Schedule 2
Restricted Medicines
Fluorides; in pastes, gels or powders for cleaning the teeth containing more than 0.1%
Haemophilus influenzae vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds
Pneumococcal vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds
Schedule 3
Pharmacy-only Medicines
Fluorides; for internal use in medicines containing 2.2 milligrams or less per dose form of sodium fluoride; for external use in medicines other than pastes, gels or powders for cleaning the teeth containing 2.5% or less; except in oral hygiene products other than pastes, gels or powders for cleaning the teeth containing 0.01% or less;
Hyoscyamus niger; for oral use in liquid form in medicines containing 0.03% and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids or in solid dose form in medicines containing 0.3 milligrams or less
per dose unit and not more than 1.2 milligrams per recommended daily dose except in packs containing
30 micrograms or less of total solanaceous alkaloids
*Nizatidine; in medicines which have received the consent of the Minister or the director-general to their sale
as pharmacy-only medicines and which are sold in the manufacturer's original pack containing not more than 14 days supply
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.
Fluorides; in pastes, gels or powders for cleaning the
teeth containing 0.1% or less; in oral hygiene products other than pastes, gels or powders for cleaning the
teeth containing 0.01% or less; in parenteral nutrition replacement preparations; in medicines containing
15 milligrams or less per litre or per kilogram
Hyoscyamus niger; in packs containing 30 micrograms or less of total solanaceous alkaloids
Ibuprofen; for external use
Ketoprofen; for external use
*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 22nd day of July 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).