Pursuant to section 106 (1) of the Medicines Act 1981,
I, Don Matheson, Deputy Director-General, Public Health Directorate, 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
Aripiprazole
Bevacizumab
Bosentan
Eplerenone
Fenofibrate
Hydroquinone; except in medicines for external use containing 2% or less
Isosorbide dinitrate
Norelgestromin
Octocog alfa
Pemetrexed
Pregabalin
Sevelamer
Strontium ranelate
Tenofovir
Trichloroacetic acid; except for external use in medicines containing 12.5% or less for the treatment of warts other than anogenital warts
Schedule 2
Restricted Medicines
*Fluconazole; for oral use in medicines which have received the consent of the Minister or the Director-General to their distribution as restricted medicines and are sold
in the manufacturer's original pack containing 150 milligrams or less as a single dose for the treatment of vaginal candidiasis
Schedule 3
Pharmacy-only Medicines
Hydroquinone; for external use in medicines containing 2% or less except in hair preparations containing 1% or less
Triamcinolone; in aqueous nasal sprays delivering up to
55 micrograms per actuation when the maximum daily dose is no greater than 220 micrograms and the medicine has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine
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.
Hydroquinone; for external use in hair preparations containing 1% or less
Trichloroacetic acid; for external use in medicines containing 12.5% or less for the treatment of warts other than anogenital warts
*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 14th day of July 2004.
DON MATHESON, Deputy Director-General, Public Health Directorate.