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
Adefovir
Amygdalin; at all strengths
Cinacalcet
Collagen; in injections or implantations for tissue augmentation or cosmetic use
Deferiprone
Duloxetine
Efalizumab
Emtricitabine
Enfurvirtide
Epinastine
Ephedra spp; except ephedra navadensis
Everolimus
Hyaluronic acid; in injections or implantations for tissue augmentation or cosmetic use
Hylan polymer; in injections or implantations for tissue augmentation or cosmetic use
Oxedrine; in medicines containing more than 30 milligrams per recommended daily dose
Pegfilgrastim
Schedule 2
Restricted Medicines
Ciclopirox; for dermal use in medicines containing more than 2%
Schedule 3
Pharmacy-only Medicines
Acetylcysteine; for oral use in medicines containing more than 1 gram per recommended daily dose
*Beclomethasone; in aqueous nasal sprays delivering up
to 50 micrograms per actuation when the maximum recommended daily dose is not greater than 400 micrograms and the medicine has received the consent
of the Minister or the Director-General to its distribution as a pharmacy-only medicine
*Budesonide; in aqueous nasal sprays delivering up to
50 micrograms per actuation when the maximum recommended daily dose is not greater than 400 micrograms and the medicine has received the consent
of the Minister or the Director-General to its distribution as a pharmacy-only medicine
Ciclopirox; for dermal use in medicines containing 2% or less except in medicines for tinea pedis only
Dextromethorphan; in liquid form containing more than 0.25% or in solid dose form containing more
than 15 milligrams per dose form when in packs containing not more than 600 milligrams and with
a recommended daily dose of not more than 120 milligrams
*Fluticasone; in aqueous nasal sprays delivering up to
50 micrograms per actuation when the maximum recommended daily dose is not greater than 200 micrograms and the medicine has received the consent
of the Minister or the Director-General to its distribution as a pharmacy-only medicine
*Ibuprofen; for oral use in liquid form in packs containing not more than 4 grams 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; for oral use in solid dose form containing not more than 200 milligrams per dose form 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; except in packs containing 200 milligrams or less per oral solid dose form and not more than 25 dose units per pack when in medicines which have received the consent of the Minister or the Director-General to their sale as general sale medicines and which are sold in the manufacturer's original pack
*Mometasone; in aqueous nasal sprays delivering up to
50 micrograms per actuation when the maximum recommended daily dose is not greater than 200 micrograms and the medicine has received the consent
of the Minister or the Director-General to its distribution as a pharmacy-only medicine
Nicotine; in lozenges or sublingual tablets
Sodium picosulfate; for laxative use
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.
Acetylcysteine; for external use; for oral use in medicines containing 1 gram or less per recommended daily dose
Collagen; except in injections or implantations for tissue augmentation or cosmetic use
Dextromethorphan; in liquid form containing 0.25% or
less or in solid dose form containing 15 milligrams
or less per dose form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams
Ephedra navadensis
Hyaluronic acid; except in injections or implantations for tissue augmentation or cosmetic use
Hylan polymer; except injections or implantations for tissue augmentation or cosmetic use
*Ibuprofen; for external use; for oral use in solid dose form containing 200 milligrams or less per dose form when in packs containing not more than 25 dose units and when in medicines which have received the consent of the Minister or the Director-General to their sale as general sale medicines and which are sold in the manufacturer's original pack
Injectable medicines; except when specified in the First Schedule to the Medicines Regulations
Oxedrine; in medicines containing 30 milligrams or less per recommended daily dose
*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 23rd day of April 2004.
DON MATHESON, Deputy Director-General, Public Health Directorate.