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 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
Articaine
Bortezomib
Ciclesonide
Felypressin; except when combined with a local anaesthetic and when used in practice by a registered dental therapist
Fluorides; except when specified elsewhere in the Schedule; except in parenteral nutrition replacement preparations; 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
Fulvestrant
Ketotifen; except for ophthalmic use in medicines containing 0.025% or less
Methyl mercury; except in medicines containing 300 micrograms of methyl mercury per litre or per kilogram
Mitragyna speciosa
Mitrogynine
Orlistat; except in medicines containing 120 milligrams or less per dose form
Palonosetron
Piridoxine; in medicines containing more than 200 milligrams per recommended daily dose
Terlipressin
Treprostinil.
Schedule 2
Restricted Medicines
Fluorides; in pastes, gels or powders for cleaning the teeth containing more than 0.1%
Ketotifen; for ophthalmic use in medicines containing 0.025% or less
Orlistat; in medicines containing 120 milligrams or less per dose form
Triamcinolone; for buccal use in medicines containing
0.1% or less of triamcinolone acetonide and in pack
sizes no greater than 5 grams.
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 dental hygiene products other than pastes, gels or powders for cleaning the teeth containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride
Nicotine; for inhalation except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist or psychologist
Phenylephrine; for nasal use in medicines containing more than 1%; for ophthalmic use in medicines containing 5% or less and more than 1%; for oral use in medicines containing more than 50 milligrams per recommended daily dose and in packs containing more than 250 milligrams of phenylephrine per pack.
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 parenteral nutrition replacement preparations; in oral hygiene products other than pastes, gels or powders for cleaning the teeth containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride; in other medicines containing 15 milligrams or less per litre or per kilogram
Nicotine; for transdermal use or in chewing gum, lozenges or sublingual tablets
Phenylephrine; for nasal or ophthalmic use in medicines containing 1% or less; for oral use in medicines containing 50 milligrams or less per recommended daily dose and in packs containing 250 milligrams or less of phenylephrine per pack
Piridoxine; in medicines containing 200 milligrams or less per recommended daily dose.
Dated this 8th day of March 2005.
DON MATHESON, Deputy Director-General, Public Health Directorate.