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 or the concentration of the total active principles 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
Abatacept
Aliskiren
Amyl nitrite; except when sold from outlets licensed to sell cyanide paste for the purpose of vertebrate pest control
Azelastine; except when specified elsewhere in the Schedule
Chlorquinaldol
Choline salicylate; except in medicines containing 10% or less and in pack sizes of 15 grams or less
Darunavir
Dasatinib
Deslorelin
Dimethoxinate
Diphenylpyraline
Etidronic acid; except in medicines for external use containing 1% or less
Fomivirsen
Fosaprepitant
Ipriflavone
Lanthanum
Lapatinib
Lefetamine
Levonorgestrel; except when specified elsewhere in the Schedule; except in medicines for use as emergency post-coital contraception when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health
Lithium; except when specified elsewhere in the Schedule; except when present as an excipient in dermal medicines containing 0.25% or less
Lodoxamide; except in medicines for ophthalmic use
Natalizumab
Nepafenac
Nilotinib
Olmesartan
Oxiconazole; except when specified elsewhere in the Schedule
Palifermin
Paliperidone
Pegvisomant
Pyridoxal; in medicines containing more than 200 milligrams per recommended daily dose
Pyridoxamine; in medicines containing more than 200 milligrams per recommended daily dose
Rasagilin
Riluzole
Rimexolone
Rimonabant
Ruboxistaurin
Sabadilla
Schoenocoulon officinale
Scopolia carniolica
Tipepidine
Tolpropamine
Vildagliptin
Schedule 2
Restricted Medicines
Azelastine; in medicines for ophthalmic use containing 0.05% or less
Levonorgestrel; in medicines for use as emergency
post-coital contraception when in packs containing
not more than 1.5 milligrams except when sold by
nurses recognised by their professional body as having competency in the field of sexual and reproductive health
Oxiconazole; for vaginal use
Salicylic acid; except in medicines for dermal use containing 40% or less
Schedule 3
Pharmacy-only Medicines
*Beclomethasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years
of age when in aqueous nasal sprays delivering up
to 50 micrograms per actuation and when the maximum recommended daily dose is no 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; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age when in aqueous nasal sprays delivering up to 50 micrograms per actuation and when the maximum recommended daily dose is no 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
Diclofenac; in solid dose form in medicines containing 12.5 milligrams or less per dose form in packs containing
not more than 20 tablets or capsules and with a recommended daily dose of not more than 75 milligrams
*Fluticasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age when in aqueous nasal sprays delivering up to 50 micrograms per actuation and when the maximum recommended daily dose is no 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 and with a recommended daily dose of not more than 1200 milligrams and in packs containing
not more than 100 tablets or capsules and when 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
Lithium; for dermal use in medicines containing 1% or less but more than 0.01%; except when present as an excipient in dermal medicines containing 0.25% or less
Lobeline; except when in medicines for smoking or burning
*Mometasone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age when in aqueous nasal sprays delivering up to 50 micrograms per actuation and when the maximum recommended daily dose is no 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
Oxiconazole; for dermal use except in medicines for tinea pedis only
*Triamcinolone; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age when in aqueous nasal sprays delivering up to 55 micrograms per actuation and when the maximum recommended 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.
Choline salicylate; in medicines containing 10% or less
and in pack sizes of 15 grams or less
Etidronic acid; in medicines for external use containing
1% or less
Liquorice, deglycyrrhizinised
Lithium; for dermal use in medicines containing less than 0.01%; when present as an excipient in medicines for dermal use containing 0.25% or less
Lobeline; in medicines for smoking or burning
Oxiconazole; for dermal use in medicines for tinea pedis only
Pyridoxal; in medicines containing 200 milligrams or less per recommended daily dose
Pyridoxamine; in medicines containing 200 milligrams or less per recommended daily dose
Salicylic acid; in medicines for dermal use containing 40% or less
*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 12th day of April 2007.
DON MATHESON, Deputy Director-General, Public Health Directorate.