Pursuant to section 106(1) of the Medicines Act 1981,
I, Anthony Hill, Deputy Director-General, Sector Accountability and Funding Directorate, acting under delegated authority, hereby declare that:
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
Azacitidine
Butoconazole; except for vaginal use
Dabigatran
Di-isopropylamine dichloroacetate
Felbinac; except for external use
Guanidine
Ivabradine
Ketoprofen; except when specified elsewhere in the Schedule; except for dermal use
Methyl salicylate; for internal use except when present as an excipient in medicines containing 1.04% or less per dose form
Picric acid
Pyrvinium
Rifampicin
Selenium; except when specified elsewhere in the Schedule; except for oral use in medicines containing 150 micrograms or less per recommended daily dose; except for external use in medicines containing 3.5% or less of selenium sulfide
Tiprinavir
Trinitrophenol
Vitamin A; for internal use in medicines containing more than 3000 micrograms of retinol equivalents per recommended daily dose except in parenteral nutrition replacement preparations; for external use in medicines containing more than 1%
Vitamin D; for internal use in medicines containing more than 25 micrograms per recommended daily dose except in parenteral nutrition replacement preparations
Schedule 2
Restricted Medicines
Butoconazole; for vaginal use
*Ibuprofen; for oral use in tablets or capsules containing up to 400 milligrams per dose form and in packs containing not more than 50 dose units and 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 labelled for use by adults and children over 12 years of age
Nicotinic acid except nicotinamide; in medicines containing more than 100 milligrams per dose form
Prochlorperazine; in packs containing not more than
10 tablets or capsules for the treatment of nausea associated with migraine
Schedule 3
Pharmacy-only Medicines
Benzydamine; for external use except for dermal use
Clotrimazole; for external use except in medicines for tinea pedis only
Pyrithione zinc; for treatment of the scalp in medicines containing more than 2%
Selenium; for oral use in medicines containing 300 micrograms or less and more than 150 micrograms per recommended daily dose; for external use except in medicines containing 3.5% or less of selenium sulfide
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.
Benzydamine; for dermal use
Methyl salicylate; for external use; for internal use when present as an excipient in medicines containing 1.04% or less per dose form
Nicotinamide
Pyrithione zinc; for treatment of the scalp in medicines containing 2% or less
Salicylic acid; in medicines containing 40% or less
Selenium; for oral use in medicines containing 150 micrograms or less per recommended daily dose; for external use in medicines containing 3.5% or less of selenium sulfide
Vitamin A; for internal use in medicines containing 3000 micrograms or less of retinol equivalents per recommended daily dose; in parenteral nutrition replacement preparations; for external use in medicines containing 1% or less
Vitamin D; for external use; for internal use in medicines containing 25 micrograms or less per recommended daily dose; in parenteral nutrition replacement preparations
*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 15th day of August 2007.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate.