Pursuant to section 106(1) of the Medicines Act 1981,
I, Graeme Gillespie, Acting 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
Amphotericin
Anagrelide
Azatadine; except when specified elsewhere in this Schedule
Brompheniramine; except when specified elsewhere in this Schedule
Brugmansia spp
Chlorpheniramine; except when specified elsewhere in this Schedule
Dexchlorpheniramine; except when specified elsewhere in this Schedule
Dimenhydrinate; except when specified elsewhere in this Schedule
Diphenhydramine; except when specified elsewhere in this Schedule
Diphenylpyraline; except when specified elsewhere in this Schedule
Doxylamine; except when specified elsewhere in this Schedule
Exenatide
Mepyramine; except when specified elsewhere in this Schedule
Oseltamivir; except when sold by a registered pharmacist between the months of May to September inclusive
for the treatment of seasonal influenza to a consumer
12 years of age or more presenting in a pharmacy with early symptoms of influenza
Paracetamol; except when specified elsewhere in this Schedule
Phenyltoloxamine
Promethazine; except when specified elsewhere in this Schedule
Sitagliptin
Sorafenib
Sumatriptan; except when specified elsewhere in this Schedule
Sunitinib
Telbivudine
Thenyldiamine
Trimeprazine; except when specified elsewhere in this Schedule
Triprolidine; except when specified elsewhere in this Schedule
Varenicline
Schedule 2
Restricted Medicines
Azatadine; for oral use in adults and children over 2 years
of age
Brompheniramine; for oral use medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Chlorpheniramine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Dexchlorpheniramine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Dimenhydrinate; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Diphenhydramine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Diphenylpyraline; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Doxylamine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone; for dermal use in medicines containing 1% or less but more than 0.5% by weight
of hydrocortisone base with no other ingredient except an antifungal and in a quantity of 30 grams or less or
30 millilitres or less per container; in rectal medicines containing 1% or less but more than 0.5% by weight
of hydrocortisone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or up to 12 suppositories per pack
*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 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
Mepyramine; for oral use in medicines for adults and children over 2 years of age
Promethazine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
*Sumatriptan; for oral use in medicines for the acute relief of migraine attacks with or without aura in patients
who have a stable, well-established pattern of symptoms when in tablets containing 50 milligrams or less per tablet and when sold in a pack containing not more
than 2 tablets which has received the consent of the Minister or the Director-General to its sale as a restricted medicine
Trimeprazine; for oral use in medicines for adults and children over 2 years of age
Triprolidine; for oral use in medicines for adults and children over 2 years of age except when specified elsewhere in this Schedule
Schedule 3
Pharmacy-only Medicines
Brompheniramine; for oral use in medicines for adults or children over two years of age when combined in the same container with one or more other therapeutically active substances, either when in the bedtime dose of a day-night pack containing brompheniramine or when at least one of the other therapeutically active substances is a sympathomimetic decongestant
Chlorpeniramine; for oral use in medicines for adults
and children over 2 years of age when combined in the same container with one or more other therapeutically active substances, either when in the bedtime dose of a day-night pack containing chlorpheniramine or when at least one of the other therapeutically active substances is a sympathomimetic decongestant
Dexchlorpheniramine; for oral use in medicines for adults and children over 2 years of age when combined in the same container with one or more other therapeutically active substances, either when in the bedtime dose of a day-night pack containing dexchlorpheniramine or when at least one of the other therapeutically active substances is a sympathomimetic decongestant
Dimenhydrinate; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 2 years of age except when sold at a transport terminal or aboard a ship or plane
Diphenhydramine; for oral use in medicines for adults
and children over 2 years of age when combined in the same container with one or more other therapeutically active substances, either when in the bedtime dose of a day-night pack containing diphenhydramine or when at least one of the other therapeutically active substances
is a sympathomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules of diphenhydramine theoclate for the prevention or treatment of motion sickness in adults and children over 2 years of age except when sold at a transport terminal or aboard a ship or plane
Diphenylpyraline; for oral use in medicines for adults
and children over 2 years of age when combined in the same container with one or more other therapeutically active substances, either when in the bedtime dose of a day-night pack containing diphenylpyraline or when at least one of the other therapeutically active substances is a sympathomimetic decongestant
Doxylamine; for oral use in medicines for adults
and children over 2 years of age when combined in the same container with one or more other therapeutically active substances, either when in the bedtime dose of a day-night pack containing doxylamine or when at least one of the other therapeutically active substances is a sympathomimetic decongestant
Hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone; for dermal use in medicines containing 0.5% or less by weight of hydrocortisone base with no other ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container; in rectal medicines containing 0.5% or less by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or up to 12 suppositories per pack
Mepyramine; for dermal use
Paracetamol; in liquid form; in suppositories; in tablets
or capsules containing 500 milligrams or less and in packs containing more than 10 grams; in slow release forms containing 665 milligrams or less and more than 500 milligrams; in powder form containing not more than 1000 milligrams per sachet and more than 10 grams per pack
Promethazine; for oral use in medicines for adults
and children over 2 years of age when combined in the same container with one or more other therapeutically active substances, either when in the bedtime dose of a day-night pack containing promethazine or when at least one of the other therapeutically active substances is a sympathomimetic decongestant; for oral use in a sealed container of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 2 years of age except when sold at a transport terminal or aboard a ship or plane
Trimeprazine; for oral use in medicines for adults
and children over 2 years of age when combined in the same container with one or more other therapeutically active substances, either when in the bedtime dose of a day-night pack containing trimeprazine or when at least one of the other therapeutically active substances is a sympathomimetic decongestant
Triprolidine; for oral use in medicines for adults
and children over 2 years of age when combined in the same container with one or more other therapeutically active substances, either when in the bedtime dose of a day-night pack containing triprolidine or when at least one of the other therapeutically active substances is a sympathomimetic decongestant
*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 1st day of February 2007.
GRAEME GILLESPIE, Acting Deputy Director-General, Public Health Directorate.