Notice Type
Departmental
Notice Title

Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981,
I, Barbara Phillips, Acting Deputy Director-General, Population Health Directorate, Ministry of Health, 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 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
Benzocaine; except when specified elsewhere in this
notice; except in dermal preparations containing 2% or less of total anaesthetic substances; except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit
Canakinumab
Certolizumab pegol
Clofarabine
Eltrombopag olamine
Fampridine
Flurbiprofen; except in locally acting oromucosal preparations containing 10 milligrams or less per preparation
Omeprazole; except when specified elsewhere in this notice
Schedule 3
Pharmacy-only Medicines
Benzocaine; in preparations for topical use, other than
eye drops, containing 10% or less of total anaesthetic substances except in dermal preparations containing
2% or less of total anaesthetic substances; in divided preparations containing 200 milligrams or less of total anaesthetic substances per dosage unit except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit
Brompheniramine; for oral use in medicines for adults
and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose
of a day/night pack containing brompheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant
Chlorpheniramine; for oral use in medicines for adults
and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose
of a day/night pack containing chlorpheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant
Dexchlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose
of a day/night pack containing dexchlorpheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant
Diphenhydramine; for oral use in medicines for adults
and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose
of a day/night pack containing diphenhydramine or
when at least one of the other active ingredients is a sympathomimetic decongestant
Doxylamine; for oral use in medicines for adults
and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose
of a day/night pack containing doxylamine or when
at least one of the other active ingredients is a sympathomimetic decongestant
Flurbiprofen; in locally acting oromucosal preparations containing 10 milligrams or less per preparation
Omeprazole; in divided solid dosage forms for oral use containing 20 milligrams or less, with a maximum daily dose of 20 milligrams in a pack size of up to 14 dosage units, for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine
Pheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing pheniramine or when at least one of the other active ingredients is a sympathomimetic decongestant
Promethazine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing promethazine or when at least one of the other active ingredients is a sympathomimetic decongestant
Trimeprazine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing trimeprazine or when at least one of the other active ingredients is a sympathomimetic decongestant
Triprolidine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with one or more other therapeutically active ingredients either when in the bed-time dose of a day/night pack containing triprolidine or when at least one of the other active ingredients is a sympathomimetic decongestant
Medicines for General Sale
Please note that the following medicines are now available for general sale.
Benzocaine; in dermal preparations containing 2% or less
of total anaesthetic substances; in lozenges containing
30 milligrams or less of total anaesthetic substances per dosage unit
Nicotine; in preparations for oromucosal or transdermal absorption
Dated this 8th day of February 2011.
BARBARA PHILLIPS, Acting Deputy Director-General, Population Health Directorate, Ministry of Health.