Pursuant to section 106(1) of the Medicines Act 1981,
I, Mark Richards, Acting Deputy Director-General, Regulation and Governance 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 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
Chloramphenicol; except when sold in practice by a registered optometrist; except when specified elsewhere in this notice
Corifollitropin alfa
Famciclovir; except when specified elsewhere in this notice
Fexofenadine; except for oral use
Heparins; for internal use; except when present as an excipient
Human papillomavirus vaccine
Ibogaine
Japanese encephalitis vaccine
Lansoprazole; except when specified elsewhere in this notice
Loperamide; except when specified elsewhere in this notice
Noribogaine
Omeprazole; except when specified elsewhere in this notice
Pazopanib
Phosphodiesterase type 5 inhibitors; except when present as an unmodified, naturally occurring substance; except when specified elsewhere in this notice
Stramonium; except for oral use when specified elsewhere in this notice; except datura stramonium or datura tatula for smoking or burning
Zolmitriptan; except when specified elsewhere in this notice
Schedule 2
Restricted Medicines
Chloramphenicol; for ophthalmic use; except when sold in practice by a registered optometrist
*Famciclovir; in tablets containing 500 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine
*Lansoprazole; in tablets or capsules containing
15 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine
*Omeprazole; in tablets or capsules containing
20 milligrams or less when sold in a pack approved by the Minister or the Director-General for distribution as a restricted medicine
*Zolmitriptan; in a prefilled nasal spray device containing not more than 5 milligrams for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms when sold in a pack of not more than two devices approved by the Minister or the Director-General for distribution as a restricted medicine
Schedule 3
Pharmacy-only Medicines
*Fexofenadine; for oral use; except when in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride when sold in a pack approved by the Minister or the Director-General for distribution as a general sale medicine
Loperamide; in packs containing not more than 20 tablets or capsules
Stramonium; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids; in solid dose form in medicines containing 0.3 milligrams or less
per dose form and not more than 1.2 milligrams per recommended daily dose of total solanaceous alkaloids
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.
Heparins; for external use; when present as an excipient
*Fexofenadine; in capsules containing 60 milligrams or less of fexofenadine hydrochloride or in tablets containing 120 milligrams or less of fexofenadine hydrochloride when sold in a pack approved by the Minister or the Director-General for distribution as a general sale medicine
*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 2nd day of February 2010.
MARK RICHARDS, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health.