Classification of Medicines
Recent NZ Gazette Notices Relating to Classification
22 July 2010
22 July 2010 (this notice comes into force
on 1 May 2011)
22 July 2010 (a cumulative notice)
1 April 2010
Gazette notice for 22 July 2010. This notice puts into effect changes recommended by the Medicines Classification Committee at its 43rd meeting on Tuesday 13 April 2010.
Prescription Medicines
Amyl nitrite; except when sold to a person who holds a valid Controlled Substances Licence authorising them to possess cyanide
Calcipotriol; except in medicines containing not more than 50 micrograms per gram or per millilitre and when sold in a pack of not more than 30 grams or 30 millilitres by a pharmacist to an adult with mild to moderate psoriasis previously diagnosed by a doctor
Fluorides; for internal use in medicines containing more than 0.5 milligrams per dose unit except in medicines containing 15 milligrams or less per litre or per kilogram; except in parenteral nutrition replacement preparations; for external use in medicines containing more than 5500 milligrams per litre or per kilogram except when supplied to a dental professional recognised by the Dental Council of New Zealand
Loperamide; except when specified elsewhere in this notice
Nebivolol
Rizatriptan; except when specified elsewhere in this notice
Roflumilast
Saxagliptin
Staphylococcus aureus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds
Streptococcus beta-haemolyticus vaccine; except in oral vaccines for the prophylaxis of bacterial complications of colds
Succimer
Tapentadol
Ustekinumab
Vaccines; except when specified elsewhere in this notice
Vaccinia virus vaccine
Vernakalant
Vinflunine
Restricted Medicines
Fluorides; for external use in liquid form in medicines containing 5500 milligrams or less and more than 1000 milligrams per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as restricted medicines; for external use in non-liquid form in medicines containing 5500 milligrams or less and more than 1000 milligrams per litre or per kilogram, except in medicines containing 1500 milligrams or less and more than 1000 milligrams per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as general sale medicines; except when supplied to a dental professional recognised by the Dental Council of New Zealand
Rizatriptan; 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 wafers containing 5 milligrams or less per wafer and when sold in a pack containing not more than 2 wafers approved by the Minister or the Director-General for distribution as a restricted medicine
Staphylococcus aureus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds
Streptococcus beta-haemolyticus vaccine; in oral vaccines for the prophylaxis of bacterial complications of colds
Pharmacy-only Medicines
Diclofenac; in solid dose form in medicines containing 12.5 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 75 milligrams
Fluorides; for internal use in medicines containing 0.5 milligrams or less per dose unit; except in parenteral nutrition replacement preparations; for external use in liquid form in medicines containing 1000 milligrams or less per litre or per kilogram and when sold in packs approved by the Minister or the Director-General for distribution as pharmacy-only medicines, except in medicines containing 220 milligrams or less per litre or per kilogram and in packs containing not more than 120 milligrams of total fluoride which have been approved by the Minister or the Director-General for distribution as general sale medicines; except when supplied to a dental professional recognised by the Dental Council of New Zealand; except in medicines containing 15 milligrams or less per litre or per kilogram
Loperamide; in packs containing not more than 20 tablets or capsules; except in divided solid dosage forms for oral use containing 2 milligrams or less of loperamide per dosage form when sold in a pack containing not more than eight dosage forms approved by the Minister or the Director-General for distribution as a general sale medicine for the symptomatic treatment of acute non specific diarrhoea
Sodium nitrite; except when present as an excipient
Medicines for General Sale
Please note that the following medicine is now available for general sale.
Loperamide; in divided solid dosage forms for oral use containing 2 milligrams or less of loperamide per dosage form when sold in a pack containing not more than eight dosage forms approved by the Minister or the Director-General for distribution as a general sale medicine for the symptomatic treatment of acute non-specific diarrhoea
Gazette notice for 22 July 2010. This notice puts into effect changes recommended by the Medicines Classification Committee at its 43rd meeting on Tuesday 13 April 2010. This notice shall come into force on 1 May 2011
Pharmacy-only Medicines
Dextromethorphan; in liquid form containing more than 0.25% or in solid dose form containing more than 15 milligrams per dose form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams; in medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
Phenylephrine; for nasal use in medicines containing more than 1%; for ophthalmic use in medicines containing 5% or less and more than 1%; for oral use in medicines containing more than 50 milligrams per recommended daily dose or in packs containing more than 250 milligrams of phenylephrine per pack; in medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
Medicines for General Sale
Please note that the following medicines are now available for general sale.
Dextromethorphan; in liquid form containing 0.25% or less or in solid dose form containing 15 milligrams or less per dose form when in packs containing not more than 600 milligrams and with a recommended daily dose of not more than 120 milligrams; except in medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
Phenylephrine; for nasal or ophthalmic use in medicines containing 1% or less; for oral use in medicines containing 50 milligrams or less per recommended daily dose and in packs containing 250 milligrams or less of phenylephrine per pack; except in medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
Gazette notice for 22 July 2010. This cumulative notice keeps in effect changes recommended by the Medicines Classification Committee at its 42nd meeting on Tuesday 3 November 2009.
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
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
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
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
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.
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
Heparins; for external use; when present as an excipient
Gazette notice for 1 April 2010. This notice is to widen public access to oseltamivir.
Prescription medicines
Oseltamivir; except when sold in a pharmacy between the months of April to September inclusive by a registered pharmacist who is satisfied that the medicine is for the treatment of a consumer who is resident in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza