10 MARCH 2005

NEW ZEALAND GAZETTE, No. 48

1261

Dated this 2nd day of March 2005.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Classification of Medicines

Pursuant to section 106 (1) of the Medicines Act 1981,
I, Don Matheson, 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 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.\n

Schedule 1

Prescription Medicines

Articaine

Bortezomib

Ciclesonide

Felypressin; except when combined with a local anaesthetic
and when used in practice by a registered dental therapist

Fluorides; except when specified elsewhere in the Schedule;
except in parenteral nutrition replacement preparations;
for external use in medicines other than pastes, gels or
powders for cleaning the teeth containing more than
2.5% except when used in practice by a registered dental
therapist; except in medicines containing 1.5 milligrams
or less per litre or per kilogram

Fulvestrant

Ketotifen; except for ophthalmic use in medicines
containing 0.025% or less

Methyl mercury; except in medicines containing 300
micrograms of methyl mercury per litre or per kilogram

Mitragyna speciosa

Mitrogynine

Orlistat; except in medicines containing 120 milligrams or
less per dose form

Palonosetron

Piridoxine; in medicines containing more than 200 milligrams
per recommended daily dose

Terlipressin

Treprostinil.

Schedule 2

Restricted Medicines

Fluorides; in pastes, gels or powders for cleaning the teeth
containing more than 0.1%

Ketotifen; for ophthalmic use in medicines containing
0.025% or less

Orlistat; in medicines containing 120 milligrams or less per
dose form

Triamcinolone; for buccal use in medicines containing
0.1% or less of triamcinolone acetonide and in pack
sizes no greater than 5 grams.

Schedule 3

Pharmacy-only Medicines

Fluorides; for internal use in medicines containing
2.2 milligrams or less per dose form of sodium
fluoride; for external use in medicines other than
pastes, gels or powders for cleaning the teeth containing
2.5% or less; except in dental hygiene products other
than pastes, gels or powders for cleaning the teeth
containing 220 milligrams or less per litre or per kilogram
and in packs containing not more than 120 milligrams of
total fluoride

Nicotine; for inhalation except when sold from a smoking
cessation clinic run under the auspices of a registered
medical practitioner, nurse, pharmacist or psychologist

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 and in packs containing more than 250
milligrams of phenylephrine per pack.

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.

Fluorides; in pastes, gels or powders for cleaning the
teeth containing 0.1% or less; in parenteral nutrition
replacement preparations; in oral hygiene products other
than pastes, gels or powders for cleaning the teeth
containing 220 milligrams or less per litre or per kilogram
and in packs containing not more than 120 milligrams of
total fluoride; in other medicines containing 15 milligrams
or less per litre or per kilogram

Nicotine; for transdermal use or in chewing gum, lozenges
or sublingual tablets

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

Piridoxine; in medicines containing 200 milligrams or less
per recommended daily dose.

Dated this 8th day of March 2005.

DON MATHESON, Deputy Director-General, Public Health
Directorate.

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