Pursuant to section 106(1) of the Medicines Act 1981,
I, Anthony Hill, Deputy Director-General, Sector Accountability and Funding 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.
Schedule 1
Prescription Medicines
Alglucosidase alfa
Aspirin; for injection; when combined with caffeine, paracetamol or salicylamide
Boron including borax and boric acid; except for internal use in medicines containing 6 milligrams or less per recommended daily dose; except in dermal medicines for use other than paediatric use containing 0.35% or less; except when present as an excipient
Daptomycin
Furosemide
Galsulfase
Ixabepilone
Laropiprant
Levomepromazine
Nicotinic acid except nicotinamide; in medicines containing more than 250 milligrams per dose form
Paricalcitol
Polysulfated glycosaminoglycans; for injection except in intraocular viscoelastic products
Raltegravir
Ranibizumab
*Ranitidine; except when specified elsewhere in this Schedule; except in medicines containing 150 milligrams or less per dose unit which have received the consent of the Minister or the Director-General to their distribution as general sale medicines and which are sold in the manufacturer’s original pack containing not more than
7 days’ supply
Sitaxentan
*Zinc; for internal use in medicines containing more than
25 milligrams per recommended daily dose; except for internal use in medicines containing 50 milligrams or less and more than 25 milligrams per recommended daily dose in packs which have received the consent of the Minister or the Director-General to their distribution as general sale medicines and which are sold in the manufacturer’s original pack and when labelled with a statement that the product may be dangerous if taken in large amounts or for long periods; except in parenteral nutrition replacement preparations
Schedule 2
Restricted Medicines
Aspirin; in slow release forms; in enteric coated forms containing more than 300 milligrams per dose form; except when specified elsewhere in this Schedule
Nicotinic acid except nicotinamide; in medicines containing 250 milligrams or less but more than 100 milligrams per dose form
Schedule 3
Pharmacy-only Medicines
Antazoline; for ophthalmic use except when sold in practice by a registered optometrist
Dibromopropamidine; for ophthalmic use except when sold in practice by a registered optometrist
Levocabastine; for nasal use; for ophthalmic use except when sold in practice by a registered optometrist
Lodoxamide; for ophthalmic use except when sold in practice by a registered optometrist
Naphazoline; except for ophthalmic use when sold in practice by a registered optometrist
Oxymetazoline; except for nasal use when sold at an airport; except for ophthalmic use when sold in practice by a registered optometrist
Pheniramine; for ophthalmic use except when sold in practice by a registered optometrist; for oral use
in medicines for adults and 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 pheniramine or when at least one of the other therapeutically active substances is a sympathomimetic decongestant
Propamidine; for ophthalmic use except when sold in practice by a registered optometrist
*Ranitidine; in medicines which have received the
consent of the Minister or the Director-General to their distribution as pharmacy-only medicines and which
are sold in the manufacturer’s original pack containing not more than 14 days’ supply; except in medicines containing not more than 150 milligrams per dose unit which have received the consent of the Minister or the Director-General to their distribution as general sale medicines and which are sold in the manufacturer’s original pack containing not more than 7 days’ supply
Pyrethrins; in medicines containing more than 10%
Sodium cromoglycate; for nasal use; for ophthalmic use except when sold in practice by a registered optometrist
Tetrahydrazoline; except for ophthalmic use when sold in practice by a registered optometrist
Xylometazoline; except for nasal use when sold at an airport; except for ophthalmic use when sold in practice by a registered optometrist
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.
Aspirin; except when specified in the First Schedule to the Medicines Regulations 1984
Boron including borax and boric acid; in medicines for internal use containing 6 milligrams or less per recommended daily dose; for dermal use other than paediatric use in medicines containing 0.35% or less; when present as an excipient
Nicotinamide
Nicotinic acid; in medicines containing 100 milligrams or less per dose form
Octocog alfa
Perflutren
Polysulfated glycosaminoglycans; except in injections other than intraocular viscoelastic products
Pyrethrins; in medicines containing 10% or less
*Ranitidine; in medicines containing not more than 150 milligrams per dose unit which have received the consent of the Minister or the Director-General to their distribution as general sale medicines and which are
sold in the manufacturer’s original pack containing not more than 7 days’ supply
*Zinc; for external use except in medicines containing more than 5% of zinc chloride; for internal use in medicines containing 25 milligrams or less per recommended
daily dose; for internal use in medicines containing
50 milligrams or less and more than 25 milligrams
per recommended daily dose in packs which have received the consent of the Minister or the
Director-General to their distribution as general sale medicines and which are sold in the manufacturer’s original pack and when labelled with a statement that
the product may be dangerous if taken in large amounts or for long periods; in parenteral nutrition replacement preparations
*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 April 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate.