Pursuant to section 106(1) of the Medicines Act 1981,
I, Mark Richards, Acting 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.
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
Agomelatine
Alpha1-proteinase inhibitor
Cadmium
Dapoxetine
Etravirine
Idursulfase
Iron; for injection except in parenteral nutrition replacement preparations
Lenalidomide
Maraviroc
Miglustat
Panitumumab
Sugammadex
Tocilizumab
Zonisamide
Schedule 3
Pharmacy-only Medicines
Iron; for oral use either in medicines containing more
than 24 milligrams per recommended daily dose or
in medicines containing more than 5 milligrams per recommended daily dose and more than 750 milligrams of iron per pack; except in parenteral nutrition replacement preparations
Potassium; for internal use: in slow release or enteric coated forms; in medicines containing more than 100 milligrams per recommended dose except in medicines for oral rehydration therapy, parenteral nutrition replacement, dialysis; except in glucosamine sulfate complexed products containing 600 milligrams or less of potassium chloride per recommended dose
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.
Iron; for oral use in packs containing 24 milligrams or
less per recommended daily dose either in medicines containing not more that 5 milligrams per dose unit or
in medicines containing more than 5 milligrams per
dose unit and in packs containing not more than 750 milligrams of iron; in parenteral nutrition replacement preparations
Potassium; for external use; for internal use in medicines containing 100 milligrams or less per recommended
dose except in glucosamine sulfate complexed products containing 600 milligrams or less of potassium chloride per recommended dose; for oral rehydration therapy, parenteral nutrition replacement or dialysis
Dated this 26th day of September 2008.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate.