Pursuant to section 106(1) of the Medicines Act 1981,
I, Janice Wilson, Deputy Director-General, Population Health Directorate, Ministry of Health, acting under delegated authority, hereby declare the following:
1. The medicine listed in Schedule 2 to this notice is classified as a restricted medicine.
2. The medicine listed in Schedule 3 to this notice is classified as a pharmacy-only medicine.
This notice shall come into force on 4 October 2010.
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 2
Restricted Medicine
Codeine; in medicines for oral use, containing not more than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, when combined with one or more active ingredients, in such a way that the substance cannot be recovered by readily applicable means or in a yield which would constitute a risk to health, for use
as an analgesic and when sold in a pack of not more than five days’ supply, approved by the Minister or the Director-General for distribution as a restricted medicine.
Schedule 3
Pharmacy-only Medicine
Codeine; in medicines for oral use, containing not more than 15 milligrams of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 milligrams of codeine, when combined with one or more active ingredients, in such a way that the substance cannot be recovered by readily applicable means or in a yield which would constitute a risk to health, for the treatment of the symptoms of cough and cold and when sold in a pack of not more than six days’ supply, approved by the Minister or the Director-General for distribution as a pharmacy-only medicine.
Dated this 22nd day of September 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health.