Notice Type
Departmental
Notice Title

Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981,
I, Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health, 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
Aclidinium bromide
Amyl nitrite; except when sold to a person who holds a controlled substances licence (issued under section
95B of the Hazardous Substances and New Organisms Act 1996) authorising the person to possess cyanide; except when sold to an exempt laboratory covered by
a Hazardous Substances and New Organisms Act 1996 approved code of practice
Articaine; except when used as a local anaesthetic in practice by a dental therapist registered with the Dental Council
Bendamustine hydrochloride
Besifloxacin hydrochloride
Crizotinib
Dabrafenib mesilate
Diphtheria, tetanus and pertussis (acellular, component) vaccine; except when administered in a single dose
to a person 18 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health
Enobosarm
Ghrelin
Hexarelin
Human growth hormone secretagogues
Insulin-like growth factors; except where specified elsewhere in the schedule
Ipamorelin
Loteprednol etabonate
Melanocyte stimulating compounds
Meningococcal vaccine; except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who
is complying with the immunisation standards of the Ministry of Health
Obinutuzumab
Ocriplasmin
Pralatrexate
Regorafenib
Ruxolitnib
Selective androgen receptor modulators
Sofosbuvir
Tesamorelin
Umeclidinium bromide
Vandetanib
Zoster immunoglobin, human; except when administered
to a person 50 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health
Schedule 2
Restricted Medicines
Hyoscine butylbromide; for oral use in medicines containing not more than 20 milligrams per dose form and in packs containing not more than 10 tablets or capsules for the relief of muscle spasm of the gastrointestinal tract
Medicines for General Sale
Please note that the following medicines are now available for general sale.
Mepyramine; for external use in medicines containing 2% or less in packs not exceeding 25 grams.
Dated this 30th day of January 2014.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health.