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:

  1. preparations and admixtures containing any proportion of any substance listed in the notice.
  2. salts and esters of any substance listed in the notice.
  3. preparations or extracts of biological materials listed in the notice.
  4. salts or oxides of elements listed in the notice.

Unless specific reference is made otherwise, every reference to a medicine applies:

  1. if the medicine is in an injection or eye preparation, to any concentration of that medicine; and
  2. 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

Alectinib

Amifampridine

AOD-9604

Artesunate

Asunaprevir

Benzbromarone

Benzydamine; except for oromucosal or topical use

Cholic acid

CJC-1295

Daclatasvir

Defibrotide

Elbasvir

Felbamate

Flunarizine

Grazoprevir

Growth Hormone Releasing Peptide-6

Growth Hormone Releasing Hormones

Growth Hormone Releasing Peptides

Idebenone

Influenza vaccine; except when administered to a person 13 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

Lesinurad

Levomilnacipran

Methylhexanamine (1,3-dimethylamylamine (DMAA)); except when present as an unmodified, naturally occurring medicine

Milnacipran

Naloxegol

Netupitant

Nitazoxanide

Nivolumab

Pentostatin

Ponatinib

Picibanil

Pralmorelin

Ranitidine; except when specified elsewhere in this schedule; except in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than seven days’ supply

Rufinamide

Sargramostim

Stiripentol

Steptozocin

Sunifiram

Tizanidine

Trientine

Ulipristal

Schedule 2

Restricted Medicines

Cyclizine; for oral use other than in medicines used for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than six dosage units; for oral use in medicines used for the treatment of anxiety or insomnia when sold in the manufacturer’s original pack containing not more than 10 dosage units

Schedule 3

Pharmacy-only Medicines

Ranitidine; in medicines for the symptomatic relief of heartburn, dyspepsia and hyperacidity or to be used on the recommendation of a registered medical practitioner when sold in the manufacturer’s original pack containing not more than 14 days’ supply; except in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than seven days’ supply

Medicines for General Sale

Please note that the following medicines are now available for general sale.

Benzydamine; for oromucosal or topical use

Ranitidine; in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than seven days’ supply

Dated this 22nd day of February 2016.

DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health.