Notice Title

Classification of Medicines

Publication Date
29 Aug 2025

Tags

Medicines Act Classification of medicines Health

Notice Number

2025-go4844
Title
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Pursuant to section 106(1) of the Medicines Act 1981, I, Chris James, Group Manager, Medsafe, 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.

In accordance with section 106(2) of the Act, to the extent that any part of this notice is inconsistent with any provisions of any regulations made under section 105(1)(j) of the Act, the provisions in those regulations cease to have effect while this notice remains in force.

Schedule 1

Prescription Medicines

Abrocitinib

Allopurinol; except when provided for the prophylaxis of gout to people who meet the clinical and eligibility criteria of an approved training program, when provided by pharmacists who meet the requirements of the Pharmacy Council and the Pharmaceutical Society of New Zealand Incorporated training programme, for a maximum of 3 months’ supply

Bulevirtide

Elranatamab

Empagliflozin

Epcoritamab

Etranacogene dezaparvovec

Etrasimod

Fezolinetant

Foscarbidopa

Foslevodopa

Glucagon-like peptide-1 receptor agonists

Inavolisib

Lebrikizumab

Lecanemab

Maribavir

Momelotinib dihydrochloride

Naratriptan; except when included elsewhere in this Schedule

Nelarabine

Recombinant varicella zoster virus glycoprotein E; except when administered for the prevention of herpes zoster (shingles) to a person 50 years of age or over, or a person aged 18 to 49 years at increased risk of herpes zoster, by a registered pharmacist who has successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who comply with the immunisation standards of the Ministry of Health.

Rimegepant

Tebentafusp

Zilucoplan

Schedule 2

Restricted Medicines

Cytisine; in divided oral and oromucosal preparations as an aid in withdrawal from nicotine dependence in adults

Naratriptan; when divided in oral preparations containing 2.5 milligrams or less of naratriptan per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms

Dated this 25th day of August 2025.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health.