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

Melatonin; except when supplied in medicines for oral use containing 3mg or less per immediate release dose unit, or 2mg or less per modified release dose unit, when sold in the manufacturers original pack that has received consent from the Minister of Health or the Director General for the treatment of primary insomnia for adults aged 55 years or older for up to 13 weeks by a registered pharmacist; except when specified elsewhere in this schedule.

Schedule 3

Pharmacy-only Medicines

Melatonin; when supplied in medicines for oral use in immediate release preparations containing 5mg or less per dose unit for the treatment of jet lag in adults aged 18 or over, containing not more than 10 days’ supply, in the manufacturers original pack that has received consent from the Minister or Director-General for sale as a pharmacy only medicine; when supplied in medicines for oral use containing 3mg or less per immediate release dose unit, or 2mg or less per modified release dose unit, for the treatment of primary insomnia for adults aged 18 years or older, containing not more than 30 days’ supply, in the manufacturers original pack that has received consent from the Minister or Director-General.

Dated this 9th day of October 2025.

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