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.

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

Nitrofurantoin; except when supplied for oral use containing 100 mg per dose unit when sold in a pack of 10 solid dosage units to a woman aged 16-65 years for the first-line empiric treatment of an uncomplicated urinary tract infection by a registered pharmacist who has successfully completed the Pharmaceutical Society of New Zealand training in the treatment of urinary tract infections.

Naloxone; except when supplied as ampoules with needles and syringes, or as a prefilled syringe, by those enabled to do so under the Health (Needles and Syringes) Regulations 1998 for the treatment of opioid overdose, and when supplied with instructions for use.

Levomefolic acid; for injection.

Amivantamab

Glu-urea-Lys(ahx)-hbed-CC

Icosapent ethyl

Zanubrutinib

Faricimab

Ciltacabtagene autoleucel

Belumosudil

Estetrol monohydrate

Finerenone

Fostemsavir

Inclisiran

Pegcetacoplan

Pegvaliase

Sacituzumab govitecan

Trastuzumab deruxtecan

Vericiguat

Bufexamac

Schedule 2

Pharmacy-only Medicines

Folic acid: For oral use in medicines containing more than 500 micrograms per recommended daily dose. When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose.

Folinic acid: For oral use in medicines containing more than 500 micrograms per recommended daily dose. When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose.

Levomefolic acid; for oral use in medicines containing more than 500 micrograms per recommended daily dose. When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose.

Dated this 13th day of October 2022.

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