Pursuant to section 106(1) of the Medicines Act 1981, I, Chris James, Group Manager, Medsafe, Ministry of Health, acting under delegated authority since 11 September 2013, 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 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

Alirocumab

Armodafinil

Asfotase alfa

Atezolizumab

Betaine; for the treatment of homocystinuria

Bifonazole; except when specified elsewhere in this Schedule

Desogestrel; except when supplied for oral contraception to women who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand approved training programme on oral contraception when sold in the Medsafe approved manufacturer’s original pack containing not more than six months’ supply by a registered pharmacist who has successfully completed the approved training programme

Di-iodohydroxyquinoline

Ethinyloestradiol; except when supplied at a strength of 35 micrograms or less in combination with either levonorgestrel or norethisterone for oral contraception to women who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand approved training programme on oral contraception when sold in the Medsafe approved manufacturer’s original pack containing not more than six months’ supply by a registered pharmacist who has successfully completed the approved training programme

Flubromazolam

Follitropin delta

Hexyl aminolevulinate

Ixekizumab

Levonorgestrel; except when specified elsewhere in this Schedule; except in medicines for use as emergency post-coital contraception when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health; except when supplied for oral contraception to women who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand approved training programme on oral contraception when sold in the Medsafe approved manufacturer’s original pack containing not more than six months’ supply by a registered pharmacist who has successfully completed the approved training programme

Norethisterone; except when supplied for oral contraception to women who meet the clinical and eligibility criteria of the Pharmacy Council and the Pharmaceutical Society of New Zealand approved training programme on oral contraception when sold in the Medsafe approved manufacturer’s original pack containing not more than six months’ supply by a registered pharmacist who has successfully completed the approved training programme

Ocrelizumab

Osimertinib

Phleum pratense extract

Tofacitinib

Velpatasvir

Vorapaxar

Schedule 3

Pharmacy-only Medicines

Bifonazole; for dermal use; except for dermal use in medicines for tinea pedis only or in shampoos containing 1% or less or when sold in practice by a podiatrist registered with the Podiatrists Board

Paracetamol; in liquid form; in suppositories; in tablets or capsules containing 500 milligrams or less and in packs containing more than 10 grams and not more than 50 grams; in slow-release forms containing 665 milligrams or less and more than 500 milligrams; in powder form containing not more than 1 gram per sachet and more than 10 grams per pack

Medicines for General Sale

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

Albutrepenonacog alfa

Bifonazole; for dermal use in medicines for tinea pedis only or in shampoos containing 1% or less or when sold in practice by a podiatrist registered with the Podiatrists Board

Deoxycholic acid; for oral use

Rurioctocog alfa pegol

Dated this 6th day of March 2017.

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