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 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

Adapalene; except in medicines containing 1 milligram or less per millilitre or gram and when supplied by a pharmacist in a pack containing not more than 30 grams for the treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back

Alectinib

Alirocumab

Aloracetam

Amifampridine

Aniracetam

AOD-9604

Apremilast

Artesunate

Asunaprevir

Azelastine; except when specified elsewhere in this notice

Bedaquiline

Benzbromarone

Benzydamine; except for oromucosal or topical use

Bilastine; except when specified elsewhere in this notice

Bosutinib

Brentuximab vedotin

Brivaracetam (and its stereoisomers)

Carglumic acid

Cebaracetam (and its stereoisomers)

Cholic acid

CJC-1295

Cobimetinib

Coluracetam

Daclatasvir

Defibrotide

Dimiracetam (and its stereoisomers)

Doliracetam (and its stereoisomers)

Dupracetam

Elbasvir

Elosulfase alfa

Esomeprazole; except when specified elsewhere in this schedule

Etiracetam

Fasoracetam (and its stereoisomers)

Felbamate

Flunarizine

Fomepizole

Fonturacetam (and its stereoisomers)

Grazoprevir

Growth Hormone Releasing Hormones

Growth Hormone Releasing Peptide-6

Growth Hormone Releasing Peptides

Idarucizumab

Idebenone

Idelalisib

Imuracetam

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

Ketoprofen; except when specified elsewhere in this notice

Lesinurad

Levomilnacipran

Lignocaine; for injection except when used as a local anaesthetic in practice by a nurse whose scope of practice permits the performance of general nursing functions or by a podiatrist registered with the Podiatry Board or dental therapist registered with the Dental Council; for oral use; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except when specified elsewhere in this schedule; except for external use and in throat sprays in medicines containing 2% or less; in throat lozenges in medicines containing 30 milligrams or less per dose form

Loratadine; except when specified elsewhere in this schedule; except in divided solid dosage forms for oral use containing 10 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than ten days’ supply

Mepolizumab

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

Milnacipran

Molracetam

Naloxegol

Naloxone; except when provided as part of an approved emergency kit for the treatment of opioid overdose

Nebracetam (and its stereoisomers)

Nefiracetam

Nepidermin

Netupitant

Nicoracetam

Nitazoxanide

Nivolumab

Noopept (and its stereoisomers)

Olaparib

Otilonium bromide

Oxiracetam (and its stereoisomers)

Paritaprevir

Peginterferon beta-1a

Pembrolizumab

Pentostatin

Picibanil

Piperacetam

Pirfenidone

Ponatinib

Pralmorelin

Pramiracetam

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

Ramucirumab

Ranolazine

Recombinant human Epidermal Growth Factor

Rolipram (and its stereoisomers)

Rolziracetam

Rufinamide

Sacubitril

Sargramostim

Secukinumab

Seletracetam (and its stereoisomers)

Sodium phenylbutyrate

Stiripentol

Streptozocin

Sunifiram

Suvorexant

Tizanidine

Trientine

Ulipristal

Velpatasvir

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 ten dosage units

Ketoprofen; in solid dose form containing 25 milligrams or less per dose form in packs of not more than 30 capsules or tablets

Schedule 3

Pharmacy-only Medicines

Azelastine; in preparations for nasal use containing 0.15% azelastine hydrochloride or less; in topical eye preparations containing 0.05% or less

Bilastine; in divided solid dosage forms for oral use containing 20 milligrams or less for the treatment of the symptoms of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria when sold in a pack containing not more than 30 dosage units

Esomeprazole; in divided solid dosage forms for oral use containing 20 milligrams or less with a maximum daily dose of 20 milligrams for the short-term symptomatic relief of gastro-oesophageal reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer’s original pack containing not more than seven dosage units

Loratadine; for oral use; except in divided solid dosage forms for oral use containing 10 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing not more than ten days’ supply

Macrogols; in preparations for oral use as a liquid concentrate for laxative use

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

Efmoroctocog alfa

Lignocaine; for external use and in throat sprays in medicines containing 2% or less; in throat lozenges in medicines containing 30 milligrams or less per dose form

Loratadine; in divided solid dosage forms for oral use containing 10 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer’s original pack containing not more than ten days’ supply

Simoctocog alfa

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 7th day of February 2017.

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