Classification of Medicines
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:
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:
Unless specific reference is made otherwise, every reference to a medicine applies:
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.