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, 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.
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
Armodafinil
Artesunate
Articaine; except when used as a local anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council
Asfotase alfa
Asunaprevir
Atezolizumab
Azelastine; except when specified elsewhere in this notice
Bedaquiline
Benzbromarone
Benzodiazepine derivatives; except when specified elsewhere in this notice
Benzodiazepines; except when specified elsewhere in this notice
Benzydamine; except for oromucosal or topical use
Betaine; for the treatment of homocystinuria
Bifonazole; except when specified elsewhere in this notice
Bilastine; except when specified elsewhere in this notice
Bosutinib
Brentuximab vedotin
Brivaracetam (and its stereoisomers)
Carfilzomib
Carglumic acid
Cebaracetam (and its stereoisomers)
Cholic acid
CJC-1295
Cobimetinib
Coluracetam
Daclatasvir
Daratumumab
Defibrotide
Deoxycholic acid; for injection
Dermatophagoides farinae
Dermatophagoides pteronyssinus
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 manufacturer’s original pack that has received the consent of the Minister or Director-General to their distribution as medicines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme
Di-iodohydroxy quinoline; except when specified elsewhere in this notice
Dimiracetam (and its stereoisomers)
Diphtheria, tetanus and pertussis (acellular, component) vaccine; except when administered in a single dose to a person 18 years of age or over or to a pregnant woman aged 13 years and 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
Doliracetam (and its stereoisomers)
Dupracetam
Elbasvir
Elosulfase alfa
Elotuzumab
Eluxadoline
Esomeprazole; except when specified elsewhere in this notice
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 manufacturer’s original pack that has received the consent of the Minister or Director-General to their distribution as medicines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme
Etiracetam
Fasoracetam (and its stereoisomers)
Felbamate
Felypressin; except when combined with a local anaesthetic and used in practice by a dental therapist or oral health therapist registered with the Dental Council
Fibroblast growth factors
Flubromazolam
Flunarizine
Follitropin delta
Fomepizole
Fonturacetam (and its stereoisomers)
Glecaprevir
Grazoprevir
Growth Hormone Releasing Hormones
Growth Hormone Releasing Peptide-6
Growth Hormone Releasing Peptides
Hexyl aminolevulinate
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
Ixazomib
Ixekizumab
Ketoprofen; except when specified elsewhere in this notice
Lenvatinib
Lesinurad
Levomilnacipran
Levonorgestrel; except when specified elsewhere in this notice; 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 manufacturer’s original pack that has received the consent of the Minister or Director-General to their distribution as medicines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme
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 by a dental therapist or oral health therapist registered with the Dental Council; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; for oral use except in throat lozenges in medicines containing 30 milligrams or less per dose form; for external use in medicines containing more than 10%; except in throat sprays in medicines containing 2% or less; except when specified elsewhere in this notice
Lipegfilgrastim
Lisdexamfetamine
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 10 days’ supply
Lumacaftor
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)
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 manufacturer’s original pack that has received the consent of the Minister or Director-General to their distribution as medicines, containing not more than 6 months’ supply by a registered pharmacist who has successfully completed the approved training programme
Ocrelizumab
Olaparib
Osimertinib
Otilonium bromide
Oxiracetam (and its stereoisomers)
Palbociclib
Paritaprevir
Pegaspargase
Peginterferon beta-1a
Pembrolizumab
Pentostatin
Phleum pratense extract
Pibrentasvir
Picibanil
Piperacetam
Pirfenidone
Ponatinib
Pralmorelin
Pramiracetam
Prilocaine; for injection except when used as a local anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council; except when specified elsewhere in this notice
Ranitidine; except when specified elsewhere in this notice; except in medicines containing 300 milligrams or less per dose unit when sold in the manufacturer’s original pack containing not more than 7 days’ supply
Ramucirumab
Ranolazine
Recombinant human Epidermal Growth Factor
Rolipram (and its stereoisomers)
Rolziracetam
Rufinamide
Sacubitril
Sargramostim
Sarilumab
Secukinumab
Seletracetam (and its stereoisomers)
Sodium phenylbutyrate
Sodium zirconium cyclosilicate
Sonidegib
Stiripentol
Streptozocin
Sunifiram
Suvorexant
Talimogene laherparepvec
TB-500
Thymosin beta-4
Tizanidine
Tofacitinib
Trientine
Ulipristal
Velpatasvir
Venetoclax
Vorapaxar
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 6 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 10 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
Levonorgestrel; in medicines for use as emergency post-coital contraception when in packs containing not more than 1.5 milligrams except when sold by nurses recognised by their professional body as having competency in the field of sexual and reproductive health
Azelastine; in preparations for nasal use containing 0.15% azelastine hydrochloride or less; in topical eye preparations containing 0.05% or less
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
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 7 dosage units
Lignocaine; for urethral use; for external use in medicines containing 10% or less and more than 2%
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 10 days’ supply
Macrogols; in preparations for oral use as a liquid concentrate for laxative use
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
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 7 days’ supply
Please note that the following medicines are now available for general sale.
Albutrepenonacog alfa
Benzydamine; for oromucosal or topical use
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
Efmoroctocog alfa
Lignocaine; in throat lozenges in medicines containing 30 milligrams or less per dose form; for external use in medicines containing 2% or less; in throat sprays in medicines containing 2% or less
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 10 days’ supply
Rurioctocog alfa pegol
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 7 days’ supply
Dated this 27th day of July 2017.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health.