Note: See sections 16 and 31, subsections 54(2) and 57(1) and section 59.
ADAPALENE in topical preparations containing 0.1% or less of adapalene for the treatment of acne vulgaris in adults and in children over 12 years of age.
ADRENALINE in preparations containing 1% or less of adrenaline except in preparations containing 0.02% or less of adrenaline unless packed and labelled for injection.
ALCLOMETASONE as the only therapeutically active substance in preparations for dermal use containing 0.05% or less of alclometasone in packs containing 30 g or less of the preparation.
ALIMEMAZINE:
(a) in solid oral preparations except when included in Schedule 2; or
(b) in liquid oral preparations containing 10 mg or less of alimemazine per 5 mL;
AMINOPHYLLINE in liquid oral preparations containing 2% or less of aminophylline.
AMYL NITRITE when in preparations for human therapeutic use and packaged in containers with child‑resistant closures.
ASTODRIMER SODIUM except in a condom lubricant.
AZATADINE in oral preparations.
BILASTINE in divided oral preparations containing 20 mg or less of bilastine for the treatment of adults and adolescents 12 years of age and older.
BROMPHENIRAMINE in oral preparations except:
BUCLIZINE in oral preparations.
BUTOCONAZOLE in preparations for vaginal use.
CANNABIDIOL in oral, oromucosal and sublingual preparations included in the Register when:
(a) the cannabidiol is either plant derived or, when synthetic, only contains the (‑)‑CBD enantiomer; and
(b) the cannabidiol comprises 98% or more of the total cannabinoid content of the preparation; and
(c) any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the preparation and of which tetrahydrocannabinol (THC) can only comprise 1% of the total cannabinoid content; and
(d) the maximum recommended daily dose is 150 mg or less of cannabidiol; and
(e) packed in blister or strip packaging or in a container fitted with a child‑resistant closure; and
(f) in packs containing not more than 30 days’ supply; and
(g) for persons aged 18 years and over.
CELECOXIB in tablets or capsules each containing 200 mg or less of celecoxib, in a primary pack containing not more than 10 dosage units for the short‑term treatment of acute pain due to primary dysmenorrhea or musculoskeletal or soft tissue injuries in adutlts.
CHLORAMPHENICOL for ophthalmic use only.
CHLORBUTANOL in preparations for human use except:
(b) in preparations containing 0.5% or less of chlorbutanol.
CHLORPHENAMINE in oral preparations except:
CICLOPIROX in preparations for dermal use and for application to the nails except:
CIMETIDINE in a primary pack containing not more than 14 days’ supply.
CLEMASTINE in preparations for oral use.
CLOBETASONE (clobetasone‑17‑butyrate) as the only therapeutically active substance in preparations for dermal use containing 0.05% or less of clobetasone in packs containing 30 g or less of the preparation.
CLOTRIMAZOLE in preparations for vaginal use.
CYCLIZINE in divided preparations for oral use in primary packs containing 6 dosage units or less.
CYPROHEPTADINE in oral preparations.
DEXCHLORPHENAMINE in oral preparations except:
DICLOFENAC in divided preparations for oral use containing 25 mg or less of diclofenac per dosage unit in a pack containing 30 or less dosage units except when included in Schedule 2.
DIHYDROCODEINE when indicated for cough suppression and compounded with one or more other therapeutically active substances:
(a) in divided preparations containing 10 mg or less of dihydrocodeine per dosage unit and with a recommended dose not exceeding 15 mg of dihydrocodeine; or
(b) in undivided preparations containing 0.25% or less of dihydrocodeine with a recommended dose not exceeding 15 mg of dihydrocodeine.
DIIODOHYDROXYQUINOLINE (iodoquinol) for vaginal use.
DIMENHYDRINATE in oral preparations except when included in Schedule 2.
DIMETHINDENE in oral preparations.
DIPHENHYDRAMINE in oral preparations except:
DIPHENOXYLATE in packs of 8 or less dosage units, each dosage unit containing 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1% of the dose of diphenoxylate.
DITHRANOL for therapeutic use.
DOXYLAMINE in oral preparations except:
ECONAZOLE in preparations for vaginal use.
ELETRIPTAN for oral use in tablets containing 40 mg or less per tablet and when in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well‑established pattern of symptoms.
ERYTHRITYL TETRANITRATE for therapeutic use.
FAMCICLOVIR for oral use, in divided preparations containing a total dose of 1500 mg or less of famciclovir for the treatment of herpes labialis (cold sores).
FLAVOXATE.
FLUCONAZOLE in single‑dose oral preparations containing 150 mg or less of fluconazole for the treatment of vaginal candidiasis.
FLUORIDES for human topical use:
(a) in liquid preparations containing 5500 mg/kg or less of fluoride ion, in a container with a child‑resistant closure except when included in or expressly excluded from Schedule 2; or
(b) in non‑liquid preparations containing 5500 mg/kg or less of fluoride ion except:
(i) in preparations for therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, compliant with the requirements of the required advisory statements for medicine labels; or
(ii) in preparations for non‑therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, labelled with warnings to the following effect:
(A) Do not swallow; and
(B) Do not use [this product/name of product] in children six years of age or less; or
(iii) in preparations for supply to registered dental professionals or by approval of an appropriate authority.
GLUCAGON.
GLYCERYL TRINITRATE:
(a) in preparations for oral use; or
(b) in preparations for rectal use.
GLYCOPYRRONIUM except when included in Schedule 4.
HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 1% or less of hydrocortisone:
(a) for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
(b) for dermal use, in packs containing 2 g or less of such preparations, containing no other therapeutically active constituent other than aciclovir (5% w/w or less) in adults and adolescents (12 years of age and older); or
(c) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:
(i) in undivided preparations, in packs of 35 g or less; or
(ii) in packs containing 12 or less suppositories;
HYOSCINE BUTYLBROMIDE in undivided preparations for oral use with a recommended single dose not exceeding 20 mg of hyoscine butylbromide in a pack containing 100 mg or less of hyoscine butylbromide when labelled for adults and children 6 years and over.
IBUPROFEN when:
(a) either:
(i) in divided preparations, each containing 400 mg or less of ibuprofen, in a primary pack containing not more than 50 dosage units; or
(ii) in a modified release dosage form, each containing 600 mg of ibuprofen, in a primary pack containing not more than 32 dosage units; and
(b) labelled:
(i) with a recommended daily dose of 1200 mg or less of ibuprofen; and
(ii) not for the treatment of children under 12 years;
(c) included in Schedule 2; or
(d) in preparations for oral use that are labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided preparations, each containing 200 mg or less of ibuprofen, in a pack containing not more than 100 dosage units when:
(i) ibuprofen is the only therapeutically active constitutent, other than phenylephrine or when combined with an effervescent agent; and
(ii) packed in a blister or strip packaging or in a container with a child-resistant closure; and
(v) not labelled for the treatment of children 6 years or under; and
(vi) when combined with phenylephrine—not labelled for the treatment of children under 12 years.
INOSITOL NICOTINATE.
ISOCONAZOLE in preparations for vaginal use.
ISOSORBIDE DINITRATE in oral preparations containing 10 mg or less of isosorbide dinitrate per dosage unit.
KETOPROFEN in divided preparations for oral use containing 25 mg or less of ketoprofen per dosage unit in a pack containing 30 or less dosage units.
LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2.
LEVONORGESTREL for emergency post‑coital contraception.
MACROGOLS in preparations for oral use for bowel cleansing prior to diagnostic, medical or surgical procedures.
MAGNESIUM SULFATE for human therapeutic use in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose.
MALATHION in preparations for human external use except in preparations containing 2% or less of malathion.
MANNITYL HEXANITRATE for therapeutic use.
MELATONIN in:
(a) modified release tablets containing 2 mg or less of melatonin for monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep for adults aged 55 or over, in packs containing not more than 30 tablets; or
(b) immediate release preparations containing 5 mg or less of melatonin for the treatment of jet lag in adults 18 years and over, in a primary pack containing no more than 10 dosage units.
MEPYRAMINE in oral preparations.
METHDILAZINE in oral preparations.
METOCLOPRAMIDE when combined with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with migraine, in packs containing not more than 10 dosage units.
MICONAZOLE for human use in topical preparations:
(a) for the treatment of oral candidiasis; or
(b) for vaginal use.
MOMETASONE as the only therapeutically active substance in preparations for dermal use containing 0.1% or less of mometasone in packs containing 15 g or less.
NALOXONE when used for the treatment of opioid overdose.
NAPROXEN in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age.
NICOTINIC ACID for human therapeutic use in divided preparations containing 250 mg or less of nicotinic acid per dosage unit except:
(a) in preparations containing 100 mg or less of nicotinic acid per dosage unit; or
(b) nicotinamide.
NICOTINYL ALCOHOL except in preparations containing 100 mg or less of nicotinyl alcohol per dosage unit.
NYSTATIN in preparations for topical use except when included in Schedule 2.
OMEPRAZOLE in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2.
ORLISTAT in oral preparations for weight‑control purposes containing 120 mg or less of orlistat per dosage unit.
OXICONAZOLE in preparations for vaginal use.
PANTOPRAZOLE in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2.
PARACETAMOL:
(a) when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2; or
(b) in modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing not more than 100 tablets or capsules; or
(c) in modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine and labelled “For dispensing only” and “This pack is not to be supplied to a patient”; or
(d) in liquid preparations for oral use except when in Schedule 2.
PHENIRAMINE in oral preparations except:
PODOPHYLLOTOXIN in preparations containing 1% or less of podophyllotoxin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.
PODOPHYLLUM EMODI (podophyllin) in preparations containing 20% or less of podophyllin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.
PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 20% or less of podophyllin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.
PROCHLORPERAZINE in divided preparations for oral use in packs containing not more than 10 dosage units for the treatment of nausea associated with migraine.
PROMETHAZINE in oral preparations except:
(b) in preparations for the treatment of children under 2 years of age.
PSEUDOEPHEDRINE (other than preparations for stimulant, appetite suppression or weight‑control purposes) when supplied in a primary pack:
(a) in liquid preparations containing 800 mg or less of pseudoephedrine hydrochloride (or its equivalent); or
(b) in other preparations containing 720 mg or less of pseudoephedrine hydrochloride (or its equivalent).
RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2.
RIZATRIPTAN when in divided oral preparations containing 5 mg or less per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well‑established pattern of migraine symptoms.
SALBUTAMOL as the only therapeutically active substance:
(a) in metered aerosols delivering 100 micrograms or less of salbutamol per metered dose; or
(b) in dry powders for inhalation delivering 200 micrograms or less of salbutamol per dose.
SALICYLIC ACID in preparations for dermal use except in preparations containing 40% or less of salicylic acid.
SANTONIN.
SODIUM PHOSPHATE in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures.
SODIUM PICOSULFATE in preparations for oral use for bowel cleansing prior to diagnostic medical or surgical procedures.
SULFACETAMIDE in preparations for ophthalmic use containing 10% or less of sulfacetamide.
SUMATRIPTAN when in divided oral preparations containing 50 mg or less per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well‑established pattern of symptoms.
TERBUTALINE as the only therapeutically active substance:
(a) in metered aerosols delivering 250 micrograms or less of terbutaline per metered dose; or
(b) in dry powders for inhalation delivering 500 micrograms or less of terbutaline per dose.
THEOPHYLLINE in liquid oral preparations containing 2% or less of theophylline.
TIOCONAZOLE in preparations for vaginal use.
TRIAMCINOLONE for buccal use in preparations containing 0.1% or less of triamcinolone in a pack of 5 g or less.
TRIPROLIDINE in oral preparations except:
ULIPRISTAL for emergency post‑coital contraception.
VITAMIN D for human internal therapeutic use in preparations containing 175 micrograms or less of vitamin D per recommended single weekly dose except in preparations containing 25 micrograms or less of vitamin D per recommended daily dose.
ZOLMITRIPTAN when in divided oral preparations containing 2.5 mg or less per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well‑established pattern of symptoms.