Document ID: chunk:federal_register_of_legislation:F2025L00049:schedule:3:p5
Version: federal_register_of_legislation:F2025L00049
Segment Type: schedule
Provision Reference: sch 3 (pt 5/8)
Character Range: 171253–174059

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.
NARATRIPTAN when in divided oral preparations containing 2.5 mg or less of naratriptan 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.
NICOTINE in therapeutic vaping goods (within the meaning of the Therapeutic Goods Regulations 1990) in final dosage form for smoking cessation or the management of nicotine dependence when:
 (a) for supply to persons aged 18 years and over; and
 (b) the pharmacist requests and sights evidence of the patient's identity and age; and
 (c) the pharmacist provides professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines; and
 (d) the pharmacist provides contact details about smoking cessation support services to the patient; and
 (e) the quantity of the goods does not exceed the quantity that is reasonably required for a patient's therapeutic use for 1 month and that quantity is supplied to the patient only once in a month; and
 (f) the concentration of nicotine in the goods does not exceed 20 mg/mL; and
 except:
 (g) in preparations for oromucosal or transdermal administration for human therapeutic use when included in the Register as an aid in withdrawal either from tobacco smoking or nicotine vaping; or
 (h) in tobacco prepared and packed for smoking.
NICOTINIC