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:

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.

In accordance with section 106(2) of the Act, to the extent that any part of this notice is inconsistent with any provisions of any regulations made under section 105(1)(j) of the Act, the provisions in those regulations cease to have effect while this notice remains in force.

Schedule 1

Prescription Medicines

Brompheniramine; except when specified elsewhere in this schedule.

Chlorpheniramine; except when specified elsewhere in this schedule.

Cyclizine; except when specified elsewhere in this schedule.

Dexchlorpheniramine; except when specified elsewhere in this schedule.

Diphenhydramine; except when specified elsewhere in this schedule.

Doxylamine; except when specified elsewhere in this schedule.

Meclozine; except when specified elsewhere in this schedule.

Mepyramine; except when specified elsewhere in this schedule.

Nirsevimab

Olopatadine; except when specified elsewhere in this schedule.

Palovarotene

Pheniramine; except when specified elsewhere in this schedule.

Promethazine; except when specified elsewhere in this schedule.

Schedule 2

Restricted Medicines

Brompheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; For oral use for sedation in adults only when sold in the manufacturer’s original pack.

Chlorpheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; For oral use for sedation in adults only when sold in the manufacturer’s original pack.

Cyclizine; for oral use in medicines for adults or children over 2 years of age other than in medicines for the treatment of 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 insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; for oral use for sedation in adults only when sold in the manufacturer’s original pack containing not more than 6 dosage units.

Dexchlorpheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; For oral use for sedation in adults only when sold in the manufacturer’s original pack.

Diphenhydramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; For oral use for sedation in adults only when sold in the manufacturer’s original pack.

Doxylamine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; For oral use for sedation in adults only when sold in the manufacturer’s original pack.

Meclozine; for oral use for the treatment of insomnia in adults and children over 12 years of age when sold in the manufacturer’s original pack containing not more than 10 dosage units.

Mepyramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; For oral use for sedation in adults only when sold in the manufacturer’s original pack.

Pheniramine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; For oral use for sedation in adults only when sold in the manufacturer’s original pack.

Promethazine; for oral use in medicines for adults or children over 2 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer’s original pack containing not more than 10 dosage units; For oral use for sedation in adults only when sold in the manufacturer’s original pack.

Schedule 3

Pharmacy-only Medicines

Olopatadine; in preparations for nasal use delivering 600 micrograms or less of olopatadine per dose when the maximum recommended daily dose is no greater than 4,800 micrograms for the treatment of allergic rhinitis or rhinoconjunctivitis for up to 6 months in adults and children 12 years of age and over.

Brompheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing brompheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant.

Chlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing chlorpheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant.

Dexchlorpheniramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing dexchlorpheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant.

Diphenhydramine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing diphenhydramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant; for oral use when sold in the manufacturer’s original pack of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 6 years of age except when sold at a transport terminal or aboard a ship or aircraft for adults and children over 6 years of age.

Doxylamine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing doxylamine or when at least 1 of the other active ingredients is a sympathomimetic decongestant.

Meclozine; when sold in the manufacturer’s original pack of not more than 12 tablets or capsules for the prevention or treatment of travel sickness in adults and children over 6 years of age except when sold at a transport terminal or aboard a ship or aircraft for adults and children over 6 years of age.

Mepyramine; for dermal use; except for external use in medicines containing 2% or less in packs not exceeding 25 grams.

Pheniramine; for ophthalmic use except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a Pharmacy day/night pack containing pheniramine or when at least 1 of the other active ingredients is a sympathomimetic decongestant.

Promethazine; for oral use in medicines for adults and children over 6 years of age when combined in the same container with 1 or more other therapeutically active ingredients either when in the bedtime dose of a day/night pack containing promethazine or when at least 1 of the other active ingredients is a sympathomimetic decongestant; for oral use when sold in the manufacturer’s original pack of not more than 10 tablets or capsules for the prevention or treatment of motion sickness in adults and children over 6 years of age except when sold at a transport terminal or aboard a ship or aircraft for adults and children over 6 years of age.

Medicines for General Sale

Mepyramine; for external use in medicines containing 2% or less in packs not exceeding 25 grams.

Dated this 17th day of April 2025.

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