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.

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

Alanylglutamine

Amethocaine; for internal use; for external use in medicines containing more than 10%; for ophthalmic use except when used in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board; except when containing 2% or less and used topically as a local anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council.

Benzocaine; except when specified elsewhere in this schedule; except in dermal preparations containing 2% or less of total anaesthetic substances; except in lozenges containing 30 milligrams or less of total anaesthetic substances per dosage unit; except when containing 20% or less and used topically as a local anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council.

Cariprazine

Elexacaftor

Filgotinib

Hyaluronidase

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 schedule; except when containing 2.5% or less and used topically as a local anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council.

Onasemnogene abeparvovec

Opicapone

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 schedule; except when containing 2.5% or less and used topically as a local anaesthetic in practice by a dental therapist or oral health therapist registered with the Dental Council.

Trifarotene

Dated this 6th day of December 2021.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health