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.

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

Fenbendazole

Glecaprevir; except when supplied in combination with pibrentasvir for treatment of chronic hepatitis C virus infection to people who meet the clinical and eligibility criteria of the approved training programme, when provided by nurses who meet the requirements of the Nursing Council.

Pibrentasvir; except when supplied in combination with glecaprevir for treatment of chronic hepatitis C virus infection to people who meet the clinical and eligibility criteria of the approved training programme, when provided by nurses who meet the requirements of the Nursing 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, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council.

Prilocaine; for injection except when used as a local anaesthetic in practice by a dental therapist, or oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) 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, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council.

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, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council; except when containing 2.5% or less and used topically as a local anaesthetic in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) 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.

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, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council.

Articaine; except when used as a local anaesthetic in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council.

Felypressin; except when combined with a local anaesthetic and used in practice by a dental therapist, oral health therapist or dental hygienist (without local anaesthetic exclusion on their scope of practice) registered with the Dental Council.

Dostarlimab

Diroximel fumarate

Infigratinib

Ponesimod

Selinexor

Selumetinib

Sotorasib

Tepotinib

Belzutifan

Enfortumab vedotin

Lurbinectedin

Mavacamten

Somapacitan

Schedule 2

Restricted Medicines

Adrenaline; in medicines containing 1% or less except in medicines for injection containing 0.02% or less; except in medicines for injection containing 0.1% for use in practice in an emergency by a dental therapist, an oral health therapist or a dental hygienist registered with the Dental Council.

Dated this 16th day of May 2023.

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