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 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

Abemaciclib

Alkyl nitrites; except when specified elsewhere in the schedule

Aniracetam

Avibactam

Bilastine; except when specified elsewhere in this notice

Cenegermin

Coluracetam

Dimiracetam

DMHA including the isomers 2-amino-6-methylhelptane (also known as 1,5-dimethylhexylamine, and octodrine) and 2-amino-5-methylheptane (also known as 1,4-dimethylhexamine)

Doravirine

Entrectinib

Esketamine

Fasoracetam

Galcanezumab

Influenza vaccine; except when administered to a person 13 years of age or over by a registered pharmacist or registered intern pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health

Isavuconazole

Lanadelumab

Meldonium

Metamizole

Methylphenylpiracetam

Nebracetam

Nefiracetam

Omberacetam

Oxiracetam

Phenylpiracetam

Plitidepsin

Pramiracetam

Racetams; except when specified elsewhere in this notice

Rolziracetam

Seletracetam

Semaglutide

Sunifiram

Unifiram

Upadacitinib

Voglibose

Schedule 2

Pharmacy-only medicines

Bilastine; in divided solid dosage forms for oral use containing 20 milligrams or less for the treatment of the symptoms of allergic rhinoconjuctivitis (seasonal and perennial) and urticaria.

Dated this 4th day of March 2020.

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