Pursuant to section 106(1) of the Medicines Act 1981 (“Act”), I, Chris James, Group Manager, Medsafe, Ministry of Health, acting under delegated authority, hereby declare that:

1. The medicines listed in Schedule 1 to this notice are to be classified as prescription medicines.
2. The medicines listed in Schedule 2 to this notice are to be classified as restricted medicines.
3. The medicines listed in Schedule 3 to this notice are to be 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 to a medicine in this notice 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

Alpelisib

Baloxavir marboxil

Cilnidipine

Darolutamide

Human papillomavirus vaccine; except when administered 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.

Lorlatinib

Niraparib

Talazoparib

Dated this 8th day of October 2020.

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