Pursuant to section 106(1) of the Medicines Act 1981, I, Derek Fitzgerald, Acting Group Manager, Medsafe, Ministry of Health, acting under delegated authority since 11 September 2013, hereby declare the following:

1. The medicine listed in Schedule 1 to this notice is classified as a prescription medicine.

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.

Schedule 1

Prescription Medicine

Velpatasvir

Dated this 21st day of October 2016.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health.