Notice Title

Classification of Medicines

Publication Date
4 Sep 2014

Tags

Medicines Act Classification of medicines

Notice Number

2014-go5489

Page Number

2993

Issue Number

107
Title
View PDF
Description
Principal Edition, 4 September 2014.
File Type and Size
PDF (299 KB)
Page Number
See page 2993
Pursuant to section 106(1) of the Medicines Act 1981,
I, Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health, acting under delegated authority,
hereby declare that 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:
(a) preparations and admixtures containing any proportion of any substance listed in the notice.
(b) salts and esters of any substance listed in the notice.
(c) preparations or extracts of biological materials listed in the notice.
(d) salts or oxides of elements listed in the notice.
Unless specific reference is made otherwise, every reference to a medicine applies:
(i) if the medicine is in an injection or eye preparation, to any concentration of that medicine; and
(ii) 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 Medicines
Avanafil
Empagliflozin
Ledipasvir
Riociguat
Dated this 27th day of August 2014.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health.