Notice Title

Classification of Medicines

Publication Date
21 Jul 2022

Tags

Medicines Act Classification of medicines Health

Notice Number

2022-go3006
Title
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File Type and Size
PDF (29 KB)

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

Cardarine

Arbutin; in oral preparations except herbal preparations containing 500 milligrams or less beta-arbutin per recommended daily dose.

Ripretinib

Faricimab

Deutetrabenazine

Eslicarbazepine

Lemborexant

Luspatercept

Trabectedin

Schedule 2

Restricted Medicine

Please note that the following medicine is now classified as a restricted medicine.

Ibuprofen 300 milligrams in powder form; for oral use in powder form containing 300 milligrams per dose with a recommended daily dose of not more than 1.2 grams and sold in the manufacturers original packs containing not more than 12 dose units, and labelled for use in adults and children over 12 years of age.

Dated this 19th day of July 2022.

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