Notice Title

Classification of Medicines

Publication Date
8 Oct 2024

Tags

Medicines Act Classification of medicines Health

Notice Number

2024-go5016
Title
View PDF
File Type and Size
PDF (30 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.
  3. The medicines listed in Schedule 3 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 Medicine

Paracetamol, except when otherwise specified in this schedule.

Schedule 2

Restricted Medicine

Paracetamol; in modified-release forms containing 665 milligrams or less, in liquid form in packs containing more than 10 grams and not more than 50 grams.

Schedule 3

Pharmacy-only Medicine

Paracetamol; in liquid form in packs containing not more than 10 grams; in suppositories; in tablets or capsules containing 500 milligrams or less and in packs containing more than 10 grams and not more than 50 grams; in powder form containing not more than 1 gram per sachet and more than 10 grams per pack; except in tablets or capsules containing 500 milligrams or less and in packs containing not more than 10 grams; except in powder form in sachets containing 1 gram or less and in packs of not more than 10 grams.

Dated this 26th day of September 2024.

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