Notice Type
Departmental
Notice Title

Classification of Medicines

Pursuant to section 106(1) of the Medicines Act 1981, I, Derek Fitzgerald, Acting 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.

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

Naloxone; except when provided as part of an approved emergency kit for the treatment of opioid overdose; except when supplied as ampoules with needles and syringes, or as a prefilled syringe, by those authorised by regulation 3, 4 or 5 of the Health (Needles and Syringes) Regulations 1998 for the treatment of opioid overdose, and when supplied with instructions for use.

Dated this 14th day of August 2023.

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