Published: 7 June 2019

Publications

The Medsafe Files – Episode 10: Medicines classification

Prescriber Update 40(2): 41
June 2019

Key Messages

  • Medicines are generally classified according to their active ingredients.
  • The Medicines Act 1981 defines three classifications for medicines: prescription medicine, restricted medicine (pharmacist only) and pharmacy-only medicine.
  • Medicines not listed in the classification schedules are deemed to be unclassified, and are referred to as general sales medicines.
  • The Medicines Classification Committee provides advice to the Minister of Health’s delegate on the classification of medicines.


The Medsafe Files series continues with this article on classification of medicines.

Medicines are classified according to their active ingredients

Schedule 1 of the Medicines Regulations 1984 contains a list of active ingredients grouped under their respective classifications. Active ingredients are listed by their International Non-Proprietary Name (INN).

If a medicine has more than one active ingredient, the active ingredient with the most restrictive classification determines the classification of that medicine.

To find out the classification of an active ingredient you can search Medsafe’s classification database. Alternatively, you can refer to the latest amendment of the Medicines Regulations 1984 (available at www.legislation.govt.nz) and any subsequent notices published in the New Zealand Gazette.

Legislation defines three different classifications of medicines

The Medicines Act 1981 defines three classifications for medicines.

  • Prescription medicines may be supplied only on the prescription of an authorised prescriber.
  • Restricted medicines (also referred to as Pharmacist-Only medicines) may be sold without a prescription, but the sale must be made by a registered pharmacist in a pharmacy, and the details of the sale must be recorded.
  • Pharmacy-only medicines may only be sold in a community or hospital pharmacy, and the sale may be made by any salesperson.

Medicines not listed in Schedule 1 are deemed to be unclassified and are referred to as general sales medicines. These medicines may be sold from any outlet.

Medicines Classification Committee

The Medicines Classification Committee (MCC) is an advisory committee that makes recommendations to the Minister of Health’s delegate regarding the classification of medicines. The MCC considers applications for the reclassification of medicines and recommends the classification of new active ingredients. The MCC meets twice a year and secretarial support is provided by Medsafe. You can find out more information about the MCC on the Medsafe website.

Anyone can make a submission to the MCC to reclassify a medicine. Guidance on how to change the legal classification of a medicine in New Zealand (PDF 408 KB, 22 pages) is published on the Medsafe website.

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