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Classification of Medicines

Classification Process

Classification categories and criteria

Definition of medicines
First Schedule to the Medicines Regulations 1984
Classification of controlled drugs
Classification of medicines
Classification criteria

Definition of medicines

The Medicines Act 1981 defines three classification categories for medicines:

  1. Prescription Medicine
    Prescription medicines may be supplied only on the prescription of an authorised prescriber (as defined in the Medicines Act 1981). They may also be used by a registered member of another specified health profession when permitted in the First Schedule to the Medicines Regulations 1984 or amendments.
  2. Restricted Medicine (also referred to as Pharmacist Only Medicine)
    Restricted medicines may be sold without a prescription, but the sale must be made by a registered pharmacist, in a pharmacy, and details of the sale must be recorded.
  3. Pharmacy-Only Medicine (also referred to as Pharmacy Medicine)
    Pharmacy-only medicines may only be sold in a community or hospital pharmacy, or a shop in an isolated area that is licensed to sell that particular medicine. The sale may be made by any salesperson.

Medicines in each of these classification categories are listed in the First Schedule to the Medicines Regulations 1984 and amendments. Medicines not listed in the classification schedules are deemed to be unclassified, and are referred to as General Sale Medicines. These medicines may be sold from any outlet.

Note: To avoid confusion, the full term should be used when referring to a medicine's classification. Avoid using acronyms (PM, POM, etc.).

First Schedule to the Medicines Regulations 1984

Medicines are generally classified according to their active ingredients. The International Non-proprietary Name (INN) is the name of choice. If the medicine has more than one active ingredient, the active with the most restrictive classification determines the classification of the product. The First Schedule to the Medicines Regulations 1984 is a list of active ingredients grouped under their respective classifications.

Classification changes occur approximately every six months. Updates may occur either through an amendment to the Medicines Regulations 1984 or through publication of a notice in the New Zealand Gazette. Amendments are usually published in June each year. For the latest amendment see the Current amendment to the Classification Schedule When checking a classification, refer to the latest amendment to the Regulations and any subsequent updates published in the Gazette. Alternatively, check the classification on the Listing of Classifications.

Classification of controlled drugs
Narcotics and certain psychotropic agents are regulated under the Misuse of Drugs Act 1975 as controlled drugs. The Misuse of Drugs Act 1975 defines three classes of controlled drugs. These are Class A, Class B (further subdivided into Parts I, II & III) and Class C (further subdivided into Parts I to VII). The controlled drugs in each class are listed in the Schedules to the Misuse of Drugs Act 1975.

The Misuse of Drugs Act 1975 and Regulations contain the requirements for the manufacture, sale, supply, prescribing and labelling of controlled drugs. Controlled drugs that are also medicines are required to meet the requirements of both the Misuse of Drugs legislation and the Medicines legislation. Where there is any inconsistency between the two sets of legislation the Misuse of Drugs legislation takes precedence over the Medicines legislation.

Classification of medicines
The Medicines Classification Committee (MCC) recommends the classification of active ingredients where these have not previously been scheduled. Most new active substances are initially classified as prescription medicines.  The MCC also considers applications for the reclassification of medicines.

Classification criteria
To qualify for a shift from prescription to non-prescription status, a prescription medicine should:

Note: The three-year period of use need not have been in New Zealand. However, it must have been in a country with a well-developed pharmacovigilance system.

The MCC uses the following definition adopted in 1990 by the Commission of the European Communities for suitability for non-prescription sale: Medical products which may be available without prescription shall show a substantial safety in use in the treatment of minor ailments or symptoms, usually capable of rapid and spontaneous relief, which are easily identifiable by users and do not justify a medical consultation.

The MCC considers the following factors when reviewing a medicine for reclassification for non-prescription sale. The list is not ranked in any order of importance. The criteria may vary in importance according to the medicine being considered for reclassification. In some cases one factor alone may be sufficient to outweigh all others in determining whether or not a medicine should be reclassified.