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Published: 24 June 2019

Committees

Reclassification of Melatonin

Background

At the 61st meeting of the Medicines Classification Committee held on 2 November 2018, the Medicines Classification Committee recommended that melatonin tablets up to 3 mg and melatonin modified release tablets up to 2 mg should be reclassified from a prescription medicine to 'prescription except when’ with the following conditions:

  • supplied for the treatment of primary insomnia for adults aged 55 years or older for up to 13 weeks
  • by a New Zealand registered pharmacist who has completed training required by the Pharmacy Council and the Pharmaceutical Society of New Zealand
  • in a pack that has received consent from the Minister of Health or the Director General.

Implementation

The Minister’s Delegate has agreed with this recommendation and the new classification of melatonin is:

Prescription except when supplied in medicines for oral use containing 3 mg or less per immediate release dose unit, or 2 mg or less per modified release dose unit, when sold in the manufacturers original pack that has received consent from the Minister of Health or the Director General for the treatment of primary insomnia for adults aged 55 years or older for up to 13 weeks by a registered pharmacist.

This new classification means that melatonin is a prescription medicine except when supplied under the conditions described in the classification statement. This new classification is effective immediately following publication of the gazette notice  on 24 June 2019.

Only approved medicines containing melatonin may be supplied without a prescription

Currently there is only one approved medicine containing melatonin, Circadin.

You can search for products that have been approved and given consent to market in New Zealand using the Product/Application Search .

Unapproved medicines containing melatonin may not be supplied without a prescription

Melatonin products that have not received consent (unapproved melatonin products supplied under section 29 of the Medicines Act 1981) will not be able to be supplied by a pharmacist under this new classification. A prescription from a medical practitioner will still be required for section 29 melatonin products.

Competency requirements for pharmacist to supply melatonin

Information regarding the competency requirements for pharmacists to supply melatonin without a prescription can be found on the Pharmacy Council’s website.

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