Published: 5 September 2019


Medicines classification update

Prescriber Update 40(3): 60
September 2019


At the 61st meeting of the Medicines Classification Committee (MCC) in November 2018, the MCC recommended that melatonin should be reclassified to ‘prescription except when’.

The new classification for melatonin was implemented on 24 June 20191.

Melatonin is now classified as:

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. Pharmacists may only supply melatonin if they meet the competency requirements set by the Pharmacy Council.

Updates following the 62nd meeting of the Medicines Classification Committee

At the 62nd meeting held on 11 April 2019, the MCC recommended several changes to the classification of medicines. These included:

  • the classification of budesonide and fluticasone should harmonise with Australian requirements. The limit on the primary pack size for both these substances and the limit on the dose per actuation for budesonide should be removed from the pharmacy-only classification statement
  • the following new chemical entities should be classified as prescription medicines: brigatinib, crisaborole, lanadelumab, romosozumab, safinamide, tilmanocept, tivozanib.

These classifications were implemented on 12 July 20192.

The MCC considered applications to reclassify ropivacaine and bupivacaine. The MCC requested further information from the applicant.

More information

The Medsafe website has information on the classification process and minutes of the MCC meetings. You can search the classification database to check the classification of an active ingredient.


  1. New Zealand Gazette. Classification of Medicines 24 June 2019. Notice Number: 2019-go2911. URL: (accessed 15 July 2019).
  2. New Zealand Gazette. Classification of Medicines 12 July 2019. Notice Number: 2019-go3281. URL: (accessed 15 July 2019).
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