Published: 2 April 2018
Revised: 23 October 2020


Reclassification of codeine


At the 59th meeting of the Medicines Classification Committee (MCC) held on 7 November 2017, a recommendation was made to reclassify medicines containing codeine as the only active ingredient to:

  • prescription medicine; except when specified elsewhere in this Schedule
  • restricted medicine; for oral use in adults and children over 12 years of age in medicines containing not more than 15mg per solid dosage unit with a maximum daily dose not exceeding 90mg of codeine for use as an analgesic and when sold in a pack of not more than three days’ supply.

The proposed date for the recommendation to take effect was suggested as 31 January 2020.

The finalised minutes for the 59th meeting and the rationale behind the recommendation can be found on the Medsafe website.

The Minister’s Delegate requested more information before accepting this recommendation.

At the 62nd meeting of the MCC on 11 April 2019, an informational paper was requested to provide a summary of the risks and benefits of harmonising the classification of codeine with Australia and the alternative option recommended by the MCC at the 59th meeting.

At this meeting, the implementation date of 30 January 2020 was not considered practicable and Medsafe was requested to work with stakeholders to revise the timeframe.

Updated recommendation and implementation date

The information paper was presented to the 63rd meeting of the MCC on 10 October 2019. The Committee recommended that all codeine-containing medicines should be classified as prescription medicines.

The minutes of the 63rd meeting and the rationale behind the recommendation can be found on the Medsafe website (

Medsafe worked with industry and are advising that the new implementation date is 5 November 2020. The new classification will be gazetted on this date and take immediate effect.

Medsafe will gazette this change on 5 November 2020. On this date, codeine and codeine-containing combination products will only be able to be supplied in accordance with a prescription.

Regulations 15(5) and 15(4) of the Medicines Regulations 1984 allow some transition time for the relabelling of stock. At wholesale level, the Regulations allow for three months from the date of notification of a classification change for stock to be relabelled, and for stock at retail level the Regulations allow for 6 months for relabelling. However, from 5 November, regardless of how stock is labelled and regardless of the labelling transition period, stock will only be able to be supplied on a prescription. This gives affected sponsors of products and healthcare professionals until 5 May 2021 to transition to fully compliant prescription labelled codeine-containing products.

Products on pharmacy shelves will have to be removed from self-selection or pharmacist recommendation on or before 5 November 2020.

Affected pharmaceutical companies should submit a Changed Medicine Notification for changes to labelling to include the prescription classification statement, and a revised data sheet as soon as possible. For more information on making a Changed Medicine Notification, please contact

New labelling should be available at wholesale level by 5 February 2021.
Information for healthcare professionals on how to approach this change will be available in mid-October through bpacNZ.

For further information about the reclassification of codeine, please contact the Secretary of the Medicines Classification Committee (email:

Links to health professional advice regarding the reclassification of codeine-containing products

bpacnz  has published some guidance to health professionals on managing the reclassification of codeine.

Link to Media Release on Codeine-containing medicines to be reclassified

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