Published: 26 September 2023
Revised: 25 October 2023
Committees
Reclassification of naproxen
Background
Currently the classification of naproxen is:
- Prescription: except when specified elsewhere in this schedule.
- Pharmacy only: in solid dose form containing 250 milligrams or less per dose form in packs of not more than 30 tablets or capsules .
Naproxen was reviewed at the 70th meeting of the Medicines Classification Committee (MCC) held on 25 May 2023. The minutes for the 70th meeting can be found on the Medsafe website.
The Minister of Health’s Delegate has considered the recommendation and has decided to reclassify medicines containing naproxen to:
- Prescription: except when specified elsewhere in this schedule.
- Restricted (pharmacist only): in solid dose forms in medicines containing 250 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of more than 750 milligrams per day.
- Pharmacy only: in solid dose forms in medicines containing 250 milligrams or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 750 milligrams per day.
Due to the time needed for affected sponsors to make regulatory changes, and to enable manufacturing lead-in, the implementation date for this classification change is 1 October 2024.
Regulations 15(4) and 15(5) of the Medicines Regulations 1984 allow additional transition time to enable stock bearing superseded labelling to be sold through for three months at wholesale level and 6 months at retail level, from the classification implementation date (1 October 2024).
Medsafe has contacted sponsors of these medicines to ensure they are aware of the regulatory submissions they need to make to ensure a smooth transition. For queries regarding regulatory changes as a consequence of the classification change, please contact medsafeapplications@health.govt.nz.
Contact details
For further information about the reclassification of naproxen, please contact the Secretariat of the Medicines Classification Committee (email: committees@health.govt.nz).
