Published: 26 September 2023
Committees
Reclassification of paracetamol (liquid formulations)
Background
Currently paracetamol in liquid form is classified as pharmacy-only in New Zealand. At the 70th meeting of the Medicines Classification Committee (MCC) held on 25 May 2023; the classification of paracetamol in liquid form was reviewed. The minutes of the 70th meeting can be found on the Medsafe website.
The Minister of Health’s Delegate has considered the MCC’s recommendation and has made the decision to reclassify medicines containing paracetamol to:
- Prescription: except when specified elsewhere in this schedule.
- Restricted (pharmacist only): in liquid form in packs containing more than 10 grams and not more than 50 grams.
- Pharmacy only: in liquid form in packs containing not more than 10 grams.
Due to the time needed for sponsors to make regulatory changes to affected products, 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Regulations 15(4) and 15(5) of the Medicines Regulations 1984 allow additional transition time to enable stock bearing superseded labelling to be sold through three months at wholesale level and 6 months at retail level, from the classification implementation date (1 October 2024).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 paracetamol, please contact the Secretariat of the Medicines Classification Committee (email: committees@health.govt.nz).
