Published: 26 October 2023
Updated: 28 November 2023
Committees
Reclassification of methenamine hippurate
Update
This page has been updated with the revised implementation date of 4 December 2023 (previously 1 December 2023), and to remind pharmacists that methenamine hippurate medicines must be held behind the counter from 4 Dec 2023.
Background
Methenamine hippurate is indicated for suppression or elimination of urinary tract infections. Currently methenamine hippurate is unscheduled in Aotearoa New Zealand and so is available at general sales (e.g. can be sold from supermarkets or dairies). At the 69th Medicines Classification Committee (MCC) meeting (25 October 2022) the MCC recommended methenamine hippurate be classified as a restricted (pharmacist-only) medicine. The minutes of the 69th meeting can be found on the Medsafe website.
The Minister of Health’s Delegate has considered the MCC’s recommendation and on the 16 May 2023 made the decision that methenamine hippurate should be classified as a restricted medicine.
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 4 December 2023.
From 4 December 2023 medicines containing methenamine hippurate will need to be held behind the pharmacy counter as with other pharmacist-only medicines. Pharmacists should ensure any online listings for medicines containing methenamine hippurate are also compliant. Regulations 15(4) and 15(5) of the Medicines Regulations 1984 allow additional transition time to enable stock bearing superseded labelling to be sold through three months at wholesale level and 6 months at retail level, from classification implementation date (4 December 2023).
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
Should consumers, healthcare professionals, or those in pharmaceutical industry be unsure of what this change in classification means for them, please email Medsafe at: committees@health.govt.nz
