Published: 27 February 2023
Consultations
Outcome of the consultation on the proposed warning and advisory statements for ocular decongestants for eye redness and/or minor eye irritation
Summary
- Medsafe completed a Label Statements Database (LSD) consultation regarding an age limit for use on ocular decongestant medicines that are used for eye redness and/or minor eye irritation.
- 10 responses to the consultation were received.
- Download the Consultation outcome document to view the consultation feedback, Medsafe’s response and the finalised warning and advisory statements: Proposed warning and advisory statements for ocular decongestants - Consultation outcome (PDF, 262 KB, 18 pages)
- The implementation date for the new statements will be 1 February 2025.
About the consultation
This Medsafe consultation proposed new warning and advisory statements for ocular decongestants. The LSD consultation was undertaken following a recommendation from the Medicines Adverse Reaction Committee to include an age limit on the package labelling for Clear Eyes (naphazoline) 0.01% eye drops. The consultation was then extended to other ocular decongestant medicines.
The consultation opened on 11 July 2022 and closed on 23 September 2022.
More information about the consultation.
Submissions received
There were 10 responses to the consultation. Respondents included healthcare professionals, and industry. Most respondents agreed that the LSD should include a warning statement for ocular decongestants with an age restriction for use.
You can view the submissions that we have permission to publish.
Medsafe would like to thank all those who took the time to respond to the consultation and provided comments.
Outcome
The information below is only a brief summary of the consultation outcomes. For the full consultation feedback and Medsafe’s response, please download the consultation outcome document.
- Proposed warning and advisory statements for ocular decongestants - Consultation outcome (PDF, 262 KB, 18 pages)
Based on respondent feedback, it was suggested that each ocular decongestant should have a separate age restriction. We have made some changes to our initial proposed statements - see the consultation outcome document for details.
A new warning statement for ocular decongestants will be added to the LSD, with separate age restrictions for use for naphazoline and tetrahydrozoline.
Implementation date
The proposed implementation date for the new warning and advisory statements was 12 months following the update of the Label Statements Database. However, based on feedback from industry, the implementation date has been revised to 18 months.
The Label Statements Database will be updated on 1 August 2023. Affected products are required to have these statements by 1 February 2025. However, we encourage sponsors to update their labels before this date, if feasible.
We expect that all New Medicine Applications will comply with the updated labelling requirements unless we have agreed to alternative arrangements proposed by the sponsor.
Enquiries
Any questions relating to this consultation should be emailed to: medsafeapplications@health.govt.nz.
