Revised: 23 June 2014
Consultations
Outcome of consultation on the planned changes to the Label Statements Database for codeine-containing medicines
About the consultation
In December 2013, Medsafe published a proposed change to the labelling requirements for codeine-containing medicines on the Medsafe website, and sought feedback on the proposal by 3 March 2014.
Consultation
Medsafe proposed that the following statements be added to the Label Statements Database for codeine-containing medicines:
- this medicine may cause drowsiness
- be cautious about driving a vehicle or operating machinery within 8 hours of taking this medicine.
Consultation feedback
Three submissions were received. All submitters expressed support for the removal of ‘non-drowsy’ statements on codeine-containing medicines. Two submitters expressed support for a change in labelling requirements to harmonise with Australia. One submitter raised concerns that the statement “be cautious about driving a vehicle or operating machinery within 8 hours of taking this medicine” was unjustified. The submissions raised the following issues for consideration by Medsafe:
- The wording included in the Label Statements Database should align with that in the Australian Required Advisory Statements for Medicines Labels (RASML).
Medsafe accepts that changes to the Label Statements Database should harmonise with Australia where possible. The wording in the RASML is:
- this medicine may cause drowsiness
- if affected do not drive a vehicle or operate machinery.
- The statement “Be cautious about driving a vehicle or operating machinery within 8 hours of taking this medicine” is unjustified.
Medsafe agrees that the statement should align with the Australian labelling requirements instead.
- It is important that a reasonable transition period is permitted to allow for the introduction of revised labelling.
It is standard practise that the mandatory date is usually 12 months following the change to the Label Statements Database.
Implementation
From 1 April 2015, “non-drowsy” claims must be removed from the labels of codeine-containing medicines, and the following statements will become labelling requirements:
- this medicine may cause drowsiness
- if affected, do not drive a vehicle or operate machinery.
Enquiries
Any questions relating to this consultation should be directed via email to: askmedsafe@health.govt.nz
** Note: since the outcome of this consultation, Medsafe has received feedback from a sponsor company, who advised that the implementation date of 1 April 2015 would be insufficient to allow companies to adequately manage stock for the upcoming 2015 cold and flu season.
Medsafe agreed that the implementation date could be extended to 1 September 2015.
