Medsafe Policy on the acceptability of claims for pain relief
11/3/2004
Medsafe would like to thank all those who submitted comments regarding the discussion paper posted on the Medsafe Website entitled "Therapeutic claims for analgesic medicines". These comments have been considered with the following outcomes.
No change has been made to Medsafe's policy regarding allowable therapeutic claims for analgesic medicines. Medsafe would, however, like to take this opportunity to confirm standing policy regarding the acceptability of claims for relief from mild, moderate, severe and strong pain.
Claims for the relief of "mild to moderate pain" will be accepted for OTC products that contain appropriate analgesic/anti-inflammatory active ingredients.
OTC products making claims for the relief of "severe pain", or "strong pain" will require the submission and evaluation of clinical data where relief from these pain states has been specifically investigated.
Medsafe would also like to confirm that for those OTC analgesic products historically consented with the claims "relief from strong pain" consent for these products will continue. Companies are alerted to the possibility that the acceptability of these claims may be reviewed as part of the transition to a Joint Trans-Tasman Therapeutics Agency.