Medsafe advises the objector of the outcome and gives the original applicant a chance to comment to the Committee about the objection. Confirmation The Minister s Delegate signs a notice for publication in the Gazette to confirm those recommendations which have not been the subject of an objection. Notification Classification changes are effected by notification in the Gazette. They are subsequently incorporated into the First Schedule of the Medicines Regulations by means of an amendment. At the time of gazettal, the classification List on the web site is updated and a copy of the Gazette notice is published on the web site.
Implementation Following a reclassification, a change of labelling is usually necessary.
This requires the sponsor to submit a Self-assessable Change Notification. The legislation allows three months from the date of notification of a classification change for stock labelled with the old classification to be replaced at wholesale level and six months for replacement of stock at retail level. Companies should contact Medsafe if they are unable to meet these time-frames. Submissions for reclassification Submissions to the MCC are usually made by pharmaceutical companies, health professional organisations or Medsafe. Individuals or groups making submissions are advised to liaise with the pharmaceutical companies who market the medicines for which a change of classification is sought.