Prescription/non-prescription Medicines

Both Prescription and Non-prescription (OTC) medicines require approval by Medsafe before they can be distributed in New Zealand.  Additionally, medicines with approval that undergo material changes may also require Medsafe approval through a Changed Medicine Notification before these changes can take effect.  We can advise you about getting your product approved and maintaining the currency of the registration.  We offer:

  • Advice and co-ordination for product development or product sourcing
  • New Medicine Application preparation, submission and follow-up 
  • Changed Medicine Notification preparation, submission and follow-up
  • Preparation of medicine datasheets and consumer medicine information
  • Advice concerning product labelling and advertising
  • Applications for Clinical Trials
  • Product Sponsorship