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