Medsafe's Evaluation and Approval Process
How are medicines approved in New Zealand? Companies who wish to sell a new medicine in New Zealand make an application to Medsafe (called a New Medicine Application or NMA). This application includes information that demonstrates the medicine meets New Zealand and internationally recognised standards for quality, safety and efficacy. Medsafe reviews this information and makes a recommendation to the Minister as to whether the medicine is approvable, or otherwise. If the medicine is approved, the New Zealand sponsor company then decides if the medicine will be supplied in New Zealand. Companies also submit notifications to Medsafe for planned material changes to an approved medicine (called a Changed Medicine Notification or CMN). Medsafe evaluates the change(s) to ensure that it does not affect the established quality, safety and efficacy of a registered medicine. Changed medicines cannot be marketed without the consent of the Director-General of Health (or delegate). Medsafe is not responsible for funding or purchasing medicines in New Zealand. The government organisation responsible for determining which medicines will be publicly funded is PHARMAC.
How can I know that a medicine has been approved for sale in New Zealand? Medsafe lists all medicines that have been approved in New Zealand on its website, and any medicines where an application was submitted but approval was not granted. This list includes information on where the medicine is made, the ingredients it contains, how it is packaged, what it is used for (indications) and who is legally responsible for the product (known as the Sponsor). Tip: This information can be found on the Product/Application Search page: https://www.medsafe.govt.nz/regulatory/DbSearch.asp
[5] Medsafe Evaluation Process
Healthcare & Pharmaceutical Landscape of NZ
29
