The Medicines Act 1981 regulates medicines, related products and medical devices in New Zealand. The Act ensures that the medicines and products used in New Zealand are safe and effective.
Medicines cannot be advertised, sold or distributed without the approval of the Minister of Health (except in a few limited circumstances, which are described in the Act).
The Act defines what a medicine is and sets out the requirements for the approval, classification, manufacture, sale, distribution, advertising, prescribing and dispensing of medicines.
Companies who wish to sell a new medicine in New Zealand make an application to Medsafe (the business unit responsible for administering most aspects of the Medicines Act 1981 and its associated regulations). This application includes information that demonstrates the medicine meets New Zealand and internationally recognised standards for quality, safety and efficacy. Pharmaceutical companies have to undertake clinical trials to demonstrate the safety and efficacy of a medicine before it can be approved and this process can take several years. Currently there is only one cannabis medicine approved in New Zealand, and it will take years to have more cannabis medicines approved.