How to get a psychoactive product approved

Before making an application

Applicants must read and understand product approval guidelines before making an application to the Psychoactive Substances Regulatory Authority. No fees will be refunded if the application is rejected due to insufficient or incorrect information.

Anyone seeking to put in a product application is strongly advised to contract the services of a regulatory affairs person experienced in collating pharmaceutical applications.

What to do before making an application

All psychoactive products must have approval from the Psychoactive Substances Regulatory Authority before they can be sold on the New Zealand market. This is under section 37 of the Psychoactive Substances Act 2013.

Products must pose no more than a low risk of harm to users, and go through a pre-market approval process similar to that required for medicines. This approval process ensures that the products have been formulated, manufactured and tested to a high level of quality and safety that satisfies the Authority and meets the intention of the Act.

The pre-market approval requirements mean that comprehensive information on the product needs to be provided. This includes developing quality systems for manufacturing and testing for safety which includes the specific, pharmacological, psychoactive and toxicological effects of the substance. It also includes the potential for dependence, the potential misuse of the substance, and its effects on vulnerable members of the community.

All this information must be created, collated, assessed and approved. It is considered that the first product approval would not be able to be granted for at least 2 years after an application has been submitted.