How to get a product approved
It is important that applicants read and understand the product approval guidelines BEFORE making an application to the Authority, as no refunds of fees will be given if the application is rejected for insufficient or incorrect information provided. It is strongly advised that anyone seeking to put in a product application contracts the services of a regulatory affairs person experienced in collating pharmaceutical applications.
On November 3 2014, the moratorium on processing applications for psychoactive products ended. All psychoactive products must have approval from the Authority under section 37 of the Psychoactive Substances Act 2013 before they can be sold on the New Zealand market. The 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.
Products that previously had an interim product licence will have to reapply for approval and meet the new requirements. Approvals will not be automatically renewed.
The pre-market approval requirements means 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 will need to be created, collated, assessed and approved. It is considered that the first product approval would not be able to be granted for at least two years after an application has been submitted.
The fees and levies include GST.
Product approval fees
- application for approval of psychoactive product $175,000
- application for approval of subsidiary product $10,000
- approval of psychoactive product granted by the Authority $88,000
Do not send money with your application. You will be invoiced for the amount after acceptance of your application.