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.
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.
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 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.
Fees
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
Annual Levy
- approval of psychoactive product granted by the Authority $88,000
Note: Do not send money with your application. You will be invoiced for the amount after acceptance of your application.