The Act requires all products to pose “no more than a low risk of harm” to the consumer if they are to be given an interim licence for sale.
The interim licensing regimen is designed to risk manage products already on the market. For more information please continue reading.
The Safety Assessment of Psychoactive Products report (pdf, 79 KB) explores the safety of psychoactive products (through a literature review), considers how to use New Zealand data to assess the risk profile of product applications received by the newly established regulatory authority; and determines the risk threshold for “low risk of harm” based on available data. The table below sets out the assessed risk scores for product applications which have been assessed and either given interim licences or rejected.
The Risk Assessment Score Table (pdf, 65 KB) includes information on the product name and its active ingredient; the number of minor, moderate and severe adverse reactions reported, the risk score given to each of these events, and the total assessed risk score. Where a manufacturer has changed the ingredients in the product, the table provides information on the new formulation of these products as a separate entry.
The interim licensing regimen is designed to risk manage products already on the market. The regulatory authority has the powers to refuse an interim licence if an application is incomplete or withdraw an interim licence for a product if safety issues emerge. Where a product application has been rejected, the table displays the risk assessment score and the date of rejection.
Following the passage of the Psychoactive Substances Regulations, the interim licensing scheme will be revoked and existing licence holders will be required to reapply for full product licences. The Regulations will require manufacturers of products to submit further data about the safety and quality of their product to demonstrate their product poses no more than a low risk of harm to a consumer. In addition to making a comprehensive review of safety data, the Regulations will also allow the Authority to place further conditions on the product licence including a requirement for on-going safety monitoring of products after they are on the market.
Reporting Adverse Effects to Psychoactive Products (pdf, 33 KB). Now that the Psychoactive Substances Act is operational, monitoring the safety of products that have received an interim licence for sale is a critical part of the regulatory scheme. The Psychoactive Substances Regulatory Authority needs information about the side effects of psychoactive substances in order to monitor the safety of licensed psychoactive products. This note provides detailed information to help healthcare practitioners report adverse effects associated with the use of psychoactive products to the Centre for Adverse Reactions Monitoring (CARM). These reports should include the full brand name of the product when this is known.
Tags: Interim Licence