Media  release         Ministry of Health                July 18, 2013

Psychoactive Substances Act now law

Dairies and many other retailers are barred from selling psychoactive substances from today, as a new law comes into force.

The Psychoactive Substances Act allows regulation of psychoactive substances and products in New Zealand.

It immediately curtails aspects of current product retailing and establishes a Psychoactive Substances Regulatory Authority within the Ministry of Health.

The Authority will be responsible for ensuring products meet adequate safety requirements before they can be distributed in New Zealand. It will also license importers, distributors, and retailers to ensure products are not supplied to minors.

Dr Stewart Jessamine, Group Manager Medsafe, says the most immediate effect of the law is that dairies, supermarkets, service stations, or anywhere with a liquor licence are no longer allowed to sell psychoactive substances. No-one under 18 years of age will be permitted to purchase or possess psychoactive products.

“This change is from day one, and police and health officers are working together to ensure that those retailers understand they should remove products from their shelves as they can no longer trade in these substances.

“To do so places them at risk of prosecution and substantial penalties of up to $10,000 for an individual and $50,000 for a body corporate.”

Dr Jessamine says the Ministry and police also welcome the assistance and input of the public in ensuring the regime is as effective as possible as rapidly as possible.

Besides the immediate effect on some retailers, the new law sets out a clear transition process between the Act coming into force and the completion of the Psychoactive Substances Regulations expected towards the end of this year.

Dr Jessamine says: "The transition period licenses and places legal requirements on the limited range of ‘specialty’ retailers and wholesalers still permitted to sell psychoactive substances, manufacturers of these products and researchers undertaking studies of psychoactive substances. It also places controls on advertising, labelling and promotion of these products.”

More detail on this transition is provided below.

Background to the transition to Psychoactive Substances Regulations

Distributors and manufacturers have 28 days from the commencement of the Psychoactive Substances Act to obtain interim approvals:

·        A product manufacturer will be required to apply for an interim approval for each product they make. Each application requires a fee of $10,000. This will require the manufacturer to certify that it has been on the market for more than 3 months and that no harm has been reported.  A condition is that all products will be required to carry labelling describing the product ingredients and specified warning statements;

·        Permitted retailers and wholesalers of psychoactive substances will be required to apply for interim licences to sell products in each location they operate.  Each licence will cost $500.  The licence will limit their ability to advertise products to within their premises, restrict sale to persons aged 18 years and over; and to store product for sale behind the counter such that self-selection is not possible.  

While dairies, supermarkets, service stations, or anywhere with a liquor licence are immediately prohibited from selling psychoactive substances, from 28 days after commencement all non-licensed businesses must also cease trading in psychoactive substances. All non-approved products must be removed from the distribution chain.

The Ministry will publish on its website a list of the products, manufacturers, retailers, wholesalers and researchers that have applied for and been granted interim approval during the transition period. This website will also include information on the legislation and the regulatory regimen as it is developed. Ultimately the website will include information on the outcomes of applications for approval of psychoactive substances.

Dr Jessamine says: "Interim licences only cover the period until the completion of the regulations. Once the regulations are in place, manufacturers of products with interim approval will be required to submit a further application containing information required by the regulations for approval to the Authority within 3 months. While the cost of developing a product for application and the cost of the application process is yet to be determined the total cost of bringing a product to the market is likely to be several million dollars.

“An application for approval will contain detailed information about the quality of the manufacture of the product and any delivery system associated with its use, as well as sufficient pre-clinical and clinical information to satisfy an independent expert advisory committee that the product poses no more than a low risk of harm. Within a relatively short period of time I expect that only products that have gone through the full Regulatory Authority process will be able to be sold”.

“While companies are collecting the information required for applications, products with interim approval will continue to be available for sale as long as confirmed evidence from use in the community indicates they pose no more than a low risk of harm.  If reports of harm are confirmed, the Act allows a product to be immediately banned and removed from the market.”

More details on the Act can be found here:

http://www.health.govt.nz/our-work/regulation-health-and-disability-system/psychoactive-substances

ENDS

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