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Frequently asked questions

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General

Why are you bringing in these regulations?

The Psychoactive Substances Act 2013 cannot be fully implemented without regulations. Regulations provide details of how the Act is to be applied. The Amendment to the Psychoactive Substances Act 2014 introduced a moratorium on applications for product approvals and for licences until the regulations come into force.

But didn't the government get rid of the Act?

No. the Government did not get rid of the Act. In May 2014, the Act was amended which revoked the approvals for all interim psychoactive products and a moratorium on processing applications for product approvals and licences was introduced. However, the Act still stands.

What are in these regulations?

There are three sets of regulations that will come into force on 3 November 2014. The Psychoactive Substances Regulations 2014 provide details on what is required for applications for product approvals and licences for importing, research, manufacturing, and sale of unapproved psychoactive substances to be processed. These details include what information is required to support that the product is low risk, what kinds of psychoactive product will not be able to be approved, labelling and packaging requirements, and record keeping.

The Psychoactive Substances (Fees and levies) Regulations 2014 set out the fees for each product approval and licence application, and annual levies for holding such approvals and licences.

The Psychoactive Substances (Infringement Fees and Form of Notices) 2014 set out the fee for infringements of the Act (specifically for breaking the age restrictions when supplying, buying and possessing of psychoactive substances, and for personal possession of a psychoactive substance that is not an approved product).

So does this mean people can start selling Psychoactive Substances again?

No, not in the near future. The Regulations that will come into force on 3 November will only partially remove the moratorium – licences for wholesale and retail sale cannot be issued at this time.

What is the point of the regulations if no-one can sell Psychoactive Substances yet?

It is the intention for psychoactive substances to be sold again in the future, but only after they have gone through a pre-market assessment for safety and quality, and only low risk products will be allowed to be sold. These Regulations have to be in place to enable potential importers and manufacturers to develop their systems in order to meet the new requirements. These requirements are new and closely resemble the pre-market approval regime for medicines, and therefore the industry needs some time to understand and progress to a point where they are meeting those requirements.

Is it going to be harder to get a licence?

Yes, it is. People wanting licences will now have to meet more stringent requirements including a “fit and proper person” test, and conditions can be placed on the licence that must be met and continue to be met.


Products

Can the old products now be sold again?

Any products that were previously on the market, including those that held an interim product approval, will have to meet all the requirements for pre-market approval before they can be sold again. No product will automatically be granted a licence.

What do applicants need to do to get a licence?

Applicants will need to carefully read the guide to making an application for the relevant licence they are seeking (at this point in time, this does not include wholesale or retail licences). Application forms are available on this website and must be filled out in full and should not contain any false or misleading information, particularly with regard to previous convictions. An applicant should not send any money with the application form – an invoice will be issued once the application has been accepted.

How is this different from before?

The Psychoactive Substances Act 2013 has not been fully implemented before now. The interim regime issued licences for some people in advance, and then subsequently followed up that the licensee’s were suitable people and meeting conditions of the licence. In the new process, applicants will be checked before licences are granted.

How will be products be tested?

The pre-market approval regime will require the applicants to prove that their product meets the requirements of a low risk product. These requirements are quite onerous and mirror the regime in place for medicines. Psychoactive products will be required to provide this evidence to the Psychoactive Substances Expert Advisory Committee to support their claims that the product is low risk to users.

Will animal testing be allowed?

No. Tests and trials that use animals will not be able to be presented by applicants in support of their product application.

How soon will it be before products are approved?

The pre-market approval requirements are very similar to those for medicines. This 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.


Importation

Can psychoactive substances start to be imported again?

Yes, if the importer has an import licence. However, they cannot be sold by wholesale or retail. At this stage, it is likely that most imports will be psychoactive substances in order to develop manufacturing processes with a view to obtaining a manufacturing licence and product approval.

Who will track imports?

Customs NZ stops all psychoactive substances at the border. A condition of an import licence is that the licence holder must inform the Authority of the importation prior to the import, and provide the Authority with the name and quantity of the psychoactive substances to be imported, and the intended date of importation. This will allow the Authority and Customs NZ to work together to ensure that only licensed importers are importing psychoactive substances and to track where the substance goes once it enters New Zealand.

Could a foreign-made Psychoactive Substance be imported and sold here?

Yes (but not sold as yet), but only if the manufacturing facility and process meets our requirements and standards.


Manufacturing

What will manufacturers have to do to get a licence?

Manufacturers will have to develop and meet some fairly rigorous requirements. They will have to meet the Code of Manufacturing Practice (the Code) [link] to ensure their psychoactive substance and products meet quality controls.

How will you monitor compliance?

The Authority has the ability to conduct an audit of a manufacturing facility at any time to assess compliance with the Act. Enforcement officers employed by District Health Boards can inspect a manufacturing site to monitor compliance with licence and product approval conditions  and an auditor, experienced in evaluating manufacturers’ compliance with pharmaceutical requirements, will visit manufacturing sites to monitor compliance with the Code.

How many manufacturers were there and would they qualify now?

It is unclear how many manufacturers there were before the Psychoactive Substances Act came into force in 2013. During the interim regime, there were 11 manufacturers granted an interim licence and 1 who was declined a manufacturing licence. Between January and May 2014, all manufacturers had their licences revoked as they did not meet the Code of Manufacturing Practice.