Submissions closed at 5pm on 8 January 2014.
The Psychoactive Substances Act 2013 (the Act) regulates the importation, manufacture and supply of psychoactive substances and products. The Act requires a Code of Manufacturing Practice to be developed that will ensure all products on the market in New Zealand are made to a consistently high standard in clean, controlled environments.
The Code is a technical document aimed at manufacturers of psychoactive substances and products. This consultation document presents a draft Code for feedback.
The Code sets out in detail the quality requirements necessary for manufacturers to demonstrate that they are able to produce psychoactive substances and products that are manufactured in licensed facilities, to defined quality standards, using ingredients that comply with internationally established standards.
The Code will take effect from 17 January 2014. The first set of quality requirements will need to be available to the Psychoactive Substances Regulatory Authority from that date. These requirements include detail about each psychoactive substance or product; for example its source, components, their quantity and quality, along with proof that a product’s quality can be accurately tested. Further information about active ingredients and other packaging, product and delivery components will be required after 22 April 2015. This information is also set out in this document.
Making a submission
Submissions closed at 5pm on 8 January 2014.
- any submissions received after this time will not be included in the analysis of submissions
- submissions should be confined to the specific subject matter of this consultation paper. Any submissions received that do not directly relate to the subject area, or that reference other consultation papers, will not be considered.
There are two ways you can make a submission.
- Send your comments, with the submission form (Word, 53 KB) to:
Psychoactive Substances Regulatory Authority
Ministry of Health
PO Box 5013
- Electronically complete the submission form (Word, 53 KB), add your comments and email to:
Need assistance with making your submission?
If you would like advice or support during the consultation period until 8 January 2014 please email email@example.com and put 'Code of Manufacturing Consultation' in the subject line
Why is the Psychoactive Substances Authority consulting?
Under section 29 of the Psychoactive Substances Act (the Act) the Psychoactive Substances Regulatory Authority (the Authority) must issue a Code of Manufacturing Practice (Code) no later than 6 months after the Act came into effect. The Code sets out the quality controls that will ensure psychoactive products are manufactured in a controlled and consistent way.
What is this consultation about?
This consultation describes the quality control systems and measures that must be in place to ensure that psychoactive products are manufactured in a controlled and consistent way. The consultation will tell manufacturers of psychoactive products what data and information they will have to provide to prove that the manufacturing process is able to produce products that show they use:
- a controlled process
- good quality ingredients
- internationally accepted quality standards.
What does the Code detail?
The Code details the outputs that a systematic approach to quality risk management will deliver and sets out a framework for the risk management of psychoactive product manufacturing.
Who does it affect?
The consultation is targeted towards manufacturers of psychoactive products, particularly, at this stage, those who hold a current interim licence to manufacture.
Why doesn’t the draft Code include safety requirements?
The Code details only the quality control systems and measures that must be in place for manufacture, with the focus on the quality of the product. Demonstration of the relative safety of the product can only be determined through study of the product in preclinical and clinical studies (an initial assessment of safety has been made for all interim product approvals). Being able to manufacture psychoactive substances in controlled environments, with quality ingredients, will also help deliver a safer product.
When will there be a consultation on safety?
The safety requirements will be fully described in the Psychoactive Substances Regulatory Guidelines, and will be consulted on after the Psychoactive Substance Regulations have been passed.
When will the Code come into effect?
The final Code will be published on 16 January 2014 and will come into effect from 17 January 2014. The initial data and information will be required to be available from 17 January 2014.
What happens if a manufacturer of a psychoactive substance isn’t able to meet the standard by the time it comes into law?
Manufacturers and suppliers will be required to make an initial set of data and information available following 17 January 2014. This data will include:
- detailed specifications of active ingredients and psychoactive products that are manufactured
- certificates of analysis for active ingredients and psychoactive products that are manufactured
Assessment of this information by the Authority will commence from 17 January 2014 to ensure it meets the requirements of the Code. Any data deficiencies or incomplete information will be followed up by the Authority. If no information is forthcoming within a reasonable period of time, or the Authority is not satisfied that the information provided complies with the Code, then the Authority will advise the manufacturer of the action the Authority proposes to take. This could include audit of the manufacturing facility and issuing of a compliance notice, which may subsequently affect the status of their licence to manufacture.
By what date will all manufacturers of psychoactive substances have to meet the code?
An initial set of information will need to be available from 17 January 2014, with additional requirements to be provided by 22 April 2014 and then a third set after 22 April 2015 (eg, stability data to show the product does not ‘go off’). Evidence of international Good Manufacturing Practice will be required one year after commencement of the Psychoactive Substance Regulations.