Psychoactive
Substances
Code of Manufacturing
Practice
Implementation plan
Citation: Ministry of Health. 2014. Psychoactive Substances: Code of Manufacturing
Practice – Implementation plan. Wellington: Ministry of Health.
Published in January 2014
by the Ministry of Health
PO Box 5013, Wellington 6145, New Zealand
ISBN 978-0-478-41587-2 (online)
HP 5786
This document is available at www.health.govt.nz
This work is licensed under the Creative Commons Attribution 4.0 International licence. In essence, you
are free to: share ie, copy and redistribute the material in any medium or format; adapt ie, remix, transform and build
upon the material. You must give appropriate credit, provide a link to the licence and indicate if changes were made.
Foreword
New Zealand is a world leader in the regulation of psychoactive substances. The importation,
manufacture and supply of these substances are regulated through the Psychoactive Substances
Act 2013.
The Psychoactive Substances Regulatory Authority (the Authority) is responsible for ensuring
products meet adequate safety requirements before they can be distributed in New Zealand.
Risk assessments focus on approving only those substances that pose no more than a low risk of
harm to users.
The details of the quality control requirements for manufacturers of psychoactive substances are
outlined in the Code of Manufacturing Practice (the Code). The Code focuses on making sure all
psychoactive products on the market in New Zealand are made to a consistently high standard
in clean, controlled environments. The Code is based on New Zealand’s approach to regulating
pharmaceuticals and takes into account international best practice in chemical manufacturing.
The Code has been structured into two documents: the technical requirements of the Code and
the Implementation Plan. These two components make up the Code in its entirety, and both are
effective from 17 January 2014.
The implementation of the Code is being undertaken in a staged approach, with an initial set of
requirements from 17 January, and further information to be provided at later specified dates.
The implementation timeframes and information requirements are outlined in this document,
and should be referenced in conjunction with the Code, now published on the Ministry of
Health’s website.
All holders of interim licences to manufacture psychoactive substances are required to comply
with the Code, and the Implementation Plan, in relation to products manufactured in their
facility from 17 January 2014.
Donald Hannah
Manager, Psychoactive Substances Regulatory Authority
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
iii
Contents
Foreword
1
2
iii
Introduction
1
1.1
Background to the Code of Manufacturing Practice
1
1.2
Interim licensing regime
1
1.3
Implementation of the Code
2
1.4
Assessment of information
3
1.5
How to submit your information
3
Overview of the Code implementation
4
2.1
General approach to the information required
4
2.2
Overview of initial requirements from 17 January 2014
4
2.3
Overview of additional requirements by 22 April 2014
4
2.4
Overview of additional requirements by 22 April 2015
5
2.5
Overview of additional requirements to be phased in after 22 April 2015
5
Appendix 1: Summary of requirements for implementation of the Code
6
List of tables
Table A1.1: Summary of data requirements for compliance with the Code and associated
implementation timeframes
6
List of figures
Figure 1:
Overview of Code of Manufacturing Practice Implementation
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
2
v
1 Introduction
1.1 Background to the Code of
Manufacturing Practice
The Psychoactive Substances Act 2013 (the Act) came into force on 18 July 2013. The purpose of
the Act is to regulate the availability of psychoactive substances in New Zealand to protect the
health of, and minimise harm to, the individuals who use these substances. The Act establishes
the Psychoactive Substances Regulatory Authority (the Authority) within the Ministry of Health.
The Authority is responsible for ensuring products meet adequate safety requirements before
they can be distributed in New Zealand, and also licenses importers, researchers,
manufacturers, wholesalers and retailers.
Section 29 of the Act requires the Authority to develop a code of manufacturing practice relating
to the manufacture of psychoactive substances and products. Under section 17 of the Act, it is a
compulsory condition of any licence to manufacture that the licence holder complies with the
code.
The Code of Manufacturing Practice (the Code) came into effect on 17 January 2014, six months
after the commencement of the Act. The Code is available on the Ministry of Health’s website,
and details the expectations to both new and existing manufacturers to ensure that they produce
psychoactive substances that consumers and the Authority can rely on.
The Code details the quality requirements necessary for manufacturers to demonstrate that they
are able to produce psychoactive substances and products that:

are manufactured in Good Manufacturing Practice (GMP) licensed facilities

are manufactured to defined quality standards

use ingredients that comply with internationally established standards

comply with a set of specifications agreed by the Authority as part of the product approval.
1.2 Interim licensing regime
The Act established an interim regime during the transition to regulations. The interim regime
was established to allow time to further develop the full regulatory requirements. This regime
required companies and individuals who wished to remain active in the market to apply for an
interim licence or product approval within 28 days of the passage of the legislation.
The Psychoactive Substances Regulations (the Regulations) will be developed during 2014 and
will set out the detail for the regulatory scheme. Following the passage of the Regulations,
existing interim licence holders will be required to apply for full licences, and new product
applications will need to demonstrate that the manufacturing facility in which products are
made is in full compliance with the Code before a licence will be granted. The same
requirements will apply to new applications for a licence to manufacture, and all manufacturers
will need to show that they comply with the Code at all times.
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
1
During the interim regime, a Code of Manufacturing Practice Implementation Plan (the
Implementation Plan) is in place for the staged implementation of the manufacturing quality
aspects in the Code. It allows manufacturers to progressively develop the documentation that
will allow them to move into a fully compliant environment, yet start to provide the assurance
around the manufacturing process that the Authority expects.
1.3 Implementation of the Code
A summary of the information that currently licenced manufacturers must provide to the
Authority, by the specified dates, is outlined in section 2 below. Manufacturers must make
available specifications and certificates of analysis following 17 January 2014, with additional
requirements by 22 April 2014, 22 April 2015 and 12 months after commencement of the
Regulations (eg, requirement to be GMP certified), when implementation of the Code will be
complete.
The information required from 17 January 2014 is the minimum set of requirements to ensure
that there is an adequate level control on the manufacture of psychoactive substances in New
Zealand. Non-compliance with these requirements will constitute non-compliance with the
Code and will result in the Authority taking regulatory action.
The Authority acknowledges that there are a number of areas where manufacturers will need
further time to develop/implement new systems (eg, additional information on psychoactive
substance manufacture and subsequent characterisation, stability data, or certification of GMP).
In these cases, the Authority has given manufacturers additional time to develop the
information, and implement any processes required.
A diagram outlining the timeframes for submission of required information is given in Figure 1.
The key dates are 17 January 2014, 22 April 2014, 22 April 2015, and 12 months after
commencement of the Regulations (date to be confirmed during 2014). The specifics of the
requirements are outlined in section 2, and are also summarised in Table A1:1 in Appendix 1.
Figure 1: Overview of Code of Manufacturing Practice Implementation
2
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
1.4 Assessment of information
The Authority will undertake to assess all information submitted in support of compliance with
both the Implementation Plan, and the Code, in a timely manner. The assessment will be in the
form of a technical review of the information against the requirements outlined. Data
deficiencies or incomplete information will be followed up by the Authority, and, dependant on
the extent of the deficiencies, manufacturers may be given the opportunity to provide additional
information. If no information is forthcoming, or the Authority is not satisfied that the
information provided complies with both the Code and the Implementation Plan, then the
manufacturer will be advised of what 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.
The Authority will formally notify manufacturers when compliance with each stage of the
Implementation plan and the Code, has been demonstrated. However, manufacturers should
note that no changes can be made to the chemistry, composition, manufacture or quality control
of any psychoactive substances or products without prior notification from the Authority that
the changes do not affect compliance with the Code.
1.5 How to submit your information
All manufacturers should submit the required information to the Authority promptly following
17 January, and by the required subsequent dates specified. The information should be compiled
together as one complete document, and supported by:

a cover letter that clearly identifies the:
– manufacturer and manufacturing licence
– manufacturing facility
– psychoactive substances and products manufactured

a table of contents that indexes the information

individual pages numbering.
If the information is not easily accessible it will be returned to the manufacturer, which may
result in the Authority taking regulatory action for non-compliance.

Information may be provided to the Authority in hard copy by sending it to:
The Manager
Psychoactive Substances Regulatory Authority
Ministry of Health
PO Box 5013
Wellington.

Or electronically to:
psychoactives@moh.govt.nz
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
3
2 Overview of the Code
implementation
2.1 General approach to the information
required
The Code describes the specific information required to demonstrate that a manufacturer can
consistently produce psychoactive products by using:

a controlled process

ingredients that comply with internationally established standards

detailed specifications

defined quality standards.
2.2 Overview of initial requirements from
17 January 2014
For each psychoactive substance or product manufactured in the
facility
The Authority will require:

details on what psychoactive substances and products are manufactured in the facility, the
dose forms (products only), the number (and dates) of batches produced since commercial
production began, the batch sizes, and number of individual units produced (products only)

information on the source, quantity and quality of the psychoactive substance in any
psychoactive product, presented as certificates of analysis1

agreed specifications (quality tests) that any psychoactive substance and product
manufactured must meet before it is released to be sold.
2.3 Overview of additional requirements by
22 April 2014
For the manufacturing facility
All manufacturers with an interim licence to manufacture will be required to submit to the
Authority a manufacturing quality development plan that sets out how the manufacturer will
move to a licensed GMP operating environment within 12 months from commencement of the
Regulations.
1
4
A certificate of analysis refers to an authenticated document that is generally issued by Quality Assurance that
ascertains that a product has met its stated specifications.
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
For each psychoactive substance or product manufactured in the
facility
The Authority will require:

the quantitative formulation of the psychoactive product

the dose form of the psychoactive product (eg, tablet, suspension, capsule)

detailed information on how the psychoactive product is made, and proof that the process
consistently produces a high-quality product

proof that the manufacturing facility can test the quality of the psychoactive product
accurately

validation of the test methods used for both psychoactive substances and psychoactive
products manufactured at the facility

an outline of stability trials that will be conducted to show the psychoactive product does not
degrade.
2.4 Overview of additional requirements by
22 April 2015
For each psychoactive substance or product manufactured in the
facility
The Authority will require:

additional information to demonstrate the full characterisation of the psychoactive
substance, including full details of the chemistry, the manufacture and the controls placed on
manufacture, and information on the stability of the psychoactive substance

additional information on the controls on the quality of the excipients, packaging materials,
delivery devices and intermediate products used

information to support the ongoing stability of the psychoactive product.
For the manufacturing facility

An update on the ‘manufacturing quality development plan’ showing how the facility will
move to a fully GMP certified environment within 12 months following enactment of the
Psychoactive Regulations for all bulk psychoactive substance, psychoactive product, packing,
filling and sterilisation sites.
2.5 Overview of additional requirements to
be phased in after 22 April 2015
For the manufacturing facility
GMP compliance for all psychoactive substance and product manufacturing sites to be in place
12 months after commencement of the Regulations, with appropriate certification provided to
the Authority.
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
5
Appendix 1: Summary of requirements for
implementation of the Code
Table A1.1: Summary of data requirements for compliance with the Code and associated implementation timeframes
Aspect of
manufacture
Requirements available from 17 January 2014
Requirements by 22 April 2014
Requirements by 22 April 2015
Psychoactive
substance
Psychoactive substance manufacturer
Psychoactive substance manufacturer
Psychoactive substance manufacturer






6
Details of each psychoactive substance manufacturing
site must be provided, including postal address.
Specifications applied by the psychoactive substance
manufacturer to the bulk psychoactive substance must
be provided.
Specifications must cover all relevant quality
parameters, including:
– identity
– physiochemical properties
– organoleptic
– physical (including crystalline form and particle size
distribution, if applicable)
– chemical
– stereochemical
– microbiological quality parameters.
A justification must be provided for nonpharmacopoeial tests, test procedures, requirements
and limits. If certain tests are not carried out routinely,
a justification must be provided.
Satisfactory representative batch analytical data must
be supplied for typical batches of bulk active
substance, preferably as certificates of analysis. Note
that any certificates of analysis submitted must have
been signed.



All test methods must be shown to have been

validated.
All assay and related product/degradation product
and residual solvent impurity-level tests must
have been validated (as appropriate) for
specificity/selectivity, limit of detection, limit of
quantitation, accuracy, precision, repeatability,

linearity, stability of solutions, and
robustness/ruggedness.
Proof must be provided that the related substance
assay procedure is adequate to detect and control
all the related substance impurities actually or
potentially present in the bulk substance
produced using the intended manufacturing
process.
Any ‘house’ reference standard(s) used in the
testing must be characterised and the suitability of
use demonstrated by the provision of analytical
data.
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
Full compliance with the relevant sections of
the Code of Manufacturing Practice by
22 April 2015, excepting that evidence of GMP
will be required for all sites that manufacture
psychoactive products 12 months after
commencement of the Regulations.
The most significant requirement will be that a
drug master file (DMF) or a certificate of
suitability to the monographs of the European
Pharmacopeia (CEP), issued by the European
Directorate for the Quality of Medicines, must
be submitted for each supplier of bulk
psychoactive substance.
Aspect of
manufacture
Requirements available from 17 January 2014
Requirements by 22 April 2014
Requirements by 22 April 2015
Psychoactive
substance
(continued)
Psychoactive product manufacturer
Psychoactive product manufacturer
Psychoactive product manufacturer









Details on what psychoactive substances are
manufactured in the facility, the number (and dates) of
batches produced since commercial production began
and, the batch sizes, and number of individual units
produced.
Copies of the ‘in-house’ or pharmacopoeial
specifications applied by the psychoactive product
manufacturer to the bulk psychoactive substance must
be provided.
Specifications must cover all relevant quality
parameters, including:
– identity
– physiochemical properties
– organoleptic
– physical (including crystalline form and particle size
distribution, if applicable)
– chemical
– stereochemical
– microbiological quality parameters.
A justification must be provided for non-pharmacopoeial
tests, test procedures, requirements and limits.
If certain tests are not carried out routinely, a
justification must be provided.
If the psychoactive product manufacturer does not
carry out all tests, or uses different test procedures,
requirements and limits to those on the specification
from the psychoactive substance manufacturer, a
justification must be provided.
Satisfactory representative batch analytical data
generated by the psychoactive product manufacturer(s)
must have been supplied for typical batches of bulk
active substance from each supplier, preferably as
certificates of analysis. Note: any certificates of
analysis submitted must have been signed.
Specified limits for all tests on the specifications must
be adequately justified and supported by batch
analysis data.



All test methods must be shown to have been

validated.
All assay and related product/degradation product
and residual solvent impurity-level tests must
have been shown to be validated (as appropriate)
for specificity/selectivity, limit of detection, limit of
quantitation, accuracy, precision, repeatability,
linearity, stability of solutions, and robustness/
ruggedness.
Proof must be provided that the related substance
assay procedure is adequate to detect and control
all of the related substance impurities actually or
potentially present in the bulk psychoactive
substance produced using the intended
manufacturing process.
Any ‘house’ reference standard(s) used in the
testing must be characterised and the suitability of
use demonstrated by the provision of analytical
data.
Full compliance with the relevant sections of
the Code of Manufacturing Practice by
22 April 2015.
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
7
Aspect of
manufacture
Requirements available from 17 January 2014
Requirements by 22 April 2014
Requirements by 22 April 2015
Psychoactive
product
Psychoactive product testing
Composition








8
Details on what psychoactive products are
manufactured in the facility, the dose forms, the
number (and dates) of batches produced since
commercial production began, the batch sizes, and
number of individual units produced.
Details of each psychoactive product manufacturing
site (including every packing, filling and sterilisations
site) must be provided, including the postal address.
Copies of the pharmacopoeial or ‘in-house’
specifications applied by the psychoactive product
manufacturer to the psychoactive product must be
provided.
Specifications must cover all relevant quality
parameters, including those appropriate for the relevant
dose form and mode of dose delivery, including:
– identity
– physiochemical properties
– organoleptic
– physical (including crystalline form and particle size
distribution, if applicable)
– chemical
– stereochemical
– dissolution
– microbiological quality parameters.
If applicable, any non-pharmacopoeial test procedures
used as replacements for, or in addition to, used as
replacements for, or in addition to, those specified for a
product otherwise controlled to a pharmacopoeial
monograph must be appropriate and adequately
justified.
Documentation must be available to demonstrate that
the identity and quality of the psychoactive product are
adequately controlled at release by appropriate
pharmacopoeial or ‘in-house’ psychoactive product
specifications that cover all the necessary organoleptic,
physical, dissolution, chemical, microbiological and
dose delivery parameters relevant to the dose form.
Full quantitative formulation details of the
ingredients in the product, including both the
active and non-active constituents (excipients),
must be provided.
 The quality standards applied to the ingredients
must be stated and defined (eg, pharmacopoeial
or ‘in-house’ standards).
Manufacture




Full details of the manufacturing process must be
supplied, including:
– batch size(s)
– batch formulation (including details of any
overages)
– a detailed description of the manufacturing
process, including any sterilisation steps and
hold stages
– details of the packaging materials and filling/
packaging processes
– in-process controls and critical stages,
including acceptance criteria for each step in
the process (note: controls applied during the
manufacturing and packaging processes need
to be defined, appropriate and adequate to
assure ongoing product quality).
All test procedures must be shown to be selfvalidating or evidence provided to demonstrate
they have been adequately tested in accordance
with pharmacopoeial or ICH requirements.
Evidence of validation, in the form of analytical
validation reports, must be provided.
The method validation must have been generated
on psychoactive product for the final market
formulation(s) manufactured at least at pilot scale
at each of the testing sites. Results for each test
on the specifications must be reported, and any
results that do not meet the specifications must
be adequately justified.
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
Full compliance with the relevant sections of
the Code of Manufacturing Practice by
22 April 2015, excepting that evidence of GMP
will be required for all sites that manufacture
psychoactive products 12 months after
commencement of the Regulations.
Aspect of
manufacture
Requirements available from 17 January 2014
Psychoactive
product
(continued)

The documentation should detail two batches of the
final market formulation(s) of the psychoactive product,
manufactured at least at pilot scale (a minimum of 10%
of proposed full-scale manufacture), at each of the
proposed manufacturing sites must be provided.
Results must be included for each specified test, and
all the reported test results must comply with the
specifications. If not, an adequate explanation or
justification must be provided. Please note: the
Authority would prefer the documentation to be in the
form of certificates of analysis; however, analytical
testing from an acceptably accredited laboratory will be
accepted. Certificates of analysis submitted must be
signed to be accepted.
Control of
excipients

No requirements.
Requirements by 22 April 2014
Requirements by 22 April 2015


Details of the excipients used in psychoactive
products must be provided as part of the
manufacturing requirements, but no quality
control measures are required.



Full compliance with the relevant sections of
the Code of Manufacturing Practice by
22 April 2015. The most significant data
requirements are listed below.
The identity and quality of all excipients
(including capsule shells and their
constituents) must be controlled by either
pharmacopoeial or appropriate ‘in-house’
specifications must be provided.
Any non-pharmacopoeial specifications must
be appropriate to control the identity and the
physical, chemical and microbiological quality
of the material adequately.
Adequate measures must be taken to ensure
that any ingredients of animal origin (eg,
gelatin, magnesium stearate, calcium
stearate, stearic acid) used in the product are
free from TSE contamination in accordance
with European Community and United States
guidelines (see additional information in
Appendix 1).
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
9
Aspect of
manufacture
Requirements available from 17 January 2014
Requirements by 22 April 2014
Requirements by 22 April 2015

Control of
excipients
(continued)

Control of
packaging

No requirements.

A description of the packaging materials must be 
provided as part of the manufacturing
requirements, but no quality control measures are
required.


Control of
delivery
devices

No requirements.

A description of the delivery device must be

provided as part of the filling/packaging aspects of
the manufacturing process, but no quality control
measures are required.

10
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
Satisfactory representative batch analytical
data must be provided for any excipients
controlled by non-pharmacopoeial
specifications. Any certificates of analysis
submitted must have been signed.
Any colouring agents must be compliant with
those accepted for use (see additional
information in Code of Manufacturing Practice).
Full compliance with the relevant sections of
the Code of Manufacturing Practice by
22 April 2015. The most significant data
requirements are listed below.
Any plastic or rubber packaging/closure
materials in contact with the product must be
free from any leachable toxic impurities and
must comply with European Pharmacopeia
(Ph Eur) and United States Pharmacopeia and
National Formulary (USP) requirements for
polymeric materials used in packaging.
Satisfactory representative batch analytical
data must be provided for any primary
packaging materials, containers and closures
in contact with the product. Any certificates of
analysis submitted must have been signed.
Full compliance with the relevant sections of
the Code of Manufacturing Practice by
22 April 2015. The most significant data
requirements are listed below.
Any delivery device(s) supplied with the product
must be clearly defined, suitable for
pharmaceutical use and adequately controlled
for identity, dimensions, physical and chemical
properties, manufacturing defects, sterility, and
dose delivery, as applicable. Where a novel
delivery device is proposed (eg, an electronic
vaporiser), the application must contain
information supporting the use of the device,
including information validating the testing
system used to demonstrate the effectiveness
and safety of the delivery device.
Aspect of
manufacture
Requirements available from 17 January 2014
Requirements by 22 April 2014
Requirements by 22 April 2015
Control of
intermediates



No requirements.
No quality control measures required.

Stability

No requirements.

A stability protocol developed in line with ICH
guidelines must be provided. The protocol must
outline the stability trials to be undertaken to
demonstrate the ongoing quality of the
psychoactive product.




Full compliance with the relevant sections of
the Code of Manufacturing Practice by
22 April 2015. The most significant data
requirements are listed below.
If there is an intermediate product, it must
controlled by separate appropriate
specifications that adequately control all
relevant parameters. Satisfactory
representative batch analytical data must be
provided. Any certificates of analysis
submitted must have been signed.
Full compliance with the relevant sections of
the Code of Manufacturing Practice by
22 April 2015. The most significant data
requirements are listed below.
At least six months’ data demonstrating
stability under real-time storage conditions,
and three months’ data under accelerated
storage conditions will need to be provided.
The stability data submitted must have been
produced in accordance with ICH guidelines
and adequately establish that the bulk active
substance packaged in the intended storage
container and stored under the prescribed
storage conditions will remain within
specifications for the whole of the claimed
shelf life or retest period.
The stability of the market formulations of the
psychoactive product (or formulations that
may reasonably be expected to have the
same stability) packaged as intended for
marketing must have been tested in
accordance with ICH guidelines (including the
ICH requirements for the number and sizes of
batches used) unless otherwise justified.
Preferably, more than one batch of active
substance should have been used in the
manufacture of the stability batches.
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
11
Aspect of
manufacture
Requirements available from 17 January 2014
Requirements by 22 April 2014
Stability
(continued)
Requirements by 22 April 2015




12
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
The stability trial protocol, packaging,
packaging orientation (if relevant), storage
conditions and test procedures must be
described in detail. All of the stabilityindicating organoleptic, physical, chemical and
microbiological quality parameters relevant to
the dose form and type of packaging must
have been included in the testing schedule
and have been monitored using appropriate,
clearly defined, validated (in the testing
laboratory used for the stability samples),
stability-indicating test procedures.
Any changes in test procedures during the
stability trials must be justified and the results
correlated. At least 12 months’ data for
storage under the recommended storage
conditions must be available and must be
submitted with the application (unless
otherwise justified). The stability data should
be updated before submission. Wherever
relevant, results should be expressed
quantitatively rather than as ‘complies’ or
‘passes test’. Any lack of mass balance
between assays and degradation products
must be explained or discussed. If relevant,
preservative levels or effectiveness must be
monitored.
The results (and allowing for extrapolation
within reasonable limits) must adequately
support the proposed shelf life under the
recommended storage conditions (otherwise a
shorter shelf life may be granted until adequate
stability data can be provided to support the
proposed shelf life).
If relevant, the stability of the product after first
opening, reconstitution or dilution (as
applicable) must have been investigated and
shown to be adequate for the intended use of
the product.
Aspect of
manufacture
Requirements available from 17 January 2014
Requirements by 22 April 2014

Stability
(continued)
GMP
Requirements by 22 April 2015

No requirements.

Provision of a ‘manufacturing quality development 
plan’ setting out how the manufacturer proposes
to move to a licensed GMP operating
environment must be provided within the time
period stipulated.

If relevant, adequate storage instructions and
time limits for use of the product after first
opening or reconstitution or dilution must be
stated on the draft product label, and in any
package insert.
An update on the ‘manufacturing quality
development plan’ showing how the facility will
move to a fully GMP certified environment
within 12 months following enactment of the
Psychoactive Regulations for all bulk
psychoactive substance, psychoactive
product, packing, filling and sterilisation sites.
Note: Acceptable evidence of GMP must be
provided within 12 months following
enactment of the Psychoactive Regulations for
all bulk psychoactive substance, psychoactive
product, packing, filling and sterilisation sites.
Psychoactive Substances: Code of Manufacturing Practice – Implementation plan
13