GUIDELINE ON THE PART 1: REGULATION OF Guidance for MEDICINAL IN Applicants for a Medicinal Cannabis Licence Edition 1.0

February 2020

Medicinal Cannabis Agency, Ministry of Health

This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

Contents

Contents ...... 1 Introduction ...... 2 The licensing framework ...... 2 Duration of licence [regulation 44] ...... 2 Completing the application form for a medicinal cannabis licence ...... 3 Section 1 – Applicant information ...... 3 1.1 Eligibility to hold a licence - individuals ...... 3 1.2 Applicant details - individual ...... 4 1.3 Eligibility to hold a licence - entity ...... 4 1.4 Applicant details – entity ...... 5 Section 2 - Responsible persons ...... 5 2.1 Eligibility to be a responsible person ...... 5 Section 3: Request for criminal conviction history ...... 5 Activities covered by the medicinal cannabis licence ...... 6 Application fees ...... 7 Completing the application form for activities to be added to a medicinal cannabis licence...... 8 Section 1 – Description of the Activity ...... 8 Section 2 - The location or locations to be used for each activity ...... 9 Section 3 - Security arrangements at the location ...... 10 DRAFT - Tool to use when submitting an application - Security procedures ...... 10 Section 4 - Tracking and record keeping ...... 13 Section 5 - Destroying waste material ...... 13 Section 6 Transport of cannabis material ...... 14 Additional information specified for cultivation activity ...... 14

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This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

Introduction

In December 2017, the Government committed to establishing a Medicinal Cannabis Scheme (the Scheme) to improve access to quality medicinal cannabis products through: • Establishing a licensing regime to enable the commercial cultivation of medicinal cannabis and the manufacture and supply of medicinal cannabis products in New Zealand; and • Setting quality standards for medicinal cannabis products to give prescribers, consumers and export markets confidence that the medicinal cannabis products available meet minimum standards of quality. The Medicinal Cannabis Agency (the Agency) has been established within the Ministry of Health to administer the Scheme. Part 1 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (the Regulations) sets out the minimum quality standard that applies to medicinal cannabis products. Part 2 of the Regulations sets out the licensing framework for activities relating to the cultivation of medicinal cannabis and the manufacture and supply of medicinal cannabis products. This guidance document is provided to assist you, the applicant, to apply for a Medicinal Cannabis Licence under the (the Act) and the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 (the Regulations). While every attempt has been made to explain the scope of the information that is required, it is your responsibility to ensure that you understand what your obligations are under the Act and Regulations and that all the information provided is true and accurate. You should submit your application to the Medicinal Cannabis Agency (the Agency) on the following form and include all the supporting information requested on the form. You should retain a copy of the application for your records. [link to form] Note that the application form identifies the minimum information required by the Regulations. You should provide as much additional information as necessary to describe your proposed activities.

The licensing framework The Regulations provide for a single medicinal cannabis licence which authorises the licence holder to carry out one or more of the following types of licensed activity: a) a cultivation activity [regulation 23] b) a nursery activity [regulation 24] c) a research activity [regulation 25] d) a possession for manufacture activity [regulation 26] e) a supply activity [regulation 27] You must apply for a medicinal cannabis licence and at least one of the above activities. You can choose whichever activity or combination of activities for which you wish to be licensed. The licensing framework enables you to submit a single application to conduct multiple activities, with the intention of reducing the overall administrative burden on applicants.

Duration of licence [regulation 44]

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This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

The medicinal cannabis licence is valid for one year from the date of issue and may be renewed on application. The activities authorised under the medicinal cannabis licence will be valid for the period of the licence. This means that an activity that is added to the licence at the time the licence is issued is also valid for one year. You can apply for activities to be added to your medicinal cannabis licence at any time during the one year licence period, but the activities will only be authorised for the duration of the licence period, unless renewed. Example: A medicinal cannabis licence which authorises cultivation activity issued on 10 October 2020 is valid until 9 October 2021. An application is made to add possession for manufacture activity to the activities authorised under the licence, which is approved on 10 April 2021. The medicinal cannabis licence authorising both the cultivation activity and the possess for manufacture activity will expire on 9 October 2021. An application to renew the medicinal cannabis licence, the cultivation activity and the possess for manufacture activity will need to be made at least one month before 10 October 2021 in order for you to continue these activities.

Completing the application form for a medicinal cannabis licence

The application form for a medicinal cannabis licence requires you to supply the following information: • applicant details (individual or an entity (body corporate or partnership)) • types of activities to be covered by the application for a licence Section 1 – Applicant information

You can apply for a medicinal cannabis licence as an individual or an entity (a body corporate or partnership).

1.1 Eligibility to hold a licence - individuals [regulation 29] To hold a licence, you must be 18 years or older and live in New Zealand. Ministerial approval is required to issue a licence if you - • have had a conviction under the Misuse of Drugs Act 1975; or • have had a licence issued under the Misuse of Drugs Act 1975 or any regulations1 made under that Act that has been revoked [regulation 40(3)] In deciding whether to approve an application, the Director-General may also have regard to whether you have been convicted of a crime involving dishonesty in New Zealand or overseas, or an offence overseas that, if committed in New Zealand, would be an offence under the Misuse of Drugs Act 1975.

A crime involving dishonesty is described in the Crimes Act 1961. It generally includes theft, fraud, receiving, conversion, corruption, bribery, trading in influence and corrupt use of information. Offences against the Misuse of Drugs Act 1976 include the manufacture, supply or

1 Misuse of Drugs Regulations 1977; Misuse of Drugs (Industrial ) Regulations 2006; Misuse of Drugs (Medicinal Cannabis) Regulations 2019 Page 3 of 14

This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

possession of illicit substances, including the possession of utensils. Convictions covered under the Criminal Records (Clean Slate) Act 2004 may not need to be disclosed. For more information, please visit the Ministry of Justice website (https://www.justice.govt.nz/criminal-records/clean-slate/) or seek independent legal advice.

You must be entitled to use the location or locations specified in the application for the licence for the types of licensed activity sought. If you don’t own the property, you must obtain written permission from the owner to use the property for the licensed activity sought and submit this with your application. You must also be familiar with, and have the expertise and resources to comply with, the obligations imposed on the licence holder under these Regulations for the types of licensed activity sought.

1.2 Applicant details - individual The applicant is the contact person to whom the Agency will communicate on all matters regarding the licence application. Information required: • Full name and date of birth (an individual applicant must be 18 years or older) • Physical address (street address) • Postal address • Contact details (contact phone number and email address).

1.3 Eligibility to hold a licence - entity Directors or partners of an entity must be 18 years or older. A body corporate must be incorporated in New Zealand or the partners of the entity must reside in New Zealand. Ministerial approval is required to issue a licence if the entity or any director or partner of the entity - a) has a conviction under the Misuse of Drugs Act 1975; or b) has had a licence issued under the Misuse of Drugs Act 1975 or any regulations2 made under that Act that has been revoked. [regulation 40(3)] In deciding whether to approve an application, the Director-General may also have regard to whether the entity or any director or partner of the entity, has been convicted of a crime involving dishonesty in New Zealand or overseas, or an offence overseas that, if committed in New Zealand, would be an offence under the Misuse of Drugs Act 1975.

The entity must be entitled to use the location or locations specified in the application for the licence for the types of licensed activity sought. This means that they will either own the property or have written permission from the owner to use the property for the types of licensed activity sought. One or more directors or partners of the entity must have the expertise, and the entity the resources to comply with the obligations imposed on the licence holder by the Regulations for the types of licensed activity sought.

2 Misuse of Drugs Regulations 1977; Misuse of Drugs (Industrial Hemp) Regulations 2006; Misuse of Drugs (Medicinal Cannabis) Regulations 2019 Page 4 of 14

This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

1.4 Applicant details – entity The entity contact person is the person who is authorised to communicate with the Agency on all matters regarding this licence application. Information required: • Entity contact details – name of contact person, phone number and email address • Entity name - (body corporate / partnership / organisation) • New Zealand Companies Office Company registration number – a body corporate must be incorporated in New Zealand • Physical address of entity - street address • Postal address of entity - if the postal address is the same as the physical address, check the box. You do not need to provide the details again. • For each director or partner of the entity - full name and date of birth (directors or partners of the entity must be 18 years or older). Section 2 - Responsible persons

2.1 Eligibility to be a responsible person If the licence holder is an individual, they must have the expertise and the resources to comply with the obligations imposed by the Regulations and any conditions imposed by the Director General. If the licence holder is an entity, the Regulations require the entity to nominate one or more individuals to be a responsible person who is familiar with and has the expertise to comply with the obligations imposed by the Regulations and any conditions imposed by Director General. [regulation 30(f)] The nominated responsible person must be authorised by the entity concerned to control the activity or activities for which the licence is sought, and to communicate with the Director General on behalf of the entity. [regulation 31(a)] Responsible persons must be 18 years or older and live in New Zealand. Ministerial approval is required if the nominated responsible person – a) has a conviction under the Misuse of Drugs Act 1975 b) has had a licence issued under the Misuse of Drugs Act 1975 or any regulations3 made under that Act that has been revoked..

Section 3: Request for criminal conviction history

[regulation 39] The Regulations require the Agency to check with the Ministry of Justice whether an applicant, director, partner or nominated responsible person has a conviction for a relevant crime or offence. To enable the Agency to do this, each applicant individual, director, partner or nominated

3 Misuse of Drugs Regulations 1977; Misuse of Drugs (Industrial Hemp) Regulations 2006; Misuse of Drugs (Medicinal Cannabis) Regulations 2019 Page 5 of 14

This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

responsible person must fill in steps 2-5 on the Ministry of Justice Request criminal convictions history – third party form: https://www.justice.govt.nz/criminal-records/get-someone-elses/ The request form must be accompanied by the necessary identification. The identification must: • be a clear and readable copy • exactly match the details in the form - the person’s name on the form must be exactly as it appears on their ID • not be defaced • be one of the following: • a New Zealand drivers licence - this can be current or expired within the last 2 years, but must not be cancelled or a temporary licence • a New Zealand passport - this must be signed and can be current or expired within the last 2 years, but must not be cancelled • an overseas passport - this must be signed and current • a New Zealand firearms licence - this must be current. If the person doesn’t have any of the above forms of identification, they will need to ask someone to confirm their identity by filling in step 5 on the form. Guidance on how to fill in the form is on the Ministry of Justice’s website at: https://www.justice.govt.nz/assets/Documents/Publications/completing-request-for- criminal-conviction-history-3rd-party2.pdf The Agency will complete Step 1 of the request form when it is received and submit the requests to the Ministry of Justice when the application has been accepted for assessment.

Activities covered by the medicinal cannabis licence

At least one activity must be included in an application for a medicinal cannabis licence. Further activities can be added once the licence has been issued but will only be covered by the licence for the remainder of the duration of the licence. The medicinal cannabis licence can cover: • one activity at one site only; or • one or more activities at the same site; or • one or more activities at different sites. Consideration of your application involves an assessment of the activity and an assessment of the site (including an inspection of the site to verify security arrangements). A separate application is required for each activity and/or for each site.

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This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

Application fees

Table 1. Fees payable (exclusive of GST)

Application for Fee for initial Fee for consideration Fee for consideration check if new if renewal

Anything (licence $300 and any activities)

Medicinal cannabis $300 $2,250 $2,250 licence

Cultivation activity $300 $4,750 $2,950

Nursery activity $300 $650 $650

Research activity $300 - -

Possession for $300 $2,700 $$2,300 manufacture activity

Supply activity $300 $5,550 $5,150

Declaration of a $650 $650 variety of cannabis established in New Zealand

The initial check is to confirm that an application appears to be in order. Incomplete applications will be returned and you will be advised that a new application will be required. The fee for the initial check must be paid when the application is submitted. If the initial check verifies that the application appears to be in order then you will be invoiced and must pay the full application fee before your application can be considered. During the assessment of your application, the Agency may need additional information and clarification. If further information is requested, a licence cannot be granted until that information has been provided and the Agency is satisfied that all concerns have been addressed. The application fee is calculated on the cost of the medicinal cannabis licence plus the cost for each activity. Example: If someone applies for a new licence for a cultivation and supply activity, they must initially pay $300 for the initial check of the application. If the initial check confirms that the application appears to be in order, the applicant must then pay $12,550, comprising— (a) $2,250 for consideration of the new licence; and (b) $10,300 for consideration of the 2 new types of licensed activity ($4,750 for the cultivation activity + $5,550 for the supply activity). If the application is for supply of a new dosage product, the applicant must also pay a further $13,400 under regulation 36. All amounts exclude GST.

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This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

Once you have submitted your application form and paid the required fee, your application cannot be altered. If you become aware that changes are needed, then you need to discuss those changes with the Agency. Minor changes such as correction of a phone number or misspelt address details may be allowed, however if you want to make substantial changes such as changes to site information that may affect the outcome of the consideration you may be asked to submit a new application and to pay the relevant application fee again. The application fee is non-refundable.

Completing the application form for activities to be added to a medicinal cannabis licence

Section 1 – Description of the Activity

[regulation 32(3)(a)(i)] Table 2. Activities that can be added to a medicinal cannabis licence

Activity This activity covers

Cultivation activity • Cultivation of cannabis for therapeutic use, including growing, harvesting and drying cannabis plant material [regulation 23] • Procurement of cannabis: • from a holder of a medicinal cannabis licence that authorises its supply • no more than 50 seeds and 20 plants from each holder of a licence issued under the Misuse of Drugs (Industrial Hemp) Regulations 2006 that authorises its supply • no more than 50 seeds and 20 plants (from any source) of a variety of cannabis that is established in New Zealand and that the applicant has declared under regulation 35 • import under a MoDA licence to import controlled drugs • Production of starting material, including by harvesting or drying cannabis • Supply within New Zealand to a person who is authorised to receive it • Possession of cannabis

Nursery activity • Supply of cannabis seeds or plants for cultivation of cannabis for therapeutic use [regulation 24] • Procurement of cannabis from a holder of a medicinal cannabis licence that authorises its supply • import under a MoDA licence to import controlled drugs • Supply within New Zealand to a person who is authorised to receive it • Possession of cannabis

Research activity • Research about cannabis for therapeutic use • Procurement of cannabis for research purposes from a [regulation 25] holder of a medicinal cannabis licence that authorises its supply • import under a MoDA licence to import controlled drugs for research purposes • produce or manufacture a cannabis-based ingredient or medicinal cannabis product for research purposes

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This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

Activity This activity covers • supply or administer a medicinal cannabis product for research purposes • Possession of any starting material, cannabis-based ingredient, or medicinal cannabis product for research purposes

Possession for • Procurement of any starting material, cannabis-based manufacture activity ingredient, or medicinal cannabis product • from a holder of a medicinal cannabis licence that [regulation 26] authorises its supply [note: a licence to • by import under a MoDA licence to import controlled manufacture medicines drugs issued under the • The following manufacturing activities but only to develop or Medicines Act 1981 is test the related processes or products or to validate that also required to testing manufacture products for • extracting a cannabis-based ingredient patient use] • manufacturing or packing a medicinal cannabis product • testing any cannabis or medicinal cannabis product • Possession of any starting material, cannabis-based ingredient, or medicinal cannabis product

Supply activity • Procurement of any starting material, cannabis-based ingredient, or medicinal cannabis product [regulation 27] • from a holder of a medicinal cannabis licence that authorises its supply; or • by import under a MoDA licence to import controlled drugs • Supply of • starting material not intended for export, cannabis based ingredient, or medicinal cannabis product within New Zealand to a person authorised to receive it • Supply by export of starting material intended for export, cannabis-based ingredient, or medicinal cannabis product that is specified on a licence to export controlled drugs issued under the Misuse of Drugs Regulations 1977 • Possession of any starting material, cannabis-based ingredient, or medicinal cannabis product

The following information is required for each type of licensed activity to be added to the medicinal cannabis licence. Section 2 - The location or locations to be used for each activity

[regulation 32(3)(a)(ii)] Activities are usually site specific. If you intend to conduct licensed activities at more than one site, a separate application must be submitted for each site. The following information is required for the site at which the activity will be carried out: • Physical address • Legal description and area of land and premises • Geographical coordinates for the site • A plan or map, if required to identify the location. Attach a geographical plan of the site showing those areas where the cannabis is Page 9 of 14

This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

proposed to be grown or stored. Provide a full description of the geography of the cultivation area, including natural features, structures (for example, fence lines, buildings or sheds), roads or paths present. It would also be helpful to include clearly marked maps and Land Information New Zealand (LINZ) photographs of the site showing: • The property with GPS coordinates marked • Fence lines • Roads, buildings, residences and any publicly accessible areas • Storage and processing areas • The paddocks, blocks or glasshouses intended for . For buildings, include details of the nature of the construction of the facilities, access points such as windows and doors, and restricted areas of access. Floor plans and photographs of the buildings and facilities (if relevant) should also be included.

Section 3 - Security arrangements at the location

You must ensure that your application includes details of the security arrangements in place to minimise the risk of diversion of cannabis to illicit use. The Agency will take into account a range of factors in determining whether your security arrangements are adequate for the activities you wish to undertake. This includes, but is not limited to, the nature and size of the crop, physical site security, operational procedures and personnel security arrangements. Your application should include detailed arrangements for physical and procedural security, and the security of staff members at the location. The Agency’s assessment of the security arrangements involves a desktop assessment of your application and a site inspection to verify that the security arrangements are in place and operational. At the time of your application, you should have completed construction of the facility and have installed the physical security features outlined in your application. The assessment of your application is not considered complete until an inspection of the site has verified that adequate security arrangements are in place before a license can be issued. Once verified, your security arrangements will form part of your licence conditions which may be reviewed through the ongoing inspection and compliance framework.

DRAFT - Tool to use when submitting an application - Security procedures The Agency will assess the adequacy of the security measures based on the risk of diversion of cannabis material to illicit use. The Australian Office of Drug Control has published guidance for assisting licence applicants to design and meet required security standards, which can be used as guidance for information that should be covered in the security plan: https://www.odc.gov.au/publications/guideline-security-medicinal-cannabis It may be useful to engage a security specialist to do a security assessment of the site and operations. Low THC cultivars (less than one percent THC4) have minimal intoxicating potential and would be of little use to the illicit market compared to high THC cultivars. If you intend to

4 WHO Expert Committee on Drug Dependence – Critical Review - Cannabis and Cannabis Resin published by World Health Organization 2018. Page 10 of 14

This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

cultivate only approved hemp (low THC) cultivars then the expectations around intruder resistance and access controls would be significantly reduced compared to high THC cultivars. If you intend to cultivate high THC cultivars or cultivars with unknown or mixed THC levels, then the default is that a higher level of security would be required. To assist you in preparing your application, please complete the Applicant Response and Reference Document columns in the table below. Guidance on what information is required has been provided in italics.

Table 3. Security arrangements

Q Question Applicant Response Reference Document(s)

1 What do the premises look like? [Please provide a site [Attach a site plan and a plan and a floor plan of floor plan of any buildings if any buildings if applicable] applicable]

2 Where will cannabis material be [With reference to the handled, stored on the premises? plan(s) provided for Q1, indicate the areas where cannabis will be stored and handled including waste materials]

3 How is visitor access to the [Provide a description of premises managed? the measures in place [Attach any SOPs or and how these documents needed to measures achieve demonstrate measures in control of visitor access place] to the premises] What prevents the public from 4 [Provide a list of the [Attach a site plan and a accessing the premises? features of the premises floor plan if applicable with that prevent public any physical features access. Provide a referred to in your description detailing how description attached] these features act to prevent public access. Examples may include physical features such as trenches, fences, gates] [Describe the measures 5 What will stop intruders from [Attach any procedures or in place and include how accessing the premises? other documents these will achieve referenced in your protection from description] intruders. This may include physical features, procedures, controls on equipment or buildings]

6 What measures are in place to [Provide a description of [Attach any procedures or control and monitor staff access the measures and how other documents to cannabis material? they achieve control and referenced in your monitoring of staff description] access to cannabis]

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This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

Q Question Applicant Response Reference Document(s) [Please describe what is 7 What measures are in place to [Reference and attach any in place and how it detect unauthorised access to the relevant procedures or detects unauthorised site and theft of cannabis diagrams to assist in your access or theft. material? response] This should include any measures to detect the unauthorised access at the time it is occurring and any measures to detect the unauthorised access or theft after the fac.]

8 What procedures are in-place to [Please describe the [Reference and attach deal with theft or loss? step-by-step actions that relevant procedures] will be taken in event of theft or loss. This should include an indication of when police and the Medicinal Cannabis Agency will be informed of the theft or loss]

9 What procedures are in place to [A review of your [Attach disposal SOPs that manage waste cannabis materials processes should be demonstrate measures in including waste plant materials completed and the place] and waste cannabis extracts? different sources of waste identified. Waste should be risk assessed and an appropriate method of disposal implemented that addresses any risk of diversion to illicit sources while adhering to any relevant environmental regulations]

10 How will cannabis material be [Provide a description of [Attach inventory control tracked through its lifecycle from how the inventory SOPs that demonstrate seed sowing through to finished control measures enable measures in place] product. Include a description of traceability of cannabis how waste material is tracked. material throughout the lifecycle]

11 For outdoor cultivation only: What [Please describe how measures are in place to address risk is managed] the risk of dispersal of the plants from the cultivation area?

12 For outdoor cultivation of cultivars [Please describe how that are not approved industrial risk is managed] hemp cultivars: What measures are in place to address the risk of cross-pollination from your medicinal cannabis to any industrial hemp crops in the vicinity?

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This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

Q Question Applicant Response Reference Document(s)

13 For outdoor cultivation of cultivars [Please describe how What measures are in place to risk is managed]

protect the plants from access by any animals?

Section 4 - Tracking and record keeping

Licence holders with a cultivation activity must keep records of the amounts of cannabis that they – • Cultivate; or • Maintain for the purposes of propagation; or • Produce and store; or • Supply within NZ to another licence holder; or • Destroy or dispose of. Records must also be kept of • failure by the licence holder to sow cannabis seeds intended for sowing • failure of any cannabis seeds to germinate, or of any crop to reach maturity • the amount of material you possess at the time of stocktake. You should provide details of the record keeping arrangements in place to track and trace the life cycle of each of the prohibited plants grown from seed or cutting, through to harvest, drying and processing, and if applicable, through extraction/manufacture, including accounting for destruction or disposal of any prohibited plant material. This can be recorded electronically or held on paper or some other means. The method of recording should be secure, and you must ensure that they cannot be tampered with, or destroyed. you should consider means of backing up records. Records should be able to be produced for viewing on demand by the Ministry of Health. Section 5 - Destroying waste material

You must outline procedures to ensure that all unwanted or excess material (particularly seed head, seed and flower) is disposed of in a way that renders the material unusable, unrecognisable and irretrievable. This includes documenting procedures for destruction and any arrangements in place with a third party to dispose of or destroy waste material. Third party arrangements should also include: • Secure transport to and from another site • Security arrangements at the third-party site.

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This DRAFT guidance has been prepared for discussion at the Industry and Māori Industry workshops February – March 2020. It is work in progress and should not be taken as final.

Section 6 Transport of cannabis material

If transportation of cannabis material is involved, you should adhere to the requirements of regulation 23 of the Misuse of Drugs Regulations 1977 (MODR) regarding written authority, endorsement of receipt, and delivery personally (or by an employee) or a carrier, or by registered or insured post. If these requirements are met, the carrier is not required to hold a Licence to Deal in Controlled Drugs.

Additional information specified for cultivation activity You should provide sufficient information to cover the scale of your operations, beginning from obtaining the seed, through sowing/planting, and treatment after harvest. There should be enough information in the operating procedures to describe the nature of the operations involved in sufficient detail so that the steps in any particular procedure can be understood and followed. Describe how the harvested crop material will be stored, used, disposed of, or retained in undertaking this activity. The extent of the processing of cannabis plant material allowed under a medicinal cannabis licence with cultivation activity is limited to physical processes such as harvesting, collection/discarding, and drying. These operating procedures can be provided in the form of standard operating procedures attached to the application. We would expect companies undertaking cultivation to have formal operating procedures. List the name and THC content of the cultivars you wish to grow. Outline the purpose of cultivation activity – cultivation of cannabis for a nursery, research, possession for manufacture, or supply activity. Do you intend to undertake these activities yourself, or do you have an agreement to supply cannabis to the holder of a licence for a cultivation, nursery, possession for manufacture, or supply activity. Provide the agreement if possible.

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