Guidance on personal production of cannabis for medical purposes

On this page

• Disclaimer
• Purpose
• Background
• Registering with Health Canada to produce cannabis for medical purposes
• Authorities to refuse to issue, renew, amend or revoke a registration
• Factors which may be considered in assessing the risk to public health or public safety
• Notice of refusal
• Conclusion
• Contact us

Disclaimer

This document provides guidance on the access to cannabis for medical purposes program, and the provisions of the Cannabis Regulations to refuse (to issue, renew, amend) or to revoke a registration to produce cannabis for medical purposes. This includes registration by individuals to produce cannabis for their own medical purposes or to designate someone to produce it for them.

In the event of any inconsistency or conflict between the Cannabis Act and the Cannabis Regulations and this document, the aforementioned legislation will take precedence.

This document is not intended to provide legal advice regarding the interpretation of the Cannabis Act and the Cannabis Regulations. If an individual has questions about their legal obligations or responsibilities under the Cannabis Act and the Cannabis Regulations, they should consider seeking the advice of legal counsel.

Health Canada reserves the right to modify this document as appropriate and without notice.

Purpose

This document is meant to provide guidance regarding the Cannabis Act and the Cannabis Regulations to individuals who apply for a registration or are authorized to access cannabis for medical purposes by growing it themselves or by designating someone to grow it for them. Some of this guidance can also be found in other documents on Health Canada's website or that are sent to applicants or registered persons. This information has been brought together in this one document to better support applicants and registered persons and to promote understanding among other stakeholders.

This document also provides guidance on factors that Health Canada may consider in making decisions to refuse or revoke a registration on public health and public safety grounds pursuant to the Cannabis Regulations.

Health Canada may request or consider information not specifically described in this and other guidance and registration application documentation in order to make decisions respecting an application or an existing registration.

Guidance documents are administrative instruments not having force of law. Alternative approaches to the principles, factors and practices described in this document could be used. This document should be read in conjunction with the Cannabis Act, the Cannabis Regulations, and other applicable guidance documents.

Background

The Cannabis Act (the Act) and the Cannabis Regulations (the Regulations) came into force on October 17, 2018. The purpose of the Act is to protect public health and public safety. The Act creates a strict legal framework for controlling the production, distribution, sale and possession of cannabis across Canada. The Act aims to accomplish 3 goals:

• keep cannabis out of the hands of youth
• keep profits out of the pockets of criminals
• protect public health and safety by allowing adults access to legal cannabis

Consistent with the advice of the Task Force on Cannabis Legalization and Regulation, which was mandated to consult and provide advice to the Government of Canada on the design of a legislative and regulatory framework for legal access to cannabis in Canada, the Act and the Regulations maintain a separate system to provide patients with reasonable access to cannabis for medical purposes.

The Regulations give patients that have a signed medical document from their health care practitioner the following options to access cannabis for medical purposes:

• purchase quality-controlled cannabis from a wide variety of federally licensed sellers inspected by Health Canada
• produce a limited amount of cannabis for their own medical purposes as authorized by their health care practitioner ("personal production")
• designate someone to produce it for them ("designated production")

Subject to the legal age limit in their province or territory, individuals authorized to use cannabis for medical purposes may also access cannabis by purchasing it directly from:

• provincial or territorial authorized retail outlets
• provincial or territorial authorized online sales platforms

Registration with the Minister^{Footnote 1} for personal or designated production is subject to a limited number of requirements set out in the Regulations. The Regulations also provide the Minister with the authority to refuse or to revoke a registration in certain circumstances where public health or public safety concerns exist.

Health Canada administers the Act and Regulations. In doing so, it is responsible for administration of the Medical Access Program, and uses authorities under the Act and Regulations to undertake activities such as:

• conducting additional verifications when warranted (for example, contacting the health care practitioner to confirm the validity of the medical document, to confirm the daily amount, and to request additional information);
• refusing or revoking a registration, for among other reasons, if it is determined that an applicant has submitted false or misleading information as part of their application, such as a forged medical document;
• proactively sharing information with provincial and territorial medical licensing bodies (for example, College of Physicians and Surgeons of Ontario, Collège des médecins du Québec) about the authorizing practices of health care practitioners in their jurisdiction, to inform any action they decide to take;
• verifying that there are no more than four registrations at any given production site—the maximum allowed in the Regulations; and
• conducting inspections of personal registration and designated production sites to further verify compliance with the Regulations.

The Regulations specify the information that Health Canada may disclose to a Canadian police force or member in the context of an active law enforcement investigation, and on the condition the information is only used for the purposes of the investigation or the administration and enforcement of the Act or the Regulations. Health Canada supports law enforcement representatives by confirming, when necessary, that specific individuals are authorized to possess or produce a limited amount of cannabis for medical purposes. In the context of an investigation, law enforcement also has the ability to enter residences and any production sites.

Registering with Health Canada to produce cannabis for medical purposes

The Regulations establish requirements for patients to register with Health Canada to produce their own cannabis for medical purposes or designate someone to produce it for them. Detailed information on how to register with Health Canada can be found on the Health Canada website.

Authorization from a health care practitioner

Patients who wish to register to produce cannabis for their own medical purposes or to designate someone to produce it for them require a medical document provided by a health care practitioner. The Regulations set out the information that must be included in the medical document. For example, the medical document must include the daily amount of dried cannabis (expressed in grams) that the health care practitioner authorizes and the period of use, which cannot exceed one year.

Upon receiving an application, Health Canada may require the submission of any additional information from the patient and / or health care practitioner that is necessary to consider the application.

Health Canada has published documents on its website for health care practitioners that provide information on research into the medical use of cannabis, dosing and administration and patient information. Many provincial and territorial licensing bodies, as well as the College of Family Physicians of Canada, have published their own guidance for health care practitioners.

Requirements

Individuals must meet the requirements of the Regulations to produce cannabis for their own medical purposes or to designate someone to produce it for them.

• To be eligible to grow for oneself, an individual must ordinarily reside in Canada, be an adult, and must not have been convicted as an adult of certain cannabis-related offences in the preceding 10 years while they were authorized to produce cannabis for medical purposes.
• In the case of a designated person, similar eligibility criteria apply, though it is a prerequisite that the individual must not have been convicted of certain cannabis and controlled substances-related offences, regardless of whether the individual was a registered or designated person at the time.
• A designated producer may produce for a maximum of two registrations (for themselves and one other person, or for two other persons).
• A maximum of four registrations can be authorized at any one site.

The individual signing the application must attest that they will take reasonable steps to ensure the security of the cannabis in their possession. While the appropriate measures to secure cannabis should be assessed on a case-by-case basis, some examples of best practices include installing:

• strong locks on the doors to all areas where cannabis is produced
• a safe or an equally protected location that can be secured with a lock (for example: cabinet, closet or trunk) for storage, and if there are children present, use of childproof containers to avoid accidental ingestion
• an alarm system
• a tall fence with a locking gate if growing outside
• an air filtration system to prevent the escape of odours from the production site to reduce the risk of alerting others to the existence and location of the production site

The application and related documents may also be submitted by an adult who is responsible for the applicant. This may occur, for example, if the applicant is a child. The role of the responsible adult includes more than completing and signing the application form on behalf of an applicant. It carries a degree of responsibility for the individual, such as a willingness to:

• be responsible for the individual's use of cannabis for medical purposes
• help administer the cannabis
• be responsible for the security of the cannabis

Personal and / or designated production can take place indoors or outdoors (although not at the same time), and can take place in a residence or at an alternate production site. The authorized location of activities will be set out on the registration.

If producing outdoors, the production site cannot be adjacent to a school, public playground, daycare facility or other public place frequented mainly by persons under 18 years of age.

Once registered for personal or designated production, a person:

• must take reasonable steps to ensure the security of the cannabis in their possession that was produced by personal or designated production, and the security of their registration certificate, if they possess it.
• must operate within the limits set out in the registration certificate, and abide by the maximum possession limit and, where applicable, maximum plant production limit.
• cannot share, sell or provide the cannabis to anyone else. If more cannabis is produced than the registered person intends to use, the excess amount should be destroyed. Prior to disposal, proper steps should be taken to render the cannabis unfit for use or consumption.
• is the only individual (registered person and / or designated person) authorized to possess cannabis plants or tend to them. Unauthorized persons are not entitled to handle the cannabis.
• must report the theft or loss of any cannabis or the registration certificate to a police force within 24 hours and to the Minister (in writing) within 72 hours.
• must not obstruct Health Canada inspectors who may inspect the production site.

In addition to the requirements set out in the Regulations, a registered or designated person remains responsible for complying with all relevant provincial / territorial and municipal laws including building codes and local bylaws about zoning, electrical safety and fire safety, together with all related inspection and remediation requirements and orders.

An individual can take a number of simple precautions to reduce risks to health and safety. If an individual:

• is growing cannabis plants indoors, they should ensure that there is enough ventilation to remove excess moisture and humidity to stop mold from building up on the cannabis plants or in the building.
• makes changes to the structure of a home or electrical system, it may require a building permit or other authorization. It is recommended that advice be sought from a licensed professional to ensure compliance with municipal bylaws and provincial / territorial building codes.
• plans to use chemical products, such as pesticides, ensure that these products are safe for use on a plant that could be eaten or vaporized. Health Canada's homeowner guidelines for using pesticides should be consulted for more information about using pesticides safely.
• is making a product containing cannabis, such as oil or butter, the use of an organic solvent, such as butane, isobutene, propane or propylene, is not permitted. Organic solvents pose significant safety risks, such as fire and explosion. They also pose health risks if the product contains residue from the production process.

Additional guidance on how to safely and securely grow cannabis can be found on the Health Canada website.

In some cases, Health Canada may request additional information with respect to an application. It is the responsibility of the registered or designated person to meet all regulatory requirements and respond to any requests for additional information from Health Canada in a timely manner. In the event that there is a change to the information contained in a registration certificate, the registered person or an adult who is responsible for them, must submit an application to amend the registration certificate to ensure it is kept current at all times.

Authorities to refuse to issue, renew, amend or revoke a registration

Circumstances in which a registration must be refused or revoked

Sections 317 and 318 of the Regulations specify circumstances in which the Minister must refuse to issue, renew, amend or revoke a registration:

The Minister must refuse to issue, renew or amend a registration where:

• the applicant or the designated person is not eligible pursuant to the Regulations
• the medical document does not meet all the regulatory requirements or is no longer valid
• at the time the medical document was provided to an applicant, the individual who provided it was not a health care practitioner, or was not entitled to practise their profession in the province in which the applicant consulted them
• the health care practitioner who provided the medical document notifies the Minister in writing that the use of cannabis by the applicant is no longer supported for clinical reasons
• the given name, surname or date of birth of the applicant is different than what appears on the medical document
• the Minister has reasonable grounds to believe that false or misleading information has, or false or falsified documents have, been provided in, or in support of, the application
• the registration, renewal or amendment would result in the applicant or designated person being authorized to produce cannabis plants under more than two registrations, or where it would result in the proposed site being authorized under more than four registrations

Similarly, the Minister must revoke a registration where:

• the registered person or the designated person are not eligible pursuant to the Regulations
• the registration was issued, amended or renewed on the basis of false or misleading information or false or falsified documents
• the health care practitioner who provided the medical document notifies the Minister in writing that the use of cannabis by the registered person is no longer supported for clinical reasons
• the registered person or the adult who is named in the registration document requests revocation in writing
• the registered person dies

Circumstances in which a registration may be refused or revoked on public health and public safety grounds

The purpose of the Act and the Regulations is to protect public health and public safety, including reducing the risk of cannabis being diverted to the illegal market. In keeping with the purpose of the Act, the Regulations include authorities to refuse or revoke a registration for personal or designated production on public health or public safety grounds.

In particular, subsection 317(2) of the Regulations states that the Minister may refuse to register an applicant or to renew or amend a registration if, in the case where cannabis is to be produced by the applicant or a designated person, the registration, renewal or amendment is likely to create a risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.

Subsection 318(3) of the Regulations states that the Minister may revoke a registration if, in the case where the registered person or designated person is authorized to produce cannabis, the Minister has reasonable grounds to believe that the revocation is necessary to protect public health or public safety, including to prevent cannabis from being diverted to an illicit market or activity.

Factors which may be considered in assessing the risk to public health or public safety

The following information is intended to assist applicants, registered or designated persons and other stakeholders in understanding some of the possible factors that could be considered in assessing public health and public safety concerns in relation to decisions made under subsections 317(2) and 318(3) of the Regulations.

The Minister's authority is exercised on a case-by-case basis. When making decisions under subsections 317(2) or 318(3) of the Regulations, the Minister may examine all factors that are relevant to assessing the risk to public health or public safety, including the risk of cannabis being diverted to an illicit market or activity.

Examples of the factors that may be considered include, but are not limited to:

• Amount of daily authorized cannabis by the health care practitioner and information to support the amount authorized:
  • Is the authorized daily amount of cannabis supported by credible clinical evidence and / or published treatment guidelines?
  • Is the amount of daily authorized cannabis considered reasonable, after taking into account elements, such as the diagnosis, previous treatments, as well as potency, strain, route of administration, cultivation methods, and potential for product loss from processing activities?

In order to seek additional information regarding the amount of daily authorized cannabis, Health Canada may request this information in writing in the application form and / or may contact the applicant or their health care practitioner. Supporting information could, among other things, include data, references or sources to support the authorized daily amount.

Examples of these sources include, but are not limited to, documents published by Health Canada, the provincial / territorial medical licensing authorities, or other research findings by research or health organizations.

Health Canada will examine submitted information, and will consider the source and quality of the information, including whether the information is sourced from peer-reviewed published clinical trials, treatment guidelines, or observational studies.

• Non-compliance or history of non-compliance with the Cannabis Act and Regulations by the registered or designated person, including the relevant circumstances:
  • What is the overall history of non-compliance, including the number, nature and severity of previous instances of non-compliance?
  • How much time has elapsed since the last non-compliance, and how has the person responded to previous non-compliance?
  • Is the registered or designated person growing, or have they grown, more than the amount authorized by the registration?
  • Is the registered or designated person taking, or have they taken, reasonable steps to ensure the security of the cannabis in their possession?
  • Is someone other than the designated or registered person tending, or has someone other than them tended, to the cannabis plants?
  • Is the registered person "selling or renting", or has the registered person "sold or rented", their registration?
  • Is there, or has there been, an apparent, intentional effort on the part of the registered or designated person to circumvent the Act or Regulations such as obstruction of Health Canada inspectors?

The Minister's authority is exercised on a case-by-case basis taking into consideration all available information, including answers to the questions above. As such, there is no pre-determined number of non-compliance events that may result in the refusal to issue, renew, amend or revoke a registration.

• Criminal activity relevant to public health and public safety and / or diversion of cannabis (for example, selling or transferring cannabis produced under a registration to an illegal market):
  • Is the production site linked, or has it been linked, to diversion of cannabis produced under a registration, a controlled substance or a precursor, or to criminal activities?
  • Are the registered or designated person, the owner of the production site, or an individual with another direct link to the site or operation involved in diversion of cannabis, a controlled substance or a precursor, or have they been involved in or do they contribute or have they contributed to such activities?
  • Is the production site linked, or has it been linked, to organized crime? Are the registered or designated person, the owner of the production site, or an individual with another direct link to the site or operation associated with organized crime or have they been associated with organized crime?
• Heath care practitioner is or has been involved with criminal activities in relation to their prescribing practices with cannabis or controlled substances, or has been subject to disciplinary review or action by a licensing authority in relation to their prescribing practices with cannabis or controlled substances:
  • Has a provincial licensing authority investigated or disciplined the health care practitioner in relation to their prescribing practices with cannabis or other controlled substances?
  • Is or has the health care practitioner, in the course of their profession, been involved in or contributed to activities prohibited by or conducted in contravention of the Cannabis Act or the Controlled Drugs and Substances Act?
  • Is or has the health care practitioner been a member of a criminal organization as defined in subsection 467.1(1) of the Criminal Code, or is or has been involved in, or contributes or has contributed to, the activities of such an organization?

If the applicant or registered person is notified in writing of the intent to refuse or revoke their application or registration on the basis of this factor, they will be provided with the opportunity to seek and submit another medical document from a different health care practitioner in support of their application or registration.

These factors may overlap, they are not exhaustive, and other relevant factors could be considered in assessing the risk to public health or public safety. The number of factors present, as well as the circumstances of any events that may be relevant to the determination of the risk, such as the seriousness, recentness, number and frequency, may be considered. If a factor listed above is satisfied, this does not necessarily mean that there will be a refusal or revocation. The Minister will consider the totality of the circumstances.

Information related to these and other factors not listed could be obtained from a wide variety of sources, including but not limited to: an inspection, law enforcement, an international organization, local authority, regulatory or licensing authority or body, the public, or from online sources.

In addition to considering the risks to public health and public safety, other relevant information, including information about the extent to which a negative decision would impair an individual's ability to access cannabis for medical purposes, could be considered before making a decision to revoke or refuse to issue, renew or amend a registration. For example: Is the applicant or registered person able to access cannabis for medical purposes through alternate means? Does the applicant or registered person intend to produce a variety of cannabis or a cannabis product that is not available through other legal access channels?

The circumstances of every application or registration are different and no two cases are identical. As such, the overall merits of each individual application or registration must be assessed on its own, in accordance with the facts that are presented.

Notice of refusal

In the case where the intention is to refuse to issue, renew, amend or revoke a registration due to a risk to public health or public safety, the following steps will be taken as per the Regulations s. 317(3) and s. 318(4):

• The applicant or registered person will be notified in writing of the intent to refuse or to revoke a registration. If applicable, the designated person would be notified in writing of a proposed revocation.
• The notice will set out the reason for the proposed refusal or revocation and the applicant or registered person will be given an opportunity to make written representations. If applicable, the designated person will be notified in writing of the intent to revoke.
• The notice will generally specify a period to make representations and that a final decision on the application or registration will not be made until the representations have been received and considered. If no representations are made within the period of time specified in the notice, a final decision will not be made before the period of time has expired.

If a decision to refuse (to issue, renew or amend) or revoke a registration is made, a notice of the decision will be sent to the applicant or the registered person (as applicable).

If an applicant or registered person does not agree with a decision made by Health Canada and wishes to challenge it, this is generally done by way of judicial review in Federal Court. If you are considering challenging a decision made by Health Canada, you may wish to seek legal advice as soon as possible.

Health Canada publishes administrative data on the personal and designated production program on its website, including the number of personal or designated refusals and revocations.

Conclusion

The Act and the Regulations maintain a separate system to provide patients with reasonable access to cannabis for medical purposes. This document provides guidance on the access to cannabis for medical purposes program.

To achieve the objectives of protecting public health and public safety, including reducing the risk of cannabis being diverted to the illegal market, the Regulations provide the authority to refuse to issue, renew, amend, or revoke a registration for personal or designated production on public health or public safety grounds. Any determination on the use of the power to refuse or revoke on these grounds will be made in accordance with the authority set out in the Regulations and further to the purposes of the Act, taking into consideration the facts of each case.

The information contained in this document is intended to provide applicants, registered persons and stakeholders with information about the powers to refuse or to revoke a registration on public health or public safety grounds in the Regulations.

Contact us

For questions related to a specific application or registration, please contact us directly at 1-866-337-7705 or an email may be sent to cannabis@canada.ca. The email should clearly indicate the application file number, the applicant or registered person's name and the subject of the correspondence in the subject line of the email.

If you have concerns or complaints about cannabis in your community, you may contact Health Canada via the Cannabis Reporting Form.