History for: Cannabis Licensing Application Guide

From Health Canada

On this page

Summary of changes

Table: Changes to the Cannabis Licensing Application Guide: Cultivation, Processing and Sale for Medical Purposes
Version Summary of changes

August 1 2019
ISBN: 978-0-660-32052-6

Changes to the Cannabis Licensing Application Guide were triggered by the new regulatory requirements of the amended Cannabis Regulations. As well the requirements relating to analytical testing and research licence applications have been removed from this guide as they will now be found in their new respective guides (Cannabis Licensing Application Guide: Analytical Testing and Cannabis Licensing Application Guide: Research).

May 8, 2019

ISBN : 978-0-660-31398-6

Changes to the Cannabis Licensing Application Guide were triggered by a new licensing approach for applicants for cultivation, processing, and/or sale for medical purposes licences under the Cannabis Act and Regulations. Health Canada requires new applicants for cultivation, processing or sale for medical purposes licences with possession to have a fully built site that meets all the requirements of the Cannabis Regulations at the time of their application, as well as satisfying other application criteria. The Cannabis Licensing Application Guide was updated to support applicants in this new approach.

August 28, 2018

ISBN: 978-0-660-27609-0

Changes to the Cannabis Licensing Application Guide were primarily triggered by a new Cannabis Tracking and Licensing System (CTLS) Release (Release 1.1), including:
  • Ability to include a responsible person in the application within the licence ownership section of the CTLS
  • For research, in the case of an academic institution, clarity on who should be the identified licence holder
  • Ability to include head of security for nursery and sale for medical purposes within the site personnel section of the CTLS
Updates were also made to provide additional clarity, in particular to the physical security requirements.
Detailed list of changes

June 27, 2018

ISBN: 978-0-660-27006-7

Initial release

Detailed list of changes: August 1 2019 version

Table: Changes to the Cannabis Licensing Application Guide (August 1, 2019 version)
Application Guide Section Change

Title

  • Change in title to reflect the removal of the analytical testing and research testing licences from this guide.

1.0 Purpose

  • Addition of note that the Guide provides the requirements for 'certain' licences only, to reflect the removal of the analytical testing and research testing licences from this guide.
  • Addition of an "Important" box to clarify that this guide is to be used for information purposes only until October 17, 2019.

3.0 Scope

  • Removal of analytical testing and research licences as a licence type within scope of this guide.
  • Addition of analytical testing and research licences in the list of activities not covered in this guide.
  • Addition of hyperlinks where applicable.
  • Changed the version of the CTLS which the guide is based on.
  • Changed note on the cost recovery information as it is now available on the Health Canada website.

4.0 Definitions and Abbreviations

  • Addition of definition for cannabis extract, cannabis topical, edible cannabis, dried cannabis, fresh cannabis and cannabis plant.
  • Addition of definition for ingredient.
  • Provided greater clarity in the 'site organizational chart' definition.
  • Changed colours of Information and "Tip" boxes to align with all other Health Canada guidance documents and webpages.

5.0 Application Requirements

  • Provided greater clarity to Figure 1 by stating that each box references a section in this Guide.

5.1 Knowledge Areas

  • Table 1: Addition of the Canada Consumer Product Safety Act and Tobacco and Vaping Products Act as acts which the applicant are responsible for complying with.
  • Table 1: Moved the Canada Revenue Agency to be included in the Other federal Acts and Regulations row as the excise legislation is covered under federal Acts and regulations.
  • Table 1: Removal of the information regarding the requirement for some research licences to have additional approvals as this is not in the scope of this guide.
  • Table 1: Removed 'and regulations' as regulations are a type of law and legislation.

5.2 Determine the type of licence to apply for

  • Figure 3: Addition of note that research licences and analytical testing licences are out of the scope of this guide.
  • Figure 3: Changed <200m2 to ≤ 200m2 with respect to the threshold limits for micro-cultivators and changed <600kg to ≤600kg with respect to the threshold limits for micro-processors for greater accuracy.
  • In "Important" box provided a new example of which application combinations the CTLS would not allow to be submitted at the same time to provide greater clarity.
  • Referenced the Cannabis Licensing Application Guide: Research for applicants who wish to conduct research and development activities outside of their authorized licence activities.

5.4 Associated individuals create accounts in the CTLS

  • Table 3: Removed reference to analytical testing and research licences, and associated personnel.
  • Table 3: Changed 'Licence holder (where holder is an individual)' to 'Licence holder (where applicant is an individual)', to provide greater accuracy as the individual will not be a licence holder at this stage.

5.5 Create a corporate profile for organizations

  • Changed 'corporation' to 'organization' for a more accurate description.
  • Table 4: Changed 'The Account ID' to 'The Corporation ID' for a more accurate description.
  • Table 4: Changed the required details to include for the Organizational chart to better align with the definition of Corporate Organizational Chart. Changed the requirement to 'Corporate organization chart' for consistency.
  • Table 4: Removed content regarding who Health Canada considers an officer as it is unnecessary as all officers of the corporation are required to submit a security clearance.
  • Table 4: Provided a reference to the Health Canada webpage with more information on security clearances under the Cannabis Act and Regulations.
  • Table 4: Provided further clarity on who is required to hold a security clearance with the addition that individuals who exercise or are in a position to exercise direct control are required to hold a security clearance.
  • Addition to "Tip" box regarding changes to the corporate profile.

6.0 Application Requirements: Creating an Application

  • Reordered the text to provide greater clarity that licences may be issued once applicable requirements as outlined in this guide are met.
  • Removal of reference to analytical testing and research licences in list of licence classes covered by this guide.
  • Addition of the classes of licences not addressed in this guide.
  • Provided clarification in the "Important" box on which licence classes are in scope of this guide.
  • Table 5: Removed reference to analytical testing and research licences as outside the scope of this guide.
  • Provided further clarification on which new areas in the CTLS are opened when sale with possession is selected by the applicant.

6.3 Licence Class and Subclass

  • Added in new CTLS requirement for processors to identify the classes of cannabis they intend to conduct activities with, to reflect change implemented in release 2 of the CTLS to provide greater information for statistical purposes.
  • Removal of "Information" box related to analytical testing and research as new research and analytical testing guide being developed
  • Addition of reference to the Research Licence Application Guide in "Tip" box.

6.4 Site Details

  • Removed example of how an analytical testing licence has different licence requirements as it outside the scope of this guide. Included a new example related to sales for medical purposes.
  • Changed "Important" box to remove the reference to research licences. Included a new note that if an applicant wishes to conduct activities at two separate locations, then separate applications will be required, as licences are site specific.
  • Table 6: Renamed table as it applies to all licence types covered by this guide.
  • Table 6: To increase clarity with respect to both the site survey and aerial view included the addition of 'accurately depict the site at point of submission'.
  • Table 6: Changed the name of activities to be identified for room activities, to reflect the change is CTLS for release 2.
  • Table 6: Provided further clarification on which new areas in the CTLS are opened when sale with possession is selected by the applicant.
  • Addition of new "Important" box to highlight the prohibition for processors to conduct activities with food in the same building as processing activities.
  • Removal of Table 7 and 8 as analytical testing and research licences are outside the scope of this guide.

6.5 Site Personnel

  • In "Tip" box removed the note to submit qualifications for head of laboratory as this is outside scope of guide.
  • In "Important" box removed 'for cultivations, process and sale for medical purposes licences' as it applies to all licence types covered by guide.
  • Table 7: Removed reference to site personnel requirements associated with analytical testing and research licences.
  • Table 7: Addition of new "Important" box to highlight the requirement to have a individual with a security clearance be present at the site when activities with cannabis are being conducted.
  • Table 7: Updated QAP qualifications to include new requirements under new amended regulations.
  • Table 7: Addition of new "Important" box for processors conducting activities with cannabis extracts or edible cannabis to highlight the requirement for the QAP to possess the training, experience and technical knowledge related to biological, chemical and physical hazard identification and analysis as well as the preparation and implementation of preventive control plans.
  • Table 7: Addition of new "Important" box for processors conducting activities with edible cannabis, highlighting the requirement to retain an individual with the required training, experience and technical knowledge related to edible cannabis in the event their QAP does not possess the training, experience and technical knowledge required.

6.6 Site Ownership

  • Removal of reference to analytical testing and research licences as this is out of scope of this guide.

6.7 Notices to local authorities

  • Removal of reference to analytical testing and research licences as this is out of scope of this guide.

6.8 Physical Security

  • Clarification on how the organizational requirements apply to all licence classes, and highlighting the differences in physical security requirements.
  • Renamed Table 10 as it applies to all licence types covered by this guide.
  • Table 10: Clarified that the they physical security attestation (9) is not required by a sale for medical purposes without possession licences.
  • Table 11: Clarified that the 'Product flow between rooms' being asked to identify on the floor plan should be the 'cannabis flow between rooms'
  • Table 11: Addition that the Additional Information requested concerning the visual monitoring devices and intrusion detection devices are to be of devices which are installed and operating.
  • Table 11: Addition of the information that the Access Log is required to contain and record.
  • Table 11: Clarified the requirement in Monitoring and Response section to submit the procedure in place for responding to intrusion detection alarms, and the information which must be recorded when an occurrence is detected.
  • Table 12: Clarified that the 'Product flow between rooms' being asked to identify on the floor plan should be the 'cannabis flow between rooms'.
  • Removed Table 15 as it is now out of scope of this guide.

6.9 Good production practices

  • Removal of reference to analytical testing and research licences from "Information" box as they are out of scope of guide.
  • Table 13: Separated the gpp requirements to highlight which regulation they pertain to.
  • Table 13: Included the new requirement for the good production practices to apply to both cannabis and 'anything to be used as an ingredient' where applicable.
  • Table 13: Provided greater detail on the requirements associated with the filtration or ventilation system.
  • Table 13: Provided clarity on the supply of water requirement to include evidence that the water source is appropriate for the activity being conducted, and a description of how if water sources are cross connected with non-potable water sources how the risk will be eliminated.
  • Table 13: Included the new requirement to submit a description of cleaning effectiveness verification.
  • Table 13: Addition of new requirements related to the Lighting, hand cleaning, sanitizing stations, and lavatories regulations.
  • Table 13: Included the former Industrial Hemp Regulations and the Industrial Hemp Regulations as a starting material source.
  • Table 13: Included the new requirement for processing licences to submit the signed completed Appendix J form: Good Production Practices Attestation
  • Table 13: Addition of new "Important" box to highlight the prohibition of conducting activities with food that is intended for sale in the same building where activities with cannabis is being conducted.

6.10 Record Keeping (and Reporting)

  • Table 14: Removal of note that the record keeping attestation applies only to cultivation, processing and sale for medical purposes licences. This is no longer necessary as it applies to all licence types covered by the scope of this guide.
  • Table 14: Removed copy of government issued identification requirement as this is no longer in the scope of this guide.
  • Table 14: Removal of note that the key investor reports applies only to cultivation, processing and sale for medical purposes licences. This is no longer necessary as it applies to all licence types covered by the scope of this guide.

7.1 Submitting the application

  • Addition of new declarations and attestations which are now a part of the CTLS application for processing applicants.
  • Addition of note that an application cannot be changed after submission by an pplicant, but the corporate profile can continue to be changed after submission.

7.2.1 Application screening

  • Provided greater clarity on the service standard for the screening process to include that it is a 30 business day nonbinding service standard.
  • Removed the note that the inspection team will schedule a pre licence inspection with the applicant.

7.2.4 Issuance of a licence

  • In "Tip" box further clarified that the graduated licensing approach allows Health Canada to verify the quality of the cannabis to be sold.

7.3.1 Receivinga nd responding to a request for more information

  • Changed 'Health Canada asks the applicant to clarify information' to 'Health Canada may require the applicant to submit additional information' to more accurately represent the process.
  • Changed the time an applicant has to respond to a request for more information from 5 business days to 10 business days.
  • Included further information in the types of information that may need to be submitted in response to a request for more information. This may include visual evidence.

7.3.2 Refusals and withdrawals

  • Included the new licence refusal circumstance.
  • Changed the timeframe in which an application has to respond after Health Canada sends a notice of intent to refuse. Health Canada will provide the timeframe within which to respond when the notice is sent.

Appendix A

  • Changed name of table to Key Individuals at the Site to more accurately reflect the individuals captured in this table.
  • Addition of new requirements for QAP to have training, experience and technical knowledge related to Part 6, and the new requirement for approving a preventive control plan if conducting activities with edible cannabis or cannabis extracts.
  • Removal of the Head of Laboratory as this role is not in scope of this guide.

Appendix B

  • Removal of references to analytical testing and research licences as they are not in scope of this guide.
  • Added that the table provides examples of activities only as it is not a comprehensive list of activities.

Appendix E

  • Update to references to the applicable record keeping regulations to reflect the changes as a result of the new amended regulations.
  • Addition of new attestations stating that all information in the document is accurate and that the responsible person has read and understands all requirements highlighted on the form.

Appendix G

  • Removed references to defacto control.

Appendix H

  • Renamed appendix.
  • Edited appendix to provide greater clarity on what constitutes direct control.

Appendix F

  • Edited table to more accurately reflect the application status in the CTLS.

Appendix J

  • New appendix: Good Production Practices Attestation to address the new GPP requirements specific to processors only.

Detailed list of changes: May 8, 2019 version

Table: Changes to the Cannabis Licensing Application Guide (May 8, 2019 version)
Application Guide Section Change
General (Throughout)
  • Update references to Appendices to reflect the removal of Appendix D: Physical Security Requirements and Appendix F: GPP Requirements.
2.0 Background and 3.0 Scope
  • Changed wording in both sections to account for the transfer of the Cannabis Act from the Minister of Health to the Minster of Border Security and Organized Crime Reduction.
4.0: Definitions
  • Addition of definition for "Cannabis Products".
Section 5.1: Knowledge Areas
  • Addition of website for the CTLS.
5.3 Create an account in the CTLS
  • Addition of new "Important" box to highlight the limitations of the CTLS with respect to number of files and file size able to be uploaded into the system.
  • Addition of new "Information" box to inform Indigenous affiliated applicants of the navigator service.
6.0 Application requirements: creating an application
  • Clarification that applications will be assessed based on the requirements outlined in the guide. In addition applicants are expected to comply with all applicable regulations and verification of this compliance may occur at any time.
  • Addition of new "Information" box to note that processing, cultivation and sale for medical purposes with possession licences will require a complete and functional facility at time of application submission. In addition a site evidence package will need to be submitted prior to application processing.
  • Updated "Important" box to include that the guide provides details on how to submit information into the CTLS and directly to Health Canada as a site evidence package.
  • Updated "Tip" box to include instructions for clear naming of files that apply to both documents uploaded to the CTLS and files submitted in site evidence package.
  • Table 5: Updated to include the requirement to submit additional visual evidence outside the CLTS for the required areas of physical security and good production practices for cultivation, processing and sale for medical purposes (with possession) licences.
  • Table 5: Clarified that in the required area of physical security the requirement is to only submit an organizational security plan for a sale for medical purposes (without possession) licence.
6.4: Site Details
  • Table 6: Removed the requirement to submit zoning information as a part of an applicant's site survey. This information is no longer required by Licensing.
  • Table 6: Addition of a new application requirement to submit information relating to proposed production amount and production area.
  • Table 6: Clarification provided on how indoor spaces should be identified in the CTLS and that applicants do not need to identify non cannabis or transitory areas in the CTLS, however they must be included on the floor plan.
  • Table 7: Changed tetrahydrocannabinolic acid (THC) to delta-9-tetrahydrocannabinolic acid.
  • Table 8: Updated to include the option for a research applicant to submit either a no objection letter from Health Canada or an acknowledgement email from the Office of Clinical Trials.
  • New "Tip" box added to provide more information on research licence applications.
6.5: Site Personnel
  • Clarification within "Tip" box that qualifications should be submitted for the QAP and any alternates as applicable.
  • Table 9: Updated to provide clarification on the requirement to submit an explanation, including clear examples and details on how and when the QAP or any alternates obtained their knowledge, training and experience related to the requirements of Part 5. Also added the requirement to identify if the QAP employed as a QAP at another licensed site.
  • Table 9: Addition of new "Tip" box referring applicants to the Good Production Practices Guide for Cannabis for more information on the responsibilities of a quality assurance person.
6.7 Notices to local authorities
  • Table 11: Updated to clarify the date required on the notice to authorities is to be the date each notice was sent or provided.
6.8 Physical Security
  • Removed the reference to Appendix D as it was removed from the application guide and added a new reference to the Physical Security Measures Guide for Cannabis document.
  • Removal of "Important" box stating that physical security requirements for sale for medical purposes without possession do not apply. This information is now captured in Table 12.
  • New "Information" box relating to nomenclature. This information has been taken from Table 12 and moved into a stand-alone box as it applies to Tables 12, 13, 14, and 15. Added the requirement to use consistent nomenclature with information submitted in the documents submitted in the CTLS as well as the site evidence package.
  • Table 12: Split into 4 separate tables to better reflect the different requirements for the separate licence classes.
    • Table 12: Organizational Security Plan requirements for processing, cultivation and sale for medical purposes licences.
    • Table 13: Physical Security requirements for standard processing, standard cultivation and sale for medical purposes with possession of cannabis licence classes.
    • Table 14: Physical Security requirements for micro-processing, micro-cultivation and nursery licence classes.
    • Table 15: Physical Security requirements for research and analytical testing licence classes.
  • Table 12: Updated table name to reflect that table contains the Organizational Security Plan requirements for processing, cultivation and sale for medical purposes licences.
  • Table 12 changes:
    • Head of security - included clarification on the emergency phone number which Health Canada is requesting as a part of the application submission.
    • Addition of a new requirement to submit a business plan and the details to be submitted.
    • Site organization chart
      • Change to the site organizational chart to reflect the request of both titles and names of all individuals
      • The requirement to include those individuals who have knowledge of "product movement beyond minimal amounts" was further clarified to "product movement of a significant amount in relation to the overall operations of the facility"
    • List of individuals in key positions - added the requirement to submit security clearance application number in lieu of security clearance status.
    • Physical security - this section was relocated to section (9) Attestation.
    • Security awareness and training - Included clarification on the requirements to be included in the descriptions.
    • Approval - changed title to "Attestation" to better capture the content required. Added the requirement to submit an attestation from the head of security that they reviewed the physical security plan. In addition, removed "proposed" in reference to the head of security and the responsible person to maintain consistency within the document.
  • Table 12: Addition of note that for sales for medical purposes without possession there is no specific section in CTLS in which to upload this information and directs applicant to upload in the Record Keeping Description section.
  • Table 13: Updated table name to reflect that table contains the physical security requirements for standard cultivation, standard processing, and sale for medical purposes with possession licences.
  • Table 13 Changes:
    • Site Plan (previously located within Table 12), added the following:
      • Requirement to indicate if site perimeter is defined by either a fence or building envelope.
      • Include the footprint of building.
      • Requirement to include a floor plan of all buildings with required details to be included on the floor plan.
    • New requirement to submit security reports, and includes all required details to be included in reports.
    • New requirement to submit visual evidence, and includes all required details to be included in site evidence package.
    • New requirement to submit additional information. Contents of this section were largely taken from Appendix D, and incorporates more detail to provide further clarification on submission requirements for applicants.
    • Addition of note that there is no specific section in CTLS in which to upload the Site Plan and directs applicant to upload in the Aerial View section.
    • Addition of note that there is no specific section in CTLS in which to upload the Security Reports and directs applicant to upload in the Organizational Security Plan section.
    • Addition of note that there is no specific section in CTLS in which to upload the Additional Information and directs applicant to upload in the Organizational Security Plan section.
    • Addition of note that due to limitations of the CTLS the Visual Evidence must be submitted outside of the CTLS directly to Health Canada.
  • Table 14: Updated table name to reflect that table contains the physical security requirements for micro-cultivation, micro-processing and nursery licences.
  • Table 14: Includes new requirement to submit additional information. Contents of this section were taken from the Appendix D, and incorporates more detail to provide further clarification on submission requirements for applicants.
  • Addition of note that there is no specific section in CTLS in which to upload the Site Plan and directs applicant to upload in the Aerial View section.
  • Addition of note that there is no specific section in CTLS in which to upload the Additional Information and directs applicant to upload in the Organizational Security Plan section.
  • Addition of note that due to limitations of the CTLS the Visual Evidence must be submitted outside of the CTLS directly to Health Canada.
  • Table 15: Updated table name to reflect that table contains the physical security requirements for analytical testing and research licences.
  • Addition of note that there is no specific section in CTLS in which to upload the Site Plan or Additional Information and directs applicant to upload in the Physical Security Document section.
6.9 Good Production Practices
  • Removal of reference to appendix F - as it was removed and content moved to Table 16. Link added to the Good Production Practices Guide for Cannabis.
  • Table 16: Title change to indicate that the requirements are specific to cultivation, processing and sale with possession licences.
  • Table 16: Certain requirements have been removed as a requirement to submit as a part of the application process, although compliance to all applicable regulations is still required. Applicants are no longer required to submit information relating to the following regulations:
    • Standard operating procedures
    • Pest control product
    • Distribution
    • Equipment
    • Quality assurance
    • Methods and procedures
    • Approval prior to sale
  • Table 16: Addition of the requirement to provide evidence for potable water on site.
  • Table 16: Addition of the requirement to submit visual evidence, and includes all required details to be included in site evidence package.
  • Table 16: Addition of the requirement to submit the type of starting material as well as the authorized source for this material.
  • Addition of note that due to limitations of the CTLS the Visual Evidence must be submitted outside of the CTLS directly to Health Canada.
6.10 Record Keeping (and Reporting)
  • Changed the reference to Appendix G, as it has been changed to the record keeping attestation.
  • Table 17: Updated to remove the previous requirements to submit information relating to the record keeping method and record keeping examples.
  • Table 17: Addition of the new requirement of the completion and submission of a signed record keeping attestation form.
  • Table 17: Provided clarification on what an applicant for a sale for medical purposes licence should submit.
7.0 Submitting an application
  • Figure 3 was updated to reflect the requirement to submit both the application in CTLS and the site evidence package to Health Canada prior to an application entering the screening process.
7.1 Submitting the application
  • Addition of a reminder that after an application is submitted, it can no longer be edited or changed by the applicant.
  • New "Important" box added to highlight that the site evidence package needs to be received by Health Canada before review will begin. The package must be received by Health Canada within 10 days of the submission into the CTLS.
7.1.1 Submission of site evidence
  • New section added to give direction on the requirements for format of visual evidence to be submitted as a part of the site evidence package.
7.2.1 Application Screening
  • Addition of note that application screening will not take place until Health Canada receives the site evidence package. The 30 day service standard for screening does not start until receipt of site evidence.
7.2.2 Review and security clearance
  • Addition that review involves both documents submitted into CTLS and visual evidence submitted in the site evidence package. Addition of reference to new Security Clearance under the Cannabis Act and Regulations website to provide more information on Health Canada's security clearance process.
7.2.3 Pre-licensing
  • Removed information related to the confirmation of readiness email as this is no longer part of the Licensing review process.
  • Removed "Information" box related to the site evidence package as this is now captured earlier in the review process.
7.2.4 Issuance of a licence
  • Clarification on authorized activities provided with the addition of information related to the activities authorized on a licence, and information on how to request the authorization for the sale of additional cannabis classes.
  • "Tip" box changed to reflect that licensed activities may be limited upon licensure.
7.3.1 Receiving and responding to a request for more information
  • Changed the 30 day response time for an applicant to respond to a request for more information to 5 business days to reflect changes in the Licensing review process.
  • Updates in the "Tip" box to correct email address and to clarify the process for applicants to request a consent to communicate. Addition of new content to reflect that as an applicant proceeds through the review process, the application status and contact information of the applicant may be shared with persons authorized under subsection 69(1) of the Cannabis Act.
7.3.3 Changes to an application /unsolicited information
  • Addition of statement that any unsolicited information or submissions not labeled clearly may not be assessed by Health Canada.
8.0 Contact Us
  • Updated branch name to the Controlled Substances and Cannabis Branch.
Appendix B: Cannabis Licence Classes and Subclasses
  • Included reference to section 21 of the Cannabis Regulations for further information related to the equivalents for the micro-processing threshold.
Appendix D: Physical Security Requirements
  • Deleted appendix, all applicable information moved into Tables 12, 13, 14 and 15.
Appendix E: Organizational Security Plan SOP Priority Areas
  • Under Priority area 3 added a new potential mitigation measure to consider: Testing of response procedures.
Appendix F: Good Production Practices
  • Deleted appendix, all applicable information moved into Table 16.
Appendix G: Licensing Record Keeping Information Requirements
  • Renamed Licensing Record Keeping Attestation. Removed all previously required information and included a new attestation form.
Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: