Health Canada Guidance Documents
Health Canada has been hard at work developing updated guidance documents for cannabis licence holders to use with the implementation of the revised regulations (introducing new classes of products) in the fall. If you don't already have these documents, you should grab them from the links below. We all know the regulations can be both vague and cryptic; guidance documents are welcome chance to get some detail on how to implement the regs.
What follows are the notes provided by Health Canada.
Cannabis Voluntary Recall Guide
The Cannabis Voluntary Recall Guide document has been revised to reflect the new regulatory requirements. This guide provides information on the requirements of the Cannabis Act and Cannabis Regulations related to voluntary recalls of cannabis and cannabis products.
Updates of note:
New requirement under section 5.3 of the Cannabis Regulations - Provincial and territorial distributors and retailers are prohibited from selling a cannabis product they know is subject of a voluntary recall in Canada.
New requirement under subsection 46(2) of the Cannabis Regulations – Licence holders, other than a licence holder for analytical testing or a cannabis drug licence holder, must conduct a recall simulation at least every 12 months in order to ensure a recall plan is effective.
The Cannabis Voluntary Recall Guide can be accessed using the following Dropbox link.
Health Canada documents and monitors recalls, provides guidance to licence holders and verifies compliance with the recall requirements of theCannabis Regulations. Health Canada is committed to making data and information available to Canadians, including posting recall notices on the Recalls and Safety Alerts website.
CTS Reporting Guidance
Further to the new Cannabis Tracking System (CTS) Order that was published along with the amended regulations in the Canada Gazette, Part II on June 26, 2019, new guidance materials to aid in the preparation of monthly submissions to adhere to the new reporting requirements are available at the following Dropbox link. The materials will also be available on the Cannabis tracking system resource page on Health Canada’s website shortly.
Consistent with the current CTS Order, the new Order will apply to holders of federally issued licences for cultivation, processing and sale for medical purposes, public provincial and territorial bodies that are authorized to sell cannabis under a provincial or territorial Act, and private distributors and retailers, who are required to provide data to the public body authorized to sell cannabis or that authorizes sale under provincial and territorial legislation.
The individuals and organizations subject to the Order will be required to report on the quantity of cannabis and on the value, in Canadian dollars, of certain quantities of cannabis. As is currently the case, all reporting parties must report electronically, through the Cannabis Tracking and Licensing System (CTLS). The CTLS will be updated on October 17, 2019 to allow for the submission of the data elements prescribed by the new Order, and reporting parties will still be able to choose the reporting method that is preferable to them (i.e., manually using fillable fields or via a file upload).
As the new CTS Order will come into force on October 17, 2019, all reports submitted on or after October 17 must be submitted using the new format.
Cannabis Licensing Application Guide: Cultivation, Processing and Sale for Medical Purposes
The Cannabis Licensing Application Guide: Cultivation, Processing and Sale for Medical Purposes has been revised to reflect the new regulatory requirements. The Guide and a change summary document outlining all changes to the guide are now available and can be accessed using the following Dropbox link. The revised Guide is being released in advance of the amended regulations coming into force on October 17, 2019 to help applicants identify the new requirements that are applicable to their licence application.
Note applicants for research and analytical testing licences should continue to refer to the Cannabis Licensing Application Guide as released on May 8, 2019 for all application requirements. New Licensing Application Guides specific to research and analytical testing licences will be made available in advance of October 17, 2019. Additionally, Health Canada will release updated guidance at the end of August on licence management to reflect the amended regulations.
Policy Statement on Cannabis Act prohibitions referring to appeal to young persons
Health Canada strives to make its decision-making process clear and understandable. To that end, we have developed a policy statement intended to provide information to assist industry and other stakeholders in complying with the prohibitions referring to appeal to young persons set out in paragraphs 17(1)(b), 26(a) and 27(a) and section 31 of the Act. Consistent with the commitment in the Regulatory Impact Analysis Statement for theRegulations Amending the Cannabis Regulations (New Classes of Cannabis), it also sets out Health Canada’s commitment to take action to protect the health and safety of young persons.
Please find the statement using the following Dropbox link. This statement will also be published on the Health Canada website shortly.
This statement will be an important tool in supporting the ongoing implementation of the Cannabis Act and its regulations, including the new regulatory controls that will come into force on October 17, 2019 to address the public health and public safety risks associated with edible cannabis, cannabis extracts, and cannabis topicals.
For specific questions related to proposed or authorized activities on your licence and the process for applying to add the new classes of cannabis products to your licence, please contact HC.licensing-cannabis-licences.SC@canada.ca
Promotion Prohibitions Fact Sheet
The Promotion Prohibitions Fact Sheet is intended to provide guidance on the prohibitions related to the promotion of all cannabis, including edible cannabis, cannabis extracts and cannabis topicals, cannabis accessories, and services related to cannabis, as well as limited authorizations to engage in specific types of promotion. The fact sheet focuses on the prohibitions and authorizations found in Sections 16 to 24 of the Cannabis Act and Part 6.1 of the Cannabis Regulations.
The fact sheet can be accessed using the following Dropbox link.