On November 21, 2017, Health Canada released a consultation document titled “Proposed Approach to the Regulation of Cannabis”. The purpose of this consultation document was to solicit public input and views on the approach of the proposed regulations (regulatory framework) that will be used to support the implementation of the proposed Cannabis Act (here now known as the proposed Act).

The consultation document is subdivided into eight different sections, each section focusing on a different section of the proposed regulations and how they relate to the proposed Act. These eight sections are as follows:

Regulation of Cannabis

1. Licences, Permits and Authorizations
2. Security Clearances
3. Cannabis Tracking System
4. Cannabis Products
5. Packaging and Labelling Requirements
6. Cannabis for Medical Purposes
7. Health Products and Cosmetics with Cannabis; and
8. Miscellaneous Issues

A brief overview of each of these sections is provided below.

1. 1. Licences, Permits and Authorizations
      This section of the consultation document focuses on the different types of licenses and authorizations under the proposed Act. According to the consultation paper, it has been proposed that the regulations set out the following categories of licensed activities: Cultivation, Processing, and Sale to the Public. Authorizations for Analytical Testing, Import/Export and Research are additional activities that would be authorized by the Minister of Health. Each activity would be subject to specific regulatory requirements tailored to the level of risk associated with the activity involved. It has also been proposed that only a single application would need to be submitted should an individual wish to conduct multiple activities; applicants would be free to choose whichever activity or combination of activities for which they choose to be licensed. This section also touches upon licence requirements (e.g. validity period, security requirements, record keeping), permit and authorization requirements (e.g. for import/export, research), and application requirements (for licenses and permits).

1. 1. Security Clearances
      This section of the consultation document focuses in more detail on the proposed regulations for security clearances involving cannabis. The main purpose of this portion of the document is to focus on mitigating against the risks that individuals associated with organized crime could infiltrate licensed organizations and use their positions to conduct illegal activities that would benefit criminal organizations. Criteria listed under this section include: decisions on whether to grant or refuse security clearance, criminal record and law enforcement record checks, suspension or cancellation of security clearance and how to apply for security clearance.

1. 1. Cannabis Tracking System
      This section of the consultation document focuses on the establishment and maintenance of a national Cannabis Tracking System (CTS) that would enable and allow for the tracking of cannabis through the supply chain (under Part 6 of the proposed Act). It is proposed that the CTS, in combination with the proposed security requirements mentioned above, would prevent cannabis from the legal supply chain from being diverted into an illegal market or activity. The CTS would also be used to prevent illegal cannabis from entering the supply chain in the legal market. This section goes on to list the requirements under the CTS such as required information, frequency of reporting, and disclosure and submission of information to the CTS.

1. 1. Cannabis Products
      This section of the consultation document focuses on Schedule 4 of the proposed Act which sets out the classes of cannabis that may be sold to the public. The proposed Act would permit the sale of the following five classes of cannabis at the outset: dried cannabis, cannabis oil, fresh cannabis, cannabis plants, and cannabis seeds. Edibles and concentrates would automatically be added to Schedule 4 one year following the coming into force of the proposed Act. This is being done to allow the government time to develop and consult on appropriate regulatory controls regarding these classes. This section goes on to outline acceptable product forms, ingredients and composition of cannabis products (Schedule 5 of the proposed Act).

1. 1. Packaging and Labelling
      This section of the consultation document focuses on packaging and labelling requirements for cannabis and cannabis accessories (Part 1 of the proposed Act). In summary, this section details packaging requirements (e.g. packaging that appeals to youth would be strictly prohibited), labelling requirements (e.g. name and contact information of the processor who packaged the product, product description, lot number), health warning messages (e.g. risks associated with cannabis use) and the appearance of packaging. This section also touches upon the use of a standardized cannabis symbol. The regulations propose that products intended for ingestion that contain more than 10 ppm THC (equivalent to 0.001% THC) be labelled with a clearly recognizable standardized cannabis symbol in order to prevent accidental ingestion.

1. 1. Cannabis for Medical Purposes
      This section of the consultation document focuses on the government’s desire to maintain a distinct framework under the proposed Act to provide access to cannabis for medical purposes. The government’s objective is to ensure that rules surrounding patient access to cannabis for medical purposes remain largely unchanged from the current framework. In addition, the government has also indicated that a number of improvements are being proposed for new regulations with the goal of facilitating patient access to cannabis for medical purposes.

1. 1. Health Products and Cosmetics with Cannabis
      This section of the consultation document focuses on health products (e.g. drugs, NHPs, medical devices), that are already currently approved for sale in Canada.

1. 1. Miscellaneous Issues
      This section of the consultation document focuses on issues related to the amendment of regulations and implementation of regulations similar to currently existing regulations (e.g. Amendments to the Narcotic Control Regulations (NCR), Qualifications for Designations as Analysts Regulations under the CDSA, Amendments to the New Classes of Practitioners Regulations).

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