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Health Canada Seeks Regulations Feedback

Health Canada recently announced it is seeking feedback on potential amendments to the Cannabis Regulations in an attempt to reduce regulatory burdens while addressing public health and safety risks. Stakeholders also have the opportunity to identify and comment on additional regulatory issues.

The regulatory body goes onto explain, “Since the coming into force of the Act and the CR in 2018, the legal cannabis industry has matured, the marketplace has evolved, and there is increased knowledge and data on public health and public safety risks associated with certain activities.”

Health Canada says potential amendments to the Cannabis Regulations would streamline and clarify existing requirements, eliminate inefficiencies in the regulations, and reduce administrative and regulatory burdens where possible, without compromising the public health and public safety objectives in the Cannabis Act.

This proposal is separate from the federal government’s review of the Cannabis Act.

They are targeting the following five priority areas:

1.      Licensing
Some license holders have raised concerns that some licensing requirements may not be necessary or could be streamlined. Health Canada is considering changes to licensing requirements.

Their questions reference activities with cannabis that are not currently authorized under existing licenses or activities with cannabis that organizations should be able to carry out, without the need to hold a license or permit—for instance, the possession of small amounts of licit cannabis for the purpose of lab research.

2.      Personnel and Physical Security Measures
A license holder must comply with the personnel and physical security requirements specific to their license. These requirements include having a head of security, an organizational security plan, and physical security measures, such as visual recording devices.

Health Canada has received feedback that certain personnel or physical security requirements may not be necessary or could be streamlined—for example, visual monitoring during off-season for outdoor cultivation.

3.      Production Requirements for Cannabis Products
There are regulatory requirements related to the formulation, production, and composition of cannabis products, including microbial and chemical contamination limits and prohibited ingredients.

Health Canada has heard that there are product requirements that are more burdensome than those in ‘analogous frameworks,’ such as those for medical devices or cosmetics, and is considering regulatory changes for some product requirements that would remove unnecessary burden.

4.      Packaging and Labelling Requirements for Cannabis Products
The Cannabis Regulations set out requirements for the packaging and labelling of cannabis and cannabis products for sale, distribution, or export. These requirements include plain packaging and labelling for all cannabis products to make packages ‘less appealing’ to young people.

Health Canada has received stakeholder feedback that some packaging and labelling requirements are onerous or unnecessary to achieve the Cannabis Act’s public health and public safety objectives. Health Canada is considering what packaging and labelling requirements could be changed or simplified without compromising these objectives.

5.      Record Keeping and Reporting for Cannabis License Holders
Federal license holders have to comply with requirements around the retention of documents and reporting of certain information to Health Canada, like establishing and maintaining up-to-date inventories and retaining documents such as those related to the production of cannabis products, packaging and labelling, investors, and notices of new cannabis products to be sold in Canada for the first time.

Some licence holders have raised concerns with respect to onerous and duplicate requirements. Health Canada is considering regulatory changes that would aim to eliminate duplication between requirements where possible, remove requirements that are not effective in supporting public health and public safety, and simplify the reporting process.

For the full list of questions from Health Canada and to submit your feedback, please visit their website. Health Canada is accepting feedback until May 24, 2023.

Tags: Cannabis Act (40), Cannabis Regulations (101), Health Canada (64), Health Canada regulations (12), regulatory burden (7)