Cannabis Legalization was the big news that made the headlines last year. The first and foremost objective of legalizing Cannabis in Canada is displacing the illegal market and keeping profits out of the hands of criminals and disperse the organized crime.
The Cannabis Act establishes a framework to control and regulate production, distribution and sale of Cannabis products. The purpose is to protect public health and public safety, including reducing the risk of cannabis being diverted to an illegal market. Knowing the fact that there is shortage across Canada, Health Canada needs to expedite the process of licensing more cultivators and processors. There is one thing that cannot be over looked even if there is shortage and that is compliance with the regulations.
Inspection is an integral and significant part of licensing a cannabis facility. You can expect anything during an inspection. All the answers to WHO, WHAT, WHERE and HOW related to the activities performed with the Cannabis products in a facility can be verified during an inspection. Some of the parameters are:
- Physical Security
- Activities corresponding to the licence
- Key personnel
- GPP parameters in the facility
- Reporting and Records Keeping
- And more…
Responsibility As A LP
Apart from being aware of all the laws and legislation that surround the production of Cannabis, the LP is responsible to comply with these laws and understand the obligations clearly. LP should be aware of the role of an inspector and ensure complying with the ethical obligations set out in the Values and Ethics Code for Public Sector. It is the responsibility of the LP to ensure that all products comply with the regulations in order to demonstrate compliance.
HC is responsible for compliance promotion, monitoring and enforcement to protect public health. There are 5 main guiding principles that apply to compliance and enforcement activities which are accountability, fairness & consistency, transparency, targeted and outcome based and evidence based.
Enforcement includes all that are initiated by Health Canada or voluntary compliance actions initiated by the Licensed Producers.
Health Canada takes numerous factors in consideration while performing compliance and enforcement activities like Public Health and Safety risk and compliance history to name a few. The compliance and enforcement activities not only applies to the categories of the licences under Cannabis Act but it also applies to the some other categories that do not require authorization from Health Canada like the packagers and labellers of cannabis accessories, parties involved in advertising and promotions of cannabis accessories. It is the responsibility of the licence holder that they comply with all the regulations.
Know Your Rights
As a regulated party, you can discuss the roles and responsibilities with the inspector. You can ask for explanation why the regulated party is being contacted. Among other rights, as a regulated party i.e. Licensed Producers can contest the decision of the inspector. You can ask for clarifications on any aspects of the inspection and the laws that pertain to those aspects.
With the new classes of Cannabis products being introduced and regulated in the near future, interested parties need to be proactive. The basic principle of compliance and enforcement remain the same for all the classes with the goal of minimizing the risk to public health and safety. Understanding the laws and regulations can be confusing at times but dicentra is here with expert skills in preparing you for your readiness, pre-licensing inspection and ongoing/regular inspections by Health Canada. Don’t wait and call us today for more information.
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dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products.