The Canna Regulations were officially published in Canada Gazette Part II on July 11, 2018. The regulations outline several different types of licenses which will be issued to companies throughout the industry. These licenses are set in place to regulate the permitted activities associated with the cultivation, processing, testing, sale and research of canna.
Cultivation licences are divided into 3 subclasses based on the area in which the canna is to be grown:
- Standard cultivation – for growing and handling of canna (dried, fresh, plants & seeds) in areas greater than 200 m2
- Micro-cultivation – for growing and handling of canna (dried, fresh, plants & seeds) in areas up to 200 m2
- Nursery licence – for growing canna (plants & seeds) in areas up to 50 m2.
Additionally, in order to receive approval of any type of cultivation licence, the applicant must have a master grower and alternate master grower on staff. These individuals must pass security clearance, are responsible for the cultivation, propagation and harvesting of the canna and must have sufficient knowledge in order to carry out these duties.
Processing licences are issued to authorize the possession, manufacturing and sale of canna and canna products.
These types of licences are divided into 2 subclasses the quantity of canna processed on an annual basis:
- Standard processing – for quantities greater than 600 kg dried canna, or equivalent
- Micro-processing – for quantities up to 600 kg or more dried canna, or equivalent
In order to receive approval of for a processing licence, the applicant must have 1 trained quality assurance person and may have 1-2 alternate quality assurance person(s) on staff. These individuals are responsible to ensure the quality of the canna prior to sale and must pass security clearance. The quality assurance persons are also responsible to investigate and take corrective actions, if necessary, in response to all quality-related complaints. It is important to note that an application must be submitted and approved in order to make a change to the listed quality assurance persons. Therefore, it is beneficial to have more than 1 quality assurance person on your application.
Analytical Testing Licences
Holders of licences for analytical testing are authorized to possess and obtain canna by altering its chemical or physical properties by any means. A holder of an analytical testing licence is required to have 1 qualified head of the laboratory on staff and may have 1 or more alternate heads of the laboratory. Each head and alternate head of the laboratory must have a degree in science from a Canadian or accredited foreign university, have sufficient knowledge and experience to fulfill the required duties and be responsible for the test methods carried out. It is important to note that an application must be submitted and approved in order to make a change to the listed laboratory head or alternate. Therefore, it is beneficial to list more than 1 individual on your application.
Licence for Sale for Medical Purposes
Holders of a licence for the sale of canna for medical purposes are permitted to possess and sell canna products. Licence holders are permitted to sell as follows:
- Canna products to licence holders (other than cultivation licence holders),
- Canna products (i.e. Dried, fresh, plants and seeds) to a holder of a licence for micro-cultivation or standard cultivation
- Canna products (i.e. plants and seeds) to a holder of a licence for a nursery
- Canna products to hospital employees
Licence for Research
Holders of a licence for research are authorized to possess, produce and transport canna for research purposes only. The licence also authorizes the sale of canna plants and seeds to a licensed cultivator, another licensed researcher, a holder of a canna drug licence and to administer canna to a research subject.
Licence for Canna Drugs
Holders of licences for canna drugs are authorised to possess canna and manufacture and/or sell a drug containing canna. In order to be eligible for a canna drug licence, the manufacturing facility must possess a valid establishment licence as approved by Health Canada.
Holders of a canna drug licence must retain a senior person in charge who is responsible for the management of the canna-associated activities as authorized in the licence. Additionally, a licence holder must retain a qualified person in charge and may designate an alternate. A qualified person in charge must pass a security clearance, work at the facility, have a relevant post-secondary education, sufficient knowledge/experience with drugs and a familiarity with the applicable regulations. This person is responsible for supervising the canna-related activities as authorized under the licence and for ensuring that those activities comply with the Canna Regulations. It is important to note that an application must be submitted and approved in order to replace the senior person in charge, qualified person in charge or the alternate person in charge.
If you are looking to enter the Canadian canna industry, Quality Smart Solutions and its new division, Canna License Experts, has a team of specialists who can assist you in obtaining the correct license for your business. Contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com and www.cannabislicenseexperts.com.
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Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.
Contact us today to learn more about how we can support your compliance needs during and after licensing!