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Analytical Testing License

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Why Apply For Analytical Testing License

Under the Cannabis Act & Regulations, applicants are required to obtain a license issued by Health Canada in order to conduct activities relating to analytical testing involving cannabis. Therefore, individuals and corporations who wish, for the purposes of testing, to possess cannabis and to alter the chemical or physical properties of this cannabis by any means for the purposes of testing, may apply for an Analytical Testing License.

Benefits Of Analytical Testing License

An Analytical Testing License is useful to confirm the purity and potency of all medicinal and recreational cannabis allotted for sale, as these products must be put through an extremely rigorous chemical and microbiological testing process. Analytical Testing license holders are able to work closely with cultivators and processors, as both of these license holders require the services of a testing laboratory.

Important Requirements

The application for an analytical testing license is not as extensive as that of a cultivation or processing license application, however there are still some important requirements that need to be met, as well as documents that need to be included with the application. Security measures for Analytical Testing license holders are more relaxed, as there will only be a small quantity of product allowed on-site at any given time.

License Overview

Who Is An Analytical Testing License For?

This Analytical Testing License is for businesses that are looking to alter the chemical or physical properties of medicinal and/or recreational cannabis products for the purpose of testing.

What Can You Do With An Analytical Testing License?

Analytical Testing license holders are permitted to possess small amounts of cannabis and alter its chemical or physical properties for purposes of analysis by any means, including with an organic solvent. When it comes to the activities covered under an analytical testing license, there are quite a few to choose from. Analytical testing license holders may conduct activities that include, but are not limited to, any combination of the following testing processes:
  • Chemical contaminants (e.g. heavy metals, solvent residues)
  • Microbial contaminants (e.g. yeast, molds, bacteria, aflatoxins)
  • Cannabinoid content (e.g. delta-9-tetrahydrocannabinol [THC], tetrahydrocannabinolic acid [THCA], cannabidiol [CBD], and cannabidiolic acid [CBDA])
  • Dissolution or disintegration
  • Sterility
  • Stability (e.g. if the license holder proposes to include a product expiry date)
  • Pesticides
  • Other (e.g. seed viability testing)

What Isn’t Covered Under An Analytical Testing License?

Analytical Testing license holders are not permitted to cultivate cannabis or produce cannabis products. Furthermore, license holders are not allowed to sell or distribute cannabis or cannabis products to anyone. All samples of cannabis provided to the licensed testing laboratory must be destroyed within 90 days of the testing of the sample of the lot or batch being completed. If testing of the sample is not initiated within 120 days of its receipt, the license holder must, by the end of that period, either destroy the sample or distribute it to another holder of a license for analytical testing.

Analytical Testing License Requirements

  • The holder of an Analytical Testing license must retain the services of one individual as the Responsible Person, who has the authority to bind the holder. The Responsible Person will be accountable for the license holder’s activities and should have an adequate understanding of how the Cannabis Act and Regulations apply to the license holder.
  • Analytical Testing license holders are required to retain the services of one individual as the Head of Laboratory who has the training, experience and technical knowledge related to the duties of the position. The Head of Laboratory will be responsible for the testing activities under section 91 of the Cannabis Regulations (testing each lot/batch for composition). The Head of Laboratory must possess a degree in a science related to the work to be carried out. The degree must have been bestowed by a Canadian university, or by a foreign university that is recognized by a Canadian university or a Canadian professional association. A holder of a license for analytical testing may designate one or more individuals as the alternate heads of the laboratory, provided they are qualified. These alternates must be identified and their credentials included with the application.
  • The license holder’s testing laboratory must have an on-site storage area surrounded by a physical barrier in order to safeguard against unauthorized access to the testing samples. It should be possible to demonstrate how the barrier’s construction, as well as any access controls on the exit and entry points, are able to achieve this goal. Access to all storage areas must be restricted to necessary personnel only.

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Cannabis License Experts is a compliance solutions provider consisting of in-house professionals with extensive Cannabis, Pharma, Food, Medical Device and Drug regulatory
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