The proposed changes to the Cannabis Regulations include but are not limited to new cannabis classes, changes to GPP, testing, packaging, and labeling. Although the most significant changes are proposed for the Processor Class, all Licence Holders are impacted by the updated regulations to some degree.
Transitional provisions of 12 months have been provided for some changes including but not limited to product labelling and oil processing. No transitional provisions have been identified for the production and sale of new classes of cannabis.
As a Licence Holder, it is suspected that full compliance will be verified by Health Canada through a combination of paper review (through amendments) and/or on-site inspections.
Further details are provided for the addition of new cannabis classes.
Overview for New Classes of Cannabis:
As a Licence Holder, you will be required to apply for an amendment and submit an attestation to confirm full compliance with the new regulatory requirements.
Health Canada has confirmed that the sale of new cannabis classes can be requested through an amendment, attestation and 60-day new product notice. Details regarding this amendment and the new attestation form will be provided from Health Canada by July 15th.
After July 15th, an amendment may be submitted including the required information requested by Health Canada.
If you would like to engage CCI proactively to support in completing this amendment, please connect with your CCI Business Development Consultant to discuss next steps.
Health Canada has proposed the following timeline to implement the production and sale of new cannabis classes.
High Level Overview:
Of note, although specific information which must be included with the amendment will be released by July 15th, full compliance with the regulation is required for all new products produced and sold.
It is anticipated that licensed processors may wish to begin producing products within the new classes in advance of the amended Regulations (and in advance of their licence being amended to permit them to sell these new products). The transitional provisions clarify that it will be prohibited for a licence holder to sell, distribute, or export products in the new classes that was produced, packaged, labelled, stored, sampled, and tested prior to October 17, 2019, unless, at the time those activities were carried out, the applicable requirements set out in Parts 5 (good production practices), 6 (products) and 11 (record keeping) of the amended Regulations were met. Furthermore, the Quality Assurance Person or retained individual will need to have the necessary qualifications applicable to the class of cannabis they are producing during this period of time.
*Pending approval by Health Canada, amendment, attestation and 60-day new product notice.
If you are intending to produce the new cannabis classes, or if you have begun to produce the new cannabis classes and would like support in confirming activities are carried out in compliance with the proposed regulations or in developing the updated programs required, contact us for next steps.