License Amendment Process
Licence amendment process for the new classes of cannabis (edibles/topicals/extracts) – July 13th announcement.
For existing licensed oil processors:
- As of July 15, 2019, existing oil processors can submit their request to add the new classes of cannabis to their processing licence. Health Canada is requesting the amendment be filed by Sept. 2, 2019 for processors who want to sell the new classes of cannabis later this year.
- The request to add edibles/topicals/extracts to the licence takes the form of an attestation confirming the processor will comply with all aspects of the updated Regulations in production of the new classes. They indicate which of the new classes they will be producing, and multiple classes can be selected. The request is submitted by email (not in CTLS).
- Edibles/extracts/topicals can be manufactured by existing oil processors today (in advance of the amendment being approved and the updated Regulations coming into force). The products made today can be sold after Dec. 15th, 2019 if the processor
- Has amended their licence to add the new class(es)
- Has submitted the 60-day product notification (can be submitted Oct. 17, 2019)
- Can demonstrate the products were produced in accordance with the new Regulations (i.e. PCP, new GPP requirements, QAP (or employee) with food experience for edibles etc.)
- Compliance with the updated Cannabis Regulations for production of the new classes (edibles/extracts/topicals) will be confirmed at the next inspection
For existing licensed processors with an amendment in queue to add oil:
- Do not withdraw the amendment
- Amendments to add oil will continue to be processed until Oct. 16, 2019
- Health Canada will contact this group with further instructions.
- Processors who do not receive their oil amendment by Oct. 16, 2019 will not be eligible for the 1 year “grace period” by which they may follow the original Cannabis Regulations, so will need to demonstrate compliance with the new Regulations b(i.e. PCP for extracts/edibles; new GPP requirements; employee with food experience for edibles etc.) before being authorized to process/sell cannabis oil (which, after October 17th, 2019 will be called a “cannabis extract”). This group should be updating operations now.
- An inspection may be required before the amendment is approved
For existing licensed processors that have not yet submitted an amendment to add oil:
- Existing processors without an amendment already in queue to add oil may submit amendment requests now, but these will not be approved before Oct. 17, 2019
- Starting July 15th, all new amendments for existing processors are filed using a Health Canada form via email to licensing-cannabis-licences.SC@canada.ca (not in CTLS)
- The amendment request requires processors to identify which of the new classes they will be producing (edibles/topicals/extracts) and attest that products in the new classes are manufactured in accordance with the updated Regulations (e.g. updated GPP requirements; PCP for edibles/extracts etc.)
- The amendment request must be accompanied by supporting documentation (e.g. packaging records, product photographs, release forms, CofAs etc.). The supporting documentation required is the same as was required for previous amendments to add cannabis oil, though it should reflect the changes in operations implemented to come in line with the new Cannabis Regulations
- This group should be updating operations now.
- The requirements for representative lots/batches differ depending on the class(es) that will be added:
An inspection may be required before the amendment is approved.