Manage your cannabis cultivation, processing or sale for medical purposes licence: Add sale activities for new cannabis class
How to add sale activities for a new cannabis class to your processing licence in Health Canada's Cannabis Tracking and Licensing System (CTLS).
On this page
- Selling new cannabis products
- Before you submit
- Required information
- Organizational security plan
- Notices to local authorities
This page will help processing licence holders add sale activities for:
- cannabis extracts
- edible cannabis
- cannabis topical
This includes:
- selling and distributing to provincially and territorially authorized retailers and sale for medical purposes licence holders
- sending and delivering on behalf of provincially and territorially authorized retailers and sale for medical purposes licence holders
If you request sale activities for extracts or edibles, you'll be authorized to sell extracts, edibles and topicals. If you request sale activities for topical products, you'll only be authorized to sell topical products.
Important: If you don't fully produce the cannabis products at your site, you're still required to submit a request to add sales activities. In this case, Health Canada won't be able to assess how you maintain product quality and compliance through all processing steps. Health Canada might add conditions to your licence that will limit what you can sell.
For example, if another licence holder is processing the cannabis and packaging it into the immediate container on your behalf, Health Canada will only be able to assess your company's ability to carry out a limited number of steps involved in the production of the cannabis product, such as labeling and secondary packaging.
If you have any questions, email licensing-cannabis-licences@hc-sc.gc.ca. Use the subject line "Questions about adding sales activities to LIC-#".
Once you submit your request, Health Canada may inspect your site to verify compliance with the Cannabis Regulations (the Regulations).
Selling new cannabis products
You need to notify Health Canada at least 60 days before making any new cannabis product available for sale. This excludes cannabis plants and seeds.
You may submit a Notice of new cannabis product at any time. If you're requesting to add a new sale activity, you may only sell the cannabis product:
- after your change request has been approved
- 60 days after submitting the notice to Health Canada
Notice of new cannabis product guide
Before you submit
Before you apply to have sale activities added to your licence, you need to:
- have tested the cannabis with the required test at the appropriate time:
- cannabis extract
- pesticides, on dried or fresh cannabis used to make the cannabis extract, before processing activities
- contaminants other than pesticides, on input cannabis right before packaging and labelling activities (final form) or cannabis product after the final step during which contaminants could have been introduced or concentrated
- phytocannabinoids, right before packaging and labelling activities (final form) or on the cannabis product
- dissolution and disintegration, right before packaging and labelling activities (final form) or cannabis product if in capsule or other dosage form, if applicable
- cannabis topical
- pesticides, on dried or fresh cannabis used to make the cannabis topical, before processing activities
- contaminants other than pesticides, on input cannabis right before packaging and labelling activities (final form) or cannabis product after the final step during which contaminants could have been introduced or concentrated
- phytocannabinoids, right before packaging and labelling activities (final form) or on the cannabis product
- edible cannabis
- pesticides, on dried or fresh cannabis used to make the edible cannabis, before processing activities
- contaminants other than pesticides, on the cannabis used to make the edible cannabis
- phytocannabinoids, right before packaging and labelling activities (final form) or on the cannabis product
- cannabis extract
- make sure that testing for pesticides is conducted by a third-party laboratory that holds a licence for analytical testing under the Regulations. The laboratory must be a distinct entity that functions and reports independently of the person requesting the analysis
- have prepared the minimum number of lots or batches required to apply
- cannabis extracts and edible cannabis: minimum of 2 lots or batches of either products
- topical cannabis: minimum of 2 lots or batches. If you request edible cannabis or cannabis extracts in addition to topical cannabis, you don't need to provide lots or batches of your topical cannabis product
Mandatory cannabis testing for pesticide active ingredients: Requirements
Good production practices guide for cannabis: Testing requirements
Required information
Type of change request: Authorized activities
Requires approval from Health Canada
If you exceed the file limit in any sections, use the other sections to upload additional documents. Use the document naming convention for all your documents.
Description of change section
- Document containing a brief description of the new class of cannabis you're requesting (name: ChangeDescription_CHG-#_YYYY-MM-DD.PDF). This includes:
- cannabis classes being requested for sale (for example, cannabis extracts, edible cannabis)
- the form of cannabis products (for example, THC oil and isolates, capsules containing CBD oil, lotions, baked goods)
- the intended use of the cannabis product (for example, inhalation, ingestion or topical)
- Completed Attestation to add the activity of sale of cannabis products to a processing licence (name: Attestation_CHG-#_YYYY-MM-DD.PDF)
Good production practices report section
- Release specifications for all analytical testing (name: Specification_CHG-#_YYYY-MM-DD.PDF). The specifications need to be appropriate for the product's intended use. Include the following information:
- the parameter being tested and its tolerance limit (such as lead, less than 5.0 µg/g)
- the publication referred to in Schedule B of the Food and Drugs Act from which the specification was obtained and the location within the publication (for example, Ph.Eur.5.1.48 [Table C])
- Document about your new cannabis products (packaged and labelled for sale to a consumer at the retail level) at the time of application (name: LotDetails_LotBatch#_CHG-#_YYYY-MM-DD.PDF). Include the following information:
- your production model, for example:
- another licence holder send you the cannabis in bulk, partially packaged
- you completed all production steps at your site
- which production steps took place at another licence holder's site and which steps took place at your site
- total number of lots or batches of cannabis product prepared (for example, 2 lots of cannabis extracts)
- total amount of cannabis product prepared per lot (for example, 30 grams per bottle, 1,000 bottles per lot)
- confirmation that the lots or batches are:
- packaged and labeled for sale to a consumer at the retail level and are available on-site
- the same size as those intended for sale
- your production model, for example:
- Documents, such as certificates of analysis (name: CertificateofAnalysis_LotBatch#_CHG-#_YYYY-MM-DD.PDF), showing that each lot or batch has been tested for:
- cannabinoid content
- microbial and chemical contaminants
- dissolution or disintegration, if applicable
- pesticides
- Proof that the results have been reviewed and that they're within the identified specifications, such as signed product release forms (name: ProductReleaseDocument_LotBatch#_CHG-#_YYYY-MM-DD.PDF)
Record keeping description
Use this section to upload additional documents if you exceed the file limit in other sections.
Organizational security plan
You need to update your organizational security plan within 5 days of making the change and email Health Canada.
Cannabis organizational security plan
Notices to local authorities
Send notices to local authorities within 30 days of receiving the modified licence.
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