GETTING YOU PRODUCT

ON THE SHELVES

1 - Annexing applicable sites:
Sites that manufacture, package, label and warehouse the product (including the landing site in Canada) must be annexed onto our Site License.

This is a lengthy process taking at least a three-month review expectation from Health Canada. We will require a selection of paperwork from each of these sites in order to verify GMP standards.

This is a one-time step, repeated every 2-3 years upon licence renewal.

2 - Product setup:
Setting up your products in our files to ensure concise tracking and to stay within Health Canada’s regulations. For this, we will need related documents for easier process flow.

This is a one-time step, but we must be updated with any changes to any of the documents outlined below before the next new lot.

    1. A copy of the NPN License

    2. A copy of the finished product specifications (fps) as approved by Health Canada

    3. Copies of the complete packaging for the product, legible and fully bilingual in French and English.

    4. The master production document (batch record template)

    5. A stability study completed at the finished product stage (for physical description, packaging integrity, micro and any assayable medicinal ingredients)

  • If you do not have the required stability testing, the following will be required;

    • A real-time stability template (we can assist with this if needed) with a commitment to start the study on the first lot run for Canada.

      AND one or more of the following:

      • An accelerated stability study.

      • A real-time or accelerated study of another comparable product, on which you based your stability determination (expiry date).

      • A rationale as to how you have determined the initial shelf life of the product.

3 - Importation:
When the above has been accomplished, we are ready to Import. Once your product is ready to ship, we will need a complete package of testing and shipping information for each unique lot, we will then create a release for the Canadian warehouse stating that the product is approved for sale.

If all the paperwork is in order we work within a 48-hour turnaround.