As a license holder for Natural Health Products (NHPs), it is your responsibility to be aware of and educated on all requirements for Canada.
This blog will aim to highlight and summarize the common pitfalls of a company that manufactures NHPs outside of and imports them into Canada. Working with an importer such as Quality Import Solutions (QIS) and a consultant such as Quality Smart Solutions (QSS) will help guide you and bring your products to Canada in a safe and compliant manner.
1. Not having an Importer of Record
For Natural Health Products that are manufactured outside of Canada. You are required to have and work with an Importer of Record. This party will act as a liaison within Canada for your NHPs. Health Canada inquiries will be sent to the Senior Official of the license holder as well as the listed Importer of Record.
This requirement aims to ensure there is a domestic contact person for all marketed products that can respond and act promptly. If you do not have an importer of record, in place or marked on your label, your products may be held or refused at the time of import. This can lead to further enforcement action.
2. Not obtaining approval for Sites
Health Canada requires that all sites involved in the licensable activities (manufacturing, packaging, labeling, warehousing, and importing) hold a Site License.
Domestic/Canadian sites will hold a Site License themselves. For all foreign sites, this will mean that they are annexed/attached to the site of a licensed Importer. This licensing process aims to ensure the handling of NHPs before the sale is done so within an environment that is sanitary, well-controlled, and adheres to Good Manufacturing Practices (GMPs).
If your sites are not approved your NPNs may be suspended until GMP evidence for each site is provided to, reviewed, and approved by Health Canada. This can also lead to further enforcement action.
3. Not being aware of Site License timelines
Please know that the posted Health Canada timelines for Site License applications and amendments are not currently being met by the regulator. It is difficult to give a clear timeline for approval since there are many variables such as Health Canada’s backlog/queue, the complexity of submission/sites, gaps in testing or GMP documentation, responding to Health Canada inquires, etc. We recommend building ample buffer time for your launch plan to account for expected delays in site licensing and annexation.
If you do not anticipate and plan for proper timing with Health Canada and begin making deals with retailers prior to approval, it is possible these deadlines may not be met. We suggest wherever possible, waiting for all approvals (labels, licenses, sites) to be in place prior to setting the deadlines to avoid potential conflict.
4. Not having testing results or labels that meet Health Canada requirements
All NHPs must undergo testing at the finished product stage and through shelf life (stability). This testing will show that your product meets Health Canada requirements for physical characteristics, purity, and potency. The Quality Guide is a great reference tool that shows all required testing. Product testing results or proof of future testing in the form of a template is required at the time of site annexation.
All NHPs must have a compliant and bilingual label. The Labelling Checklist is another great reference that shows elements for an NHP label. The importer of record and license holder address must be present on your label for imported products. For all products we import, we suggest a label review be conducted before print.
If you are not testing or labeling your products compliantly, you may not receive a release decision for your product at the time of import. You may also face a Health Canada audit or a trade complaint, which can lead to further enforcement action.
5. Not knowing the above are legal requirements
Again, as a license holder (you can learn about registering here), it is your responsibility to know the requirements for Canada. The main requirements for Natural Health Products are an NPN (Natural Product Number), a compliant bilingual label, and ensuring all sites are either licensed or annexed. Review and knowledge of the regulations and associated guidance are imperative to success in the Canadian market.
Working with regulatory consultants such as Quality Smart Solutions and Quality Import Solutions will help bring your products into Canada in a safe and compliant manner. We hold an NHP Site License which allows us to import products and annex foreign sites for our clients. Please reach out to our team of specialists for all your NHP regulatory needs!
How Quality Smart Solutions can help
At Quality Smart Solutions, we have a team of experts who are skilled in NHP compliance. We offer several solutions to meet your needs like NHPID, Health Claims Substantiation, Clinical Trial Application (CTA), etc. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.