5 Common Pitfalls When Importing Natural Health Products
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5 Common Pitfalls When Importing Natural Health Products
- 1. 5 Common Pitfalls When Importing Natural Health Products June 2022
- 2. 1. Not Having An Importer of Record Clearly marked on label at time of import. Agreements in place to communicate between your company (international) and Health Canada (the regulator). Ensure all sites are reviewed and approved. Avoid: Products being refused or held at time of import.
- 3. 2. Not Obtaining Approval for Sites Licensable activities: Manufacturing, Packaging, Labelling, Warehousing, Importing. Domestic Sites obtain their own license. Foreign sites are annexed to a domestic license. GMP evidence is required for all sites. To be reviewed and approved by Health Canada. At time of application and at renewal intervals. Avoid: NPN suspension while obtaining approval for sites.
- 4. 3. Not Being Cognizant of Timelines Health Canada are not currently meeting posted/standard timelines for licensing. Taking several weeks to months longer than anticipated. Difficult to give a clear lead time on approval for sites. Many factors. Build in ample buffer time. Only set dates after all approvals are in place. Avoid: Having to delay your launch after dates with retailers and distributors have been set.
- 5. 4. Not Having Compliant Test Results or Labels Ensure your products are tested at finished product stage and for shelf life. NHP Quality Guide Testing Gap Analysis Ensure your product labels are compliant NHP Label Checklist Natural Product Number (NPN) Bilingual Text Avoid: questioning on testing and labelling from both Regulator and Consumer, be able to address and clarify concerns swiftly. Produce a safe and effective product.
- 6. 5. Not Knowing About Health Canada Requirements As license holder it is your responsibility to be aware and educated on regulatory aspects of your products. 3 Pieces: NPN Bilingual Labelling Site Licensing Avoid: Health Canada enforcement action.
- 7. We are happy to help! info@qualitysmartsolutions.com https://qualitysmartsolutions.com/ 1-866-941-1868
Editor's Notes
- Hello Everyone. My Name is Mitchell Kiernan Quality and Regulatory Affairs Specialist with Quality Smart Solutions. Please check out my newest blog entitled 5 common pitfalls when importing natural health products. I will summarize common issues new clients bring when first engaging our services, in effort to help companies improve their compliance.
- Firstly, clients will come to us if they do not have an importer of record. This must be marked on your label at time of import. Having an importer ensures Health Canada will be able to reach someone if you do not have an operation domestically. They use this registration to ensure all products and therefore sites are reviewed and approved. Not listing or having an importer may cause your product to be refused at time of import.
- Secondly, clients are not aware of the requirement to have sites that conduct licensable activities annexed. Licensable activities: Manufacturing, Packaging, Labelling, Warehousing, Importing Domestic sites get their own SL and foreign sites would be annexed to a domestic/importing license. Health Canada reviews paper based GMP evidence prior to approving sites for the purpose of importing. Your NPNs may be suspended until all sites are approved for use.
- Next, It is important you are aware of timelines especially since health Canada can take a while to approve your sites. Be sure to include ample buffer time or wait until approvals are inplace prior to making retail obligations. This is in effort to meet retail obligations rather than having to push them out or break them.
- Also, It is important all products are fully tested at finished product stage and for stability and meet health Canada requirements. And to have a compliant bilingual label that also lists your NPN. Health Canada has posted two great resources for this NHP quality guide and NHP labelling checklist. Testing and labelling your products to Health Canada requirements make it easy to respond to any Health Canada or consumer inquiries through product life-cycle.
- Finally, as license holder it is your responsibility to be aware and educated on regulatory aspects of your products. 3 primary pieces are NPN, Bilingual Labelling and Site Licensing This is in effort to avoid: Health Canada enforcement action.
- Please reach out to our team of specialists to further discuss your Supplements or Natural Health Products. We are happy to help discuss the quality, labelling, registration and importation for your products for North America! Have a great day!