Ever wonder about exporting US products to Canada? This post was written by Femi Adeoye, B. Pharm, Dip. Pharm QA/QC, RAC (Canada, EU & US), Certified Biomedical Auditor. He is also the Managing Principal Consultant for Reg-Affairs & QualiPractixis Inc.
Dietary Supplements, Nutraceuticals, Herbal/Natural Medicines and some cosmetic products (e.g. certain Anti-Acne, Sunscreens products) are classified as Natural Health Products (NHP) in Canada. If these products are non-compliant, they are often barred from entering Canada by the Canada Border Service Agency.
If you are considering exporting your products to Canada, follow these 5 key steps for compliance:
- Review your product ingredients, claims and label for correct classification and submission pathway.
- Prepare and submit your Product License Application to Health Canada for review and approval. Upon approval Health Canada will issue a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Currently no government fee is charged for this review and approval.
- Ensure your Canadian importer has a Site License issued by Health Canada or apply for one.
- Ensure your final product label is compliant and the NPN or DIN-HM is written on it.
- Ensure all product testing as per Canadian requirements are done and satisfactory (testing may be done in Canada before product is released for distribution).
Reg-Affairs & QualiPractixis Inc. is a consulting firm that can assist your supplement business in variety of regulatory activities including establishing a quality system, ensuring regulatory compliance and preparing your products for export to Canada. Please email Femi for more information.