1. CANADA REGULATORY SOLUTIONS
Quality Smart Solutions is your ideal partner for
Canadian Regulatory Compliance.
NATURAL HEALTH PRODUCTS
Two requirements must be met in order to legally sell your dietary
supplement in Canada. A Natural Product Number (NPN) must be obtained from Health Canada and,
if you are based outside Canada, you must work with a Canadian licensed importer. First, a product
license application with the necessary supporting documentation (depending on the classification of the
product) is submitted to the Natural Health Products Directorate (NHPD, a division of Health Canada).
If the product is acceptable to NHPD, a NPN
license is issued in 10 days to 6 months
depending on the risk classification of your
product. The application is assessed based
on the safety and efficacy of the product for
the Canadian marketplace. Secondly, if the
product is made outside of Canada you must
utilize a NHP licensed importer in Canada.
The licensed importer must follow current
Good Manufacturing Practices (cGMPs) to
import NHPs and your manufacturer must also
demonstrate the same.
FOODS
Foods sold in Canada typically require a nutrition facts panel on packaging, allergen statements, optional
nutrient claims and bilingual labelling. However, certain food categories such as fortified or functional
foods may require special regulatory assessment before they can be sold on the Canadian market.
These include:
• Temporary Market Authorization License - certain foods fortified with vitamins, minerals, amino acids
and/or caffeine
• Novel Food Notification - foods that are from a new species,
food source or not traditional in Canada
• Food Additive - an ingredient or chemical substance used in
preparing or storing a food and may become part of the food
during food manufacturing. These often have a purpose of
achieving a certain technical effect.
Review your product formula, provide detailed
feedback, and have open and engaging discussions
with you to ensure success in license issuance.
Prepare your Product License application and send
a full copy of the application package for your
review prior to submission.
Submit your Product License Application to Health
Canada and follow this through to license issuance.
Legally import your Natural Health Products into
Canada. Quality Smart Solutions can provide this
service as a licensed Canadian importer.
OUR SOLUTION:
Review cosmetic formula to ensure
any ingredient present in the product
is not on the cosmetic hot list.
Review label for cosmetic regulatory
compliance.
Submit cosmetic notification to
Health Canada.
OUR SOLUTION:

2. Natural Health Products
• Natural Product Number License (NPN)
• New Ingredient Submission (NHPID)
• Natural Health Product Master File
(NHP-MF)
• NHP Importation
• Site License submission (Canadian
companies only)
• Label, Advertising NHP compliance review
and French Translation
Veterinary Natural Health Products
• Low Risk Veterinary Health Product
submission (LRVHP)
• Label and advertising LRVHP compliance
review
Food
• Temporary Market Authorization License
(TMAL)
• Novel Food notification
• Food Additive submission
• Health claim substantiation
• Label food compliance review, Nutrition
Facts panel creation French Translation
Cosmetic
• Cosmetic notification
• Hotlist ingredient review
• Label advertising cosmetic
compliance review
Drug
• Over-the-counter (OTC) drug submissions
• Establishment license application
1.800.396.5144
www.qualitysmartsolutions.com
info@qualitysmartsolutions.com
COSMETICS
The sale of a cosmetic in Canada requires that a
notification be submitted to Health Canada within
the first 10 days the cosmetic is for sale.
DRUGS
Over-the-counter (OTC) drugs require a Drug Identification
Number (DIN) prior to being sold in Canada. Fees are
associated with DIN submissions depending on their category.
Licenses are issued by Health Canada within a reasonable time
period. If you are a foreign manufacturer you are required to
partner with a Canadian licensed drug importer.
Review cosmetic formula to ensure any ingredient
present in the product is not on the cosmetic hot list.
Review label for cosmetic regulatory compliance.
Submit cosmetic notification to Health Canada.
OUR SOLUTION:
Review your formula to ensure it
meets the OTC drug monograph
requirements
Prepare a DIN application and
submit to Health Canada
OUR SOLUTION:
Canadian Regulatory
Solutions
CANADIAN REGULATORY
SOLUTIONS