Your ‘One-Stop-Shop’
for Canadian Compliance,
Regulatory, GMP Licensed Warehousing
& Graphic Design
Click here for a complete list of specific services
we offer.
|
Natural Health Product Regulations in Canada
 In 2004, Health Canada implemented Natural Health Product Regulations and compliant labeling policies to ensure all Canadians have access to NHPs that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity. As regulated by the National Health Products Directorate the following is required to gain your Natural Product Number or "NPN" .
What does Natural Health Product Registration in Canada require?
We collect, validate and present the following information required by Health Canada to gain your NPN:
- Medicinal and non-medicinal ingredient disclosure including specifications and source materials
- Dosage form, recommended use, target sub-population and dose, and risk information
- Evidence Report based on scientific literature search, review and analysis to support the product's health claims
- Safety and Efficacy Summary Reports based on scientific literature search, review and analysis
- Careful scrutiny and submission of full text articles of scientific and clinical studies supporting the product's safety and efficacy
- Quality Summary report stating the final product specifications, including the identity, purity, potency and quantity of the medicinal ingredients, and describing the unit process operations and the in-process quality control points used during manufacture
- Product health claims supported by a substantial, coherent and relevant body of scientific and clinical data extracted from worldwide public and private databases
- Pertinent official product registration forms
- Full finished product testing through qualified third party laboratories licensed with Health Canada and accredited with ISO 9001 registration and/or with certification from the Standards Council of Canada
|