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The licensing process can be an anxious and overwhelming experience; we know as we hear it every time we take that first phone call from a new client. That’s what we’re here for; to make the experience less stressful.

Canada has unique regulations governing vitamins, minerals and other natural health products unlike any other regulations in the world, which can be confusing to those who want to export their products into Canada. These regulations are still evolving and will include more products in the future. Learn how you can align your products and facilities with Health Canada’s Natural Health Products Regulations that will allow your products onto the Canadian market as quickly as possible.

  • Preparation of evidence reports based on a search of scientific data, traditional medicine and information that supports the product’s health claims and dosage of the ingredients.
  • Careful selection of scientific journal articles and studies that support the dosage, safety and efficacy of each ingredient in the product.
  • Compile the Quality documents consisting of lab tests that prove identity, purity, potency and quantity of the medicinal ingredients, Attestation Form, and the Finished Product Specifications form (FPS) CNHPR will provide full finished product testing through qualified third party laboratories licensed with Health Canada.
  • We will assess your natural health product label to ensure it is compliant with the NHP Regulations and ready for sale in Canada
  • Assess your formulas for eligibility prior to selling in Canada
  • CNHPR can assist license holders in reviewing their product licenses to update them to ensure they are current with the latest monographs and other restructured regulations.
  • Prepare your product registrations, license amendments and license renewals.
  • Assist with new product development
  • Assistance with the French language required for your labels.
  • We can assess your intended sales materials for your health products
  • YellowGinkgoSOP Development
  • Site Licenses
  • GMP for Domestic  and International Sites
  • Suggest distribution outlets for your products
  • Quality control documents

 

Site Licensing

All companies in Canada that want to manufacture, package and label a natural health product for sale must have a Site License that has been issued by Health Canada. To get a license, manufacturing/distribution sites must maintain proper distribution records, have proper procedures for product recalls and for the handling, storage and delivery of their products, and demonstrate that they meet good manufacturing practice requirements.

Some considerations  before exporting supplements and other natural health products into Canada:

  • Choose a site licensed facility in Canada for importing dietary supplements and natural health product and ensure that a QA person is employed there.
  • Ask if their manufacturing and contractor facilities are compliant with Canada’s NNHPD Good Manufacturing Practices (GMP).
  • Do all buildings used in your supply chain meet GMP compliance, such as packaging and testing facilities?
  • Make sure the Canadian importer is current with all sections of the GMP’s
  • Be prepared to provide the written product release specifications for your natural health products.
  • Does your paperwork show that your dietary supplements meet the expiry date?.
  • Apply for a foreign site reference number from Health Canada

 

Leave it to us

To say the least, it is very taxing and time consuming to attempt to navigate the Health Canada requirements for product licensing yourself. Why not consider one of our consultants that has years of experience in natural health product licensing?  Experience has given us the knowledge to prepare your license application with confidence.

Cost

Our licensing work is charged on a contract basis, not at an hourly rate as we believe you would like to know the cost upfront before embarking on a project with us. Our clients are quoted an estimate on the registration work, and when approval is given, we start the process with a deposit; half of the full contract price.  If you are considering licensing your natural health product, contact us, Canadian Natural Health Product Registry to find out how to start the process.