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Probiotics/Prebiotics Registration and Notification Canada

Probiotics are live microorganisms which when administered in adequate amount can confer health benefits on the host. Probiotics promote a healthy balance of gut bacteria and have been linked to a wide range of health benefits. Another category of food additive which is beneficial to the human body is – Prebiotics. These are non-digestible ingredients which help in boosting the immune system of human body. Both prebiotics and probiotics help in boosting the immune system of human body and inhibit the growth of harmful gut bacteria, while promoting the production of natural antibodies in the body. In the current scenario of COVID-19, Probiotics/Prebiotics are considered critical to boost the immunity. But with the decline in the global supply chains of Probiotics/Prebiotics, meeting the demand right on time would be challenging.

To ensure the world sustain the international health crisis, as a prominent Probiotic/Prebiotic manufacturer you might be willing to market your products across the globe or to be specific in Canada. In Canada, Probiotics/Prebiotics are defined by the Natural Health Product Regulations as a monoculture or mixed culture of live micro - organisms that benefit the microbiota indigenous to humans and the product will be classified as a Natural Health product (NHP).

To be legally sold in Canada, all-natural health products (NHPs) must have a product license, and the Canadian sites that manufacture, package, label and import these products must have site licenses. A product license or a site license application should be submitted to NNHPD to obtain approval. For a product license, applicants must give detailed information about the product to Health Canada. Once Health Canada has assessed a product and decided it is safe, effective and of high quality, it issues a product license along with an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), which must appear on the label. This number lets you know that the product has been reviewed and approved by the Health Canada.

Probiotics/Prebiotics – Freyr’s Regional Focus

Freyr team has experience of more than a decade of working on Probiotics/Prebiotics NHP applications and interacting with the Health Canada. With a vast knowledge on the Health Canada and Probiotics/Prebiotics Regulatory requirements, Freyr team of subject matter experts (SMEs) can assist you with compliance check of the product’s registration, label and claims to identify if the product is a NHP or not. Freyr can assist you in preparing the product license application to be submitted to the Health Canada and follow up with them until approval is received and also assist in claim consultation and claim review on a probiotic product label. Freyr is specialized in:

  • Probiotics/Prebiotics registration in Canada
  • Probiotics/Prebiotics market entry
  • Evaluation of your label or labeling information for compliance
  • Review of immunity boosting claims
  • Design or develop artwork for Immunity boosters
  • Review or assess the product formula to identify the product category and to check the acceptability of all the ingredients in the product in line with the Health Canada
  • Suggesting mandatory, missing information and nutritional/supplemental facts or the corrections to be made on the label of the product as per the country specific regulations
  • Monitor compliance with the Health Canada including advising on general labeling and advertising issues, nutrition labeling, and evaluation of permissible claims (e.g., health claims, nutrient content claims, and structure-function claims)
  • Prepare and submit dossier for Probiotics/Prebiotics registration
  • Assist with devising a robust Regulatory pathway for your product

As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track the registrations of Probiotics/Prebiotics in Canada. 

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