By: Jacqui Jenskey, Senior Regulatory Affairs Specialist, email
Are you thinking of launching new Vitamin, Mineral, or Herbal Supplements in Canada as a way to promote customer self-care, health, and wellness during these unprecedented times? In the US, Vitamin, Mineral, and Herbal Supplements are considered Dietary Supplements under the US Food and Drug Administration (FDA) and, in general, do not require FDA approval before being marketed. In Canada however, these types of products do require premarket authorization as Natural Health Products (NHP) by Health Canada’s Non-prescription and Natural Health Products Directorate (NNHPD).
Your product registration could be as simple as a Vitamin/Mineral supplement, already meeting established guidelines and a shorter registration timeframe of 30 to 90 days. Or, your registration could be as complicated as a new natural active/medicinal ingredient and require full clinical data to support the safety and efficacy of the ingredient in your formula. This would have a 210-day NNHPD review and approval. Either way, Dell Tech can help. We have a staff of Professional Regulatory Affairs Specialists with decades of experience as both dietary supplement consultants and natural health products consultants.
As part of the regulation of Natural Health Products in Canada, the establishments that manufacture, package, label, and import these products require site licensing. The site registrations require government review and acceptance for Canadian facilities as well as foreign sites. Your foreign suppliers will need to provide evidence of their quality management system to ensure Good Manufacturing Practices (GMP) meet Health Canada’s strict regulatory requirements.
Dell Tech has been working in the consulting industry for 40 years providing professional, confidential consulting services. Let us assist you through the often-complex regulatory processes in Canada.
Please let us know how we can support your business.
Contact:
Dell Tech Laboratories
Jacqui Jenskey
Senior Regulatory Affairs Specialist
519-858-5021 x 2028
jjenskey@delltech.com
Dell Tech has provided professional, confidential consulting services to the chemical specialty
industry in Canada, the USA, Europe, and Asia for the last 40 years.
Contact us today for more information.
www.delltech.com
