Before a natural health product (NHP) can be sold in Canada, it requires pre-market approval. Since the Natural Health Products Regulations were put in place in 2004, Nutrasource’s regulatory team has submitted thousands of Product Licence Applications (PLAs) to Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD), with a 97% success rate.
Our team has received PLA approvals for single-ingredient NHPs and multi-ingredient products containing over 15 unique active ingredients. Our regulatory affairs personnel have experience completing and submitting all categories and variations of PLAs (e.g., Class I, II, and III) for a broad range of health indications, including:
- Joint health
- Cardiovascular health
- Immune health
- Skin health
- Weight management
- Exercise/physical activity
- Cognitive function
- Various traditional use indications (e.g., Traditional Chinese Medicine, Ayurvedic Medicine)
At Nutrasource, we are always thinking one step ahead to anticipate challenges you may face and assist you every step of the way as you seek regulatory approval for your NHP.
NHP product licensing services include:
- Health claims substantiation strategy
- Theoretical product review
- Product classification
- Compliance consulting
- Scientific literature reviews to evaluate ingredient safety and efficacy
- Preparation and filing of Product Licence Applications (PLAs) and ePLAs
- Responding to Clarification Requests (CRs) and Information Request Notices (IRNs)
- Preparation and review of quality documentation, including Finished Product Specifications and Quality Summary Reports
- Technical label review
- Preparation and filing of NHP Master File submissions
- NHP Site Licensing
Learn how we can help you successfully gain pre-market approval for your NHP in Canada.
How Health Canada’s Upcoming Self-Care Product Regulations Could Impact Your Marketed Natural Health Products, Non-Prescription Drugs, and Cosmetics
New self-care product regulations are coming to Canada. Will your brand be ready?
Case Study: Using an Integrated Regulatory and Clinical Approach to Gain Approval for a Novel Natural Health Product
Learn how Nutrasource helped a client launch a new NHP with a competitive, one-of-a-kind claim.