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Natural Product Number (NPN) & Product Licence Applications (PLA)

Obtain your NPN and enter the Canadian Natural Health Product market with confidence.

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What Is an NPN and a PLA

An NPN is an 8-digit number issued by Health Canada confirming that a Natural Health Product meets safety, efficacy, and quality standards. It allows the product to be legally sold in Canada and provides assurance of regulatory compliance. To obtain one, companies must submit a Product Licence Application (PLA) demonstrating the product’s safety, quality, and efficacy. This ensures compliance under the Natural Health Products Regulations (NHPR).

Steps to Obtain an NPN

To secure an NPN, applicants must:

  1. Determine product classification and confirm eligibility as an NHP.
  2. Compile ingredient data and supporting safety or efficacy evidence.
  3. Identify PLA class (I, II, or III) based on monograph coverage.
  4. Ensure manufacturing site compliance with NHP GMP standards.
  5. Prepare and submit the PLA package through Health Canada’s ePost system.
  6. Await NNHPD review (60–210 days depending on class) and manage communication with Health Canada throughout the review process.

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Our NPN & PLA Services

  • Preparation and filing of PLA submissions for Classes I–III.
  • Monograph assessment and evidence preparation
  • Review of product labels and claims for compliance.
  • Evidence compilation for non-monograph ingredients.
  • Assistance with GMP and site licence verification.
  • Ongoing liaison with Health Canada reviewers during application.

dicentra ensures your products meet all regulatory obligations and reach Canadian consumers with confidence.

Use Cases We Support

  • Supplement manufacturers entering Canada
  • Foreign exporters seeking Canadian market authorization
  • Brand owners developing new NHP product lines
  • Private label and contract manufacturing clients
  • Companies needing reclassification or label updates

Our goal is to make the process straightforward, predictable, and transparent.

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Why Choose dicentra?

  • One of Canada’s most experienced NHP regulatory consulting firms
  • Over 24,000 successful regulatory projects completed
  • Established working relationships with NNHPD reviewers
  • End-to-end support from formulation to market launch
  • Integrated consulting across compliance, labeling, and claims substantiation

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