Thinking About Launching Your NHPs?
We have streamlined the Natural Product License application process into 7 clear steps:
Step 1: Confidentiality Agreement
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We begin by signing a Non-Disclosure Agreement (NDA) to ensure all discussions remain confidential. Required information will only be shared with Health Canada for the application process.
Step 2: Submit Formulations
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Provide the following details for initial assessment:
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Formula information, including the list and amounts of medicinal (active) and non-medicinal (excipient) ingredients.
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Dosage directions and dosage form.
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Designated selling country.
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Designated claimed functions.
Step 3: Compliance Review
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We review your documents to ensure your product meets Canadian regulations. If modifications are needed (e.g., dosage adjustments or ingredient changes), we will advise you. For non-compliant products, we will notify you of the likelihood of rejection.
Step 4: Quotation
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Upon review, we provide an all-inclusive written quotation detailing the work and timeline required. The quoted amount is final—there are no hidden charges.
Step 5: Authorization and Application Submission
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Once the quote is approved:
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We will send you a Designated Party Authorization (DPA) Form for signature, allowing us to represent you with Health Canada.
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A 70% deposit is required upon signing the DPA.
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After receiving the deposit, we will provide you with a detailed Registration Information Checklist outlining the necessary details and documents needed for the application.
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Upon receiving the deposit and all required information, we will submit the complete application package according to the timeline specified in the quotation.
Step 6: Responding to Health Canada
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During Health Canada's assessment, additional information may be requested. We will collaborate with you to gather the required details and submit responses to Information Request Notices (IRNs) within the specified timeframe. This service is fully included in your package—no additional fees!
Step 7: Submission and Approval
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Once the NPN is approved, we will notify you and issue the final invoice for the remaining 30%.
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The following information is typically required for us to create your NPN application package:
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NPN holder’s name and contact information.
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Formula details, including all medicinal ingredients and excipients.
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The dosage form and dosage.
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Desired functional claims.
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Other ingredient-specific information (if applicable).
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Our team ensures your application is complete, accurate, and meets Health Canada’s standards. We provide:
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Pre-submission meeting arrangements and preparation of pre-submission packages.
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New company registration and obtaining a company code.
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Completion of the Product Licence Applications (PLA) form.
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Preparation of Finished Product Specifications.
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Label text drafting in compliance with regulatory requirements.
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Master File submissions.
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Attestation to NNHPD monographs and/or preparation of Scientific Rationale.
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Creation of a comprehensive Summary Report.
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Assistance with completing the Animal Tissue Form, if applicable.
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We assist in identifying and fulfilling all testing requirements to ensure your product meets compliance standards which could include:
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Testing requirements depend on your product’s classification and ingredients. Common tests include assays on potency, microbial, and heavy metal contaminants.
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Depending on the ingredients and extraction method, additional tests such as aflatoxins, solvent residues, or peroxide value may also be required.
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Processing times vary by product complexity and Health Canada’s workload. Typical timelines are:
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Class I: 60 calendar days.
Class II: 90 calendar days.
Class III: 180 calendar days for assessment, plus 210 calendar days for processing.
We work efficiently to prepare and submit your application to minimize delays.
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Yes, all NHPs sold in Canada must have an NPN. Some platforms, such as Amazon, have stricter requirements, regularly auditing product compliance and flagging non-compliant products.
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The NPN application process is complex, requiring navigation through detailed regulations. Our specialists streamline the process, helping you avoid costly errors, expedite review timelines, and maximize approval success.
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Ready To Get Started?
FAQ & Process Overview
How We Support New NPN Application
Our expertise ensures your product has the best chance of success by leveraging strategic adjustments, scientific validation, and precise regulatory knowledge.
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Strategic Consultation
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Suggest the most feasible and cost-effective pathways for securing approval of your product’s formula.
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Provide tailored recommendations to optimize your formula from both regulatory and marketing perspectives, balancing compliance and market appeal.
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Professional Supports
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Prepare a tailored, comprehensive application package designed to achieve first-submission approval.
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Compile robust scientific rationale and supporting data to meet Health Canada’s requirements.
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Expert Label Review
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Provide NPN-specific bilingual label text, clearly distinguishing between mandatory elements (e.g., directions, warnings, usage) and optional content.
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Offer reviews for finalized labels, verifying required sections and ensuring legibility details (e.g., font size, contrast) comply with regulations.
Our expertise ensures your product has the best chance of success by leveraging strategic adjustments, scientific validation, and precise regulatory knowledge.
Why do you need a NHP License?
In Canada, natural health products (NHPs) are regulated under the Natural Health Products Regulations, ensuring safety, efficacy, and quality. Products with certain active ingredients, health claims, or specific functions cannot be sold as conventional foods and must meet the requirements of a licensed NHP.
Having an NHP license (Natural Product Number, or NPN) enhances your product's credibility and sets it apart in the competitive market. Consumers associate licensed NHPs with higher regulatory compliance, giving them confidence in the product's quality and safety—allowing you to command a stronger market position and premium pricing.
Why Choose Us?
We tailor our approach to meet each client’s unique goals, ensuring compliance and minimizing risks. With a team of regulatory experts and industry professionals, we provide clear strategies and insights to navigate regulations, empowering you to grow your business confidently.
Decades of Expertise
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Prepare all documents and handle Health Canada communication.
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Deliver updates within 1 business day and responses in 3 days.
Seamless Process
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Identify cost-effective approval paths with an experienced RA team.
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Ensure timely execution of your business plans.
Ongoing Assurance
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Provide 2 complimentary notifications within 9 months post-approval.
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Keep your product compliant with minimal effort.
Comprehensive Coverage
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Offer QTA reviews, IRN responses, and post-licensing audits.
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Ensure full compliance with Health Canada’s requirements.
See What Your Certification Will Look Like
Sample of Health Canada NHP Licence
Services Designed to Fit Your Needs
Our expertise ensures you the best chance of success by leveraging strategic adjustments and scientific validation
Natural Health Products (NHP) Licensing
We simplify the NHP licensing process, ensuring your product meets Health Canada requirements quickly and efficiently, so you can focus on growing your business.
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For Amendments:
Amendments are required for significant changes that may impact the safety, efficacy, or quality of a product.
These changes must be approved by Health Canada before implementation, and the Product Licence must be updated to reflect the modifications. Examples of amendments include:
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Changing the medicinal ingredient’s source material or potency
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Altering the product’s specifications, such as test methods or purity tolerances
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Adjusting the recommended dose or duration of use
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Modifying risk information, such as removing, or updating warnings or adverse reaction
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For Notifications:
Notifications are required for minor updates that do not significantly affect a product’s safety, efficacy, or quality.
These must be submitted to Health Canada within 60 calendar days after the change is made. Examples include:
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Adding or substituting non-medicinal ingredients that do not affect safety or efficacy.
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Changing the product’s brand name.
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Updating the common or proper name of medicinal ingredients.
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Adding new risk information, such as warnings or adverse reaction details.