How to Prepare an ePLA Submission for Health Canada

Securing a Natural Health Product (NHP) licence in Canada requires navigating Health Canada's electronic Product Licence Application — commonly referred to as the ePLA. Whether you are bringing a new supplement to market or updating an existing product, understanding the ePLA process is essential. With over 127,779 active licensed NHP products currently in Canada, the competitive landscape is significant, and a well-prepared submission can be the difference between approval and a deficiency notice that sets your launch back by months.

This guide walks regulatory professionals and supplement brand owners through every major component of an ePLA submission, from pre-submission strategy to final review.

What Is an ePLA Submission?

An electronic Product Licence Application (ePLA) is the formal submission package you file with Health Canada to obtain a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) for your NHP. Under the Natural Health Products Regulations (NHPR), no NHP may be sold in Canada without a valid product licence.

Health Canada reviews ePLA submissions through its Natural and Non-prescription Health Products Directorate (NNHPD). The review pathway — and the evidence required — depends primarily on whether your product qualifies for a monograph-based submission or requires a non-monograph (full dossier) submission.

Step 1: Determine Your Submission Pathway

Before drafting a single page of your dossier, confirm which regulatory pathway applies to your product.

Monograph-Based Submissions

Health Canada has published 249 monographs that pre-assess the safety, efficacy, and quality of common NHP ingredients and product categories. If all of your medicinal ingredients, doses, claims, and dosage forms align exactly with one or more approved monographs, you can follow the simplified monograph pathway — typically resulting in faster review timelines.

Examples of monographs with broad claim sets include:

• Fixed Oil Products – Oral: 57 approved uses and 5 cautions
• Workout Supplements: 39 approved uses and 37 cautions
• Dandelion (Taraxacum officinale) – Oral: 20 approved uses and 4 cautions
• Elder (Sambucus) – Oral: 18 approved uses and 4 cautions
• Mushrooms – Oral: 18 approved uses and 2 cautions

Selecting the correct monograph — and using approved claim language verbatim — is critical. Even minor deviations from the monograph text can result in a deficiency notice. For instance, a claim such as "NMN is a NAD+ precursor which is a factor in normal growth and development" must appear exactly as worded in the Nicotinamide Mononucleotide Monograph to qualify for monograph-based review.

Non-Monograph Submissions

If your product includes novel ingredients, non-standard doses, or claims not covered by any existing monograph, you must submit a full dossier with published clinical and/or traditional evidence to support safety and efficacy. These submissions require considerably more documentation and typically have longer review timelines.

Step 2: Compile Your Product Information

The core of your ePLA is accurate, complete product data. Gather the following before opening Health Canada's online submission portal:

Medicinal Ingredients

List every medicinal ingredient with its:

• Proper name (as recognised by Health Canada)
• Potency or quantity per dosage unit
• Source organism or chemical form
• Plant part (for herbal ingredients)

Canada's licensed product database includes 6,210 unique medicinal ingredients. Common ingredients such as Vitamin C (appearing in 10,828 licensed products), Vitamin D (9,445 products), and Zinc (8,228 products) follow well-established monograph pathways. Confirming your ingredient's proper name against the Licensed Natural Health Products Database (LNHPD) before submission reduces the risk of rejection on technical grounds.

Non-Medicinal Ingredients

All non-medicinal ingredients (NMIs) must be listed and confirmed as acceptable for the intended dosage form and route of administration. Health Canada maintains an acceptable NMI list, and any ingredient not on that list requires additional justification.

Dosage Form and Route of Administration

Your product's dosage form shapes much of the submission — from acceptable excipients to stability testing requirements. The most common dosage forms among licensed Canadian NHPs are:

Confirm that your dosage form is appropriate for your chosen route of administration and that your monograph (if applicable) supports that combination.

Step 3: Draft Your Health Claims

Health claims are one of the most scrutinised elements of any ePLA. Claims must be supported either by an approved monograph or by submitted evidence, and the exact wording matters.

Using Monograph Claims Verbatim

When relying on a monograph, copy claims precisely. For example, the Workout Supplements monograph supports claims like "Helps support healthy glucose levels" and "Digestive aid to help decrease bloating after high caloric, high fat meals." Paraphrasing these claims — even slightly — removes you from monograph coverage.

Traditional Use Claims

Traditional use claims require particular care in multi-ingredient products. Health Canada's monographs specify:

"To prevent the product from being represented as a 'traditional medicine,' any indicated traditional use claim must refer to the specific medicinal ingredient(s) and recognised traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine."

When all medicinal ingredients in a product are used within the same identified system of traditional medicine and the product makes only traditional claims, listing each ingredient within the claim is not required. However, when mixing Ayurvedic claims (e.g., "Traditionally used in Ayurveda to help relieve restlessness and/or nervousness") with Herbal Medicine claims, each claim must be attributed to its specific ingredient and tradition.

Prohibited Claims

Avoid any language that implies the product diagnoses, treats, mitigates, or prevents a disease. NHP claims must stay within the permissible scope of the NHPR.

Step 4: Prepare Quality Documentation

Health Canada requires evidence that your product meets acceptable quality standards.

Good Manufacturing Practices (GMP)

Your manufacturer must hold a valid Site Licence and operate in compliance with NHP GMP regulations. Include your manufacturer's site licence number in the submission.

Specifications and Testing

Provide finished product specifications covering identity, purity, potency, and safety. Specifications should reference recognised pharmacopoeial standards (e.g., USP, BP, Ph. Eur.) where available.

Stability Data

Include stability data to support your proposed shelf life and storage conditions. Accelerated or real-time stability data from a GMP-compliant facility is expected.

Step 5: Complete the ePLA in the Submission Portal

Health Canada's online portal guides applicants through each section of the ePLA form. Key administrative elements include:

• Applicant information: Legal name, address, and contact details of the Canadian licence holder
• Product name(s): Brand name and any additional names under which the product will be marketed
• Recommended conditions of use: Dose, duration, frequency, and any sub-population directions (e.g., paediatric dosing)
• Cautions and warnings: Mandatory cautions as specified in the relevant monograph, plus any product-specific warnings
• Contraindications: Any populations or conditions for which use is not recommended

For products targeting specific sub-populations — such as pregnant women, children, or the elderly — additional labelling and safety language is typically required by the applicable monograph.

Step 6: Review Before Submission

A pre-submission review against Health Canada's completeness checklist is strongly advised. Common deficiency triggers include:

• Claim language that deviates from the approved monograph wording
• Missing or incomplete non-medicinal ingredient justifications
• Manufacturer site licence numbers that are expired or do not cover the product's dosage form
• Stability data gaps
• Inconsistencies between the label mockup and the ePLA data fields

Catching these issues before submission avoids the back-and-forth of a deficiency notice, which can add weeks or months to your approval timeline.

Common Mistakes to Avoid

• Mixing monograph and non-monograph elements without recognising that the entire submission then defaults to non-monograph review
• Using ingredient names not recognised in the LNHPD or NHPID
• Underestimating the caution requirements — the Workout Supplements monograph alone carries 37 mandatory cautions
• Omitting DIN-HM vs. NPN distinctions when the product contains homeopathic ingredients alongside conventional NHP ingredients

Check Your Product

Preparing an accurate ePLA submission starts with knowing exactly where your ingredients, claims, and dosage form stand against Health Canada's current database and monographs. BareGold's compliance engine cross-references your product against all 249 Health Canada monographs and the full LNHPD in real time — flagging gaps before they become deficiency notices.

Start your free compliance check at productcompliance.ca →

Upload your product details, identify your submission pathway, and generate a gap analysis report in minutes. Whether you are filing your first ePLA or managing a portfolio of licensed products, BareGold gives your team the data clarity to submit with confidence.