Receiving an Information Request Notice (IRN) from Health Canada does not automatically mean that a Natural Health Product (NHP) application has been rejected. An IRN identifies additional information, clarification or supporting documentation required by Health Canada to assess an application. NHP product licensing is managed by the Natural and Non-prescription Health Products Directorate (NNHPD), while site licensing is managed by the Health Product Compliance Directorate within the Regulatory Operations and Enforcement Branch.
IRNs may be issued during NHP product licensing or site licensing reviews, although the reasons for issuing them, response deadlines and submission procedures differ. Common requests involve product safety and efficacy evidence, ingredient information, product specifications, manufacturing documentation and Good Manufacturing Practices (GMP) compliance.
An effective response must address every identified deficiency, provide appropriate supporting evidence and follow the deadline specified by Health Canada. Incomplete or late responses can result in application refusal, potentially requiring applicants to restart the licensing process.
An Information Request Notice (IRN) is a formal communication from Health Canada requesting additional information or clarification concerning a regulatory submission.
For Natural Health Products, IRNs may be issued during the assessment of a Product Licence Application (PLA) or Site Licence Application (SLA). These applications are governed by the Natural Health Products Regulations, which establish requirements for obtaining authorization to sell NHPs and conduct regulated activities in Canada.
For example, a company submitting a product licence application for a botanical supplement may receive an IRN requesting additional evidence supporting a proposed health claim. Health Canada may determine that the submitted studies do not adequately support the claimed benefit at the proposed dosage.
The applicant must then provide additional scientific evidence, revise the proposed claim where appropriate or otherwise address the identified deficiency.
An IRN does not constitute a final refusal. However, it indicates that the application cannot proceed satisfactorily without further information or clarification.
Health Canada’s Natural Health Products Management of Applications Policy describes how the NNHPD manages product licensing submissions, including requests for additional information and application refusal.
Companies should begin reviewing an IRN immediately, identifying the requested information, confirming the applicable deadline and assigning responsibility for preparing the response.
Although the nature of the request may vary, the following process can help applicants prepare a complete and organized submission.
Step 1: Review Each Deficiency Identified by Health Canada
The first step is to determine precisely what information Health Canada is requesting and why the original submission was considered insufficient.
For example, an IRN concerning an NHP’s medicinal ingredients may identify inconsistencies between the Product Licence Application and the supporting scientific evidence. The issue could involve an incorrect ingredient name, insufficient characterization, an unsupported dosage or a discrepancy in the recommended conditions of use.
Each deficiency should be reviewed against the original application, applicable Health Canada guidance and any supporting documentation already submitted.
Applicants should avoid assuming that providing additional documents will automatically resolve the issue. The response must demonstrate how the information addresses the specific concern identified by the reviewer.
Step 2: Confirm the Response Deadline
IRN response periods vary depending on the application type, the stage of review and the nature of the information requested.
For product licence applications, Health Canada’s Management of Applications Policy establishes response periods that can range from 5 to 15 calendar days for certain information requests.
Site licensing IRNs operate under separate procedures, and applicants must follow the deadline specified in the correspondence.
For example, a company receiving an IRN requesting clarification of an ingredient’s recommended dosage may have considerably less time to respond than it would need to commission a new scientific study.
Applicants should therefore assess whether the requested evidence is already available and determine immediately whether the response can be completed within the specified period.
Where an extension may be permitted, it should be requested through the appropriate process before the deadline. Applicants should not assume that extensions will be granted.
Step 3: Gather Supporting Evidence and Documentation
A complete IRN response should provide information that directly addresses each identified deficiency.
For product licence applications, this may involve scientific studies, ingredient specifications, safety assessments, efficacy evidence or revised product information.
For example, an applicant seeking authorization for a combination NHP may receive an IRN questioning whether the submitted evidence supports the proposed daily dosage and health claim. The response may require additional clinical or published scientific evidence demonstrating that the product’s medicinal ingredients support the proposed conditions of use.
Where evidence is insufficient, revisions to the proposed claim, dosage or formulation may be necessary to address the identified deficiency. Any proposed revisions must remain within the scope of the IRN; NNHPD does not accept unrelated, unsolicited application changes as part of the response. For site licensing applications, supporting documentation may include SOPs, quality assurance reports, GMP records, training documentation or evidence demonstrating that regulated activities are conducted appropriately.
The required documentation should be determined by the specific deficiencies identified in the IRN rather than by submitting unrelated information.
Step 4: Prepare a Clear, Point-by-Point Response
An effective IRN response should address every question or deficiency separately and provide a clear explanation of the supporting evidence.
For example, if Health Canada requests clarification concerning three medicinal ingredients, the applicant should identify each ingredient, explain the relevant issue and provide the corresponding documentation.
A practical response structure includes:
If an IRN requests additional safety evidence for a botanical extract, the response should identify the supporting studies, explain their relevance to the proposed product and reference the specific sections addressing Health Canada’s concerns.
Simply attaching a large collection of scientific publications without explaining their relevance may make it difficult for reviewers to determine whether the deficiency has been resolved.
Step 5: Submit the Response Through the Correct Channel
Health Canada establishes specific submission procedures for product and site licensing applications.
For product licensing, applicants may need to revise their Product Licence Application and provide additional supporting documentation through the applicable submission process. Product-licensing IRN responses must be submitted through the submission-specific Connect conversation thread within the deadline stated in the IRN.
Health Canada’s web-based Product Licence Application instructions include a function allowing applicants to modify a previously finalized application in response to an IRN.
For site licensing, Health Canada’s NHP Site Licensing Bulletin No. 4 requires submissions and related correspondence, including IRN responses, to use LiquidFiles. Applicants should respond through the secure message provided by Health Canada. An outstanding request originally issued through ePost Connect should still be answered there if instructed; subsequent correspondence will move to LiquidFiles. Applicants must also meet the applicable requirements for response completeness and timeliness.
The bulletin identifies incorrect submission channels, incomplete responses and late submissions as grounds for refusal.
Applicants should verify the applicable submission instructions, ensure that documents are complete and readable, and retain confirmation that the response was submitted successfully.
Health Canada IRNs do not have one response deadline that applies across all product-licensing and site-licensing requests. The applicable timeline depends on whether the IRN concerns product licensing or site licensing, the type of deficiency and the instructions provided by Health Canada.
| Application Type | Response Timeline | Important Considerations |
| NHP Product Licence Application | Certain IRNs allow 5–15 calendar days, depending on the request. | Follow the deadline specified in the IRN and applicable Management of Applications Policy. |
| NHP Site Licence Application | The deadline is specified in the IRN and applicable site licensing correspondence. | Late or incomplete responses may result in refusal. |
| Extension request | Depends on the applicable process and Health Canada’s approval. | Extensions should be requested before the original deadline and must not be assumed. |
| Application refusal | Separate reconsideration provisions may apply. | A refusal is distinct from an IRN and may require a different regulatory response. |
Companies receiving an IRN should prioritize the specific instructions contained in their correspondence rather than relying on a general response schedule.
The reasons for issuing an IRN depend on the application being assessed.
Product licensing reviews generally focus on whether an NHP meets applicable requirements for safety, efficacy and quality. Site licensing reviews focus on whether the applicant has demonstrated compliance with the GMP requirements applicable to its proposed activities.
| Application Type | Potential Deficiency | Example of Supporting Information |
| Product licence – Safety | Insufficient evidence supporting the safety of an ingredient or proposed dosage | Toxicological data, clinical studies or a revised dosage |
| Product licence – Efficacy | Proposed health claim is not adequately supported | Clinical evidence, scientific literature or a revised claim |
| Product licence – Ingredient information | Ingredient identity, source or characterization is unclear | Updated ingredient specifications or clarification |
| Product licence – Quality | Product specifications or supporting quality information are insufficient | Revised finished-product specifications or analytical information |
| Product licence – Application consistency | Discrepancies between application fields and supporting documents | Corrected application information and an explanation of revisions |
| Site licence – GMP documentation | SOPs or records do not adequately demonstrate GMP compliance | Revised SOPs, supporting records and documented procedures |
| Site licence – Quality assurance | Quality assurance documentation is incomplete or insufficient | Completed quality assurance reports and supporting evidence |
| Site licence – Operational controls | Insufficient evidence of appropriate manufacturing, packaging, labelling or importation controls | GMP records, procedures and operational documentation |
These examples illustrate potential requests rather than an exhaustive list of Health Canada’s IRN criteria.
For product licence applications, the Natural Health Products Ingredients Database and applicable Health Canada monographs can help applicants evaluate ingredient acceptability, terminology and supported conditions of use.
Yes. Health Canada may refuse certain NHP applications without providing an opportunity to correct deficiencies through an IRN.
This distinction is particularly important for site licensing submissions.
Health Canada’s NHP Site Licensing Bulletin No. 4 identifies administrative and GMP deficiencies that may result in refusal without an IRN.
Examples include missing supporting GMP evidence, incorrect application forms, incomplete quality assurance reports and certain deficiencies involving the applicant’s licensing information.
The bulletin also establishes risk-based refusal criteria for GMP deficiencies.
For example, a new site licence application containing evidence of a critical GMP deficiency may be refused rather than returned to the applicant for clarification. Repeated major GMP deficiencies may also result in refusal, particularly where previously identified observations have not been corrected.
For submissions covering multiple sites, refusal generally applies to the site with deficiencies rather than the entire submission. The entire submission may be refused where the deficient site forms the basis of the site licence, such as the Canadian importer site.
This means that companies should not treat IRNs as a guaranteed opportunity to repair incomplete or inadequate applications. The most effective approach is to submit complete, accurate and well-supported applications from the outset.
An incomplete or late IRN response may result in Health Canada refusing the application.
For site licensing submissions, Health Canada’s refusal criteria explicitly identify responses that fail to address every deficiency, arrive after the applicable deadline or do not follow the required submission procedures.
For example, a company may receive an IRN requesting three additional GMP documents but submit only two before the deadline. Even if the submitted documents are acceptable, the response may still be considered incomplete because one deficiency remains unresolved.
Similarly, providing the requested documents through an incorrect correspondence channel may create a submission problem even when the underlying information is satisfactory.
For product licensing applications, the consequences depend on the applicable Management of Applications Policy and the stage of review. An applicant that cannot adequately address a safety or efficacy deficiency may receive a refusal rather than a product licence.
If an application is refused, the company may need to evaluate whether reconsideration is available or whether a new application is required.
Under sections 9 and 30 of the Natural Health Products Regulations, applicants may request reconsideration of a refusal to issue or amend a product licence or site licence within 30 days after the date of the refusal notice. However, reconsideration is a separate process and should not be confused with requesting an extension to respond to an IRN.
Although not every IRN can be avoided, preparing a complete and scientifically supported application can reduce the likelihood of preventable information requests.
For product licensing, applicants should ensure that medicinal ingredients, dosages, recommended uses, risk information and supporting evidence are consistent throughout the submission.
For example, a Class III NHP application involving a novel ingredient or a claim not fully supported by an existing monograph may require additional scientific evidence. Applicants should evaluate the adequacy of their safety and efficacy data before submission rather than assuming that Health Canada will request missing information during review.
Class I and Class II applications should also be checked against applicable monograph requirements, including ingredient specifications and permitted conditions of use.
For site licensing, companies should ensure that quality assurance reports, SOPs, GMP evidence and application information are complete and consistent.
Health Canada’s Site Licensing Guidance Document provides information on the documentation and GMP evidence expected for site licensing submissions.
A regulatory review before submission can help identify deficiencies that might otherwise result in an IRN, processing delay or refusal.
Understanding how to address GMP deficiencies, maintain accurate documentation and demonstrate compliance with Health Canada’s requirements is essential when responding to site licensing Information Request Notices.
dicentra’s Natural Health Product GMP Training provides practical instruction based on Health Canada’s latest GMP guidance, including requirements governing quality assurance, product specifications, testing, stability, records and lot or batch samples.
Designed for current and prospective Site Licence holders, Quality Assurance Persons (QAPs) and personnel involved in NHP operations, the online course covers the broader GMP framework and its application to manufacturing, importation and distribution. Participants who successfully complete the training and assessment receive a certificate with a unique serial ID, which can be maintained as part of their organization’s training records.
While training alone does not resolve an IRN or demonstrate that all identified deficiencies have been corrected, it can help personnel better understand their GMP responsibilities and strengthen the procedures and documentation supporting ongoing compliance.
Responding to a Health Canada Information Request Notice may require specialized regulatory, scientific or quality assurance expertise, particularly when deficiencies involve insufficient safety and efficacy evidence, incomplete application documentation or GMP compliance concerns.
With more than two decades of experience, dicentra supports NHP manufacturers, importers and brand owners with product licensing, scientific substantiation, site licensing, GMP compliance assessments, quality system development and regulatory submission support.
Our specialists can help evaluate Health Canada’s requests, identify deficiencies, prepare supporting documentation and develop responses that address the regulator’s concerns.
For companies importing NHPs into Canada, dicentra also offers NHP Importation Services through its established Canadian Site Licence. These services include foreign-site GMP assessments, product documentation review, QAP oversight and finished-product release for eligible products, helping importers meet their Canadian quality assurance obligations.
Whether you’ve received an IRN concerning an NHP product licence application, site licensing documentation or GMP compliance, preparing a complete and timely response is essential to keeping your application moving forward.
Contact dicentra’s regulatory experts to discuss your Information Request Notice, evaluate the identified deficiencies and determine the appropriate next steps for your application.