Natural Health Products Management of Applications Policy: Application screening and assessment

Administrative screening

NNHPD verifies all applications submitted through Connect for administrative completeness.

Administrative deficiencies leading to refusal

A notice of refusal (administrative deficiency) will be issued if the application contains one or more of the following deficiencies:

damaged or corrupted files
incorrect application class listed on the PLA form (without a rationale provided in the cover letter)
missing monograph attestation, if applicable
incorrect or mismatched company name and/or code
use of an incorrect or incomplete application form(s)
PLA or ANF form not finalized prior to submission
unexplained discrepancies due to technical issues (not addressed in the cover letter)
missing or incomplete contact information or DPA form (unless authorization is clearly granted for multiple applications)
mismatch between the Senior Official listed on the PLA form and NNHPD records, with no notification of change
inappropriate use of the cover letter, such as addressing issues that are not form limitations, may lead to refusal.
submission in an unacceptable format (for example: USB drive, password-protected files, paper, scanned copy)
duplicate tracking number on the PLA or ANF form (for example: reusing the same form for multiple applications)

NNHPD will not issue an IRN for the above noted deficiencies.

If the classification of the product is unclear, NNHPD may issue an IRN to request clarification. If the product clearly falls outside the scope of the NHPR (for example: prescription drugs, products that puncture the dermis), an IRN will not be issued.

Acknowledgement of applications

Class II and III applications and amendments that meet all administrative requirements will receive an Acknowledgement Letter via Connect. This letter includes the:

submission number
date of receipt of the application

Regulatory screening

All new applications and amendments are screened against the regulatory requirements of the NHPR, as well as processes and expectations explained in this document, and in other applicable guidance documents.

In addition, applications are reviewed for relevant submission requirements and, where applicable, against all parameters of the selected NNHPD monograph(s).

NNHPD will verify any parameters not automatically validated by the PLA form. This may include:

brand name(s)
NMIs
free text fields

Regulatory deficiencies leading to refusal

A notice of refusal will be issued if the application contains one or more of the following regulatory deficiencies:

product does not meet the definition of an NHP
brand name does not conform to section 9 of the Food and Drugs Act, in a manner that is:
- false, misleading or deceptive; or
- is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety
incomplete or inaccurate information in the application package
missing application requirements, such as:
- FPS (except for Class I);
- label text;
- supporting evidence for safety and/or efficacy;
- letters of access;
- Animal Tissue Form; and/or
- attestation(s)
failure to meet monograph parameters to which the applicant attested

Other deficiencies

During regulatory screening, NNHPD may issue an IRN to address minor deficiencies.

Failure to respond to IRNs

A notice of refusal will also be issued if the:

applicant fails to submit requested information in response to an IRN within the specified timeline
response to an IRN is incomplete or deficient (for example: one or more deficiencies remain unresolved)

Assessment (Class III applications)

After NNHPD completes regulatory screening of a new Class III application or amendment application, it proceeds to assessment. During this stage, NNHPD evaluates the submission against the relevant safety, efficacy, and/or quality requirements.

Assessment deficiencies leading to refusal

A notice of refusal may be issued during the assessment stage for any of the following reasons:

failure to respond to an IRN within the specified timeline
submission of an incomplete or deficient IRN response, where one or more deficiencies remain unresolved
submission of false, misleading, or inaccurate information (as per the NHPR)
insufficient evidence to support the safety and/or efficacy of the NHP under the recommended conditions of use (see section 5(g) of the NHPR)
product is likely to result in injury to the health of a consumer

Information Request Notice

NNHPD may issue an IRN to obtain additional information from you to address non-administrative deficiencies or information omissions, in accordance with section 15 of the NHPR.

The response timeline for an IRN ranges from 5 to 15 calendar days, depending on the complexity of the information requested.
IRNs may be issued during both the regulatory screening and assessment stages for deficiencies across all application classes.

This may include, in rare cases, a request for a Risk Management Plan (RMP) when:

the available information on the product's use in the Canadian context or a comparable regulatory framework is limited or not robust.

If you fail to provide the requested information or if the evidence remains insufficient, NNHPD may issue a notice of refusal.

Comprehensive IRNs

To improve efficiency and clarity, NNHPD aims to issue one comprehensive IRN per stage (regulatory screening and/or assessment).

You must respond to each item listed in the IRN.
NNHPD will not reissue IRNs for deficiencies that were previously identified but not adequately addressed.
NNHPD will not request the same information twice if the initial response is incomplete or insufficient.
NNHPD will not accept unsolicited changes (for example: changes made to the application outside of those addressed in the IRN)
A second IRN may be issued only if:
- a new issue arises during screening or assessment, or
- minor adjustments are needed to finalize the review.

Not all non-administrative deficiencies will result in an IRN. Applications with critical deficiencies will lead directly to a notice of refusal.

Responding to an IRN

You must monitor your Connect account for new messages from NNHPD. If you fail to respond to submission-related requests within the required timeframe, NNHPD may issue a notice of refusal.

As outlined above, NNHPD communicates with applicants exclusively through Connect. Responses to IRNs must be submitted:

electronically, through the submission-specific Connection conversation thread; and
within the specified time period indicated in the IRN

Request for an extension to an IRN response

If you require additional time to respond to an IRN, contact your assigned NNHPD Submission Coordinator via the submission-specific Connect conversation thread.

Approach to extension requests

Short extensions may be considered on a case-by-case basis. The request must include a:

clear reason for the extension
proposed alternative response date

NNHPD will review the request and provide a response within two business days of receipt.

It is your responsibility to ensure you (or your designated party) are available to respond to IRNs in a timely manner. NNHPD reserves the right to deny extension requests. If denied, you will be notified in writing via the submission-specific Connect thread, along with the reason for refusal.

Service standards

NNHPD has established service standards for various application types. Refer to the table in Appendix VI for a detailed overview of the applicable service standards.

Class III applications that require joint assessment with other Health Canada directorates (for example with the Medical Devices Directorate) are not subject to the 210-calendar day service standard. For such products, NNHPD encourages you to request a pre-submission meeting to help facilitate the review process.

Amendment applications are subject to the same service standards as new product applications.

Notifications do not require NNHPD approval prior to implementation. As a result, NNHPD has not established a service standard for processing these.

Product licence holders should consult NNHPD prior to submitting new PLAs, amendments, or notifications, when addressing compliance issues in collaboration with Health Canada's ROEB.

Unresolved compliance issues may prevent NNHPD from issuing or amending a product licence.

In response to a public health emergency or urgent need, NNHPD may prioritize certain submissions. In such cases, NNHPD will communicate any changes in prioritization to stakeholders.

Communicating with NNHPD

You may need to contact NNHPD during or after the submission of an application.

Contact the NNHPD Client Support Unit at nnhpd-dpsnso@hc-sc.gc.ca for questions related to:

policies
guidance documents
submission procedures
tools

Status update requests

NNHPD understands that you may wish to know the status of your application. Note, however, that NNHPD considers status update requests to be a lower-priority. A response will only be provided if an issue is identified with the application (for example if we have no record of having received the application).

If the application is still within the applicable service standard, NNHPD will not respond to the status request.

Required information for status update requests

All status update requests must include the:

submission number (if available)
name of the applicant company
primary brand name
application type
date of submission

If the status update request is complex, the NNHPD Client Support Unit will assign a subject matter expert to review and respond.

Withdrawal of an application

At any point during the application process, a Senior Official or Designated Party may withdraw their application by completing the NHP Application Withdrawal Request Form.

All withdrawal requests will be processed and acknowledged in writing, and the application status will be recorded internally as "Withdrawn by applicant."

Withdrawal of an application is without prejudice to re-submission; applicants may submit a new application at any time.

Pre-licence company transfer or merger/acquisition

When a company transfers ownership or merges with another company, you, as the applicant, must inform NNHPD as this will impact the associated regulatory responsibilities.

If a transfer request pertains to an application that has already been submitted to NNHPD, but has not yet received a regulatory decision, you must submit the request as an unsolicited information update.

The following documents must be submitted via Connect:

a signed and dated letter from the Senior Official of each company, on company letterhead, confirming the transfer
- the 2 letters must clearly identify the applications being transferred, including the submission numbers and primary brand names
- if a submission number has not yet been issued, the letters must include the primary brand names, tracking numbers, and submission date via Connect
an updated PLA form reflecting the new applicant and contact information
DPA form(s), if applicable

Regulatory decision

Once NNHPD has completed the processing of a PLA, one of the following regulatory decisions will be issued:

issuance of a product licence, or
notice of refusal to issue a licence

Issuance of a product licence

NNHPD will issue a product licence for applications that meet the regulatory requirements of the NHPR. The licence includes the NPN or DIN-HM assigned to the product.

Once NNHPD issues a product licence, the product licence status appears as 'Active' in the LNHPD approximately 48 hours later. However, the product remains listed as 'Not Marketed' until the licence holder submits a Market Notification to inform NNHPD that the product is available for sale in Canada.

It is your responsibility, as the product licence holder, to submit a Market Notification to update the status of your product(s) from "Not Marketed" to "Marketed." Details on this process are provided in the Market Notification section.

Information about licensed products is available through the LNHPD.

Notice of refusal

A notice of refusal will be issued for applications that do not meet the requirements of the NHPR and the administrative expectations and processes set out in this document.

You can contest a notice of refusal through the reconsideration process.

Request for reconsideration

In accordance with section 9 of the NHPR, you may request a reconsideration of a notice of refusal within 30 calendar days of its issuance.

Upon review, a request for reconsideration may result in one of the following outcomes:

Decision upheld: The original refusal is maintained. A letter outlining the reasons for the decision will be sent to the applicant.
Decision partially amended: If only some of the objections are resolved, the application remains refused. The file will not return to review. You may submit a new application that addresses the remaining issues.
Decision amended: If the original refusal is overturned, NNHPD will issue or amend the product licence, provided the requirements of section 7 of the NHPR are met.

For more information, refer to the Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions.

Re-submitting an application

You may re-submit withdrawn applications or those for which a notice of refusal was issued.

In all cases, you must complete a new PLA and reference the submission number of the original application.

The re-submitted application will be assessed under the regulations, policies, procedures, guidance documents, and service standards that are in effect at the time of submission.

Safety and Efficacy Assessment Report

If NNHPD issues a notice of refusal, you may request a copy of the Safety and Efficacy Assessment Report (SEAR) by contacting the NNHPD Client Support Unit at nnhpd-dpsnso@hc-sc.gc.ca. You must:

make the request in writing
include the submission number of the application

NNHPD will strive to provide the SEAR via Connect within 20 calendar days of receiving the request. This applies only to Class III applications, where safety and/or efficacy is assessed.

NNHPD does not provide a copy of the SEAR upon issuance of a product licence.

Record-keeping responsibilities

You are responsible for maintaining records of all information submitted to NNHPD. In cases where there is a change in licence holder or consulting company, the current licence holder must retain a copy of the PLA package.

Product licences are sent via Connect to the Senior Official and all company contacts listed in the application. Refer to your Connect account for submission records. You are expected to save all files received through Connect to your own secure system.

Any information or data submitted to support the application will not be returned to you.

NNHPD will not provide convenience copies of any submitted materials, including NHP-MFs. NNHPD has no regulatory obligation to provide copies of licences or documents submitted as part of an application.

All information and data submitted in support of a PLA for an NHP, will be retained by Health Canada in accordance with the retention requirements of the Library and Archives of Canada Act.

Page details

2025-12-17