Natural Health Products Management of Applications Policy: Post-licensing processes

On this page

• Produce licence correction requests
• Post-licence changes
• Monograph updates
• Discontinuing a product licence
• Post-licensing audit
• Addressing post-licence issues

Post-licensing processes refer to all actions that take place after a product has been issued a product licence.

Product licence correction requests

In accordance with section 14(2) of the NHPR, you, as the licence holder, have 60 calendar days from the date of product licence issuance to notify NNHPD of any known inaccuracies on the licence.

Correction requests must be submitted via email to the NNHPD Client Support Unit at nnhpd-dpsnso@hc-sc.gc.ca, with the subject line referencing the submission number and/or NPN.

Requests should be limited to administrative errors on the product licence (for example: spelling mistakes or discrepancies between the submitted PLA and the issued licence).

This process is not intended for post-licensing changes that fall outside the scope of the original PLA. For such changes, refer to the section on amendments and notifications in this document.

The LNHPD will be updated within 15 calendar days to reflect the correction, and a revised product licence will be issued.

Post-licence changes

Amendment applications and notifications must be submitted via Connect using the ANF. If you encounter system limitations that prevent you from using the ANF, contact the NHP Online solution team at nhp.initiative-psn@hc-sc.gc.ca for assistance. If you cannot resolve the issue after reaching out, clearly state the unresolved issue in your submission cover letter.

Adhering to this process is essential. If you do not follow these steps, NNHPD will not process your requested change.

There are three types of post-licence changes:

• fundamental change
• amendment
• notification

Each type of change has distinct regulatory requirements. Refer to Appendix VIII for a detailed list of changes and their associated requirements.

Fundamental changes

The NHPR do not permit fundamental product changes following the issuance of a product licence. As defined in section 13 of the NHPR, fundamental changes include a change to the:

• quantity of a medicinal ingredient per dosage unit, or the addition or substitution of a medicinal ingredient
• dosage form
• recommended route of administration

These changes require the submission of a new PLA. If approved by NNHPD, the product will be issued a new NPN or DIN-HM.

This requirement also applies to products that attest to a monograph, even if the proposed changes remain within the monograph's limits.

If the original product will no longer be manufactured, you should request a discontinuation of the original product licence.

Amendments

Amendments refer to changes to a licensed NHP that may impact its safety, efficacy, or quality. An amendment application must include supporting evidence demonstrating that the product remains safe and effective.

As outlined in section 11 of the NHPR, an amendment application is required for any of the following changes:

1. a change to its recommended dose;
2. a change to its recommended duration of use;
3. the deletion or modification of risk information shown on any of its labels, including the deletion or modification of a caution, warning, contra-indication or known adverse reaction associated with its use;
4. a change of its recommended use or purpose;
5. a change of the source material of any of its medicinal ingredients;
6. changing any of its medicinal ingredients to or from being synthetically manufactured;
7. a change to the potency of any of its medicinal ingredients;
8. a change affecting its safety or efficacy that does not arise as a result of
   1. a change to the quantity of a medicinal ingredient per dosage unit,
   2. the addition or substitution of a medicinal ingredient,
   3. a change to its dosage form, or
   4. a change to its recommended route of administration; or
9. one or more of the following changes to its specifications, namely,
   1. the removal of a test method set out in the specifications,
   2. the modification of a test method set out in the specifications in a manner that widens the purity tolerances of the natural health product or the quantity, identity or potency tolerances of any of its medicinal ingredients, or
   3. the modification of a test method set out in the specifications in a manner that renders it less precise, accurate, specific or sensitive.

Classification of amendments

NNHPD classifies, processes, and assesses amendment applications related to a product licence in a manner similar to new applications, following the same procedures and service standards.

Upon receipt of the amendment application, NNHPD will screen each amendment to assess whether the proposed changes align with the anticipated class as indicated on the cover letter. NNHPD may reclassify the amendment based on the nature of the product and the proposed changes:

• Class I and II: If the product and proposed changes are fully supported by NNHPD monographs, the amendment will be classified as Class I or II.
• Class III: If the changes require an assessment of safety and/or efficacy, the amendment will be classified as Class III.

Refer to Appendix VII for more information on amendment classifications.

Acknowledgement Letters

• Class I amendments do not receive an Acknowledgement Letter. A final regulatory decision will be issued in accordance with Class I performance standards.
• Class II and III amendments will receive an Acknowledgement Letter with the final classification of the amendment.

For products under previously issued licences with the statement "As authorized according to the NNHPD monograph to which the applicant attested", an amended product licence will be issued listing all product information.

Notifications

Notifications refer to changes to a licensed NHP that do not significantly impact its safety, efficacy, or quality.

You must notify NNHPD of such changes within 60 calendar days of the change, using the ANF.

As outlined in section 12 of the NHPR, a notification is required for the following changes:

1. a change to any of the information submitted under paragraph 5(a) or (b);
2. a change to any of the information provided under section 22;
3. the addition or substitution of a non-medicinal ingredient, the addition or substitution of which does not affect its safety or efficacy;
4. its sale under a brand name other than one submitted under paragraph 5(e);
5. a change of the common or proper name of any of its medicinal ingredients; and
6. the addition of risk information to any of its labels, including the addition of a caution, warning, contra-indication or known adverse reaction associated with its use.

You are responsible for identifying such updates by answering "YES" to the following question in the ANF:

• Is this amendment/notification in response to a notice issued by the NNHPD Risk Management Division?

Once a notification is processed, NNHPD will issue a notification acknowledgement letter.

Market notification

The market status of a product is displayed in the LNHPD, indicating whether a product is "marketed" or "not marketed" (that is, whether it is currently available to Canadian consumers).

For submissions that have attested to the eligibility criteria, you are required to:

• notify NNHPD when the product is being sold in Canada
• provide valid site information prior to commencing sale, as required under section 22 of the NHPR

You are strongly encouraged to update NNHPD when the market status of your product changes. This helps support efficient and effective post-market surveillance and allows NNHPD to prioritize post-licence applications.

The Senior Official of the company or an authorized Designated Party must submit market status updates using the NHP Market Notification Web form. If a Designated Party submits the update, NNHPD must have received a valid DPA form beforehand; otherwise, NNHPD will not process the request.

NNHPD processes the market status update request, notifies the product licence holder via email, and updates the market status in the LNHPD at the end of each month.

Maintaining company contact information

In accordance with section 12 of the NHPR, you are responsible for notifying NNHPD of any changes to company or contact information within 60 calendar days of the change. This requirement applies throughout the entire product life cycle. Changes requiring notification include:

Company Information:

• change in company name
• change in company address

Contact Information:

• change in the Senior Official
• updates to email, phone number, or mailing address that do not affect a manufacturing, packaging, labelling, or importing site

These changes must be submitted as a company update notification using the ANF, and must be submitted by the Senior Official or Designated Party of the company.

Post-licence company transfer or merger or acquisition

When a company merges with, acquires another or transfers ownership and associated regulatory responsibilities of one or more licensed products and the associated regulatory responsibilities, you must notify NNHPD by submitting a notification.

In addition to the ANF, the following documents must be submitted via Connect:

• a signed and dated letter on company letterhead from the Senior Official or Designated Party of each company confirming the transfer
  • The 2 letters must clearly identify the product licences being transferred, including the NPN(s) or DIN-HM(s) and the primary brand names
• DPA form(s), if applicable

For mergers and/or acquisitions, in addition to the above, you must also provide the preferred outcome of the modifications that may need to occur in NNHPD's database. For example:

• deactivating company codes
• changing company name and contact information
• transferring active NPNs

These modifications will be dealt with on a case-by-case basis, depending on each company's unique merger/acquisition situation.

Typically, the surviving company must submit legal documentation, such as a certificate of amalgamation or purchase agreement, confirming that it has merged with or acquired the other company and has assumed all associated product licences and regulatory responsibilities.

Transferred NPNs or DIN-HMs will retain their current regulatory status (for example: active, stop sale, or suspended). If a compliance file is associated with the product licence, the new company assumes responsibility for resolving the non-compliance.

Determining that a company is no longer in operation

If a company does not respond to a post-licence IRN within the 15-day response period, NNHPD follows up with a reminder via email and phone. If the company does not respond, NNHPD may begin a process to determine whether the company is no longer in business.

This process includes:

• multiple attempts to contact the company using the most up-to-date information in NNHPD's database
• researching the company and product, including business registries
• contacting DPAs, site licence holders, and other listed contacts

If these efforts are unsuccessful, NNHPD may presume the company is no longer operational.

In such cases, a regulatory notice may be issued under section 18–20 of the NHPR for all product licences held by the company. This is based on reasonable grounds that the company has contravened section 12 of the NHPR by failing to maintain current records with Health Canada.

To ensure all possible avenues of contact are exhausted, notices are sent via email and postal mail using the most current address in NNHPD's database.

If a section 18–20 notice is issued, it will outline the full regulatory pathway. The company may respond at any time within the 180-day timeframe, during which product licences will be:

• suspended 90 days after the notice is issued, pursuant to section 20
• cancelled after 180 days, pursuant to sections 20(b) and 21, if no sufficient response is received

You, as the licence holder, must submit a sufficient response to NNHPD as per the instructions in the notice. It must include updated contact information or a statement explaining that the situation leading to the intended or actual suspension did not exist.

Non-notifiable changes

Non-notifiable changes refer to revisions made to a licensed NHP that are not required to be submitted to NNHPD. They refer to changes that are not outlined in sections 7, 11, or 12 of the NHPR and generally do not impact the safety, efficacy, or quality of the product.

Refer to Appendix VIII for a detailed list of non-notifiable changes related to product quality.

Monograph updates

NNHPD monographs contain pre-cleared information that applicants may use to support the safety, efficacy, and/or quality of an NHP.

These monographs are periodically revised or updated as needed to address risks to the health and safety of Canadians.

Impact on product labelling

When monograph revisions affect product labelling, you are expected, unless otherwise notified, to align your product labelling with the most recent version of the monograph according to the following timelines, whichever occurs first:

• within 3 years of publication;
• at next label run; or
• with the next post-licensing change (amendment or notification)

These revisions must be submitted to NNHPD through an amendment application, notification or, in some cases, a resubmission.

Impact on product quality

If you attested to an NNHPD monograph to support product quality (refer to Attesting to NNHPD Monographs), the FPS should be updated to reflect the latest quality-related changes in the monograph. Note that updates to safety or efficacy information may also impact the quality parameters and FPS of the product.

Suggesting revisions to a monograph

Suggestions for revisions to existing monographs, or proposals for new monograph topics, may be submitted to NNHPD via email at ingredient_support@hc-sc.gc.ca.

Submissions should include:

• the name of the monograph being proposed or revised
• a clear rationale for the suggestion
• supporting evidence for NNHPD's consideration

Discontinuing a product licence

You are encouraged to notify NNHPD if you no longer require an active product licence (NPN or DIN-HM). To request a discontinuation, the Senior Official of the company must submit the NHP Discontinuation Request Form. Alternatively, a Designated Party (for whom a valid DPA form has been submitted) may make the request on behalf of the Senior Official.

NNHPD will notify you via email once the request has been processed or if additional information is required. The licence status will be updated in the LNHPD to reflect "Discontinued" within 48 hours of receiving the notification.

Once a product licence is discontinued, you cannot reactivate it. To regain authorization to sell the product, you must submit a new application, which will be subject to any current regulations, policies, procedures, guidance documents, and service standards in effect at the time of submission.

Post-licensing audit

NNHPD may conduct post-licensing audits on any application at any time. These audits are distinct from audits conducted by Health Canada's ROEB.

If NNHPD identifies a discrepancy during an audit, it will notify the product licence holder and issue a post-licence IRN. The IRN asks you, as the licence holder, to correct the deficiency and bring the product into regulatory compliance.

Addressing post-licence issues

Prior to initiating regulatory action, NNHPD may provide licence holders with an opportunity to address post-licence concerns (such as safety or administrative issues) through the issuance of a post licence IRN.

The post-licence IRN outlines a response timeline, determined by NNHPD, which may vary based on factors such as:

• potential risk posed by the product
• complexity of the information requested
• urgency of the issue
• impacted sub-population
• Other relevant considerations

A post-licence IRN may request specific modifications to the product licence and/or labelling to address the identified concern. You may respond by submitting a post-licence amendment or notification using the ANF.

The post-licence IRN is one of several tools used to manage post-licence issues. NNHPD may also issue regulatory notices under sections 16 to 20 of the NHPR if a safety concern or other alleged contravention of the NHPR or Food and Drugs Act is identified.

When NNHPD issues a regulatory notice requesting updates to product licence information, the product licence holder must respond using the ANF tool. The submission must be clearly marked as 'in response to a notice issued by the NNHPD Risk Management Division.' You must also submit the ANF and revised label (if applicable) according to the instructions provided in the post-licence IRN.