Clarifications for amendment and notification site licence applications for natural health products

The Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 8, October 15, 2025, from the Health Product Compliance Directorate

On this page

• Introduction
• Timing for submitting amendment and notification applications
• What is considered an amendment under the Natural Health Product Regulations (NHPR)
• Supporting documents to be provided with amendment applications in addition to the required documents listed in the web SLA
• What is considered a notification under the Natural Health Product Regulations (NHPR)
• Supporting documents to be provided with notification applications in addition to the web SLA form

Introduction

This bulletin clarifies the documentation requirements for amendment and notification applications with the objective to improve predictability and ensure you get your license decision as quickly as possible.

Filing the right documentation is key as you are not authorised to conduct any activities relating to the amendment(s) until the site licence has been amended by Health Canada.

You must submit amendment applications separately from your renewal application. An amendment included in a renewal application will not be accepted.

Timing for submitting amendment and notification applications

Service standards for managing site licence applications (new applications, renewals, and amendments) are 35, 65, and 95 business days, depending on:  

• the type of Good Manufacturing Practice evidence provided, and
• the number of sites in the application.

The service standards for notifications is 15 business days.

To improve predictability and ensure you get your license decision as quickly as possible, we recommend that you submit amendments and notifications applications either:

• at least 65 business days before your licence expiry date, or
• after the expiry of the site licence for which a renewal has been received.

What is considered an amendment under the Natural Health Product Regulations (NHPR)

Section 32 of the NHPR outlines the changes that require a site licence amendment.

Amendment applications are required when you:

• add a licensable activity (manufacturing, packaging, labelling, importing) that is not currently authorized under the existing licence
• add a new domestic building for the activities of manufacturing, packaging, labelling, importing or storage
• add a new foreign building for the activities of manufacturing, packaging, or labelling
• change the address of a building that conducts activities or stores products (manufacturing, packaging, labelling, importing or storing)
• add an activity category (for example, sterile, homeopathic or non-sterile dosage forms) that is not currently authorized under the existing licence
• merge site licences by combining two or more existing site licenses into one
• remove an activity, a domestic or foreign building or a category of activities

Supporting documents to be provided with amendment applications in addition to the required documents listed in the web SLA form

When adding an activity, a domestic building, a foreign site or a category related specifically to manufacturing or importation, include the following supporting documents:

• a finished product specification or certificate of analysis template specific to the product you intend to manufacture or import
• a stability protocol specific to the product you intend to manufacture or import:
  • Templates must include specifications and test methods 
  • Microbial contaminant specifications should indicate which chapter of the following pharmacopeias was used, based on the product dosage form, ingredients and route of administration:
    • United States Pharmacopeia (USP)
    • British Pharmacopoeia (BP)
    • European Pharmacopoeia (Ph. Eur.)

When removing an activity, building, category or a foreign site, include the following supporting documents:

• Responses to outstanding Issuance Letter observations specific to the activity, building, category or foreign site in the removal request

When changing an address, include the following supporting documents, as applicable:

• Copies of updated standard operating procedures requested in the web SLA

What is considered a notification under the Natural Health Product Regulations (NHPR)

Section 33 of the NHPR outlines the changes that require a site licence notification.

Notification applications are required when you change the:

• Quality Assurance Person (QAP), Senior Official or application contact
• address on the site licence, where no licensable activities are conducted (for example, the mailing address)
• company name on the site licence
• building, equipment, practices or procedures, including:
  • addition of new equipment
  • new or updated procedures
  • changes to the product list

Supporting documents to be provided with notification applications in addition to the web SLA form

When changing your company name, provide a cover letter signed by the Senior Official of the site that is changing its name. The cover letter should address the following questions:

• Is the name change a result of a merger and/or acquisition?
• Is the company under the same ownership?
• Are there changes to personnel (such as QAP, Senior Official and employees)?
• Are there changes to products and procedures?
• Are there changes to buildings and equipment?

If a company name change is only to correct a typographical error or reflect a minor adjustment (for example, a change from “Company ABC Limited” to “Company ABC Ltd.”), the applicant may explain this as part of the cover letter and is not required to answer the questions listed above.

When changing the QAP, provide:

• a demonstration, with supporting evidence, that the new QAP is qualified and trained to fulfil their responsibilities 

When changing the building, equipment, practice or procedure, and your evidence is not pre-cleared, provide:

• a Quality Assurance Report with completed pages and sections relevant to the changes
• updated standard operating procedures requested in the Quality Assurance Report relevant to the change
• a confirmation that licensable activities remain unchanged

Contact us

For inquiries about this bulletin, contact us by email: hpcd.nhp.sl-dcps.psn.le@hc-sc.gc.ca.