Key updates include:

Reporting Requirements: Following confirmatory testing, Market Authorization Holders (MAHs) must assess whether nitrosamine impurities exceed the established Acceptable Intake (AI) limit and determine whether market action is required. MAHs are no longer required to notify Health Canada each time an elevated nitrosamine impurity level is detected. Notification is only required when a recall decision has been made, in accordance with the Drug, Natural Health Product and Biocide Recall guide (GUI-0039).

Risk Mitigation Expectations: While the guidance maintains a 3-year CAPA implementation timeline, Health Canada expects MAHs to implement risk mitigation measures and reduce nitrosamine levels below AI limits as soon as possible.

Safety: New contact information has been added for enquiries regarding applicable Acceptable Intake (AI) limits, including proposal for new AI limits.

Appendix 2: The decision tree has been updated to reflect the revised expectations for filing nitrosamine risk mitigation-related changes. 

If you wish to understand how these changes might affect your business, please reach out to us.

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For more information, reach out to us.

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The NNHPD is contacting affected licence holders and requesting removal of these carbomers from formulations. Note that any for drug products containing these carbomer ingredients, Health Canada is also reaching out to DIN holders requesting removal of these carbomers from formulations. If you have questions or would like guidance on how this change may affect your products, please reach out to our team.

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In addition, as of April 01, 2026, all Class II, III and IV medical device applications and amendments must be submitted electronically through the Regulatory Enrolment Process via the Common Electronic Submissions Gateway. Email submissions will no longer be accepted.

Health Canada has also implemented a new Terms and Conditions framework for device licenses, strengthening post-market oversight and adopted the International Medical Device Regulators Forum Table of Contents format to align with global standards. These changes aim to streamline submissions and improve regulatory efficiency.

If you need additional information or guidance on navigating these new processes, please reach out to us.

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A FSRN is not mandatory, is not a site license and does not allow foreign sites to export directly to Canada without a licensed Canadian importer.

What’s changing?

HC is discontinuing the FSRN process to streamline site licensing and to simplify and consolidate the submission process.

Confidentiality of submitted information will be maintained with the use of direct communication between Health Canada and foreign sites as needed.

Effective February 16, 2026:

• New FSRN applications will not be accepted
• Existing FSRNs will be marked as ‘discontinued’
• GMP evidence for foreign sites must be submitted through the site license process
• References to FSRNs will be removed from guidance documents

Foreign warehouses no longer need to be listed on site licenses and the ones already listed will be removed when the license is updated as a part of an amendment or renewal. However, they must still meet all applicable GMP requirements.

Contact us if you need further understanding of this updated process and its impact on your business.

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A section 46 information-gathering notice was published on April 22, 2024 which is authorized under CEPA to allow the Minister to collect the relevant data from the industry to develop the Federal Plastics Registry.

The following is requested from companies (including resin manufacturers, service providers, and producers of plastic products):

• An annual report on the quantity and types of plastic they manufacture, import, and place on the market.
• Report on the quantity of plastic collected and diverted, reused, repaired, remanufactured, refurbished, recycled, processed into chemicals, composted, incinerated, and landfilled.
• Report on the amount of plastic waste generated on their industrial, commercial, and institutional premises.

To gather and provide accessible, consistent and robust plastic data, a Canada-wide Action Plan on Zero Plastic Waste has been introduced to ensure that the federal, provincial, and territorial governments commit to developing and maintaining Canada-wide data on how plastic moves through the economy.  Exemptions for annual reports are in place for small producers placing less than one tonne of plastic on the market.

Federal Plastics Registry’s reporting guidelines are to be declared in phases to allow sufficient time and flexibility for those obligated to report. The reporting requirements are as follows:

September 2025 – Reporting on plastic placed on the market in three categories (Packaging, Electronic and electrical equipment and Single-use or disposable plastic products) for the 2024 calendar year.

2026 – Further reporting requirements for the remaining categories including plastic waste generated at industrial, commercial, and institutional facilities, plastic collected at end-of-life to be introduced in 2026.

2027– Additional reporting requirements on plastics collected and sent for diversion and disposal for more categories will be added.

The reporting requirements plan for further years will be covered in future information-gathering notices.

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The primary objective of the monograph revision initiative is to modernize the NHP monographs, ensuring they meet the new NHP labeling standards, exhibit consistency and incorporate the most updated information. This effort seeks to enhance the quality and reliability of product information, reducing the need for duplicate licence and labeling updates.

NNHPD plans to revise 97 NHP monographs, grouped into four batches (with 20-25 monographs per batch) between October 2023 and December 2024.

The remaining 169 monographs will receive minor adjustments to align with the new labeling requirements. These revisions will have a limited impact on existing content or product licences, but it’s important to note that they will be implemented without prior consultation. These adjustments will run concurrently with the consultation cycles.

Consultation Period: Each batch of revised monographs will undergo a 30-day consultation period. During this time, licence holders and stakeholders can provide valuable feedback and suggestions.

We encourage licence holders to engage actively during consultation periods for updates to those that may impact your product line. Your feedback, concerns, and contributions are invaluable in refining the revised monographs. We also recommend licence holders refer to the Labeling of NHPs guidance documents and be prepared to comply with the new labeling requirements.

Our team is ready to assist you with any monograph queries, review your products, formulations, and labels. Feel free to contact us today.

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The goal of this new legislation is to provide a well-balanced risk-based approach to regulation. The CEPA will require risk assessments to consider real life exposure to the cumulative effects of certain substances on the environment as well as the public. One such amendment is the creation of a Watch List that will be available to the public for Canadians and businesses to note which substances to avoid. Another objective of Bill S-5 is the right to a healthy environment. This is to ensure that Indigenous people and other groups of colour are not disproportionately impacted by toxic pollution and environmental damages.

The framework to implement the proposed changes plans to be developed and published within the next two years. This includes plans:

• that specifies the substances to which the Ministers are satisfied priority should be given in assessing whether they are toxic or capable of becoming toxic;
• that may specify the activities or initiatives in relation to assessing, controlling or otherwise managing the risks to the environment or to human health posed by substances that are or will be undertaken under an Act of Parliament for whose administration either Minister is responsible and which the Ministers are of the opinion should be prioritized; and
• that specifies activities or initiatives to promote the development and implementation of methods not involving the use of vertebrate animals that would provide information sufficient for assessing risks to health or the environment posed by substances assessed.

Don’t hesitate to contact us if you have any questions about the updates or would like our assistance determining if the modernization of CEPA could impact your products.

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