Health Canada consultants Archives - Focal Point

Health Canada updates guidance on nitrosamine impurities in medications

Srishti Chaudhari — Thu, 04 Jun 2026 13:49:46 +0000

Health Canada has released an updated version of its Guidance on Nitrosamine Impurities in Medications, incorporating several important changes. The summary below applies to Non-Prescription Drugs, chemically synthesized excipients and raw materials used in the manufacturing of drug products.

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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Health Canada updates Acceptable Intake limits for Nitrosamine impurities

Srishti Chaudhari — Mon, 13 Apr 2026 18:36:15 +0000

Health Canada has updated its list of established Acceptable Intake (AI) limits for nitrosamine impurities (Appendix 1), now available online. The update includes the addition of N-nitroso-dabigatran etexilate imide as a new impurity with a corresponding AI limit, along with revised limits for seven existing nitrosamines, including N-nitroso-folic acid, N-nitroso-vancomycin, and N-nitroso-mglumine – the latter significantly reduced from 1,500 ng/day to 100 ng/day. The updated list can be filtered by date to identify recent changes. Stakeholders are encouraged to consult the latest guidance on nitrosamine impurities in medications to ensure ongoing compliance.

For more information, reach out to us.

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NNHPD Updates NHPID entries due to Benzene risk

Srishti Chaudhari — Thu, 02 Apr 2026 20:34:20 +0000

Following alerts from the US FDA regarding benzene contamination, the NNHPD has updated several entries in the NHPID. Benzene is a Class 1 solvent with unacceptable toxicity and must not be used in health product manufacturing. Key changes include the removal of carbomer grades 934, 934P, 941, and 1342 as well as the generic ‘carbomer’ entry, which will now require identification of specific grades. This aligns with proposals from the US Pharmacopeia and National Formulary to omit these carbomer monographs.

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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Health Canada modernizes Medical Device Submission Requirements

Srishti Chaudhari — Thu, 02 Apr 2026 20:06:37 +0000

Health Canada has introduced several key regulatory updates in 2026 that significantly change how medical device applications are prepared and submitted. A major update is the new Guidance on Managing Applications for Medical Device Licenses (effective February 2, 2026), which replaces the previous version and introduces stricter timelines and enhanced screening procedures.

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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Health Canada ends FSRN Process

Srishti Chaudhari — Tue, 24 Feb 2026 15:41:50 +0000

A Foreign Site Reference Number (FSRN) is generally issued by Health Canada to foreign sites that manufacture, package, or label Natural Health Products (NHPs). It confirms partial compliance with GMP requirements under Part 3 of the NHP regulations.

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.

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Changes to the Canadian Cosmetic Notification (CNF) form requirements as of October 9, 2024

Nathan John — Thu, 17 Oct 2024 14:33:41 +0000

There are number of changes that are in effect as of October 09, 2024 for the Cosmetic Notification (CNF) form requirements

Changes to the CNF came info force on October 09, 2024. The new CNF has been released by Health Canada.
Changes include having to identify whether the cosmetic is a leave-in or rinse-off product, use of different concentration ranges compared to those used previously, the need for label contact details to be listed, requiring a Canadian entity / Responsible Canadian Party / Canadian Agent to be listed, removal of the need to include distributor information.
At this time, Health Canada has informed stakeholders that the requirement to list a Canadian entity / Responsible Canadian Party / Canadian Agent will not be mandatory on the CNF until early 2025 (exact date to be confirmed) as this has a significant impact to a lot of companies. The Canadian entity / Responsible Canadian Party / Canadian Agent will be the primary contact that Health Canada will reach out to, should they require any action in relation to a notified product.
- There are ongoing discussions with Health Canada to clarify the responsibilities that this Canadian entity / Responsible Canadian Party / Canadian Agent is to have
- It is believed that the Canadian entity / Responsible Canadian Party / Canadian Agent will function as a contact between the brand owner and Health Canada, however, at this time, the regulations detail a lot more responsibility
- The Canadian entity / Responsible Canadian Party / Canadian Agent bears the same responsibility as a manufacturer
The above requirement for a Canadian entity / Responsible Canadian Party / Canadian Agent will not apply to any CNFs that have already been filed and will only impact new or amendment CNFs filed as of Oct. 09, 2024.

Additional Changes to the Cosmetic Regulations

Ingredient Disclosure Flexibility

For cosmetics sold in small packages, there will be more flexible options for ingredient disclosure. Alternatives such as attaching a tag, tape or card or providing information via a website are now permitted to ensure consumers are informed.

Strengthened Cosmetic Notification Requirements

There is now a requirement to notify Health Canada when a cosmetic is discontinued. The regulations have also been amended to allow Health Canada to halt the sale of a product if the notification requirements are not met or if requested information is not provided.

Removal of Distributor Information

Distributor information will no longer be required on the cosmetic notification. Given that Health Canada can follow up with the manufacturer, importer or Canadian entity / Responsible Canadian Party / Canadian Agent, as needed, regarding distribution of the product for compliance and enforcement purposes.

Identification of Product Type

Cosmetics must now specify whether they are rinse-off or leave-on products in their notifications.

Fragrance Allergen Disclosure

A new mandate will require the disclosure of fragrance allergens on cosmetic labels if they exceed a certain limit. The transition period for the implementation of the changes is three years (July 31, 2026) for new products placed on the market, and five years (July 31, 2028) for existing products to sell through.

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Notice to Stakeholders concerning the Cosmetic Ingredient Hotlist

Sagarika Sharma — Mon, 21 Nov 2022 15:36:08 +0000

Health Canada is considering certain substances for inclusion in future updates to the Cosmetic Ingredient Hotlist (Hotlist). The proposal includes the following:

Additions to the Hotlist
Changes to the conditions for existing entries on the Hotlist
Changes to include additional substance identifiers or make minor corrections

A detailed list of proposed updates to the Hotlist can be found here.

This Notice to Stakeholders is being issued approximately three months before the consultation period. As such, those selling cosmetics in Canada should start to determine which of their products could be impacted by the potential updates and consider any necessary changes to product formulations, distribution and sales. Health Canada will not respond to any information or comments received at this stage.

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

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Amendments to the NHP Regulation

Delsie Braganza — Tue, 19 Jul 2022 19:31:37 +0000

As recently published in the Canada Gazette, Health Canada published the final amendments to the Natural Health Products and the Food and Drugs Regulations, also known as the Self-Care Framework. These amendments are part of the Forward Regulatory Plan 2022-2024 and will ensure that Natural Health Products are labelled in a manner comparable to similar self-care products such as non-prescription drugs. Moreover, the amendments proposed will introduce a risk-based approach to regulatory oversight of all self-care products.

These proposals will be completed in phases, with Phase I involving the improvement of labelling of Natural Health Products, which has been completed as of 5th July, 2022. This amendment will include:

Product fact tables
Formatting requirements
Improving allergen labelling
Tamper evidence alignment under CUSMA
Modernized contact information

The following Phase II will introduce expedited pathways for lower-risk non-prescription drug products, with Phase III expanding the efficiencies and modernization pertaining to non-prescription drugs to NHPs.

The period in which new products will phase in the amended regulations is 3 years, with an additional 3 years for existing products. Additional details such as the associated guidance documents accompanying the regulation changes will follow via the NNHPD.

Click here to view the original article published by the Canada Gazette.

If you have any questions on the updates or would like assistance with NHP compliance, please contact us.

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Consultation on Upcoming Changes to NHP Labelling Regulations

Jenn Porter — Tue, 13 Jul 2021 17:30:56 +0000

The Natural and Non-Prescription Health Product Directorate (NNHPD) at Health Canada recently released a draft guidance document pertaining to potential upcoming changes to the current Natural Health Product (NHP) regulations published in Canada Gazette, Part I. These changes are currently under consultation for 60 days (ending Sep. 04, 2021) and include modernizing contact information on labels (such as using websites or phone numbers instead of addresses and postal codes), ensuring clear and prominent labelling of text on the product labels, better labelling of warnings for food allergens, gluten and aspartame containing NHP products, and also inclusion of a Product Facts Table with exemptions. As these are proposed changes, they may change depending on feedback obtained from industry and stakeholders.

If you would like further information on this or have any questions on how this may impact your business, please contact us. We are leading regulatory and quality consultants and can answer any questions pertaining to this.

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Health Canada Risk Evaluation of N-nitrosamine Impurities: First Step Deadline Fast Approaching

Jenn Porter — Sun, 07 Mar 2021 17:35:21 +0000

The deadline for the first step of Health Canada’s new risk evaluation for the presence of N-nitrosamine impurities in Canadian human pharmaceutical, biological and radiopharmaceutical products is fast approaching. This new Health Canada requirement for all Market Authorization Holders (MAHs) of Canadian human pharmaceuticals, biologicals and radiopharmaceuticals drug products was originally announced in October 2019with the first step of the risk evaluation process due April 2, 2020 (product risk assessments). However, due to the COVID-19 global pandemic, the first deadline was originally postponed until October 1, 2020 on March 26, 2020. It was then further extended on August 10, 2020 to March 31, 2021 for all drug products containing chemically synthesized APIs. For MAHs of biological and radiopharmaceutical products, this was extended even further to November 30, 2021.

To provide a brief background on the topic, Health Canada published a notice on a requirement for all MAHs of Canadian drug products classified as human pharmaceuticals, biologics and radiopharmaceuticals to evaluate and analyze their products for any presence of N-nitrosamine impurities. This was due to the concern that N-nitrosamine impurities have on human health as they are classified as probable carcinogens. Health Canada has requested that MAHs thoroughly review their products and manufacturing process for any potential sources of N-nitrosamine impurities (step 1: risk assessments – to be retained by the MAH) including reaching out to their API suppliers for an evaluation on their APIs, test their products for any potential presence of N-nitrosamine impurities (step 2: confirmatory testing), make any necessary changes to the product to ensure their products do not exceed the acceptable limit of nitrosamines (step 3: changes to the market authorization as a result of the previous steps), and then report the presence of nitrosamines within their products to Health Canada, if applicable.

For MAHs of drug products containing chemically synthesized APIs, please note the following due dates for the risk evaluation steps:

Risk Assessments: Due March 31, 2021
Confirmatory Testing (If a risk is identified): Due October 1, 2022
Changes to the market authorization: Due October 1, 2022

For MAHs of biological or radiopharmaceutical products, please note the following due dates for risk evaluation steps:

Risk Assessments: Due November 30, 2021
Confirmatory Testing (If a risk is identified): Due November 30, 2023
Changes to the market authorization: Due November 30, 2023

Our most recent article on this matter can be found here. For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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