NHP Consultants Archives - Focal Point

NNHPD clarifies review prioritization for NHP licence applications

Srishti Chaudhari — Mon, 13 Apr 2026 18:11:48 +0000

The NNHPD is currently experiencing a high volume of NHP licence applications and has formalized how applications will be assigned for review under its workload management approach. Applications will now be reviewed on when prioritization was requested instead of the original submission date. For applications submitted before December 15, 2025, review priority will be determined by the date the Workload Management Form was submitted.

For applications received on or after December 15, 2025, priority will be based on the application’s date of receipt, as attestation questions are now integrated directly into the PLA form. This process aligns with the NHP Management of Applications Policy and ensures a fair, transparent, and consistent review process while managing high application volumes. Applicants must ensure that all attestations in the PLA form are accurate, complete, and meet eligibility requirements.

Give us a call to understand more about NNHPD operations.

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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 updates guidance on Adverse Reaction Reporting

Srishti Chaudhari — Thu, 02 Apr 2026 20:24:09 +0000

Health Canada has issued a notice clarifying adverse reaction reporting expectations for Market Authorization Holders (MAHs) of drugs (including pharmaceuticals, biologics and radiopharmaceuticals) and Natural Health Products (NHPs). The notice replaces Section 4.3 of the Reporting Adverse Reactions to Marketed Health products – Guidance Document for Industry (2018) and the 2020 Notice to Industry.

The update aims to reduce duplicate reporting and regulatory burden. Under the revised guidance, MAHs are not required to routinely monitor the Canada Vigilance Online database or Health Product InfoWatch for Individual Case Safety Report (ICSR) obligations. However, MAHs must still report serious, unexpected adverse reactions occurring outside Canada, including those identified through foreign regulatory authority databases. If it cannot be confirmed whether the product belongs to the MAH, the report should be submitted to Health Canada with that limitation noted.

The updated guidance took effect on February 19, 2026. If you have questions or would like guidance on how this change may impact your processes, please reach out to our team.

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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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New French Language Requirements per Québec – Bill 96

Sagarika Sharma — Mon, 13 Jun 2022 16:36:37 +0000

On June 1, 2022, Québec’s Bill 96 became law. While most of the amendments will come into force at a later date, some significant changes came into force immediately on June 1, 2022. As a result, most businesses operating in Québec will have to adjust their practices to ensure compliance with the new requirements.

How may this affect your business?

Notable changes brought by Bill 96 include narrowing the recognized trademark exception (that applies to registered and unregistered marks) to only apply to registered trademarks on product packaging. Even if your non-French mark is registered, any generic or descriptive portions included in your registration will have to appear in French elsewhere on the product permanently affixed to it. Other changes include a prohibition on making available commercial publications, invoices, receipts, and other documents in another language unless the French translation is unavailable.

Businesses will have three years to comply, and these requirements come into force on June 1, 2025. Fines will be imposed for non-compliance ranging from $700 to $7000 (for individuals) and $3000 to $30,000 (for companies).

For additional information on this or if you have any questions, please do not hesitate to contact us.

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Amendment to the Quebec Charter of the French Language

Sagarika Sharma — Thu, 14 Apr 2022 19:18:22 +0000

When it comes to trademarks, there is currently an exemption for French-language requirements for owners of “recognized trademarks” who may display a trademark in a language other than French as long as the trademark is legally recognized as a trademark and there is no French version registered in Canada. This has applied to both public signage, commercial advertising and product packaging and labelling. Bill 96, which was introduced into the Quebec National Assembly in May of 2021, will impact your company if your company labels products specifically for the Quebec (or Canadian Market) or utilizes an international (North American) label to manage a single inventory. Bill 96 will necessitate the translation of any generic word or phrase or a description of a product included within a trademark. In addition, only those trademarks that are ‘registered’ may be used in a language other than French.

As this bill is now in the final stages of the legislative process and is expected to become law this spring, in advance of the upcoming provincial election, it will be important for companies to be prepared for changes needed to comply with the proposed changes.

For additional information on this or if you have any questions, please do not hesitate to contact us.

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NOTICE WITH RESPECT TO CERTAIN SUBSTANCES ON THE REVISED IN COMMERCE LIST (R-ICL)

Sagarika Sharma — Thu, 17 Mar 2022 17:50:55 +0000

The Department of the Environment published a notice on March 12, 2022 to collect information on the commercial status and use of approximately 700 substances including biopolymers, plant extracts, mineral extracts, proteins, fats, animal extracts, waxes and carbohydrates. The purpose of this notice is to gather the information on the commercial status and downstream use of the substances.

Substances that are imported or manufactured with respect to use patterns beyond the scope of the Food and Drugs Act are subject to notification requirements.

If your company manufactured or imported any applicable substance, in 2019 or 2020, in a total quantity greater than 100 kg, and that is in, or is intended to be in, an applicable product. The list of applicable substances can be found at: https://canadagazette.gc.ca/rp-pr/p1/2022/2022-03-12/html/notice-avis-eng.html#na2.

Every person to whom this notice applies shall comply with this notice within the timeframe specified. Responses to this notice shall be submitted to the Minister of the Environment, no later than September 14, 2022, using the online reporting system available through Environment and Climate Change Canada’s Single Window.

Should you not meet the requirements of the notice and have no interest in the substances, you may submit a Declaration of Non-Engagement (DNE).

If you require any assistance in determining whether or not this notice applies to your company or if you need assistance with gathering information and responding to the notice, please do not hesitate to contact us.

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Full Producer Responsibility for Post Consumer Waste in Ontario

Nathan John — Tue, 26 Oct 2021 17:11:19 +0000

Ontario is moving its existing waste diversion programs to a producer responsibility model. Producers are the companies that design, create and market products and packaging. Producers will be responsible for managing and paying for the full life-cycle of their products to make recycling easier and more accessible across the province. If you are a Producer, you will need to:

Register your 2020 tonnage with RPRA (Deadline to Register – October 1st)
Pay your 2021 registry Fee when submitting your 2020 supply data
Join a Producer Responsibility Organization (PROs)

If you would like further information on this, please do not hesitate to 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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UPDATED Health Canada Acne Therapy Monograph

Jenn Porter — Tue, 13 Jul 2021 17:28:01 +0000

The Health Canada Acne Therapy Monograph was updated on Jun. 25, 2021 to include specific acceptable dosage forms for both non-prescription drugs and Natural Health Products (NHPs) as well as an additional Directions for Use statement for aerosol and spray acne products. This is the most recent update since the last version published in December 2018.

As of the Jun. 25, 2021 effective date, all new Acne products must follow the revised Health Canada monograph labeling requirements and for existing products, these should be in transition to ensure compliance with the new monograph.

For additional information on transitioning your products or questions you may have regarding this update, please do not hesitate to contact us.

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