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.

The post Health Canada updates guidance on Adverse Reaction Reporting appeared first on Focal Point.

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.

The post Health Canada ends FSRN Process appeared first on Focal Point.

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.

The post New French Language Requirements per Québec – Bill 96 appeared first on Focal Point.

In addition to the labelling required, the manufacturer or party responsible for the labelling of a product, will be required to participate in a collection study conducted in collaboration with wastewater agencies to understand consumer behaviour. Annual reporting to specified legislative committees and the State Water Resources Control Board under this program is also mandatory.

Please note that enforcement provisions have been established, including a civil penalty not to exceed $2,500 per day, up to a maximum of $100,000 per violation, to be imposed on the manufacturer or party responsible for labelling and therefore in violation of the provisions.

To avoid last minute label changes, it will be imperative to act now. Should you have any questions or require any additional information, please do not hesitate to contact us.

The post California Assembly Bill No. 818 appeared first on Focal Point.

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.

The post NOTICE WITH RESPECT TO CERTAIN SUBSTANCES ON THE REVISED IN COMMERCE LIST (R-ICL) appeared first on Focal Point.

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.

The post Consultation on Upcoming Changes to NHP Labelling Regulations appeared first on Focal Point.

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.

The post UPDATED Health Canada Acne Therapy Monograph appeared first on Focal Point.

Talc is a naturally occurring mineral that can be found in a number of self-care products, including cosmetics, non-prescription drugs and natural health products (NHPs). The final assessment identified the following:

1. It may cause ovarian cancer when present in products intended for use in the genital area such as wipes, baby powder, diaper and rash creams, bath bombs, and genital antiperspirants or deodorants;
2. It is potentially harmful to your lungs if you breathe in loose powder products such as body, baby and face powders;
3. It does not present any health concerns if used in pressed powder products, dry shampoos, foot powders, products that come into contact with skin excluding the genital area and non-prescription products or NHPs intended to be ingested;
4. It is not harmful to the environment.

Talc is currently listed on the Cosmetic Ingredient Hotlist and is restricted in cosmetic products intended to be used on children. Given the results of the risk assessment, Health Canada is proposing further action to lower talc exposure from products that could be inhaled or used in products intended for the genital area. The proposed actions include:

• Adding talc to the Toxic Substances List in Schedule 1 of the CEPA – this would not restrict its use, manufacture or import, but rather enable the Government to take risk management actions under CEPA
• Changing existing entries on the Cosmetic Ingredient Hotlist and NHP Ingredient Database to include measures to reduce exposure to talc from products which may be inhaled or result in perineal exposure

Industry and other interested stakeholders are invited to participate in an electronic consultation on the proposed Risk Management Approach until Jun. 23, 2021.

If you have any questions or concerns or would like further clarification on the implications of the risk assessment and risk management approach, please feel free to contact us.

The post Tighter Restrictions to be implemented for Talc appeared first on Focal Point.

Health Canada has provided interim expedited licensing to support facilities to manufacture, package, and label alcohol-based hand sanitizers during this desperate time of need for these products. It should be noted that hand sanitizers containing ethanol labeled as ‘anhydrous alcohol’, ‘ethyl alcohol’, or ‘grain alcohol’ are considered Natural Health Products (NHPs). Hand sanitizers containing isopropanol labeled as ‘isopropyl alcohol’ or ‘2-propanol’ are considered NHPs as well. A Site Licence (SL) is required to import, manufacture, package, or label hand sanitizers in Canada while a Product Licence is required to distribute and sell hand sanitizers. The final hand-sanitizer product should be 60-80% ethanol or 60-75% isopropanol, as per the Antiseptic Skin Cleansers (Personal Domestic Use) Monograph. The hand-sanitizer must also fully comply with the monograph in order to qualify for the expedited process onto the Canadian market. It should be noted that Health Canada still requires the reporting of adverse reactions to products, if any develop. These temporary regulations will be in place until March 31, 2021 or until a statement is made from Health Canada to licence holders regarding timelines and next steps for this interim process.

For Site Licences, companies must state which Good Manufacturing Practices (GMPs) they are attesting to when completing the application. This may be part three of the NHPR, Division 2 of Food and Drug Regulations, Guide to Food Safety, or Good manufacturing Practices for Cosmetic Products. Certain GMPs, such as stability testing and providing GMP evidence such as Quality Assurance Reports (QARs), are temporarily waved. With that being said, facilities should ensure that the appropriate controls are in place to avoid product contamination.  The Health Canada guidance document also includes details about Product Licence Applications (PLAs) and instructs to include that the application type is ‘Compendial’ and is a ‘Antiseptic Hand Cleanser’. The primary brand name should indicate generic descriptor of the product as well as alcohol content and should not have any reference to the coronavirus or any specific virus directly. The medicinal ingredients should only include ‘ethanol’, ‘ethyl alcohol’, ‘isopropanol’, or ‘isopropyl alcohol’ within the quality per dosage unit, as indicated above. If these measures and details are properly followed, the Product Licence for the hand sanitizer product should be made available quickly.

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.

The post Health Canada Guidance Document on Interim Expedited Hand Sanitizer Approval Process appeared first on Focal Point.

Physical Sunscreens vs. Chemical Sunscreens:

According to the American Academy of Dermatology and the American Academy of Dermatology Association, physical sunscreens work like a shield while chemical sunscreens work like a sponge. Physical sunscreens contain the active(s) zinc oxide and/or titanium dioxide, and work by sitting on the skin’s surface deflecting the sun’s rays. On the other hand, most chemical sunscreens contain one or more of the following active ingredients that absorb the sun’s rays: oxybenzone, avobenzone, octisalate, octocrylene, homosalate, octinoxate.

Originally, the chemical sunscreens were used in small quantities for preventing sunburn on vacation. According to a CNN article, the FDA started to become concerned about chemical safety when sun protection agencies started recommending daily application on large parts of the body.

Oxybenzone seems to be the most concerning active ingredient in sunscreens. In a small FDA study of sunscreen chemicals, oxybenzone was absorbed into the body at a concentration of approximately 50 to 100 times higher than the other three chemicals. Other studies have shown a potential link between oxybenzone and changing hormone levels in men, including lower testosterone. According to the article, it is also the most common cause of contact allergies and can also leach into breast milk.

Experts say that you should NOT stop using sunscreens. Further studies need to be conducted to determine the medical implications, if any, of sunscreen absorption. However, the increasing awareness surrounding the potentially harmful absorption of these chemicals encourages consumers to be more cautious about the type of sunscreens they purchase. Alternative sun protection methods include avoiding sun exposure at peak times, using protective clothing, and wearing a hat.

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.

The post Can Sunscreen Absorption into the Bloodstream Pose Health Risks? appeared first on Focal Point.