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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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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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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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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The first of these three stages involves introducing a new web form for all site license applications. The NNHPD is planning to launch the new version of the form on November 12, 2020, implementing a 1-2 week grace period, after which all old versions of the web form will be removed. It should also be noted that due to current on-site limitations cause by the COVID-19 pandemic, the NNHPD has also been requesting that applicants using the paper submission method resubmit their application using the electronic system in order to lessen any delays as much as possible.

In addition, in cases of foreign sites that have no identified risk issues, the NNHPD will “align with the Regulatory Operations and Enforcement Branch (ROEB)’s approach for Finished Dosage Form Foreign Building compliance by extending the authorization period of foreign sites until further notice (or until reviewed by Health Canada)”. Foreign site applications that are not linked to at least one importer or where there is no inspection evidence are being considered low priority for the time being and will not be reviewed within NNHPD’s current service standards.

Lastly, NNHPD has a plan to implement operational efficiencies for sites with no known risk issues. NNHPD will now take a risk-based approach to its review of renewals for sites that were recently renewed and have no known compliance issues. However, it is important to note that, as per usual, “should a risk to health be identified subsequent to the renewal, Health Canada may take compliance action, which may include such actions as the issuance of an intent to suspend or immediate suspension of the site license, as deemed appropriate”.

Other key reminders that the NNHPD is asking applicants to keep in mind during this transition process include, for site licenses set to expire post December 1st, an application to renew the license is required at least 30 days before its expiry date. Furthermore, if an application is not received by the NNHPD to renew a site license by December 1st (for those sites that were extended until December 1st), the site will not be renewed. For more information regarding these upcoming changes and the site license application and renewal processes, visit the Health Canada website.  

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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According to Medical Design & Outsourcing, the FDA has warned the public of a potential medical device shortage as a result of the plant shutdown. Roughly 90% of the products sterilized at the Sterigenics Willowbrook facility were medical devices and manufacturers of those products will be greatly impacted by this plant shutdown.

Health Canada has issued a clarification notice on what sort of changes to sterilization procedures would require Medical Device Licence (MDL) amendments. According to Emergo, Health Canada has advised that facility changes alone do not warrant a new MDL application submission. However, MDL amendments are required for changes to sterilization procedures, equipment or cycle parameters. MDL amendments are also required for the following:

• Changes that increase bioburden alerts or action levels;
• Changes that introduce organisms more resistant to sterilization effects;
• Device design and material changes that introduce features more difficult to sterilize;
• Changes in density or configuration of a sterilization load;
• Changes to quality control verification and validation processes.

As a result, moving the sterilization facility may result in one or more of the above changes, therefore leading to potential MDL amendments for several medical devices.

If you require assistance complying with medical device regulatory requirements or would like more information on the matter, 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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According to Cosmetics Design USA, vice president of global digital services at Amway, Mike Edwards, states: “If you look at companies like Uber, they didn’t do anything unique. It’s still the taxi industry. But they leveraged digital tools to make that a very compelling opportunity. It’s the same thing if you look at direct selling and you look at Amway. If we don’t disrupt the industry by leveraging digital tools, we’ll become irrelevant.”

The overarching purpose of the app developments is to help Amway Business Owners (ABO) serve their customers better and drive mobile sales, while strengthening the relationship between the ABO and customer through digital technology. By storing components of the app on a global cloud storage space, standardization becomes easier to achieve between apps, and allows for brand consistency among markets in different countries.

Brian Hart, vice president of ABI customer solutions and IT at Amway, declares that the app development plan will save a substantial amount of money while allowing the company to gain international brand awareness and further improve customer experience. “Everyone has a mobile phone, but not everyone has a computer,” observes Hart. By leveraging this common device, Amway reduces the possibility of an external competitor disrupting their business with app development solutions in the future.

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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Health Canada published an updated timeline for the various phases in the framework’s implementation process.  Due to the upcoming Canadian Federal Election, there have been changes to the original schedule. After public consultations, the updated approach to regulating self-care products is targeted to be phased in over the next few years:

Phase I (Spring 2020) – Health Canada will introduce labelling amendments to Natural Health Products (NHPs). The changes will include improving the facts table for easier comparison between similar self-care products, as well as plain language on labels for consumers to easily understand.

Phase II (Spring 2020) – Health Canada will introduce a risk-based approach to regulating non-prescription drugs under the Food and Drug Regulations (FDR). The approach will include expedited pathways for lower-risk products such as sunscreens and acne products to align with regulations for self-care products with similar risk level.

Phase III (2021) – Health Canada will introduce regulatory amendments to address health claim evidence standards and extend regulatory oversight with a risk-based approach. Phase III will also seek additional controls for Health Canada such as having the ability to require recall or label change for all self-care products.

These changes to the regulatory framework are anticipated to support the safe and intended use of self-care products to help Canadians make more informed decisions when buying products. It is also intended to establish proportional regulatory rules based on risk, which would result in significant cost reduction for health care businesses..

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading Canadian regulatory and Health Canada consultants for Natural Health Products, OTC Drugs, Cosmetics, and other personal care products.

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Victor Gura, MD, an internist and nephrologist from Los Angeles, has invented a portable dialysis device that is designed to improve the overall quality of life of dialysis patients. In place of a 300-pound dialysis device, the WAK is worn on a belt and provides the benefits of daily dialysis without compromising normal routines.

How does it work?

The WAK is battery operated, which is a unique alternative to the current machines that require constant access to an electrical outlet. It features a unique concept that regularly eliminates fluid to reduce kidney strain, while also controlling blood pressure. The invention has developed from weighing 11 lbs to only 2 lbs and is connected to the patient using a single catheter, inserted under local anesthetic. This allows the patient to perform a multitude of activities while having dialysis, which would not have been remotely possible with the traditional dialysis methods. The first clinical trial filtered the patients’ blood effectively, regardless of whether their diet included salty or phosphorus-rich foods, which would normally be avoided for dialysis patients.

The later iterations of the product involved having a day mode device and a night mode device. This facilitates the ability to have a smaller device that could be used during the day and a heavier one for the night that performs clinical tasks and recharges the battery.

The U.S. FDA reduced the number of clinical trials that they wanted from five to two after the first clinical trial performed successfully in 2015. Although there was increased risk for blood clotting with this device, the benefits on patients’ quality of life became crystal clear and outweighed the risk.

If you require assistance with applying for a Class II medical device licence, 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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A risk assessment is an integral part of maintaining both the health of Canadians and the environment. Risk assessments are executed by Environment and Climate Change Canada under the CEPA (Canadian Environmental Protection Act) and are used to “determine whether there are risks resulting from exposure of Canadians to the substance or releases of the substance into the environment, and the specific ways Canadians or the environment can be affected”. The assessment of chemicals allows for proper regulatory measures to be taken.

What risks does talc pose to human health?

The assessment mainly focuses on the risks talc poses within self-care products and concludes that it be classified as CEPA toxic. This conclusion is due to two associated risks with loose powder forms of talc. One of the two risks discussed is the inhalation of talc from loose powder products. This risk encompasses products such as baby powder and industrial applications in which talc is airborne. Warning labels have already been required on products like baby powder that are marketed for the use on infants, cautioning to avoid inhalation of the product by the infant. Inhalation of talc can lead to respiratory problems including “coughing, difficulty breathing, decreased lung function and scarring of the lung tissue”. Perhaps more serious of the risks is the possible associations with ovarian cancer. When used on the perineal region in women it was found that it is possible for talc to migrate and find itself lodged in the reproductive system. This judgement comes off the heels of the July verdict of the class action lawsuit of Johnson & Johnson by 22 women who claimed consistent use of J&J Baby Powder on the perineal area had led to their ovarian cancer (due to alleged contamination of talcum powder with asbestos). Johnson & Johnson was found guilty, with the court ruling in favour of those affected. Several studies have also been conducted to observe the possible risks associated with talc, these are included in the documentation provided by CEPA. It is important to note that, in pressed form or consumables (ie. Some cosmetics or foods or drugs), Health Canada did not find talc harmful.

Where does this leave Talc?

The findings show talc as a health threat, but that it presents no threat to the environment. In terms of talc as an ingredient in self-care products; those that are non-airborne, don’t come in contact with the perineal area or are consumed are deemed safe. However, in the meantime, consumers are left to make the decision themselves if they would like to stay away from talc-based products.

Despite these published documents, nothing is set in stone until the final assessment.  A 60-day comment period has opened allowing for comments to be made upon the presented information and conclusions. If passed, the proposed conclusions published by Health Canada would result in the following outcomes as means of risk management:

• Possible modifications to the Cosmetic Ingredients Hotlist to prohibit or restrict talc and its use in cosmetics and perennial products
• Possible modifications to the Natural Health Products Database and associated monographs to reduce the exposure of talc to consumers in NHPs and OTC drugs that have risks of being inhaled or usage associated with the perineal area

Important Dates to Note

• The draft screening assessment was posted online by Health Canada on December 5^th, 2018
• A 60-day comment period has opened and will close on February 6^th, 2019

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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