Key updates:

Separate submissions: Amendment applications must be filed separately from renewal applications. Including an amendment in a renewal will not be accepted. A key reminder that companies are not authorized to conduct any activities related to an amendment until Health Canada has officially approved and amended the Site Licence.

Timelines:

• New applications, Renewals and Amendments: Service standards are 35, 65, or 95 business days, depending on the type of evidence and number of sites.
• Notifications: Processed within 15 business days.
• Health Canada recommends submitting amendment and notification applications at least 65 business days before your SL expires OR after the expiry of the SL for which a renewal has been received.

Amendments: Required for significant changes such as adding or removing new activities, sites, categories, changing addresses, and merging. 

Notifications: Required in case of change to company name, Quality Assurance Person (QAP), site equipment, procedures, or mailing address (where no licensable activities are conducted).

Supporting documents: In addition to the documents listed in the webSLA form, specific supporting documents are required for amendment and notification, as detailed in Bulletin 8.

By following these updated guidelines, you can help ensure faster approval of your site licence amendments and notifications.

Reach out to us if you need help with compiling Site Licence applications.

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This guidance is intended for market authorization holders (for drugs) and licence holders (for NHPs), providing detailed information on how to comply with Canadian regulations, including the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Product Regulations.

The draft guidance clarifies the expected content, format, and submission procedures for two key types of reports:

1. Annual Summary Report (ASR): A comprehensive assessment of all known safety information for a product currently on the market.
2. Issue-Related Summary Report (IRSR): A concise, critical analysis of a specific safety or effectiveness issue, which is prepared upon request from Health Canada.

The primary goal of this update is to enhance clarity and efficiency. Key objectives include consolidating current guidance documents, converting text to plain language, addressing stakeholder questions, and updating submission processes.

A significant change in this draft is the separation of guidance for drugs and NHPs. This change is intended to better address the distinct regulatory and operational considerations for these different product lines.

Health Canada is seeking feedback from stakeholders on the proposed changes. Interested parties are encouraged to review the draft guidance and an associated draft form (“Notifying Health Canada of a significant change in what is known about the risks and benefits of a product”). Feedback can be submitted via email until the December 23, 2025, deadline.

The post Health Canada Opens Consultation on Draft Guidance for Drug and Natural Health Product Summary Reports appeared first on Focal Point.

This is a significant move that aligns NHP oversight with other regulated health product sectors like drugs and medical devices. The DHPID will be a public resource offering detailed inspection information, including dates, compliance ratings, key observations, and regulatory actions. This increased transparency aims to benefit stakeholders and will provide valuable insights into regulatory compliance.

Our team is ready to help ensure your facility’s quality systems are not just compliant, but ‘inspection-ready’ for Health Canada.

The post Health Canada Boosts NHP Transparency: GMP Inspection Results Going Public! appeared first on Focal Point.

A significant change is that private parties can now apply directly to the Competition Tribunal to file case against a business, which may increase litigation risks. The guidelines emphasize that all environmental claims must be truthful, substantiated, and backed by “adequate and proper” testing or evidence.

The guidelines also outline six key principles for business to follow when vetting their environmental claims:

1. Truthful and not misleading: Claims should not be false or exaggerated.
2. Properly substantiated: Environmental benefits should be backed by reliable testing and evidence.
3. Specific comparative claims: When comparing products, be clear about what is being compared and the extent of the difference.
4. Avoid exaggeration: Claims should not overstate environmental benefits, considering both the literal meaning and general impression.
5. Clear and specific: Vague statements should be avoided.
6. Substantiated future claims: Any claims about future environmental benefits must be supported by a clear plan and evidence.

While the guidelines are not legally binding, they are a crucial resource for companies as they review their environmental and sustainability messaging.

If you require any assistance, have any questions or would like to understand more about how this impacts your business, please do reach out to us.

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Updates to the proposal include:

1. Lowered fees by limiting planned program enhancements.
2. Lowered the fee-setting ratio for the first 4 years.
3. Phased in fees over a 7-year period (targeting a coming into force date of December 1, 2025).
4. Removed the proposed Class III-Novel category.
5. Streamlined the annual site licensing fee categories from 5 fees to 3.

No adjustments have been made to the initial proposed fees for small businesses. The small business discounts from the initial proposal will continue to apply to the new, lower fees:

1. 100% discount for pre-market evaluation fees for the business’s first-ever NHP submission
2. 50% discounts for pre-market evaluation fees for all subsequent product submissions
3. 25% discounts for site licensing fees and the annual right-to-sell fee.

Fees have been significantly lowered based on the feedback received and the outlined program changes. Annual Site licence fees (manufacturing) have been reduced from $40,071 to $9,561 at the end of the 7 years and apply to sterile and non-sterile dosage forms. The Right to Sell (RTS) fee has been reduced from $542 to $317.

The proposal is open for consultation until April 25, 2024. We strongly advise individuals or organizations working with NHPs in Canada to promptly offer feedback and express any concerns they may have regarding the fee proposal through an online comment form.     

Please get in touch with us if you would like to know more about the proposed fee structure and how it may impact your business.

The post Revisions to Proposed NHP Cost Recovery Fees appeared first on Focal Point.

The proposed fees mimic those currently in place for drugs and medical devices sold in Canada and will apply to product licence owners, manufacturers, packagers, labellers and importers of NHPs in Canada. The proposed NHP fees and performance standards can be found here. Industry will also be required to pay an annual fee for the right to sell NHPs in Canada, which is proposed as $542 per NPN.

The introduction of cost recovery fees has raised huge concerns within the industry. Manufacturers and brand owners argue that the fees could be financially burdensome, particularly for small businesses. Health Canada is proposing small business fee reduction measures to minimize the impact of fees on small businesses. However, industry fears that the additional costs may impede innovation and limit consumer access to NHPs due to price hikes.

Health Canada expects the newly proposed fee structure to become effective on April 1, 2025. The proposal is open for consultation until August 10, 2023. We strongly advise individuals or organizations working with NHPs in Canada to promptly offer feedback and express any concerns they may have regarding the fee proposal through an online comment form.         

If you would like to know more about the proposed fee structure, how it may impact your business, whether you are eligible for the small business fee reduction, and more, please contact us.

The post Proposed Fees for Natural Health Products appeared first on Focal Point.

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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