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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What to expect?

Health Canada will inform selected MAHs in July 2022 of their inclusion in the pilot program. Selected MAHs will be asked to respond to a questionnaire and provide requested documents by the end of August 2022, which GVP inspectors will review. The questionnaire will be used to assess whether the MAH has adequate procedures and systems. If a MAHs response is deemed unsatisfactory, an inspection will be scheduled between September 2022 and March 2023. Additionally, Health Canada may decide to inspect a certain number of MAHs who provided a satisfactory response.

The results of the questionnaire assessment stage will not be made public. Only the results of regular GVP inspections will be posted.

Please contact us if you have any questions regarding this notice or would like assistance with complying with Health Canada’s GVP requirements.

The post Health Canada’s Pilot Project to assess the compliance of lower risk MAHs appeared first on Focal Point.

As a DIN Owner, you should have received your Annual DIN Renewal package from Health Canada. These are due to be submitted by July 29, 2022. Should you require assistance with this, please reach out.

FDA User Fees For OTC Monograph Drug Facility

On June 1^st 2022, OTC Monograph Drug Facility User Fees for the fiscal year of 2022 were due to the US FDA. The fee for 2022 is $24,178 for facilities that manufacture or process a finished dosage form and $16,119 for contract manufacturing facilities. The annual facility fees for covered OTC drug facilities were introduced in 2021 to help fund FDA regulatory activities.

Facilities that are exempt from these fees include sanitizer manufacturers that distributed hand sanitizer products under the COVID-19 public health emergency as well as facilities that only manufacture active pharmaceutical ingredients, produce clinical research supplies, or conduct testing.

If you are unsure about whether your US-based drug facility has any fees due to the FDA, we can help determine which applicable fee applies to your establishment. Feel free to contact us.

Reminder for Drug Listings

Should you have any Drug Listing updates, now is a good time to file. If you require assistance, we are happy to help.

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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.

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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On April 14, 2021, Health Canada issued a letter to all MAHs to confirm the status of risk assessments and verify completion for all marketed, approved and dormant DIN products. A response is required by all MAHs by May 14, 2021 in the form of a ‘Risk Assessment Attestation Letter’. Subsequently, a ‘Summary of Completed Risk Assessments’ is due to be submitted to Health Canada by Jun. 01, 2021.

If your company has initiated, but not yet completed the risk assessments, Health Canada has asked for details on the actions completed to date, actions pending, details on the challenges you are facing in completing the risk assessments, and timelines on anticipated completion of risk assessments for all marketed, approved and dormant DIN products.

Should you, as a MAH, fail to respond to this request from Health Canada, or have not completed the risk assessments per the specified timelines, enforcement action may be taken following a referral to Health Canada’s Regulatory Operations and Enforcement Branch.

If you have any questions, please feel free to contact us.

The post Update on Health Canada Risk Evaluation of N-nitrosamine Impurities in Canadian Human Pharmaceutical, Biological and Radiopharmaceutical Products 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.

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Phase I – Target Spring 2021 will include amendments to the Natural Health Product (NHP) Regulations to improve labelling of NHPs.

Phase II – Target Spring 2022 will include amendments to introduce for consultation a risk-based approach to regulatory oversight for non-prescription drugs such as expedited pathways for lower-risk products.

Phase III – To introduce for consultation, regulatory amendments to address evidence standards for similar health claims, extending risk-based regulatory oversight, and additional powers for Health Canada to require a recall or label change for all self-care products.

There will be an opportunity to provide comments on Phase I of the Self-Care Framework during the Canada Gazette, Part I, public comment period, which is expected to take place in spring 2021 and last 70 days.

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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Some highlights of implications for exceptional importation and sale of drugs, medical devices, and foods for a special dietary purpose under IO No. 2 include, but is not limited to:

• Any importer who is permitted for exceptional importation and sale under IO No. 2 must notify the Minister electronically, in a format that is specified by, or acceptable to, the Minister, at least five business days before importation. These products will still be subject to some of the requirements set out in the Food and Drugs Act and its Regulations, including reporting adverse drug reactions, recall requirements and mandatory problem reporting (medical devices).
• IO No. 2 modifies the definition of a ‘biocide’ that was defined in IO No. 1 so that the term refers only to disinfectants, and not hand sanitizers, which are regulated differently. Many biocides eligible for exceptional import and sale previously will continue to be permitted under the IO No. 2.
• Under IO No. 2, companies wishing to conduct regulated activities related to drug-based hand sanitizers must obtain and have a DEL. Companies who previously conducted such activities without a DEL and who wish to continue conducting licensable activities related to drug-based hand sanitizers will have six months to apply for a DEL. After applying, companies can continue those activities until a determination is made with respect to their applications.
• IO No. 2 no longer permits companies to provide Health Canada with label text in place of a label mock-up as part of an application for a drug identification number (DIN) or a new drug submission on behalf of a drug-based hand sanitizer.
• Under IO No. 2, products that arrive in Canada through exceptional import must have information on the safe conditions of use available in both English and French. Importers wishing to keep their products in the Canadian market will have six months to come into compliance.

For full details on IO No. 2, please refer to the Health Canada webpage. If you have any questions or would like further clarification on how this may impact your company or products, please contact us.

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