Articles
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Maine PFAS Reporting Deadline Approaching
Maine enacted a law in July 2021 requiring manufacturers of products containing intentionally added Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) to report to the Maine Department of Environmental Protection by January 1, 2023. Moreover, the sale of products...
Notice to Stakeholders concerning the Cosmetic Ingredient Hotlist
Health Canada is considering certain substances for inclusion in future updates to the Cosmetic Ingredient Hotlist (Hotlist). The proposal includes the following: Additions to the Hotlist Changes to the conditions for existing entries on the Hotlist Changes to include...
Amendments to the NHP Regulation
As recently published in the Canada Gazette, Health Canada published the final amendments to the Natural Health Products and the Food and Drugs Regulations, also known as the Self-Care Framework. These amendments are part of the Forward Regulatory Plan 2022-2024 and...
California Bill AB-2787 proposes to ban microplastics in leave-on products
In February 2022, the Assembly Bill 2787 was introduced. This Bill will ban the sale of specific products such as cosmetics, detergents, wax, polishes, etc., in California, if they contain intentionally added microplastics. Biodegradable and water-soluble materials...
Mandatory Section 71 (S. 71) Survey due by September 14th, 2022
This mandatory survey applies to your company if you manufactured or imported certain substances in Canada and meet some additional criteria. Approximately 700 substances that are on the Revised In Commerce List are subject to this notice. The notice applies to any...
Final FDA Guidance for Drugs & Biologics Containing Nanomaterials
If your company has nanomaterials in any drug (including OTC drugs) or biologic products sold in the US, this Guidance is important to you. The US Food and Drug Administration (FDA) has recently released its final industry guidance on human drug and biological...
Health Canada To Amend Cosmetic Regulations – Enhance Regulatory Oversight
Health Canada has been proposing amendments to the Cosmetic Regulations to introduce requirements to disclose certain fragrance allergens on the cosmetic product labels as well as amendments to enhance regulatory oversight for cosmetics. These amendments are part of...
New French Language Requirements per Québec – Bill 96
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...
Health Canada’s Pilot Project to assess the compliance of lower risk MAHs
Health Canada is initiating a Pilot Program to assess the compliance of sites defined as lower risk (drugs that are not likely to generate many serious adverse drug reactions) Market Authorization Holders (MAHs). The scheduling of Good Pharmacovigilance Practices...
Reminders
Reminder for DIN Renewals 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...
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