Articles
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Full Producer Responsibility for Post Consumer Waste in Ontario
Ontario is moving its existing waste diversion programs to a producer responsibility model. Producers are the companies that design, create and market products and packaging. Producers will be responsible for managing and paying for the full life-cycle of their...
FDA Withdrawal of Temporary Guidances for Alcohol-Based Hand Sanitizers
Did your company manufacture alcohol-based hand sanitizer or manufacture alcohol for use in hand sanitizers during the COVID-19 pandemic based on temporary policies outlined in FDA guidances originally issued in March 2020? If so, it is important for your company to...
Jan. 01, 2022 – An Important Date for Cosmetics Sold in California
The Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) will be in effect starting Jan. 01, 2022. There are a total of 23 designated lists that contain ingredients of concern. If any of these designated lists are updated, companies will have 6...
Consultation on Upcoming Changes to NHP Labelling Regulations
The Natural and Non-Prescription Health Product Directorate (NNHPD) at Health Canada recently released a draft guidance document pertaining to potential upcoming changes to the current Natural Health Product (NHP) regulations published in Canada Gazette, Part I. These...
UPDATED Health Canada Acne Therapy Monograph
The Health Canada Acne Therapy Monograph was updated on Jun. 25, 2021 to include specific acceptable dosage forms for both non-prescription drugs and Natural Health Products (NHPs) as well as an additional Directions for Use statement for aerosol and spray acne...
Senators Introduce Bill – Modernizing the Safety of Personal Care Products
New legislation titled the Personal Care Product Safety Act is intended to replace the 83 year old law that currently governs this category of regulated product. The bill, introduced by Senators Feinstein and Collins in mid-June 2021, will help improve safety for...
Update on Health Canada Risk Evaluation of N-nitrosamine Impurities in Canadian Human Pharmaceutical, Biological and Radiopharmaceutical Products
The deadline for the first step of Health Canada’s risk evaluation for the presence of N-nitrosamine impurities in Canadian human pharmaceutical, biological and radiopharmaceutical products was March 31, 2021. This deadline applied to Market Authorization Holders...
Tighter Restrictions to be implemented for Talc
The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA) to determine whether they present or may present a risk to human health or to the environment. A final risk assessment was recently completed...
FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021
In March 2020, provisions were added to the Federal Food, Drug, and Cosmetic Act by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which authorize FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters...
Phase I of the Self-Care Framework
Health Canada has announced that there will be updates to the approach to regulating self-care products as part of their 2020-2022 Forward Regulatory Plan. The self-care framework will roll out in phases over the coming years: Phase I – Target Spring 2021 will include...
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