Health Canada released the finalized guidance document for the labelling of acetaminophen containing products in Canada. The guidance document is relevant for both single acetaminophen products and multiple ingredient products containing acetaminophen. The labelling standard has been revised based on the outcome of a 2014 acetaminophen review which recommended that the label include stronger alcohol […]
Resveratrol has long been designated as having anti-aging properties even amidst mixed reviews of its efficacy in humans. Popular sources of resveratrol include grapes, red wine, blueberries, cranberries, and dark chocolate. Currently in Canada there are numerous resveratrol-containing supplements approved as natural health products (dietary supplements) by Health Canada’s Natural and Non-prescription Health Products Directorate. […]
This month Health Canada released the consultation document on their proposed model in Canada for regulation of “self-care” products. The aim of the new approach is to regulate this group of products in a consistent manner and approach, and remove some of the challenges of the current system. Health Canada defines self-care products as those […]
Given the exponential growth of the dietary supplement category in the United States to well over $30 billion in annual sales, it doesn’t come as much of a surprise that the US Food and Drug Administration has responded with the creation of the Office of Dietary Supplement Programs (ODSP). The primary focus of the ODSP, […]
If you would like to receive a Site License for natural health products you must operate in compliance with Division 3 of the Natural Health Product Regulations (which pertain to Good Manufacturing Practices), and you must be located in Canada. While this precludes any group outside of Canada from actually receiving their own site license, […]
The implementation of Health Canada’s Natural Health Product Regulations in 2004 left many applicants in the industry confused with submission requirements and frustrated with delays to market for their natural health products/dietary supplements in Canada. Approvals seemed to take forever. Reports surfaced of queue times of up to one year just to receive feedback on […]
Health Canada’s Natural Health Product Regulations have been in place for over one decade, and there have been some significant improvements to the application process over the past few years. Notwithstanding some upgrades there remain a handful of items that continue to be problematic for those groups who are new to the regulations for selling […]
If you plan on bringing cosmetics and drugs into Canada, then you are probably familiar with Health Canada’s Advance Notice of Importation policy. This policy involves the notice provided to Health Canada by importers when they are expecting shipments of products which will then be relabeled for compliance wth Canadian regulations. There are numerous and […]
For those wishing to register a first aid antiseptic product in Canada, the monograph is now available on the Health Canada website. Although the consultation period is still ongoing, applicants can make use of the monograph in their applications to the Natural and Non-Prescription Health Products Directorate immediately, for topical minor wound cleansers. Here’s some answers […]
The Natural and Non-Prescription Health Products Directorate is beginning to participate in Health Canada’s effort towards improving the safe use of drugs in Canada by making drug labels easier to read for consumers. While non-prescription products are not yet required to adopt plain language style and display formats as per Health Canada’s 2014 Food & […]
Regulatory Compliance Just Got Easier
