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Proposed Regulations for Self-Care Products: Canada

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 […]

US Dietary Supplements Update

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, […]

Foreign Site Reference Numbers

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, […]

Natural Health Product Approvals Moving Faster

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 […]

Advance Notice of Importation for Cosmetics & Drugs

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 […]

Registration of First Aid Antiseptic Products in Canada

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 […]

Product Facts Table for Non-prescription Drugs

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 & […]

Canadian Site Licensing News

Getting your site license application approved for natural health products just got a little bit easier in Canada. After much anticipation the Natural and Non-Prescription Health Products Directorate (NNHPD) published their new Site License Guidance Document, Version 3.0 in December of 2015. Highlights of the new document include: Explanation of the different types of deficiencies […]

Good Manufacturing Practices in Canada

Good Manufacturing Practices (GMP) is a term understood and well recognized worldwide for the control and management of manufacturing and testing of pharmaceutical products. In Canada the GMP requirements also apply to natural health products (dietary supplements). Adopting GMP can help avoid: adulteration or contaminated products, labelling errors such as the incorrect label or missing risk information, distribution […]