Health Canada’s April 2017 announcement regarding the importation of drugs for urgent public health needs confirmed that the Canadian government is indeed taking steps to respond quickly to a public health crisis. Health Canada plans to achieve this by opening up a new regulatory pathway for importation of products that have not been authorized for […]
If you are selling a drug product in Canada you are most likely familiar with the term “DIN” which stands for Drug Identification Number. In order to sell a drug product in Canada and operate in compliance with Health Canada’s Food & Drug Regulations all companies must apply for and receive a DIN for their […]
On February 18, 2017 Health Canada released the Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs for external consultation. This guidance document will ultimately replace the current 1998 Change in Manufacturer’s / Product Name Policy (CMPN). Once finalized, this new draft guidance document would replace the CMPN Policy. […]
Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) provided a glimpse of some proposed changes in their Six-Month Calendar of Activities for January-June 2017. The last one on the list, Compliance Monitoring Projects, has to do with on-site auditing of GMP compliance. This one may be of particular interest to those facilities with a […]
The sale of skin care products and cosmetics is on the rise thanks to the holiday gift season that’s now upon us, and the need for Canadians to hydrate their skin to combat the dry and cold weather during Canadian winters. Two categories of consumer products, cosmetics and over-the-counter (OTC) drug products, may be used […]
The distinction between foods and dietary supplements (natural health products) is often challenging for those groups looking to sell these products in Canada. However product classification is a first and necessary step in the process of getting these products to market. There are many ingredients that sit on the food/natural health product interface; many ingredients […]
The Canadian system of pre-market licensing for natural health products (dietary supplements) tends to be surrounded by a cloud of mystery for groups looking to sell their products in Canada. The two types of licenses required before sale are distinct in what they cover, and the licenses may be owned by different parties, which results […]
For anyone looking to sell cosmetics in Canada, a cosmetic notification form must be submitted to Health Canada for all products. The on-line notification process, which is the preferred route for submitting these forms, has been on hold while system upgrades are taking place. However Health Canada has indicated that the off-line phase is shortly […]
If you are already selling your dietary supplements in the United States or other countries outside of Canada, chances are you want to grow your business by exporting your dietary supplements and natural health products to Canada too. After all, the value of the natural products industry in Canada is estimated at over 3 billion […]
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 […]
Regulatory Compliance Just Got Easier
