A Drug Establishment License is required by importers and distributors of drugs in Canada. Applications for Drug Establishment Licenses (DEL) are reviewed by Health Canada in order to confirm that all facilities included in the application are compliant with Good Manufacturing Practices of the Food & Drug Regulations. Health Canada’s performance standard for processing a […]
Supply chains for health products in Canada face high barriers to entry due to existing regulations for drugs and natural health product. In order to import or distribute health products in Canada, companies must first demonstrate that facilities involved in supply chains are compliant with Good Manufacturing Practices (GMP). Health Canada standards are rigorous; and […]
When it comes to quitting smoking there are several products available to assist smokers such as nicotine replacement products and e-cigarettes also known as vaping products. Health Canada has introduced and amended relevant Acts and Regulations to control the manufacturing, sale, and promotion of tobacco products, vaping products and nicotine replacement therapy products sold in […]
Selling drugs in Canada requires compliance with Health Canada’s Food & Drug Regulations. Facilities involved in the distribution of drug products must operate in compliance with Good Manufacturing Practices which are contained within the regulations. Health Canada has unique titles for the specific roles within the drug supply chain and the terminology can cause some […]
Health Canada has responded to the growing concern over nitrosamine impurities contained in drug products by publishing interim acceptable upper limits for nitrosamines in drugs sold/imported into Canada. This decision is based on the fact that N-nitrosamines exhibit or likely exhibit potential carcinogenic effects. In co-ordination with the new limits Health Canada has provided insight […]
In order to legally sell a natural health product (NHP) in Canada, manufacturers of NHPs must submit a product license application to Health Canada’s Natural and Non-Prescription Health Products Directorate. The NNHPD reviews several elements of the application before approving NHPs and assigning a Natural Product Number to the product as an indication of its […]
Health Canada’s latest announcement in the cannabis space has been released with much less fanfare than the most recent one regarding cannabis edibles and topicals. However the message within the June 19 consultation document may indeed be a game changer as it points to a potential new category of cannabis products in Canada. This new […]
Health Canada’s requirement for Good Manufacturing Practices (GMP) is often a daunting prospect for those wishing to import or manufacture natural health products for sale in Canada. The GMP application process in Canada involves an initial submission to gain approval followed by an early verification by Health Canada of the applicant’s ability to maintain GMP […]
In the time period following Health Canada’s implemented approval system for cultivating and selling marijuana, several adjustments have been made to the licensing process in order to maximize efficiency and reduce backlogs. The most recent announcement has received a fair amount of attention based on its potential to exclude numerous applicants. This change involves the […]
Health Canada’s Natural and Non-Prescription Health Products Directorate provided an update today to their management policy for product license applications during a live webinar for industry. The updated performance targets were confirmed during the webinar and are as follows. Class I applications, where all conditions of a monograph are met will be reviewed within 60 […]
Regulatory Compliance Just Got Easier
