Health Canada Recall Guidance

On February 11 2019 Health Canada released its Cannabis Voluntary Recall Guide a copy of which can be accessed here. When a product is recalled or an advisory or alert is issued it means our surveillance tools are working.

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Reference Canadas Medical Device Regulations SOR-98-282 and Guidance Document for Mandatory Problem Reporting for Medical Devices for the correct reporting timeline which will depend on the severity of the incident.

Health canada recall guidance. When a product is recalled or an advisory or alert is issued it means our surveillance tools are working. The Cannabis Voluntary Recall Guide published February 11 is written for federal license holders as a guide to the requirements of the Cannabis Act and Canadian cannabis regulations that apply to the voluntary recalls of cannabis and cannabis products. Recalls and safety alerts are sent out when we have important information to sharemeaning you can feel more secure when choosing and using products.

Recall the product send the remaining product to a specific place If your company refuses to recall a product or if your recall is not adequate we may use section 213 of the Food and Drugs Act. Health Canada Medical Device Regulations. Information on Recalls of FDA Regulated Products.

If you are not able to notify us within this time frame you must provide a rationale in your initial recall report. Guidance for Industry and FDA Staff. As the health risk is associated with long-term use of a contaminated drug Health Canada continues to underscore that people who take prescription sartan ranitidine and nizatidine drugs affected by this issue including recalled ranitidine and sartan drugs should continue taking their medication until they have obtained an alternative treatment from their health care provider.

Log into RAMS to download the documents listed below along with more regulations and guidances for Canada. If Health Canada believes you are selling a medical device that may seriously or imminently harm someones health we may order you to. This guidance is intended to assist those members of industry regulated by the FDA in handling most aspects of a product recall as well as some removals and corrections which do not meet the.

Questions and Answers Regarding Mandatory Food Recalls Initiation of Voluntary Recalls. Health Canada is encouraging Canadians to read the labels of products that claim to lighten whiten fade or bleach skin. Health Canadas Recall Policy further specifies that you must provide verbal or written notification to Health Canada within 24 hours of deciding to proceed with a recall.

Health Canada has seized several products from retailers and is concerned that similar unauthorized products continue to be sold to Canadians despite their risks. Recalls and safety alerts are sent out when we have important information to sharemeaning you can feel more secure when choosing and using products. Submit a Preliminary Report to Health Canada detailing the incident and corrective action strategy.

The guide provides helpful information on the requirements of the Cannabis Act and Cannabis Regulations related to voluntary recalls of cannabis and cannabis products.

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