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Health Canada has adopted and integrated the use of risk management plans (RMPs) and the International Conference on Harmonization (ICH) E2E Guideline into the regulatory review of drugs in Canada. A risk management plan (RMP) is a document that identifies and characterizes risks and...

Information on risk management plan submissions for drugs including when to file, considerations, requirements, and compliance.

Opioid products need to include specific content within their RMP to address: the risk and uncertainties of opioid-related harms in Canada and other risks and uncertainties posed by the product, where warranted.

The RMP summary should include specific sections, which mirror the EU RMP Summary format sections.

A Canadian-specific addendum should address: risks or uncertainties that are unique to the Canadian context, and measures that the manufacturer intends to take that are unique to the Canadian context.

Opioids are medications that are usually prescribed to treat pain. When taken properly, prescription opioids can help patients experiencing pain manage their conditions, allowing them to lead full and productive lives. However, as with all medications, opioids can come with risks and potentially...

IO No. 2 supports Canada’s continued focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians.

Health Canada information the risks of using tanning beds, how to protect yourself and safety guidelines and regulations for tanning equipment.

Canadians use many different types of tanning products. Some are used to prevent tans and sunburns. Others are used to help create or fake a tan.

If you think using tanning equipment that emit ultraviolet (UV) radiation (rays) is a safe way to tan, think again. There is no safe way to tan. Health Canada recommends you do not use tanning equipment. However, if you do, it is important to know the risks.