Minister Ambrose Announces Passage of Plain Language Labelling Regulations
Easier-to-Read Labels Improves Patient Safety
OTTAWA, July 2, 2014 /CNW/ - The Government of Canada today finalized new plain language labelling regulations that will help improve the safe use of drugs by making drug labels and packaging information easier to read and understand, as promised in the 2013 Speech from the Throne. The Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) were published today in Canada Gazette, Part II and are part of the Plain Language Labelling Initiative. The regulations will gradually be phased into effect, delivering key safeguards such as:
- Labels that are clear, understandable, and in plain language;
- A standardized format for non-prescription drug labels (such as a "Drug Facts" table) to help users find and understand important information;
- Mandatory contact information on labels so that users can report problems and adverse drug reactions;
- Requiring manufacturers to provide mock-ups of labels and packages for Health Canada review; and,
- Look Alike - Sound Alike provisions requiring manufacturers to provide evidence that drug names will not be confused with other authorized products.
The regulations support the Government's Patient Safety priorities under
the proposed Bill C-17 Vanessa's Law Health Canada's Regulatory Transparency and Openness Framework and our commitment to make more data and information available to
Canadians. The regulations also support Health Canada's Roadmap for Regulatory Modernization, which identified plain language labelling as a deliverable.
- As many as 1 in 9 emergency rooms visits are related to drug adverse events, and as many as 68% of those are preventable.
- To work properly and reduce the chance of harm, drugs should be taken according to the information provided on the label or package.
- Health Canada provides guidance to industry to ensure it is clear how to comply with the drug naming, labelling and packing requirements of the new regulations.
"As Minister of Health, I am personally committed to improving safety
for Canadians every day - by making drugs safer, and also making it
easier for people to use them properly. Providing Canadians with clear,
understandable and credible information about the potential risks and
appropriate use of drugs is one of the most valuable safety tools."
Minister of Health
"Improving drug labels by putting them in plain language will help
ensure that patients only take drugs when they are safe. This will not
only reduce serious adverse drug reactions, but also save lives."
Member of Parliament for Oakville
June 2013 Plain Language Labelling Announcement
Plain Language Labelling Fact Sheet
Vanessa's Law Fact Sheet
Health Canada's Roadmap for Regulatory Modernization
Health Canada's Regulatory Transparency and Openness Initiative
Plain Language Labelling Questions and Answers for Industry
SOURCE Health Canada