Health Canada Releases Guidance on Plain Language Labeling

Health Canada released new guidelines to help prescription drug companies comply with the agency’s plain language labeling requirements.

The new guidance responds to questions that arose during implementation of the Plain Language Labeling regulation introduced in 2014. The requirements apply to labelling, packaging and brand names of prescription drugs and any product administered by or obtained through a healthcare professional, and look to make it easier for consumers to read and understand packaging and inserts and to report adverse effects.

The guidance includes simplified explanations of label mock-up requirements and more examples of acceptable fonts, formatting for expiration dates and lot numbers, and sample contact information.