proposed amendments to the food and drug regulations labelling packaging and brand names of drugs for human use improving drug safety through plain language labelling 21 pages in english and french . this proposal pertains to amendments to the em food and drug regulations em that would improve the safe and effective use of prescription and non-prescription human drugs through targeted amendments for drug names labels and packages. the proposal would align canada with international best practices and would be supported by additional interpretive guidance to industry and an appropriate and least burdensome transition period. in canada and internationally studies and health literacy research indicate that over-crowded and confusing drug labels unclear instructions and similarities between packages and names contribute to medication errors. examples include accidental overdose taking or giving the wrong drug and not knowing how to take the drug properly. these errors can result in significant patient harm. in response to the high rate of medication errors observed in the health system and recognizing the role of the label significant work has been undertaken in canada and internationally to identify opportunities to improve the clarity and accessibility of drug labels. the proposal aims to improve the safe use of drugs by making drug labelling easier to read and understand for users it would advance key safeguards such as requiring labels to be in plain language standardizing the format of non-prescription drug labels such as a drug facts table to hel users locate important information and requiring that companies include their contact information on labels so that users can report problems or adverse drug reactions. this proposal focuses on areas where gaps exist and provides flexibility for future innovation specifically it consists of five targeted amendments to the current regulations one general requirement for clear understandable plain language labels and four pre-market requirements i.e. submission of label and package mock-ups look-alike sound-alike lasa name assessment contact information on labels to report problems to the manufacturer and standard table format for non-prescription drug labels . health canada has conducted various consultations related to drug names labels and packages and stakeholders are anticipating this proposal. the proposed amendments are outcomes-focused so that guidance and operations can adjust to innovations over time. the proposal will not affect the way the sale advertising or importation of drugs is managed in canada. an appropriate transition period is being proposed to allow the industry to properly plan and adjust to the new regulatory requirements within the natural cycle of label revisions as follows two transition time frames are being proposed for these amendments. the amendments would come into force 6 months after registration to align with international obligations and at that time would apply to prescription drugs which are generally considered higher risk products. for non-prescription drugs the amendments would not apply for a period of 3 years to allow companies time to meet requirements e.g. drug facts table format within their normal cycle of re-labelling.