In July 2014, Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) were promulgated by the Government of Canada in connection with Health Canada’s Plain Language Labelling Initiative. The regulations mandate a general requirement for clear, understandable, plain language labels, and prescribe four basic requirements for manufacturers:
- mandatory contact information on labels to report problems and adverse drug reactions;
- standardized format for non-prescription drug labels (such as a Drug Facts table);
- pre-market submission of label and package mock-ups to Health Canada for review; and
- pre-market look-alike/sound-alike (LASA) name assessments, requiring manufacturers to provide evidence that drug names will not be confused with other authorized products.
The new regulations will be phased in gradually over the next 1-3 years and will apply to human drugs, specifically non-prescription and prescription, pharmaceutical and biologic drugs.
The amendments to the regulations under the Food and Drugs Act were enacted in connection with Bill C-17 (or “Vanessa’s Law”, currently before the Senate), the purpose of which is to “strengthen safety oversight of therapeutic products through their life cycle” and “improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products.” Details about Bill C-17 were previously reported here and here.