Summary

On June 22, 2013, proposed regulations amending the Food and Drug Regulations relating to the labeling of prescription and non-prescription drug products were published for a 75-day comment period.  Comments are due by September 6, 2013.  The aim of the proposal is to require product labels to be clearer, more accurate and easier to understand.  The proposal also introduces, among other elements, the regulatory authority for the Minister of Health to require from a product sponsor an assessment of the potential for medication confusion due to product names.

Proposed Amendments

The proposed regulations would change the current system as follows:

Contact information on labels to report problems:  Currently, drug labels already include this information; the proposal aims to allow flexible options such as a toll-free number, email address, or Web site, to be identified for contacting the Canadian person who is responsible for the product.

Standard table format for non-prescription drug labels:  Currently, significant information must be included on the drug label; the proposal would require the information to be in a certain table format, helping users locate and read information and make informed decisions.

Submission of mock-ups of labels and packages:  Currently, manufacturers submit written text or drafts for pre-market review, with final labels only submitted once a product is on the market.  The proposal would require submission of mock-ups of the label and package, so the actual packaging and labeling would be agreed upon at the time a product is authorized.

Submission of an assessment that a drug would not be confused with another drug because of similar names:  Currently there is no actual regulation requiring manufacturers to submit an assessment that its drug would not likely be mistaken for another drug (though the ability for Health Canada do so is stated to exist in broader authority).  The proposed regulations would make this requirement specific.

The process for drug manufacturers to ensure that drug names are not confusing has been in place at Health Canada since 2006.  Recently, Health Canada conducted consultations on revising the current policy, and in particular, setting out in more detail the kinds of information that should be provided to Health Canada so that it may determine whether there is potential for confusion between two product names; see “Draft Revised Guidance Document for Industry – Review of Drug Names for Look-alike Sound-alike (LASA) Attributes) at http://www.hc-sc.gc.ca/dhp-mps/consultation/medeff/_2013/lasa-pspcs/lasa-pspcs-eng.php.  The consultation proposed moving to a multi-step testing of proposed brand names, including name searching, simulations, and synthesizing the information obtained through searching and simulation.