G/TBT/N/CAN/392  
 
1 July 2013  
(13-3401)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English/French  
 
NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member:  CANADA  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  Department of Health 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :  Canadian 
Enquiry Point, 200-270 Albert Street, Ottawa, Ontario, Canada, K1P 6N7 
Tel.: +1 613 238 3222, Fax.: +1 613 569 7808, E-mail: enquirypoint@scc.ca        
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided  in addition, where applicable):  Human 
prescription and non-prescription drugs, pharmaceutical and biologic (ICS: 11.120).  
5. Title, number of pages and language(s) of the notified document:  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).     
6. Description of content:  This proposal pertains to amendments to the Food and Drug 
Regulations  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 wi th international best practices, and would 
be supported by additional interpretive gu idance 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 he alth 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 help 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. subm ission of label and package mock-ups, look-G/TBT/N/CAN/392 
 
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  alike/sound-alike (LASA) name assessment, co ntact 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 indust ry 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. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health and safety (safe use of drugs)  
8. Relevant documents:   Canada Gazette , Part I, 22 June 2013, Pages 1,580-1,600 
(available in English and French).   
9. Proposed date of adoption:   
 
 
 
Proposed date of entry into force:    On the date the amendments are registered, 
Notification of registration will occur through publication in Canada Gazette, Part II, which 
is anticipated to be 6-9 months following 
publication in Canada Gazette, Part I. 
It is anticipated the amendments would 
come into force in 6 months for prescription 
drugs and 3 years for non-prescription drugs after the date the amendments are adopted. 
10. Final date for comments:  5 September 2013 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:   
The electronic version of the regulatory text can be downloaded at:  
http://www.gazette.gc.c a/rp-pr/p1/2013/2013-06 -22/pdf/g1-14725.pdf ( Canada Gazette ) 
http://www.gazette.gc.c a/rp-pr/p1/2013/2013-06 -22/html/reg 2-eng.html   (English) 
http://www.gazette.gc.c a/rp-pr/p1/2013/2013-06 -22/html/reg2-fra.html   (French)