G/TBT/N/CAN/388  
 
30 April 2013  
(13-2281)  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 :   
Bureau of Policy, Science and International Programs 
Therapeutic Products Directorate Holland Cross, Tower B, 2nd Floor 1600 Scott Street 
Address Locator 3102C5 
Ottawa, Ontario K1A 0K9 
Phone: 613-948-4623 
Fax:  613-941-1812 Email:  policy_bureau_enquiries@hc-sc.gc.ca  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 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):  Non-
medicated eyewashes (ICS: 11.120). 
5. Title, number of pages and language(s) of the notified document:  Notice: 
Classification of Non-medicated Eyewashes (2 pages, in English and French).     G/TBT/N/CAN/388 
 
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6. Description of content:  Canada is proposing that all non-medicated eyewashes licensed 
as medical devices be regulated as natural health products (NHPs) under the Natural 
Health Products Regulations (NHPR) of the Food and Drugs Act. The goal of this transition 
is to increase consistency and predictability for both consumers and manufacturers of non-medicated eyewashes.  
The Department of Health (the Department) has made this proposal because non-
medicated eyewashes meet the definition of drug in section 2 of the Food and Drugs Act given they are a mixture of substances used in the treatment of an abnormal state. When 
intended for human use, they meet the definition of NHP because their medicinal 
ingredient, purified water, is a natural substance as per Schedule 1 to the NHPR. More information on the factors that influence the classification of a therapeutic product as either a drug or device can be found in the Guidance Document: Factors Influencing the 
Classification of a Product at  the Device-Drug Interface. 
Manufacturers of non-medicated eyewashes marketed as medical devices will be given an 
opportunity to make representation to the Department on the proposed classification of 
their products from a medical device to a NHP. The Department's Therapeutic Products 
Directorate (TPD) will make a final product classification determination within 30 days of receiving any submissions from manufacturers explaining why their product should remain 
a medical device.   
Under the NHP regulatory framework, all NHPs must have a product licence identified by a 
natural product number (NPN). Implicated manufacturers of non-medicated eyewashes will have their files transferred to Natural Health Products Directorate (NHPD), without 
additional filing requirements, for issuance of the NPN. Canadian sites that manufacture, 
package, label or import NHPs also must obtain site licences as per the NHPR. Implicated manufacturers, packagers, labellers and importers of non-medicated eyewashes will be 
given detailed information and support on how to complete the site licensing application 
process. 
During the transition, the Department is proposing to allow non-medicated eyewashes to 
remain on market until a NPN and site licence is issued by the NHPD. Once a NPN is issued 
for the product, the Department will expect new labelling to be made available to consumers by the sooner of the next label run, or 12 months from the date the NPN was issued.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Transition of non-medicated eyewashes from the medical devices regulatory 
framework to the natural health products regulatory framework.  
8. Relevant documents:   http://www.hc-sc.gc.ca/dh p-mps/dev-drug-instr-
drogue/eyewash_notice_avis_rinc_yeux-eng.php , Notice: Classification of Non-medicated 
Eyewashes, posted 2 April 2013 (available in English and French)    
9. Proposed date of adoption:   
Proposed date of entry into force:    29 May 2013 29 May 2013 
10. Final date for comments:  3 June 2013 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   The 
electronic version of the Notice can be downloaded at:  
http://www.hc-sc.gc.ca/ dhp-mps/dev-drug-ins tr-drogue/eyewash_no tice_avis_rinc_yeux-
eng.php  (English) 
http://www.hc-sc.gc.ca/ dhp-mps/dev-drug-ins tr-drogue/eyewash_no tice_avis_rinc_yeux-
fra.php  (French)