G/TBT/N/CAN/395  
 
30 September 2013  
(13-5210)  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 
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  
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): Non-
medicated eyewashes (ICS Codes: 11.120) 
5. Title, number of pages and langua ge(s) of the notified document:  Electronic 
Product Licence Application (Non-medicated Eyewashes) (1 page, in English and French)     
6. Description of content:  The Department of Health (the Department) wishes to inform 
trading partners that, further to notification G/TBT/N/CAN/388, manufacturers of non-
medicated eyewashes who hold a medical device licence are required to submit a product licence application to obtain a Natural Product Number (NPN). As part of the 
transition, the affected products may remain on the market until a NPN and site licence 
are issued by the Department's Natural Health Products Directorate (NHPD).  It may take up to 180 days to obtain a NPN for a non-medicated eyewash. 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. 
Implicated manufacturers will be required to complete an electronic Product Licence 
Application (ePLA). Before submitting their ePLA, manufacturers should ensure that all 
medicinal and non-medicinal ingredients in  the product are present and acceptable 
through the Natural Health Products Ingredie nt Database. Implicated manufacturers are G/TBT/N/CAN/395 
 
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  encouraged to contact NHPD for guidance, if required during the application process.  
Canadian sites that manufacture, package, label, or import natural health products 
(NHPs) must obtain site licences as per the Natural Health Products Regulations . 
Implicated manufacturers, packagers, labellers, and importers of non-medicated 
eyewashes have been given detailed informat ion and support on how to complete the 
site licensing application process. To import NHPs into Canada for the purpose of sale, 
importers are required to demonstrate that the activities in foreign sites are conducted in 
accordance with good manufacturing practice  (GMP) equivalent to the Canadian GMP for 
NHPs. Manufacturers may consult the Health Canada website for information on how to 
obtain a site licence and on Canadian GMP.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: To communicate the application requirements for the transition of non-
medicated eyewashes from the medical devices regulatory framework to the natural 
health products regulatory framework. 
8. Relevant documents:   Health Canada's website, Electronic Product Licence Application 
form (available in English and French) 
Notice: Classification of Non-medicated Eyewashes:  
http://www.hc-sc.gc.ca/dh p-mps/dev-drug-instr-
drogue/eyewash_notice_avis_rinc_yeux-eng.php  (English) 
http://www.hc-sc.gc.ca/dh p-mps/dev-drug-instr-
drogue/eyewash_notice_avis_rinc_yeux-fra.php  (French) 
Additional information on site licences an d Canadian GMPs for NHPs can be found at: 
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/app lications/licen-site-exploit/index-eng.php  
(English)  
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/app lications/licen-site-exploit/index-fra.php  
(French)   
9. Proposed date of adoption:   
Proposed date of entry into force:    31 December 2013   31 December 2013   
10. Final date for comments:  30 November 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 Product Licence Application (ePLA) can be downloaded at:  
http://www.hc-sc.gc.ca/ dhp-mps/prodnatur/applications /online-enligne/ pla-dlmm-view-
eng.php  (English) 
http://www.hc-sc.gc.ca/ dhp-mps/prodnatur/applications /online-enligne/ pla-dlmm-view-
fra.php  (French) 
The Natural Health Products Ingredient Database can be accessed at: 
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do  (English) 
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do?url=&lang=fra  (French)