G/TBT/N/CAN/616  
17 August 2020  
(20-5586) 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 telephone 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:   
Canada's Notification Auth ority and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive  
Ottawa, ON K1A 0G2  
Canada  
Telephone: (343)203 -4273 
Fax: (613)943 -0346 
Email: enquirypoint@in ternational.gc.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):  
Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  Notice of 
Proposal to expand lists of certain products for distribution as samples and a list of certain 
non-prescription drugs for which testing requirements do not apply (8 pages, available in 
English and French)  
6. Description of content:  Health Canada intends to amend the lists for non -prescripti on 
drugs set out in the Canada -United States -Mexico Agreement (CUSMA) that meets the 
identified criteria, i.e., for topical use, localized and non -systemic effect, and meets the 
definition of a cosmetic.   
The product categories that meet these criteria inc lude: toothpastes, mouthwashes, anti -
septic skin cleansers, sunscreens, anti -dandruff products, diaper -rash products, 
medicated skin care products, acne therapy products and antiperspirants, as well as 
athlete's foot products and throat lozenges.  
Health Canada is proposing that within those products categories, all lists for non -
prescription drugs will be expanded to include all approved ingredients, all approved 
quantities and all approved uses or purposes with the exception of certain medicated s kin 
care products. The CUSMA does include some exclusions related to medicated skin care 
products (i.e., antifungals, antivirals, antibiotics, corticosteroids, counterirritants, and 
analgesics), and these exclusions will be maintained for the current propo sal. G/TBT/N/CAN/616  
 
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  Health Canada's proposal also includes updates and revisions to the list of certain non -
prescription drugs for which additional (i.e., identity and confirmatory) testing is not 
required upon importation and that may be directly shipped to retailers or  wholesalers. 
Health Canada intends to expand the list of certain non -prescription drugs for which 
testing requirements do not apply.   Thus expanding the list toinclude all approved 
ingredients, all approved quantities and all approved uses or purposes wit h the exception 
of certain medicated skin care products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Health Canada wishes to advise interested stakeholders of a proposal posted 
for a 60 day consultation period to seek feedback, and make potential additions, to the 
products that will be added to the Amended List(s).; Other  
8. Relevant documents:   
Health Canada website: Notice of Proposal (available in English and French)  
List D: List of  Certain Non -prescription Drugs for Distribution as Samples  
List of Non -prescription Drugs for Which the Testing Requirements Set Out in Subsections 
C.02.019 (1) and (2) of the  Food and Drug Regulations Do Not Apply   
Guidance document: Distributing samples of prescription drugs, non -prescription drugs 
and natural health products   
9. Proposed date of adoption:  A final posting of the list of products that can distribute 
those drugs as samples or directly import to distributors or wholesalers will be posted this 
Fall/Winter 2020  
Proposed date of entry into force:  Fall/Winter 2020  
10. Final date for comments:  10 October 2020  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
The electronic versions of the regulatory text can be downloaded at:  
 
Canada's Notification Authority and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive  
Ottawa, ON K1A 0G2  
Canada  
Telephone: (343)203 -4273 
Fax: (613)943 -0346 
Email: enquirypoint@international.gc.ca   
https://www.canada.ca/en/hea lth-canada/services/drugs -health -products/natural -non-
prescription/notice -consultation -expand -lists-samples -imports -without -retesting.html  
(English)  
https://www.canada.ca/fr/sante -canada/services/medicaments -produits -sante/naturels -
sans-ordonnance/avis -consultation -elarger -listes-echantillons -importations -sans-
reteste r.html