G/TBT/N/CAN/659  
5 January 2022  
(22-0014) 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  
Technical Barriers and Regulations Division  
Global Affairs Canada  
111 Sussex Drive  
Ottawa, Ontario, K1A 0G2  
Canada  
Telephone: (343) 203 -4273 
Fax: (613) 943 -0346 
Email: enquiryp oint@international.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):  
Prescription status of medicinal ingredients for veterinary use in feed (ICS: 11.220; HS 
3004.50.55); Medicaments containing provitamins, vitamins, incl. natural concentrates 
and derivatives thereof used primarily as vitamins, put up in measur ed doses "incl. those 
for transdermal administration" or in forms or packings for retail sale (excl. containing 
antibiotics, hormones, alkaloids, or their derivatives) (HS 300450); Veterinary medicine 
(ICS 11.220)  
5. Title, number of pages and language(s)  of the notified document:  Notice of 
Consultation - Prescription Drug List (PDL): Betaine (1 page, available in English and 
French)  
6. Description of content:  The purpose of this Notice of Consultation is to provide an 
opportunity to comment on the proposa l to remove the prescription status for veterinary 
use by removing this ingredient from the Veterinary Prescription Drug List (PDL).   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Following requests from stakeholder s and investigations at Health Canada, 
it was determined that the addition of betaine to the Prescription Drug List was likely done 
in error when the ingredients on Schedule F were transferred to the newly created 
Prescription Drug List, on 19 December 201 3. The present consultation aims to determine 
the impacts of the correction of this possible error in the current scientific and regulatory 
context.; Other  G/TBT/N/CAN/659  
 
- 2 - 
 
  8. Relevant documents:   
Health Canada website: https://www.canada.ca/en/health -canada/services/drugs -
health -products/drug -products/prescript ion-drug-list/notices -changes/consultation -
betaine.html , posted : 22 December 2021 (available in English and French)    
9. Proposed date of adoption:  28 March 2022  
Proposed date of entry into force:  28 September 2022  
10. Final date for comments:  7 March 2022  
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 version of the regulatory text can be found at:  
https://www.canada.ca/en/he alth-canada/services/drugs -health -products/drug -
products/prescription -drug-list/notices -changes/consultation -betaine.html   
https://www.canada.ca/fr/sante -canada/services/medicaments -produits -
sante/medicaments/liste -drogues -ordonnance/avis -concernant -
modifications/consultation -betaine.html