. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/CAN/382 
11 January 2013  
 (13-0149) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  CANADA  
If applicable, name of local governme nt 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 :  Canadian Enquiry 
Point, 200-270 Albert Street, Ottawa, Ontari o, 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):  Prescription status of 
medicinal ingredients for human use and for veterina ry use (ICS: 11.120, 11.220). 
5. Title, number of pages and language(s) of the notified document:  Proposed amendments 
to the Food and Drug Regulations concerning Pres cription Drugs (Repeal of Schedule F to the 
Food and Drug Regulations ) (12 pages, available in English and French).     
6. Description of content:  Schedule F to the Food and Drug Regulations  lists medicinal 
ingredients that are required to be sold pursu ant to a prescription when sold as a drug in 
Canada. Currently, adding or removing medicinal ingredients to Schedule F requires changes 
to regulations following a well-establ ished scientific review process.  
Following the targeted amendments to the Food and Drugs Act  that were signed into law on 
29 June 2012 as part of the Jobs, Growth and Long-te rm Prosperity Act  (Bill C-38), the 
Government of Canada now has the ability to streamline the regulatory process to establish 
the prescription status of a dr ug while maintaining the same scientific rigor based on well-
established and publicly available criter ia.  This was previously notified under 
G/TBT/N/CAN/364. 
Regulatory amendments are required to bring in to force of the recent legislative updates. The 
proposed regulations would repeal Schedule F a nd incorporate a web-based Prescription Drug 
List (PDL) that is to be established by the Minister in accordance with the enabling 
amendments to the Food and Drugs Act .  They would also provide the scientific criteria the 
Minister must consider in main taining the PDL.  The proposed overarching scientific criteria 
would support the existing Schedule F criteria  and ensure that the scientific basis for 
assigning prescription stat us remain the same.   G/TBT/N/CAN/382 
Page 2  
 
  These changes will not affect the way the sale, direct to consum er advertising, or importation 
of prescription drugs is managed in Canada.   
This new approach will not impact the safety and efficacy of drugs in Canada. All drug 
submissions to Health Canada will continue to be subject to  rigorous safety, efficacy and 
quality assessments prior to approval. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human and animal health  
8. Relevant documents:   Canada Gazette , Part I, 22 Decembe r 2012, Pages 3572-3583 
(Available in English and French) 
For related draft Guidance Document, Frequently  Asked Questions and el ectronic versions of 
the draft PDL please visit Health Canada's website:   
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/pdl_consult_ldo-eng.php  (English) 
http://www.hc-sc.gc.ca/dhp-mps/consul tation/drug-medic/pdl_consult_ldo-fra.php   (French) 
9. Proposed date of adoption:   
 
 Proposed date of entry into force:    On the date the measure is published in Canada 
Gazette  II, anticipated to be within six months 
of publication of the measure in Canada 
Gazette,  Part I.  
The amendments would come into force six 
months after the date th e measure is adopted.  
10. Final date for comments:  7 March 2013 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
The electronic version of the regulat ory text can be downloaded at:  
http://canadagazette.gc.ca/rp-pr/p1/ 2012/2012-12-22/pdf/g1-14651.pdf#page=30 ( Canada 
Gazette )  
or 
http://canadagazette.gc.ca/rp-pr/ p1/2012/2012-12-22/html/reg2-eng.html  (English) 
http://canadagazette.gc.ca/rp-pr/ p1/2012/2012-12-22/html/reg2-fra.html   (French)