. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/CAN/364 
8 May 2012  
 (12-2433) 
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 Drugs Act , as reflected in Division 19 of Part 4 of the Jobs, Growth and 
Long-term Prosperity Act,  2012 (6 pages, available in English and French)     
6. Description of content:  A s  p a r t  o f  t h e  Jobs, Growth and Long-term Prosperity Act , the 
government of Canada is making amendments to  the Food and Drugs Act to streamline the 
regulatory process to establish the prescription status of a drug while maintaining the same 
scientific rigour based on well-established and publ icly available criteria.  
These amendments found in Divisi on 19 of Part 4 will permit the Minister of Health to 
establish a list of prescription dr ugs or classes of prescription drug s and to provide that the list 
may be incorporated  by reference.  
The proposed changes to the Food and Drug Act  will make the process of assigning 
prescription status more efficient by removi ng the requirement for a regulatory amendment 
and maintaining the list of prescr iption drugs administratively.  
These changes will not affect the way the sale, direct to consum er advertising, or importation 
of prescription drugs is managed in Canada.  Th is new approach will not impact the safety 
and efficacy of drugs in Canada. All drug submis sions 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  G/TBT/N/CAN/364 
Page 2  
 
  8. Relevant documents:   Parliament of Canada Website, P ublications (Available in English and 
French)   
9. Proposed date of adoption:   
Proposed date of entry into force:    The Bill is currently before Parliament - the date 
of adoption is unknown at this time.  
On the date the measure is adopted. This legislative proposal will be followed by subsequent regulatory amendments to bring this proposal into force. 
10. Final date for comments:  2 July 2012 
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 legisl ative text can be downloaded at: 
English: 
"http://www.parl.gc.ca/HousePublications /Publication.aspx?Mode=1&DocId=5524772&Lan
guage=E&File=809 " 
French:  
"http://www.parl.gc.ca/HousePublications /Publication.aspx?M ode=1&DocId=5524772&File
=809&Language=F "