. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/CAN/372 
15 October 2012  
 (12-5581) 
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, 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 [X], 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):  Drugs for human use 
(ICS : 11.120) 
5. Title, number of pages and langua ge(s) of the notified document:  Proposed Amendment 
to the Food and Drug Regulations (1475 - Good Manufacturing Prac tices) (22 pages, 
available in Eng lish and French). 
6. Description of content:  The quality of active ingredients (AI)  in a drug has a direct effect on 
the safety and efficacy of th at drug. Poorly manufactured a nd contaminated AI has been 
associated with negative health outcomes, including death, in a number of incidents over the 
past decades. Worldwide, there has been grow ing concern over the quality of AI as the 
manufacturing of AI and dosage-form drugs has been increasingly outsourced to developing 
countries.  
This proposed regulatory amendment would exte nd the drug GMP requirements set out in the 
Food and Drug Regulations  such that they apply to all AI; extend the drug establishment 
licensing (EL) requireme nts set out in the Food and Drug Regulations  such that they apply to 
all AI fabricators, packagers/labellers, testers and importers; a nd create a new record-keeping 
requirement to foster the traceability of AI fro m the original fabricator to the dosage-form 
drug manufacturer. G/TBT/N/CAN/372 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
The main objective of the proposed regulatory am endment is to protect the health and safety 
of Canadians by implementing into regulation internationally accepted GMP for AI requirements. A secondary objective is to ensure that the associated regulatory burden is 
mitigated by compensating efficiencies or minimized to the extent possible.  
8. Relevant documents:   Canada Gazette , Part I, 29 September 2012, Pages 2754-2775 
(available in English and French)   
9. Proposed date of adoption:   
Proposed date of entry into force:    Normally within 5 to 8 months of publication in 
the Canada Gazette , Part I. 
Six months after the day on which the measure 
is adopted. This delay in the coming into force 
of the regulatory amendment would allow all regulated parties to adjust to the new requirements. Furtherm ore, on the day the 
regulatory amendment comes into force, any 
person who fabricates, packages/labels, tests or 
imports an active pharmaceutical ingredients (API) would be allowed to continue to do so without an establishment licensing (EL) provided they submit an EL application within three months after the coming into force of the 
regulatory amendment.  
10. Final date for comments:  13 December 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 regulat ory text can be downloaded at:  
http://www.gazette.gc.ca/rp-pr/p1/2012 /2012-09-29/pdf/g1-14639.pdf#page=40  ( Canada 
Gazette)  
or 
http://www.gazette.gc.ca/rp-pr/ p1/2012/2012-09-29/html/reg3-eng.html   (English)  
http://www.gazette.gc.ca/rp-pr/ p1/2012/2012-09-29/html/reg3-fra.html  (French)