. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/286 
15 October 2009  
 (09-5073) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  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):  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 (1447 — G ood Manufacturing Prac tices)  (7 pages, 
available in English and French).  
6. Description of content:  The Good Manufacturing Pr actices regulations, Di vision 2 of Part C 
of the Food and Drug Regulations (the Regulati ons), are reviewed by Health Canada every 
three years. As a result, several provisions have been identified for amendment because they 
are not consistent with intern ational standards and/or curr ent industry practice, are not 
uniformly applied to all sectors of the industr y, or do not provide the requisite regulatory 
support to current Health Canada interpretati ons. The purpose of this regulatory proposal is 
twofold: to align the Regulations with internat ional standards and to codify existing Health 
Canada regulatory interpretations. Other provisi ons also require amendment to correct minor 
errors.  
A listing of the issues noted in  the regulatory proposal appears below. A description of the 
Quality Control Requirements follows:  
• Quality control requirements 
• Premises 
• Reworking 
• Complaints on quality • Samples • Medical gases G/TBT/N/CAN/286 
Page 2  
 
  Background on Quality control requirements 
Under the current Regulations, the requirements  related to the quality control department 
apply only to fabricators, packagers/ labellers, distributors and importers. Wholesalers are not required to have a quality control department.  
However, wholesalers play an important ro le in the pharmaceutic al industry through the 
wholesale selling of drugs regu lated under the Food and Drugs Act, and therefore have an 
effect upon the safety, quality, and efficacy of  drugs in Canada. Furthermore, the current 
Health Canada interpretation for personnel sets out the training and experience required of the 
head of the quality control de partment of a wholesaler.  
Therefore, in recognition of the role wholesal ers play, and to provide consistency of the 
Regulations with the interpretation of C.02.006,  Health Canada is amending C.02.013(1) of 
the Regulations to require wholes alers to have a quality contro l department on their premises, 
supervised by personnel referred to in C.02.006.  Under this amendment, Health Canada will 
require that the head of the quality control depart ment of a wholesaler also approve a returned 
drug for further sale, under C.02.014(2), as is the case in the quality c ontrol departments of 
fabricators, packagers/labellers and distributors.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and safety  
8. Relevant documents:   Canada Gazette, Part I, 26 September 2009, Pages 2924-2930 
(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. On the date the measure is adopted. 
10. Final date for comments:  10 December 2009 
11. Text available from: National enquiry po int [ 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 regulatory text can be downloaded at:  http://www.gazette.gc.ca/rp-p r/p1/2009/2009-09-26/pdf/g1-14339.pdf 
 (Canada Gazette) or 
http://www.gazette.gc.ca/rp-pr/p1/ 2009/2009-09-26/html/reg2-eng.html  (English)  
http://www.gazette.gc.ca/rp-pr/p1/ 2009/2009-09-26/html/reg2-fra.html  (French)