. /. WORLD TRADE  
ORGANIZATION   
G/TBT/N/CAN/102 
28 May 2004 
 (04-2302) 
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 government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Department of Health 
Name and address (including telephone and fax numbers, e-mail and web-site 
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, Onta rio, Canada, K1P 6N7 Tel.:  +1 613 238 3222, 
Fax.: +1 613 569 7808, E-mail: info@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 app licable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Disinfectants (ICS: 
11.080.20, 71.100.35) 
5. Title, number of pages and langua ge(s) of the notified document:   Proposed Amendment 
to the Food and Drug Regulations (1356 — Disinfectants) (pages 1644-1648; English and French) 
6. Description of content:    
This amendment to the Food and Drug Regulations (the Regulations) exempts antimicrobial 
agents from requirements respecting Good Manufacturing Practices (GMP) and establishment licensing while still regulating them as drugs under the Food and Drugs Act 
(FDA) and Regulations. This means that products meeting the definition of an 
"antimicrobial agent" will no longer have to co mply with the requirements of establishment 
licensing (Part C, Division 1A) or Good Manufactur ing Practices (Part C, Division 2) of the 
Regulations.  
Antimicrobial agents are a type of lower-risk disinfectant drug. An antimicrobial agent is 
defined as a drug capable of destroying pathoge nic micro-organisms and that is labelled as 
being for use in the disinfection of environmental surfaces or medical devices, that are not 
invasive devices as defined in the Medical Devices Regulations , and that are intended to 
come into contact with intact skin only.  
With this proposed amendment, all higher ri sk disinfectant drug products, which do not 
meet the definition of "antimicrobial ag ent," such as contact lens disinfectants, 
chemosterilants and high level disinfectants used to sterilize invasive devices or devices 
used for circulation, reintroduction of a body fluid or for introduction in a body cavity, will 
continue to be subject to the existing GMP and establishment licensing regulations.  G/TBT/N/CAN/102 
Page 2  
 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   Canada Gazette, Part I, 22 May 2004 
9. Proposed date of adoption:   
Proposed date of entry into force:   not stated 
10. Final date for comments:   5 August 2004  
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:        
The electronic version of the regulatory text can be downloaded at:   
http://canadagazette.gc.ca/partI/2004/20040522/pdf/g1-13821.pdf