. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/321 
16 September 2010  
 (10-4676) 
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):  Prescription status of 
medicinal ingredients for human use (ICS:  11.220) 
5. Title, number of pages and langua ge(s) of the notified document:  Proposed Amendment 
to the Food and Drug Regulations (Project No. 1626 - Schedule F) (5 pages, available in 
English and French)  
6. Description of content:  This notification announces the availa bility of a letter that provides 
an opportunity for comment on the proposal to add to Part I of Schedule F to the Food and 
Drug Regulations, collagenase when sold for de bridement of severe bur ns and skin ulcers.  
Health Canada has conducted a sc ientific review of collagenase against a set of established 
and publicly available factors fo r listing drugs in Schedule F.  These factors include, but are 
not limited to, toxicity, pharm acological properties and therapeutic uses of the medicinal 
ingredients. 
Based on this assessment, Hea lth Canada is recommending the addition to Schedule F of 
collagenase when sold for debridement of severe burns and skins ulcers.  This would result in 
affected products being regulat ed as prescription drug products under the Food and Drug 
Regulations.  Since collagenase meets the definition of a natura l health product, products sold 
for any other use would continue to be regulated under the Natural Health Products 
Regulations.  
Description of the medicinal ingredient: 
Collagenase is an enzyme de briding agent that helps br eak down tissue in the body. 
Collagenase is used to treat severe burns and sk in ulcers by helping to remove dead skin and G/TBT/N/CAN/321 
Page 2  
 
  tissue in order to promote healing.  Indivi dualized instructions and supervision by a 
practitioner are required for the treatment of th ese conditions with collagenase.  The patient 
may also require additional treatment with sche duled drugs or routine laboratory monitoring. 
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated with this medicinal ingredient.  Oversight by a practitioner is 
necessary to ensure that appropriate risk/benef it information is considered before the drug 
containing the medicinal ingredient is administ ered and that the drug therapy is properly 
monitored. 
Sections C.01.041 to C.01.049 of the Food and Drug Regulations c ontrol the sale of 
medicinal ingredients that are listed in Schedule F. Part I of Schedule F lists ingredients that 
require a prescription for human use and for vete rinary use.  Part II of Schedule F lists 
ingredients that require a prescription for hu man use, but do not require a prescription for 
veterinary use if so labelled or if  in a form unsuitable for human use. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health  
8. Relevant documents:   Therapeutic Products Di rectorate (TPD) website http://www.hc-
sc.gc.ca/dhp-mps/prodph arma/legislation/noti ce-avis/index-eng.php , Project No. 1626, letter 
posted: 27 August 2010   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Normally within 6 to 8 months from the posting 
of the letter on the TPD web site. 
On the date the measure is adopted 
10. Final date for comments:  10 November 2010 
11. Text 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 
Project No. 1626 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/project_projet_1626-eng.php  
(English)  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/proj ect_projet_1626-fra.php  
(French)