. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/CAN/360 
22 February 2012  
 (12-1019) 
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 fo r 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 (Notice of Inte nt - Project No. 1663 - Schedule F) (4 pages, 
available in English and French)     
6. Description of content:  The purpose of this Notice of Intent (NOI) is to provide an 
opportunity to comment on a proposal to add to Part I of Schedule F to the Food and Drug 
Regulations pancrelipase, pancreatin and pancreatic extracts where the strength per dosage 
unit exceeds 20 000 USP units of lipase activity or when indicated fo r the treatment of 
pancreatic exocrine insu fficiency. This would result in af fected products being regulated as 
prescription drug products under the Food and Drug Regulations . Since pancrelipase, 
pancreatin and pancreatic extrac ts meet the definition of a natural health product, products 
sold for any other use or at a lower strength  would continue to be regulated under the Natural 
Health Products Regulations.  
Sections C.01.041 to C.01.049 of the Food and Drug Regulations  control 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 ve terinary 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. 
Description of the medicinal ingredient: Pancreatic enzymes are important for the adequate  absorption of fat, proteins, and to a lesser 
extent, carbohydrates  from  the  diet. The failu re of the pancreas to produce an adequate level G/TBT/N/CAN/360 
Page 2  
 
  of enzymes results in the inab ility to properly digest food, otherwise known as pancreatic 
exocrine insufficiency (PEI). Certain medical conditions ca n cause this lack of enzymes, 
including cystic fibrosis, chronic inflammation of the pancreas, or blocka ge of the pancreatic 
ducts. 
A review of the available scientific literatu re on pancrelipase, panc reatin and pancreatic 
extracts indicates that direct supervision by a practitioner and routine laboratory monitoring 
are required to determine and maintain the optim um dose as the response to these ingredients 
varies greatly from one patient to another. Test ing is needed to determine the level at which 
these ingredients are effective as there are potential health risks if the dose is excessive. Pancrelipase, pancreatin and pa ncreatic extracts have been known to cause undesirable side 
effects such as scarring of the large intestine, which is commonly seen with excessive doses but has occurred at normal therapeutic dosage levels.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health  
8. Relevant documents:   Canada Gazette, Part I, 11 Fe bruary 2012, Pages 200-203 (Available 
in English and French)   
9. Proposed date of adoption:   
Proposed date of entry into force:    Normally within 8 to 10 months of publication 
in the Canada Gazette , Part I. 
The amendment would come into force 90 days after the date of publication in the Canada 
Gazette,  Part II. 
10. Final date for comments:  26 April 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 Project No. 1663 can be downloaded at:   
http://canadagazette.gc.ca/rp-pr/p1/ 2012/2012-02-11/pdf/g1-14606.pdf#page=26 ( Canada 
Gazette )  
or 
http://canadagazette.gc.ca/rp-pr/p1/2012 /2012-02-11/html/notice-avis-eng.html#d102 
(English)   
http://canadagazette.gc.ca/rp-pr/p1/2012/2012-02- 11/html/notice-avis-fra .html#d102 (French)