WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/108 
8 October 2004  
 
(04-4217) 
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 applicable, otherwise national tariff heading.
ICS numbers may be provided in  addition, where applicable):   Medicinal ingredients 
which require a prescription for both human and veterinary use (ICS: 11.120, 11.220) 
5. Title, number of pages and langua ge(s) of the notified document:   Proposed Amendment 
to the Food and Drug Regulations (1373 – Sc hedule F) (pages 2730-2735;  English and 
French) 
6. Description of content:   The Therapeutic Products Directorate (TPD) of Health Canada 
intends to update Schedule F to the Food and Drug Regulations  of the Food and Drugs Act  
by adding 15 medicinal ingredients to Part I of  Schedule F, and amending the listing for one 
medicinal ingredient in Part I of Schedule F.  
Schedule F is a list of medicinal ingredients, the sale of which are controlled under sections 
C.01.041 to C.01.046 of the Food and Drug Regulations . Part I of Schedule F lists 
medicinal ingredients that require a prescription for both human and veterinary use in Canada. Part II of Schedule F lists medicinal ingredients that require a prescription for 
human use, but do not require a prescription for veterinary use if so labelled or if in a form 
unsuitable for human use. The review and introduction of new drugs onto the Canadian 
market necessitates periodic revisions to Schedule F.  
New listings 
 
 It is proposed that the following 15 medicinal ingr edients be added to Part I of Schedule F:  
 
1. Anti-thymocyte globulin — an immunosuppressant. Anti-thymocyte globulin (equine- and rabbit-sourced) is used to redu ce the immune response in patients who have 
received skin, cardiac, liver, or bone-marrow transplants.    G/TBT/N/CAN/108 
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2. Bivalirudin — a direct thrombin inhibitor. Bivalirudin is used to prevent blood 
clotting in patients with unstable angina, specifically those who are undergoing procedures to eliminate areas of narrowing in cardiac blood vessels.   3. Drotrecogin — an anti-thrombotic pr ofibrinolytic anti-inflammatory enzyme. 
Drotrecogin is used to treat patients with sev ere sepsis (sepsis associated with acute organ 
dysfunction), who have a high risk of death.    4. Dutasteride — a Type I and II 5 Alpha-reduc tase inhibitor. Dutasteride is used for 
the treatment of benign prostatic hyperplasia,  enlargement of the prostate, and for the 
prevention and control of urologic events cau sed by the enlarged prostate gland.  
 5. Enfuvirtide — an antiviral agent and HIV fusion inhibitor. Enfuvirtide is used for 
the treatment of the human immuno-deficiency virus (HIV).   
6. Ertapenem and its salts — an antibiotic. Er tapenem sodium is used for the treatment 
of certain infections when caused by suscep tible bacteria in adults; for example, 
complicated intra-abdominal, urinary tract and sk in and skin structure infections and acute 
pelvic infections.   
7. Ezetimibe — a cholesterol absorption inhibi tor. Ezetimibe is used in patients with 
various lipid (water-insoluble fats and fatlike substances) disorders.  
 8. Fondaparinux sodium — a synthetic antith rombotic. Fondaparinux sodium is used 
to prevent the formation of blood clots in th e blood, specifically the blood vessels of the 
legs or lungs following orthopaedic surgery such as hip or knee surgery.  
 
9. Formoterol and its salts — long-acti ng beta-2 adrenergic receptor agonist. 
Formoterol fumarate is used for the treatment of asthma as well as chronic obstructive pulmonary disease.   
10. Levetiracetam — an anti-epileptic. Levetir acetam is used for patients with epilepsy 
whose seizures are not satisfactorily co ntrolled by conventional therapy.  
 11. Pimecrolimus — an ascomycin macrolact am derivative to inhibit secretion of 
inflammatory cytokine (non-antibody proteins).  Pimecrolimus is used for the treatment of 
mild to moderate atopic dermatitis (inflammation of the skin) in patients in whom the use of 
alternative, conventional therapies is deemed inadvisable because of potential risks, or in 
the treatment of patients who are not adequately responsive to or intolerant of alternative, 
conventional therapies.    12. Rosuvastatin and its salts — a lipid me tabolism regulator to be used for various 
lipid disorders (high levels of fatty substances in the blood). Rosuvastatin calcium is used in 
patients with excess cholesterol or other elev ated levels of lipids in the blood.  
 13. Telithromycin and its salts and derivativ es — an antibacterial agent. Telithromycin 
is used for the treatment of select in fections caused by susceptible bacteria. 
 
14. Tenofovir and its salts and derivatives — an antiretroviral agent. Tenofovir 
disoproxil fumarate is used for the treatment  of human immuno-deficiency virus (HIV). 
 15. Treprostinil and its salts — a vasodilato r. Treprostinil sodium is used in the 
treatment of pulmonary arterial hypertension (PAH).   G/TBT/N/CAN/108 
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Metropolol and its salts  
It is proposed that the current English listing for "Metropolol and its salts ( Métoprolol et ses 
sels)" in Part I of Schedule F be amended to the appropriate spelling:  
Metoprolol and its salts  
Métoprolol et ses sels   
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human and animal health 
8. Relevant documents:   Canada Gazette, Pa rt I, 2 October 2004 
9. Proposed date of adoption:   
Proposed date of entry into force:   }Not stated 
10. Final date for comments:   16 December 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/2004/20041002/pdf/g1-13840.pdf