. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/296 
21 January 2010  
 (10-0315) 
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. 1624 — 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 proposed additio n of four medicinal ingredients to Part I 
of Schedule F to the Food and Drug Regulations.  
Description of the medicinal ingredients: 
1.  Eculizumab is used to treat patients wi th paroxysmal nocturna l hemoglobinuria, a rare 
disorder characterized by ep isodes of red blood cell destru ction and blood in the urine 
occuring primarily at night. Individualized instruct ions or direct supervision by a practitioner 
is required. The patient may also require r outine laboratory monitoring. Eculizumab may 
cause undesirable or severe side effects at normal therapeutic dosage levels. 
2. Olmesartan medoxomil is used to lower blood pressure in patients in whom the cause of 
high blood pressure is unknown. Olmesartan medoxomil works by acting on the naturally 
occurring hormone in the body, angiotensin II wh ich is actively involved in blood pressure. 
Individualized instructions or direct supervision by a practitio ner is required. The patient may 
also require routine laboratory monitoring. Olmesartan medoxomil may cause undesirable or 
severe side effects at normal therapeutic dosage levels.  G/TBT/N/CAN/296 
Page 2  
 
   3. Romiplostim is a protein used  to treat low blood platelet c ounts in patients with immune 
thrombocytopenic purpura, a disease in which th e bodys immune system de stroys platelets in 
the blood. Individualized instructions or direct supervision by a practitioner is required. The 
patient may also require routine laboratory monitoring. Romiplostim may cause undesirable 
or severe side effects at normal therapeutic dosage levels. 
4. Ustekinumab is used to treat patients with moderate to severe chr onic plaque psoriasis.  
Psoriasis is an autoimmune disease that causes scaly red patches called plaques on the skin. Individualized instructions or direct supervision by a practitio ner is required. The patient may 
also require routine laboratory monitoring. Us tekinumab may cause undesirable or severe side 
effects at normal therapeutic dosage levels. 
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated with each medi cinal 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. 
Schedule F is a list of medicinal ingredients, th e sale of which is controlled under sections 
C.01.041 to C.01.049 of the Food and Drug Regulatio ns. Part I of Schedule F lists ingredients 
that require a prescription for human use and fo r veterinary 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  Directorate (TPD) we b site http://www.hc-
sc.gc.ca/dhp-mps/prodphar ma/legislation/notice-avis/index-e ng.php, Project No. 1624, letter 
posted: 11 January 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:  27 March 2010 
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 Project No. 1624 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/project_projet_1624-eng.php  
(English)  
http://www.hc-sc.gc.ca/dhp-mps/consulta tion/drug-medic/proj ect_projet_1624-fra.php  
(French)