WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/161 
14 June 2006 
 (06-2879) 
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, Ontario 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):   Prescription status of 
medicinal ingredients for 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 (Project No. 1434 - Schedule F) (5 pages, in English; 
6 pages, in French). 
6. Description of content:   This notification announces th e availability of a letter that 
provides an opportunity to comment on the propo sed addition of 10 medicinal ingredients to 
Part I of Schedule F to the  Food and Drug Regulations . 
Description of the medicinal ingredients: 
1. Agalsidase alfa  is an enzyme indicated for long-term replacement therapy in 
patients with a confirmed diagnosis of Fa bry Disease (a deficiency of the enzyme 
alpha-galactosidase A).  
2. Botulinum toxin, Type B  is a paralytic agent which blocks the release of 
acetylcholine (Ach) at the point of contact between nerve and muscle tissue. 
Botulinum type B is indicated for the treatment of adult patients with cervical 
dystonia and for the management of adult patients with cervical dystonia who are resistant to Type A toxin. Cervical dystonia is a neurological movement disorder characterized by involuntary muscle contractions of the neck that can cause abnormal posture and movement of the head and neck.  G/TBT/N/CAN/161 
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  3. Laronidase  is an enzyme used to treat the inherited metabolic disorder 
Mucopolysaccharidosis I (MPS I) which is characterized by a deficiency of the enzyme α-L-iduronidase. Reduced or absent α-L-iduronidase activity results in the 
accumulation of glycosaminoglycans substrates throughout the body and leads to widespread cellular, tissue, and organ dysfunction including stunted growth in 
children and reduced joint movement; e.g., Hurler syndrome. Laronidase is 
indicated for long term enzyme replacement therapy in patients with MPS I to treat manifestations of the disease except those related to the central nervous system.  
4. Miglustat  is indicated for the treatment of adult patients with mild to moderate 
Type 1 Gaucher disease (a rare genetic disease involving a specific enzyme 
deficiency) for whom enzyme replacement therapy is not a therapeutic option. 
5. Muromonab-CD3  suppresses a patient's immune system to aid in preventing tissue 
rejection after transplants.  It is specifi cally indicated for the treatment of acute 
kidney, cardiac or liver transplant rej ection, where conventional anti-rejection 
therapy is not effective or when conve ntional therapy is not recommended.  
6. Pegfilgrastim  stimulates the growth of white blood cells and is indicated for use in 
adult and pediatric patients with cancer who are receiving chemotherapy which suppresses bone marrow activity, resulting in low levels of circulating white blood 
cells.  Pegfilgrastim also can reduce the incidence of infection in patients with some malignancies. 
7. Pemetrexed and its salts  is a treatment for cancer.  It inhibits the growth or 
development of malignant cancerous cells by disrupting crucial metabolic processes 
that are essential for cells to multiply.  In combination with the drug, cisplatin, 
pemetrexed disodium is indicated for th e first-line treatment of patients with 
specific malignant tumours. 
8. Rasburicase  is a strong uricolytic agent that speeds up the enzymatic oxidation of 
uric acid into an inactive and soluble meta bolite.  Rasburicase is indicated for the 
treatment and prevention of excess uric acid in the blood in pediatric and adult 
cancer patients. 
9. Teriparatide and its salts  helps to stimulate bone formation and is indicated for 
the treatment of men or women with sever e osteoporosis.  Teriparatide acts in the 
regulation of bone metabolism and on the r eabsorption of calcium and phosphate in 
the kidneys. 
10. Vardenafil and its salts  is indicated for treatment of erectile dysfunction.  
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associated with each me dicinal ingredient.  Oversight by a practitioner 
is necessary to ensure that appropriate risk/ben efit information is considered before the drug 
containing the medicinal ingredient is administered and that the drug therapy is properly monitored. 
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections 
C.01.041 to C.01.049 of the Food and Drug Regulations . Part I of Schedule F lists 
ingredients that require a prescription for huma n use and for veterinary use. Part II of 
Schedule F lists 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. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health  G/TBT/N/CAN/161 
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  8. Relevant documents:   Therapeutic Products Directorate (TPD) web site  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legisl ation/acts-lois/notice-avis/index_e.html , 
Project 1434 letter posted:  31 May 2006 
9. Proposed date of adoption:  Normally within 6 to 8 months from the posting of the 
letter on the TPD website.  
Proposed date of entry into force:  On the date the measure is adopted.  
10. Final date for comments:   14 August 2006 
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 Project No. 1434 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1434_e.html