WORLD TRADE  
ORGANIZATION   
G/TBT/N/CAN/338 
13 July 2011  
 (11-3480) 
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, Ontario  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 (Project No. 1658 - Schedule F) (5 pages, in English and 
French). 
6. Description of content:   This notification announces the availability of a letter that 
provides an opportunity to comment on the proposed addition of six medicinal ingredients 
to Part I of Schedule F to the Food and Drug Regulations . 
Description of the medicinal ingredients 
 1. Alitretinoin, its salts and derivatives  is a retinoid drug that is related to Vitamin A. 
Alitretinoin, its salts and derivatives are used to  treat severe chronic eczema of the hand that 
has not responded to topical treatment with cor ticosteroids. Because alitretinoin, its salts 
and derivatives can cause severe birth defects, its use requires specific and effective 
pregnancy prevention measures for women of childbearing potential. Individualized instructions, direct supervision by a prac titioner and routine laboratory monitoring are 
required during treatment.  G/TBT/N/CAN/338 
Page 2  
 
  2. Aripiprazole and its salts  belong to a group of medicines called atypical antipsychotic 
drugs. Aripiprazole and its salts are used to treat schizophrenia and bipolar disorder. 
Aripiprazole and its salts should be prescribed  by a practitioner who is experienced in the 
diagnosis of psychiatric disorders. Due to the potential for undesirable or severe side effects from aripiprazole and its salts at normal therapeutic dosage levels, individualized 
instructions, direct supervision by a prac titioner and routine laboratory monitoring are 
required during treatment. 
 3. Besifloxacin and its salts  is an antibiotic used for the treatment of inflammation of the 
eye caused by bacteria. The use of besifloxacin and its salts requires direct supervision by a 
practitioner as there may be undesirable or sever e side effects at normal therapeutic dosage 
levels.  
4. Doripenem, its salts and derivatives is a broad-spectrum antibiotic used for the 
treatment of pneumonia that occurs in a hospital or similar setting. Individualized instructions, direct practitioner supervision an d routine laboratory monitoring are required. 
Doripenem, its salts and derivatives may have undesirable or severe side effects at normal 
therapeutic dosage. 
 5. Saxagliptin and its salts  are used to improve blood sugar levels in adult patients with 
type 2 diabetes. Saxagliptin and its salts are u sed in combination with other drugs used to 
treat diabetes when diet and exercise and ot her drugs have failed to adequately control 
blood sugar levels. Saxagliptin and its salts should be used under the supervision of a 
physician as it is indicated for use in combin ation with other prescribed drugs and requires 
routine laboratory monitoring. Saxagliptin and its salts may also have undesirable or severe 
side effects at normal therapeutic dosage levels.  6. Sevoflurane  is a halogenated inhalation anesthetic that is used for general anesthesia 
during surgery. Individualized instructions, direct practitioner supervision and routine 
laboratory monitoring are required. There is a narrow margin of safety between the 
therapeutic and toxic dosages.  The degree of regulatory control afforded by Schedule F (prescription drug) status 
coincides with the risk factor s associated with each medicinal ingredient. Oversight by a 
practitioner is necessary to ensure that appropr iate risk/benefit information is considered 
before the drug containing the medicinal ingr edient 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 
medicinal ingredients that require a prescrip tion for human use and for veterinary use. 
Part II of Schedule F lists medicinal ingredient s that require a prescription for human use, 
but do not require a prescription for veterinary u se 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 Dire ctorate (TPD) web site " http://www.hc-
sc.gc.ca/dhp-mps/prodph arma/legislation/noti ce-avis/index-eng.php ", Project No. 1658, letter 
posted: 30 June 2011    G/TBT/N/CAN/338 
 Page 3 
 
 
  9. Proposed date of adoption:   
  
Proposed date of entry into force:    Normally within 8 to 10 months from the 
posting of the letter on the TPD website. 
On the date the measure is adopted. 
10. Final date for comments:  13 September 2011 
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. 1658 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/consultati on/drug-medic/project_projet_1658-eng.php  
(English)  
http://www.hc-sc.gc.ca/dhp-mps/consultation/ drug-medic/project_projet_1658-fra.php 
(French)