WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/223 
9 January 2008 
 (08-0089) 
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: 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: 11.120) 
5. Title, number of pages and langua ge(s) of the notified document:   Proposed Amendment 
to the Food and Drug Regulations (Project No. 1583 — Schedule F)  (4 pages, in English  and French) 
6. Description of content:   This notification announces th e availability of a letter that 
provides an opportunity to comment on the pr oposed addition of six medicinal ingredients 
to Part I of Schedule F to the Food and Drug Regulations . 
 
Description of the medicinal ingredients: 
1. Aprepitant and its derivatives  is a neurokinin 1 (NK1) receptor antagonist used 
for the prevention of nausea and vomiting associated with cancer treatment. 
Aprepitant should be administered under the supervision of a practitioner 
experienced in cancer therapy. The patien t may require treatment with other drugs 
and routine laboratory monitoring. Aprepitant may cause undesirable or severe side 
effects at normal therapeutic dosage levels. G/TBT/N/CAN/223 
Page 2  
 
  2. Daptomycin  is a cyclic lipopeptide antibacteria l agent used for the treatment of 
bacterial infections, including serious skin infections and certain blood stream 
infections. Daptomycin must be administered by the intravenous route. Direct supervision by a practitioner and routin e laboratory monitoring are required. 
Daptomycin may cause undesirable or severe side effects at normal therapeutic dosage levels. 
3. Duloxetine and its salts  is a balanced serotonin and norepinephrine reuptake 
inhibitor. Duloxetine is used to treat major depressive disorder and for the 
management of neuropathic pain associated  with diabetic peripheral neuropathy. 
The safe and effective use of  duloxetine requires that an accurate diagnosis of 
depression or neuropathic pain be made by the practitioner. The practitioner must 
provide individualized dosage and other in structions, and maintain close medical 
supervision and patient foll ow-up throughout treatment. 
4. Maraviroc  is a member of a therapeutic cl ass called CCR5 antagonists used for the 
treatment of HIV-1 (Human Immunodeficiency Virus type 1) infection. Maraviroc 
is administered in combination with other anti-HIV medications. Individualized instructions or direct supervision by a practitioner are required. The patient may 
also require treatment with other drugs and routine laboratory monitoring. 
5. Paliperidone and its salts  and its derivatives is an antipsychotic drug used in the 
treatment of schizophrenia. Diagnosis of schizophrenia requires a practitioner 
specialized in the area of psychotic disorders. The practitioner must provide 
individualized dosage and other instructions, and maintain close medical supervision and patient follow-up througho ut treatment. Paliperidone may cause 
undesirable or severe side effects at normal therapeutic dosage levels. 
6. Ziprasidone and its salts  is an antipsychotic drug used in the treatment of 
schizophrenia and related psychotic disord ers. Diagnosis of schizophrenia requires 
a practitioner specialized in the area of psychotic disorders, who must then also 
decide on the most appropriate forms of treatment. The practitioner must provide individualized dosage and other instructions, and maintain close medical 
supervision and patient foll ow-up throughout treatment.  
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides 
with the risk factors associat ed with each medicinal 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/223 
 Page 3 
 
 
  8. Relevant documents:   Therapeutic Products Directorate (TPD) website  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legisl ation/acts-lois/notice-avis/index_e.htm 
Project No. 1583, letter posted: 19 December 2007 
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 website. 
On the date the measure is adopted. 
10. Final date for comments:   3 March 2008 
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. 1583 can be downloaded at:  
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1583_e.html