. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/103 
23 July 2004 
 (04-3190) 
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):   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 (1397 – Schedule F) (pages 2061-2065; 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 seven medicinal ingredients to Part I of Schedule F.  
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections 
C.01.041 to C.01.046 of the Food and Drug Regulations . Part I of Schedule F lists 
medicinal ingredients which require a prescripti on for both human and veterinary use.  Part 
II of Schedule F lists medicinal ingredients which 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 on the Canadian market necessitate 
periodic revisions to Schedule F. 
New listings
 
It is proposed that the following seven medi cinal ingredients be added to Part I of 
Schedule F:  
1. Adefovir and its salts and its derivatives  — a nucleotide analogue. Adefovir 
dipivoxil is used to treat chronic hepatitis B.  
2. Almotriptan and its salts — a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D) 
receptor agonist. Almotriptan malate is u sed for the acute treatment of migraine 
attacks with or without aura in adults.  G/TBT/N/CAN/103 
Page 2  
 
3. Cetrorelix and its salts — gonadotro pin-releasing hormone (GnRH) antagonist. 
Cetrorelix acetate injection is used to help control the release of eggs from the 
ovaries of women undergoing assisted conception procedures such as in-vitro 
fertilization.  
4. Ketanserin and its salts — serotonin S2 receptor antagonist. Ketanserin is indicated 
for the treatment of wounds in horses on or below the tarsal or carpal joints and to 
prevent the formation of excessive granulation tissue at these wound sites.  
5. Phenylpropanolamine and its salts a nd its derivatives for veterinary use  — a 
sympathomimetic amine consisting of the racemic mixture of d- and l-norephedrine. 
Phenylpropanolamine hydrochloride (PPA) is used in female dogs for the long-term treatment of urinary incontinence asso ciated with sphincter mechanism 
incompetence.  
6. Tadalafil and its salts — a cGMP-s pecific phosphodiesterase type 5 (PDE5) 
inhibitor. Tadalafil is a potent, selective, and reversible inhibitor indicated for the 
treatment of male erectile dysfunction (ED) at oral doses of 10 and 20 mg once 
daily.  
7. Teflubenzuron — antiparasite. Teflubenz uron is indicated for the treatment of 
parasitic infestations caused by the deve loping chalimus and pre-adult stages of 
Lepeophtheirus salmonis  on Atlantic salmon ( Salmo salar ).  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human and animal health 
8. Relevant documents:   Canada Gazette, Part I, 17 July 2004 
9. Proposed date of adoption:   
Proposed date of entry into force:   }Not stated 
10. Final date for comments:   30 September 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/2004/20040717/pdf/g1-13829.pdf