WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/294 
19 January 2010  
 (10-0246) 
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 : 11.120) 
5. Title, number of pages and langua ge(s) of the notified document:  Proposed Amendment 
to the Food and Drug Regulations (Notice of  Intent — Project  No. 1651 — Schedule F) 
(5 pages, available in English and French)     
6. Description of content:  The purpose of this Notice of Intent (NOI) is to provide an 
opportunity for comment on the proposal to amend the current listings in Part I of Schedule F 
to the Food and Drug Regulations for four medici nal ingredients to reta in prescription status 
for specific strengths, uses, routes of admini stration or dosages while providing exemptions 
that would allow non-prescription status.  
Since the coming into force of the Natural Heal th Products Regulations in 2004, all naturally 
sourced substances meeting the definition of a natural health product are governed by these 
Regulations. However, products containing subs tances listed in Schedule F to the Food and 
Drug Regulations are explicitly excluded from the Natural Health Products Regulations. 
Health Canada has undertaken a review of the naturally source d medicinal ingr edients listed 
in Schedule F. As part of this undertaking, the Department’s Drug Schedule Status Committee 
(“the Committee”) has reviewed science assessments for 11 naturally sourced medicinal ingredients and has recommended that these me dicinal ingredients could be regulated (in 
whole or in part) as non-pres cription natural health produc ts under the Natural Health 
Products Regulations. Four of these eleven medici nal ingredients are presen ted in this project. 
This proposed amendment would allow manufacture rs to apply for market authorization for 
products containing the proposed exempted stre ngths, uses, routes of administration or 
dosages of the following four medicinal ingredient s as natural health products pursuant to the 
Natural Health Products Regulations. G/TBT/N/CAN/294 
Page 2  
 
  Description of the medicinal ingredients: 
Dopamine and its salts — The current listing fo r dopamine and its salts would be revised to 
retain prescription status for injectable (parenteral) forms of dopamine and its salts. All other dosage forms and routes of administration at any strength and for any use would be exempt 
from prescription status. 
Dopamine is inactive in the body when administered orally. Theref ore, there are no oral drug 
products containing dopamine on the market in Ca nada. Revising the pr escription status of 
dopamine would mitigate issues with the licens ing of orally administ ered natural health 
products with ingredients that might natu rally contain trace amounts of dopamine. 
Dopamine is admini stered by intravenous injection to tr eat kidney failure, septic shock and 
acute heart failure resulting fro m a heart attack. It works by increasing blood pressure, heart 
rate and force of heart cont raction, and by causing c onstriction of blood vessels. 
Administration of dopamine by injection require s direct supervision by a practitioner and can 
cause serious adverse effects in the therapeutic dosage range. Retaining prescription status for injectable forms of dopamine and its salts is therefore recommended. 
Gold and its salts — The current listing for gol d and its salts would be revised to retain 
prescription status for injectable (parenteral) forms of gold and its salts and derivatives. The 
revised listing would be worded so  that it would not change the status of auranofin, an orally 
administered gold derivati ve that is listed separately in Schedule F. Gold and its salts and 
derivatives in any other dosage form or route of  administration at any strength and for any use 
would be exempt from prescription status. 
Gold is naturally occurring in trace amounts in nature, so it is appropriate to add qualifiers to 
the listing on Schedule F to avoid unintent ionally subjecting produc ts containing trace 
amounts of gold to prescription requi rements where it is not necessary. 
As prescription drugs, gold com pounds are administ ered parenterally (by injection) to treat 
rheumatoid arthritis in patients for whom ot her treatments have been unsuccessful. Gold 
compounds administered by the pare nteral route can have undesira ble side effects at normal 
therapeutic dosage levels and require direct practitioner supervision and routine laboratory 
monitoring. 
Lovastatin — The current listing for lovastatin would be revised to reta in prescription status 
for all strengths and dosage forms except when lo vastatin is sold in oral dosage form that 
provides less than 1.0 mg per dosage unit or pe r daily dose. Oral dosage  forms containing less 
than 1.0 mg of lovastatin would be exempt from prescription status. 
The proposed exemption for less than 1.0 mg is only 10% of the lowest therapeutic dose of 10 
mg of lovastatin. This would allow red yeast rice products containing only trace amounts of 
lovastatin to be marketed as natural health pr oducts in Canada. Red yeast rice is derived from 
yeast grown on rice and is used as food in some Asian countries. It contains several 
substances, including lovastatin, known to reduce cholesterol. 
As a prescription drug, lovastatin is available in  Canada and is used to  treat high cholesterol 
and is usually given in an initial dose of 10 to 20 mg daily, increased, if necessary, over a 
period of time to 80 mg daily to ach ieve target cholesterol levels.  
Uracil and its salts — The current listing for ur acil and its salts would be revised to retain 
prescription status for uracil and its salts when sold for the treatment of cancer. Uracil and its 
salts for other uses at any strength, dosage form  or route of administration would be exempt 
from prescription status. Uracil is found in a ll living organisms so its listing in Schedule F 
without qualifiers is inappropriate.  G/TBT/N/CAN/294 
 Page 3 
 
 
  Uracil has been used as a prescription drug in conjunction with other anti-cancer drugs to 
enhance antitumour activity and to reduce adverse effects. However, this therapeutic use is not currently in practice in Canada. If uracil we re used in the treatment of cancer it would 
require the supervision of a prac titioner and laboratory monitoring. 
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:   Canada Gazette, Part I, 26 December 2009, Pages 3847-3851 
(available in English and French)   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    Normally within 6 to 8 months of publication in 
the Canada Gazette, Part I 
On the date the measure is adopted 
10. Final date for comments:  11 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 the regulat ory text can be downloaded at:  
http://www.gazette.gc.ca/rp-p r/p1/2009/2009-12-26/pdf/g1-14352.pdf  (Canada Gazette) 
or  http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-12-26/html/notice-avis-eng.html#d122
 
(English) 
http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-12-26/html/notice- avis-fra.html#d122  (French)