WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/295 
19 January 2010  
 (10-0247) 
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 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 (Notice of  Intent — Project  No. 1656 — Schedule F) 
(4 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 three 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. Three of these eleven me dicinal ingredients are presented in this 
project.  G/TBT/N/CAN/295 
Page 2  
 
  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 three medicinal ingredie nts as natural health products pursuant to the 
Natural Health Products Regulations. 
Description of the medicinal ingredients: 
Dimethyl sulfoxide — The current listing for di methyl sulfoxide (also referred to as DMSO) 
would be revised to retain pres cription status for human use when dimethyl sulfoxide is sold 
for the treatment of interstitial cystitis or sc leroderma and for all vete rinary uses. All other 
human uses for dimethyl sulfoxide at any stre ngth and in any dosage form would be exempt 
from prescription status. Dimethyl  sulfoxide is found in many natural sources such as broad 
beans, alfalfa and garlic. 
Drugs containing dimethyl sulfoxide for hu man use are available in Canada with a 
prescription for treatment of in terstitial cystitis (a urinary bl adder condition) and scleroderma 
(abnormal growth of connective tissue that suppo rts the skin). Several products are currently 
available as prescription drugs for veterinary us e to treat conditions such as ear inflammation 
in dogs. These products would retain prescription status.  
Levocarnitine — The current listing for levoca rnitine (also called L-carnitine) would be 
revised to retain prescription st atus for levocarnitine and its salts and derivatives when sold 
for the treatment of primary or secondary le vocarnitine deficiencies. Levocarnitine and its 
salts and derivatives for any othe r uses at any strength, dosage fo rm or route of administration 
would be exempt from prescription status. Levocar nitine occurs naturally in animal products 
and in small amounts in most plants. 
Overall, levocarnitine functions in the body mainly in optimal fat utilization for energy 
production. Absorption of levocarnitine is high fro m dietary sources but if dietary intake is 
low then the body can maintain a balanced leve l by synthesizing or reducing elimination of 
levocarnitine. In most people, sufficient quan tities of levocarnitine are obtained from the diet 
or synthesized in order to meet human requirements.  
Primary levocarnitine deficiency is a genetically inherited condi tion related to the processing 
of levocarnitine in the body and can lead to muscle weakness and death from heart failure. 
Secondary levocarnitine deficiency syndromes are numerous, and include  genetic defects of 
metabolism. Treatment of these conditions with levocarnitine re quires the supervision of a 
practitioner and routine laboratory monitoring. 
L-Tryptophan — The current listing for l-tryptopha n when sold as a single ingredient would 
be revised to provide prescrip tion status for l-tryptophan  
— when sold for human use in oral dosage form as a single ingredient or in combination with 
other ingredients at a concentration of more than 220 mg l-tryptophan per dosage unit or per 
daily dose; and 
— when sold for human use or veterinary us e as a single ingredient for any route of 
administration other than oral use. 
L-tryptophan is one of the esse ntial amino acids that cannot be  synthesized in the human body 
and must be provided in the diet. L-tryptophan ac ts in the body in the formation of the vitamin 
niacin and the neurotra nsmitter serotonin.   G/TBT/N/CAN/295 
 Page 3 
 
 
  L-tryptophan is available in Canada as a pr escription drug for use in combination with 
antidepressant drugs to enhance the activity of th e antidepressant. L-tryptophan is also sold in 
combination with other amino acids in kidney dialysis and intrave nous nutrition solutions 
without a prescription. The proposed amendmen t would not change the status of these 
products. 
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 3851-3854 
(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#d123
 
(English) 
http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-12-26/html/notice- avis-fra.html#d123  (French)