WORLD TRADE
ORGANIZATIONG/TBT/N/CAN/52
6 December 2002
(02-6764)
Committee on Technical Barriers to Trade Original: English/
French
NOTIFICATION
The following notification is being circulated 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):   Substances which
require a prescription for both human and veterinary use (ICS : 11.120, 11.220)
5. Title, number of pages and language(s) of the notified document:   Proposed Amendment
to the Food and Drug Regulations (1286 – Schedule F) (pages 3514-3518;  English andFrench)
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 17 medicinal ingredients to Part I of Schedule F.
Schedule F is a list of medicinal ingredients, the sale of which are controlled specifically
under sections C.01.041 to C.01.049 of the Food and Drug Regulations . Part I of Schedule
F lists medicinal ingredients that, when contained in a drug, are sold on prescription for bothhuman and veterinary use. The review and introduction of new drugs onto the Canadian
market necessitates periodic revisions to Schedule F.
It is proposed that the following 17 medicinal ingredients be added to Part I of Schedule F:
1.  Aminolevulinic acid and its salts and derivatives  -  a photodynamic therapy
photosensitizer  -  in combination with blue light irradiation, indicated for the treatment of
single and multiple non-hyperkeratotic actinic keratoses of the face and scalp.G/TBT/N/CAN/52
Page 2
2.  Amlexanox and its salts and derivatives  -  an anti-inflammatory, anti-histaminic,
leukotriene-inhibitor agent  -  indicated for the treatment of aphthous ulcers in people with
normal immune systems.
3.  Argatroban and its salts and derivatives  -  an antithrombotic  -  indicated as
anticoagulant therapy in patients with heparin-induced thrombocytopenia syndrome.
4.  Eflornithine and its salts and derivatives  -  a hair growth inhibitor  -  indicated for
the condition of excessive facial hair growth (h irsutism) whose use is restricted to hirsute
women.
5.  Entacapone  -  an adjunct to levodopa and DDC inhibitor/COMT-inhibitor  -  indicated
as an adjunct to levodopa/carbidopa to treat patients with idiopathic Parkinson’s Diseasewho experience signs and symptoms of end-of-dose “wearing-off”.
6  Etanercept  -  a biological response modi fier  -  indicated for reduction in signs and
symptoms of moderately to severely active rheumatoid arthritis in patients who have an
inadequate response to one or more disease-modifying antirheumatic drugs.
7.  Fomepizole and its salts  -  a synthetic alco hol dehydrogenase inhibitor  -  indicated as an
antidote for ethylene glycol (antifreeze) poisoning, or for use in suspected ethylene glycol
ingestion.
8.  Gatifloxacin and its salts and derivatives  -  an antibacterial agent  -  indicated for
treatment when susceptible bacteria cause community-acquired pneumonia, acute bacterial
exacerbations of chronic bronchitis, acute sinusitis, uncomplicated skin and skin structure
infections, uncomplicated urinary tract infections (cystitis), complicated urinary tract
infections, pyelonephritis, and uncomplicated urethral, rectal and cervical gonorrhoea.
9.  Infliximab  -  a biological response modifier  -  indicated for the treatment of severe,
active Crohn’s disease in adult patients who have not responded to a full course of therapy
with corticosteroid and/or an immunosuppressant, and for treatment of fistulising Crohn’s
disease in adult patients who have not re sponded to a full course of therapy with
conventional treatment.
10.  Linezolid and its salts  -  an antibacterial agent  -  indicated in adult patients for the
treatment of:
- intra-abdominal, urinary tract, and skin and skin-structure infections (including cases
associated with concurrent bacteremia) caused by Vancomycin-resistant Enterococcus
faecium (VREF);
- nosocomial pneumonia or community-acquired pneumonia caused by Staphylococcus
aureus (methicillin-susceptible and methicillin-resistant strains) or Streptococcus
pneu-moniae  (penicillin-susceptible strains only, including community-acquired cases
with concurrent bacteremia);
- complicated skin and skin-structure infections caused by Staphylococcus aureus
(methicillin-susceptible and methicillin-resistant strains), Streptococcus  pyogenes, or
Streptococcus agalactiae ; and
- uncomplicated skin and skin-structure infections caused by Staphylococcus aureus
(methicillin-susceptible strains) or Streptococcus  pyogenes .
11.  Lopinavir  -  a Human Immunodeficiency Virus (HIV) protease inhibitor  -  in
combination with ritonavir, indicated in conjunc tion with other antiretroviral agents for the
treatment of HIV infection.G/TBT/N/CAN/52
Page 3
12.  Moxifloxacin and its salts and derivatives  -  an antibacterial agent  -  indicated for
treatment when susceptible bacteria cause community-acquired pneumonia, acute bacterial
exacerbations of chronic bronchitis, and acute sinusitis.
13.  Perflutren  -  a contrast enhancing imaging agent  -  indicated for contrast-enhanced
ultrasound imaging of cardiac structures and function in adults with suboptimalechocardiograms, and for contrast-enhanced ultrasound imaging of the liver and kidneys in
adults to improve the evaluation of pathology.
14.  Rabeprazole and its salts  -  a H
+, K+  -  ATPase inhibitor  -  indicated in the treatment
of conditions where a reduction of gastric acid secretion is required.
15.  Sirolimus and its derivatives  -  an immunosuppressive agent  -  in combination with
cyclosporine and corticosteroids, indicated for the prophylaxis of organ rejection in patients
receiving allogeneic renal transplants.
16.  Tegafur and its salts  -  an antineoplastic agent and folic acid derivative  -  in
combination with uracil and its salts, indicated for the treatment of metastatic colorectalcancer.
17.  Uracil and its salts  -  an antineoplastic agent and folic acid derivative  -  in combination
with tegafur and its salts, indicated for the treatment of metastatic colorectal cancer.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Protection of human health
8. Relevant documents:   Canada Gazette, Part I, 23 November 2002
9. Proposed date of adoption:
Proposed date of entry into force: }Not stated
10. Final date for comments:   6 February 2003
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://canada.gc.ca/gazette/part1/pdf/g1-13647.pdf