./.WORLD TRADE
ORGANIZATIONG/TBT/N/CAN/21
17 December 2001
(01-6352)
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,
ext. 491, 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 (1251 – Schedule F) (Pages 4417-4420;  English and
French)
6. Description of content:   The Therapeutic Products Directorate of Health Canada intends to
update Schedule F to the Food and Drug Regulations of the Food and Drugs Act by adding
ten substances to Part I of Schedule F a nd one substance to Part II of Schedule F.
Schedule F is a list of substances, the sale of which is controlled specifically under
sections C.01.041 to C.01.046 of the Food and Drug Regulation s.  Part I of Schedule F lists
substances which require a prescription for both human and veterinary use.  Part II ofSchedule F lists substances 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 onto the Canadian market necessitates periodic
revisions to Schedule F.
It is proposed that the following ten substances be added to Part I of Schedule F:
1.  Basiliximab - a chimeric murine/human m onoclonal antibody indicated as an adjunct
agent for the prophylaxis of acute organ rejection in renal transplant patients.
2.  Cabergoline and its salts - a dopaminergic agent indicated for the treatment of
hyperprolactinemic disorders and i nhibition of physiological lactation.
3.  Clindamycin and its salts and derivatives - a semi-synthetic lincomycin derivative used
as an antibiotic in dogs and cats.  Currently clindamycin is included in Part II of Schedule FG/TBT/N/CAN/21
Page 2
under Lincomycin and its salts and derivative s.  Professional veterinary expertise is required
to diagnose and treat dental infections and to perform corrective dental procedures.
4.  Difloxacin and its salts and derivatives - a synthetic, broad spectrum antibiotic indicated
for the treatment of urinary tract infections and for the treatment of skin and soft tissue
infections in dogs.5.  Exemestane - a steroidal aromatase inhibitor indicated for the treatment of advanced
breast cancer.
6.  Ibutilide and its salts and derivatives - an antiarrhythmic agent indicated for the rapid
conversion of atrial fibrillation or atrial flutter to sinus rhythm.
7.  Pioglitazone and its salts - an anti-diabetic agent indicated in patients with type II
diabetes mellitus not controlled by diet and exercise alone.
8.  Riluzole and its salts - a benthiazole that has been shown to provide an early increase insurvival in patients with amyotrophic lateral sclerosis (ALS).  The manufacturer of Riluzole
has received a Notice of Compliance with Conditions.  The manufacturer will conduct
timely, well-designed studies to verify and describe the clinical benefit of this drug.  For the
purposes of assuring the safe use of the drug product, the conditions under which the drug
product is approved must be clearly reflected and highlighted in the product monographand/or labelling for the product.  The sponsor must also undertake to comply with any
restrictions imposed by the Therapeutic Products Directorate on the advertisement of
Riluzole.
9.  Valrubicin and its derivatives - an anti-tumour agent indicated for the treatment of
transitional cell carcinoma in situ of the bladder.
10.  Zoledronic acid and its salts and derivatives - a bone metabolism regulator indicated for
the treatment of tumour-induced hypercalcemia.
It is proposed that the following substance be added to Part II of Schedule F:
1.  Meloxicam and its salts and derivatives - a nonsteroidal anti-inflammatory agent
indicated for the symptomatic treatment of rheumatoid arthritis and painful osteoarthritis.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Protection of human health
8. Relevant documents:   Canada Gazette, Part I, 8 December 2001
9. Proposed date of adoption:
Proposed date of entry into force: }Not stated
10. Final date for comments:   7 January 2002
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 Canada Gazette Part I can be downloaded at:http://canada.gc.ca/gazette/part1/pdf/g1-13549.pdf.