WORLD TRADE
ORGANIZATIONG/TBT/N/CAN/63
13 March 2003
(03-1423)
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 (1318 – Schedule F) (pages 660-664; 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 made under the Food and
Drugs Act  by adding 14 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 both
human and veterinary use. The review and introduction of new drugs onto the Canadianmarket necessitates periodic revisions to Schedule F.
It is proposed that the following 14 medicinal ingredients be added to Part I of Schedule F:1. Alfuzosin and its salts – an alpha 1-adrenergic blocking agent – indicated for the
treatment of benign prostatic hyperplasia (BPH).
2. Amprenavir and its salts and derivatives – an antiretroviral agent – indicated for the
treatment of protease inhibitor-experienced human immunodeficiency virus (HIV)-1-
infected patients, in combination with other antiretrovirals.
3. Bosentan and its salts and derivatives – an endothelin receptor antagonist – indicated for
the treatment of pulmonary arterial hypertension in patients with World Health Organization
(WHO) functional class III and IV primary pulmonary hypertension, or pulmonary
hypertension secondary to scleroderma.G/TBT/N/CAN/63
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4. Caspofungin and its salts and derivatives – an antifungal – indicated for the treatment of
invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
5. Doxercalciferol and its derivatives – a vitamin D analogue – indicated for the reduction
of elevated blood parathyroid hormone (iPT H) levels in the management of secondary
hyperparathyroidism in patients undergoing chronic renal dialysis.
6. Esomeprazole and its salts – a H+, K+-ATPase Inhibitor – indicated for the treatment of
acid-related gastrointestinal disorders such as reflux esophagitis and gastroesophageal reflux
disease.
7. Galantamine and its salts and derivatives – a cholinesterase inhibitor – indicated for the
symptomatic treatment of patients with mild to moderate dementia of the Alzheimer’s type.
8. Imatinib and its salts – a protein kinase inhibitor – indicated for the treatment of patients
with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase
after failure of interferon-alpha therapy.
9. Meloxicam and its salts and derivatives – a nonsteroidal anti-inflammatory agent –
indicated for the symptomatic treatment of rheumatoid arthritis and painful osteoarthritis in
humans, and for the relief of pain and inflammation associated with acute chronic musculo-skeletal conditions in dogs.
10. Mirtazapine and its salts – an antidepressant – indicated for the symptomatic relief of
depressive illness.
11. Nateglinide and its salts and derivatives – an oral antidiabetic agent – indicated as an
adjunct to diet and exercise in patients with Type 2 diabetes mellitus which cannot be
controlled by diet and exercise.
12. Pioglitazone and its salts – an antidiabetic agent – indicated as monotherapy to decrease
insulin resistance and blood glucose levels in patients with type 2 diabetes mellitus not
controlled by diet and exercise alone.
13. Tenecteplase and its salts and derivatives – a fibrinolytic agent – indicated for
intravenous use in adults for the lysis of suspected occlusive coronary artery thrombi
associated with evolving transmural myocardi al infarction to reduce the mortality associated
with acute myocardial infarction (AMI).
14. Verteporfin and its salts and derivatives – a photosensitizing agent for age-related
macular degeneration and pathologic myopia – indicated for the treatment of age-related
macular degeneration in patients with predominantly classic subfoveal choroidal
neovascularization.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Protection of human health
8. Relevant documents:   Canada Gazette, Part I, 1 March 2003
9. Proposed date of adoption:
Proposed date of entry into force: }Not statedG/TBT/N/CAN/63
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10. Final date for comments:   15 May 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://canadagazette.gc.ca/partI/2003/20030301/pdf/g1-13709.pdf