G/TBT/N/CAN/282
Page 1

World Trade
Organization
G/TBT/N/CAN/282
9 October 2009
(09-4914)
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 (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, Ontario, Canada, K1P 6N7 Tel.: +1 613 238 3222, Fax.: +1 613 569 7808, E-mail:
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 language(s) of the notified document: Proposed Amendment to the Food and Drug Regulations (Project No. 1597 — Schedule F) (5 pages, available in English and French)
6. / Description of content: This notification announces the availability of a letter that provides an opportunity to comment on the proposed addition of three medicinal ingredients to Part I of Schedule F to the Food and Drug Regulations.
Description of the medicinal ingredients:
1. Idebenone is a benzoquinone derivative that is used to manage symptoms of Freidreich’s Ataxia. Freidreich’s Ataxia is an inherited disease that causes progressive damage to the nervous system, resulting in symptoms ranging from difficulty walking to speech problems and also frequently leads to heart disease. Idebenone should only be prescribed by, or following consultation with, practitioners who are experienced in the diagnosis and management of Freidreich’s Ataxia. Direct supervision by a practitioner is required during treatment.
2. Idursulfase is an enzyme that is manufactured using recombinant deoxyribonucleic acid (DNA) technology. Idursulfase is used to treat deficiency ofthe enzyme, iduronate-2-sulfatase, in patients with Hunter syndrome, a seriousprogressive genetic disorder that can result in permanent damage such as visionand hearing loss, heart disease, breathing difficulties and joint stiffness. Direct supervision by a practitioner and routine laboratory monitoring are required.
3. Nesiritide belongs to a new drug class that is manufactured using recombinant deoxyribonucleic acid (DNA) technology. Nesiritide is used to treat patients in hospital who have symptoms of heart failure and have not responded to treatment with other drugs. Direct supervision by a practitioner is required. Nesiritide may cause undesirable or severe side effects at normal therapeutic dosage levels.
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides with the risk factors associated with each medicinal ingredient. Oversight by a practitioner is necessary to ensure that appropriate risk/benefit information is considered before the drug containing the medicinal ingredient is administered and that the drug therapy is properly monitored.
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections C.01.041 to C.01.049 of the Food and Drug Regulations. Part I of Schedule F lists ingredients that require a prescription for human use and for veterinary use. Part II of Schedule F lists ingredients that 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.
7. / Objective and rationale, including the nature of urgent problems where applicable: Protection of human health
8. / Relevant documents: Therapeutic Products Directorate (TPD) web site http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/notice-avis/index-eng.php, Project No. 1597, letter posted: 30 September 2009
9. / Proposed date of adoption:
Proposed date of entry into force: / Normally within 6 to 8 months from the posting of the letter on the TPD website.
On the date the measure is adopted.
10. / Final date for comments: 14 December 2009
11. / Text 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 Project No. 1597 can be downloaded at:
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1597-eng.php (English)
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1597-fra.php (French)