Download G/TBT/N/CAN/211 Page 1 World Trade Organization G/TBT/N/CAN

WORLD TRADE
G/TBT/N/CAN/211
25 September 2007
ORGANIZATION
(07-4029)
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.: +(613) 238 3222
Fax.: +(613) 569 7808
E-mail: [email protected]
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. 1536 — Schedule F) (4 pages, 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 two medicinal ingredients
to Part I of Schedule F to the Food and Drug Regulations.
Description of the medicinal ingredients:
1. Micafungin and its salts is an antifungal drug that is indicated for the treatment
and prevention of fungal infections of the esophagus in patients undergoing stem
cell transplantation. Direct supervision by a practitioner is required. Micafungin and
its salts is known to have undesirable or severe side effects at normal therapeutic
dosage levels. Frequent laboratory monitoring is required while using micafungin
and its salts.
2. Sitaxentan and its salts is indicated for the treatment of pulmonary arterial
hypertension (PAH), a rare progressive disease that is characterized by high blood
pressure in the blood vessels leading to the lungs. Diagnosis by a specialist in the
. /.
G/TBT/N/CAN/211
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area of PAH is required. Close medical supervision and routine laboratory
monitoring are required due to the potential for adverse effects involving the liver.
Sitaxentan and its salts may have undesirable 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 adequate risk/benefit information is available 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) website:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-avis/index_e.html,
Project No. 1536, letter posted: 14 September 2007
9.
Proposed date of adoption:
Normally within 6 to 8 months from the
posting of the letter on the TPD website
Proposed date of entry into force:
On the date the measure is adopted
10.
Final date for comments: 28 November 2007
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 Project No. 1536 can be downloaded at:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/noticeavis/project_projet_1536_e.html