Download G/TBT/N/CAN/160/Rev.1 Page 1 World Trade Organization G/TBT/N

WORLD TRADE
G/TBT/N/CAN/160/Rev.1
12 April 2011
ORGANIZATION
(11-1828)
Original: English/
French
Committee on Technical Barriers to Trade
NOTIFICATION
Revision
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: [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 (Notice of Intent – Project No. 1431 — Schedule F)
(4 pages, available in English and French).
6.
Description of content: The purpose of this Notice of Intent (NOI) is to provide an
opportunity to comment on the revised proposal to amend Part I of Schedule F to the Food
and Drug Regulations to add quinine, its salts and derivatives except in oral dosage form that
provides 50 mg or less of quinine base per dosage unit or per daily dose. This would result in
affected products being regulated as prescription drug products under the Food and Drug
Regulations. Since quinine meets the definition of a natural health product, products sold that
contain an oral dosage form of 50 mg or less per unit dose or per daily dose would continue to
be regulated under the Natural Health Products Regulations, and would not require a
prescription.
Sections C.01.041 to C.01.049 of the Food and Drug Regulations control the sale of
medicinal ingredients that are listed in Schedule F. Part I of Schedule F lists medicinal
ingredients that require a prescription for human use and for veterinary use. Part II of
. /.
G/TBT/N/CAN/160/Rev.1
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Schedule F lists medicinal 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.
Description of the medicinal ingredient:
Quinine is a medicinal ingredient that was originally made from the bark of several species of
the cinchona tree and was used for centuries as the primary treatment for malaria. The use of
quinine as a malaria treatment declined over the years as new synthetic derivatives of the drug
such as chloroquine and mefloquine were developed and used. However, with increasingly
drug-resistant strains of malaria appearing, there has been renewed interest in the use of
quinine to treat malaria. Quinine is now being used in combination with other drugs such as
antibiotics to treat non-severe malaria infections caused by specific organisms that are
resistant to other anti-malarial drugs.
A review of the available scientific literature on quinine indicates that the use of quinine to
treat malaria requires individualized instructions and/or direct practitioner supervision. There
is a narrow margin of safety between the therapeutic and toxic doses of quinine, especially in
populations such as seniors, children, pregnant women or nursing mothers. There are
potential or known undesirable or severe side effects at normal therapeutic dosage levels that
would need to be managed by a practitioner.
7.
Objective and rationale, including the nature of urgent problems where applicable:
Protection of human health
8.
Relevant documents: Canada Gazette, Part I, 26 March 2011, Pages 1083-1086
(available in English and French)
9.
Proposed date of adoption:
Normally within 6 to 8 months of publication in
the Canada Gazette, Part I.
Proposed date of entry into force:
On the date the measure is adopted.
10.
Final date for comments: 9 June 2011
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 the regulatory text can be downloaded at:
http://canadagazette.gc.ca/rp-pr/p1/2011/2011-03-26/pdf/g1-14513.pdf (Canada Gazette)
or
http://canadagazette.gc.ca/rp-pr/p1/2011/2011-03-26/html/notice-avis-eng.html#d110
(English)
http://canadagazette.gc.ca/rp-pr/p1/2011/2011-03-26/html/notice-avis-fra.html#d110
(French)