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WORLD TRADE
G/TBT/N/CAN/167
8 August 2006
ORGANIZATION
(06-3815)
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.:
Fax.:
E-mail:
(+1) 613 238 3222
(+1) 613 569 7808
[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. 1508 — Schedule F) (6 pages, in English; 7
pages, in French)
6.
Description of content: This notification announces the availability of a letter that
provides an opportunity to comment on the proposed addition of one medicinal ingredient to
Part I of Schedule F to the Food and Drug Regulations.
Description of the medicinal ingredient:
Nicotinic acid when sold in
(a)
a modified-release oral dosage form providing 500 mg or more per dosage
unit or per daily dose; or
(b)
an immediate-release oral dosage form providing more than 500 mg per
dosage unit or per daily dose.
Nicotinic acid at these doses acts as a lipid metabolism regulating agent and is used for the
treatment of patients with abnormally high levels of cholesterol in the blood.
. /.
G/TBT/N/CAN/167
Page 2
The proposal to add nicotinic acid to Schedule F was initially part of Project 1451, which
included proposals for two other medicinal ingredients (G/TBT/N/CAN/125). The
proposal, as part of Project 1451, included only the extended-release dosage form providing
500 mg or more per dosage unit or per daily dose. In light of comments received during the
consultation process, the proposal was reconsidered and has been revised. The following
changes have now been incorporated:

Expanding the amendment to include immediate-release nicotinic acid
providing more than 500 mg per dosage unit or per daily dose;

Adding oral dosage form;

Replacing the term “extended-release” by “modified-release” for consistency
with the terminology used by Health Canada, and

Removing “its salts and derivatives” from the amendment as the salts and
derivatives are not used to treat high blood cholesterol and do not have the same
toxicity profile.
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides
with the risk factors associated with this 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) web site
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-avis/index_e.html
Project No. 1508, letter posted: 27 July 2006
9.
Proposed date of adoption:
Normally within 6 to 8 months from the
posting of the letter on the TPD web site.
Proposed date of entry into force:
On the date the measure is adopted.
10.
Final date for comments: 10 October 2006
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. 1508 can be downloaded at:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/noticeavis/project_projet_1508_e.html