. /.WORLD TRADE
ORGANIZATIONG/TBT/N/CAN/39
11 June 2002
(02-3242)
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,
ext. 491, 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):   Nicotine inhaler
(ICS:11.220, 11.120)
5. Title, number of pages and language(s) of the notified document:   Proposed Amendment
to the Food and Drug Regulations (1240 – Nicotine) (pages 1698-1703; English and French)
6. Description of content:   Part I of Schedule F of the Food and Drug Regulations lists
substances intended for human or veterinary use which require a prescription to be sold in
Canada. Schedule F includes nicotine as a drug substance except when sold in natural
substances or in a gum or transdermal patch.  Products in gum and patch form are
commonly used in smoking cessation therapy to relieve nicotine withdrawal symptoms.
The nonprescription nicotine replacement therapies (NRTs) presently available on the
Canadian market were initially approved as prescription drugs.  These products are nicotine
2 mg chewing gum (nonprescription since 1992), nicotine 4 mg chewing gum(nonprescription since 1997) and nicotine tran sdermal patches (nonprescription since 1998).
This regulatory amendment proposes to remove from Schedule F, nicotine, when
administered by an oral inhalation device.  The current proposal differs from previous
prescription to nonprescription switch proposals because the product has not been sold in
Canada as a prescription drug.  The proposal would allow the new inhalation dosage formfor nicotine to be sold as a nonprescription drug immediately upon approval by Health
Canada
.
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 June 2002G/TBT/N/CAN/39
Page 2
9. Proposed date of adoption:
Proposed date of entry into force: }Not stated
10. Final date for comments:   1 July 2002
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 Canada Gazette Part I can be downloaded at:
http://canada.gc.ca/gazette/part1/pdf/g1-13622.pdf